chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site injury, Vaccination site pain, Vaccination site swelling
Clinical narrative: Caller states the next day she had tiny swelling at the injection site.; has a 2.5 inch circle around injection site.; little pain at the injection site; redness that has gotten bigger; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program COVAX US SUPPORT.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 19Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 20Mar2021, the next day after vaccination she had tiny swelling at the injection site. Caller states yesterday the area was not swollen or raised. Caller states today it is flat and has a 2.5-inch circle around injection site. On an unspecified date, she had a little pain at the injection site that has went away. Had a raised mark; redness that has gotten bigger and not gone away after two weeks now. Caller would like to know if this is normal or something she should be concerned about or report. Caller would like to know if she should send or upload picture. Is scheduled for her second shot next Friday. Outcome of the event vaccination site pain was recovered, vaccination site swelling, and vaccination site erythema was not recovered, vaccination injury was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: Caller states the next day she had tiny swelling at the injection site.; has a 2.5 inch circle around injection site.; little pain at the injection site; redness that has gotten bigger; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program COVAX US SUPPORT.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and Expiration date was not reported), via an unspecified route of administration, on 19Mar2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 20Mar2021, the next day after vaccination she had tiny swelling at the injection site. Caller states yesterday the area was not swollen or raised. Caller states today it is flat and has a 2.5-inch circle around injection site. On an unspecified date, she had a little pain at the injection site that has went away. Had a raised mark; redness that has gotten bigger and not gone away after two weeks now. Caller would like to know if this is normal or something she should be concerned about or report. Caller would like to know if she should send or upload picture. Is scheduled for her second shot next Friday. Outcome of the event vaccination site pain was recovered, vaccination site swelling, and vaccination site erythema was not recovered, vaccination injury was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site injury, Vaccination site pain, Vaccination site swelling
Clinical narrative: Slight itchy feeling underneath skin; Red unraised 2.5 inch circle around theinjection site- red rash like; Small raised bump size of nail bed; Arm felt slightly sore; Felt dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6207) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On (19Mar2021), Day 1 of initial injection, arm did not hurt. Day 2 (20Mar2021) experienced small raised bump size of nail bed (arm swelling) and arm felt slightly sore (pain in arm). On day 12 (30Mar2021), unknowingly found red unraised 2.5-inch circle around the injection site, red rash like (vaccination site erythema) slight itchy feeling underneath skin (pruritus). The patient felt dizzy and lightheaded for those 12 days as well. The patient called the 800 and asked if she should report it. She was informed that those were slight side effects that usually went away within 5 days after the shot. She asked if she should report considering it was well after that timeframe and she was informed that she could if she wanted to. She also had picture if needed. She was assuming that she had a slight allergic reaction but was wondering if anyone else had the same thing happened for that length of time. She decided to wait until the day before going to doctor. By then it had disappeared so she did not report it anywhere else. The patient was scheduled for her second dose on 09Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of light headed, arm swelling, pain in arm, vaccination site erythema and pruritus were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: Slight itchy feeling underneath skin; Red unraised 2.5 inch circle around theinjection site- red rash like; Small raised bump size of nail bed; Arm felt slightly sore; Felt dizzy and lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6207) via an unspecified route of administration in the right arm on 19Mar2021 at 16:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included phentermine (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On (19Mar2021), Day 1 of initial injection, arm did not hurt. Day 2 (20Mar2021) experienced small raised bump size of nail bed (arm swelling) and arm felt slightly sore (pain in arm). On day 12 (30Mar2021), unknowingly found red unraised 2.5-inch circle around the injection site, red rash like (vaccination site erythema) slight itchy feeling underneath skin (pruritus). The patient felt dizzy and lightheaded for those 12 days as well. The patient called the 800 and asked if she should report it. She was informed that those were slight side effects that usually went away within 5 days after the shot. She asked if she should report considering it was well after that timeframe and she was informed that she could if she wanted to. She also had picture if needed. She was assuming that she had a slight allergic reaction but was wondering if anyone else had the same thing happened for that length of time. She decided to wait until the day before going to doctor. By then it had disappeared so she did not report it anywhere else. The patient was scheduled for her second dose on 09Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of light headed, arm swelling, pain in arm, vaccination site erythema and pruritus were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: cough; slight difficulty breathing; This is a spontaneous report received from a contactable consumer (Patient). This 46-Year old (age at vaccination) female consumer (patient) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 28Mar2021 as dose 1, single for covid-19 immunisation. Patient's medical history included seasonal pollen allergy. Concomitant medications were not reported. A 46-year-old patient received her first dose of the Pfizer-BioNTech COVID-19 vaccine on 28Mar2021, in the last 2 days she has experienced a cough and slight difficulty breathing, she asks if these are symptoms associated with the vaccine COVID-19, or if they may have been caused by her seasonal pollen allergy. A review of the EUA PI (LAB-1457-6.0, revised Feb2021) did not find information about cough and difficulty breathing (several days after vaccination) associated with the Pfizer-BioNTech COVID-19 vaccine. Per PI/Contraindications (LAB-1457-6.0, revised Feb2021), those symptoms are not listed as contraindications to the 2nd dose, but was referred to an HCP for individualized guidance, suggested to mention all her symptoms, medical conditions and relevant clinical history. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Pruritus
Clinical narrative: Itchy arms,; Red and small bumps; Headache; Body aches; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 26-year-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration on 30Mar2021 at 13:00 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient had a history of allergy to lamb, dairy, corn and potatoes. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the COVID-19 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 30Mar2021 at 21:00, the patient experienced Itchy arms, red and small bumps, headache and body aches. The patient did not receive any treatment for the adverse events. The adverse 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 of Itchy arms, red and small bumps, headache and body aches were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Treatment Received selected as No for Headache.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: numbness in both legs and right arm; pain in back; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 67-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; El898Z), via an unspecified route of administration in arm left on 26Jan2021 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. Medical history included the patient was diagnosed with COVID-19 prior to vaccination and had no known allergies to medications, food, or other products. The concomitant medication included levothyroxine sodium (SYNTHROID) 50 mg for an unknown indication. On 18Jan2021, the patient underwent throat swab, and the result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After one week of the vaccination, on 02Feb2021 at 15:45, patient experienced numbness in both legs and right arm and pain in back. The patient did not receive any treatment for the adverse event. The clinical outcome of the event numbness in both legs and right arm and pain in back were not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.   Amendment: This follow-up report is being submitted to amend previously reported information: adverse event (AE) onset latency was recalculated. For lab test "Throat swab" was re-coded as "SARS-CoV-2 test". For con-med, "50 mg" was added as dose/units". Lead sentence update as "...a contactable consumer". Final sentence updated as "No follow-up attempts are possible. No further information is expected."
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Explosive diarrhea; Nausea; 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: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 11:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00 the patient experienced nausea. On 01Apr2021 at 23:45, the patient experienced explosive diarrhea which was 36 hours after vaccine. The patient did not receive any treatment for reported adverse events. The clinical outcome of the event nausea and explosive diarrhea were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Diarrhoea, Hyperhidrosis
Clinical narrative: Arm soreness,; Weakness throughout entire body; Lethargy; Fever; Migraine; Sweating,; Cold shivers; Upset stomach; Diarrhoea; This is a spontaneous report from a contactable nurse, the patient. A 22-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 29Mar2021(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included atopic dermatitis, acne and sciatica. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), tretinoin (RETIN A), probiotics (MANUFACTURER UNKNOWN) fenugreek capsules (MANUFACTURER UNKNOWN) and pre workout drinks (MANUFACTURER UNKNOWN) all taken from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 04Dec2020 and 11Mar2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and tested negative. 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-19 vaccination. On 30Mar2021 at 07:00, the patient experienced arm soreness, weakness throughout entire body, lethargy, fever, migraine, sweating, cold shivers, upset stomach and diarrhea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures included intake of ibuprofen (MANUFACTURER UNKNOWN) for the events arm soreness, fever, migraine and cold shivers. The clinical outcome of the events arm soreness, weakness throughout entire body, lethargy fever, migraine, sweating, cold shivers, upset stomach and diarrhea were resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Migraine, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Arm soreness,; Weakness throughout entire body; Lethargy; Fever; Migraine; Sweating,; Cold shivers; Upset stomach; Diarrhoea; This is a spontaneous report from a contactable nurse, the patient. A 22-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 29Mar2021(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included atopic dermatitis, acne and sciatica. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), tretinoin (RETIN A), probiotics (MANUFACTURER UNKNOWN) fenugreek capsules (MANUFACTURER UNKNOWN) and pre workout drinks (MANUFACTURER UNKNOWN) all taken from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an intramuscular route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 04Dec2020 and 11Mar2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and tested negative. 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-19 vaccination. On 30Mar2021 at 07:00, the patient experienced arm soreness, weakness throughout entire body, lethargy, fever, migraine, sweating, cold shivers, upset stomach and diarrhea. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures included intake of ibuprofen (MANUFACTURER UNKNOWN) for the events arm soreness, fever, migraine and cold shivers. The clinical outcome of the events arm soreness, weakness throughout entire body, lethargy fever, migraine, sweating, cold shivers, upset stomach and diarrhea were resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Feeling hot, Lacrimation increased, Peripheral swelling
Clinical narrative: Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; Left eye is swollen and painful and watery; arm is swollen; feels hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 47-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 31Mar2021 at 18:00 (at the age of 47-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 COVID vaccine. On 02Apr2021 at 08:00, the patient's left eye was swollen and painful and watery. The patient's arm was swollen and felt hot to touch. 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 adverse events. The clinical outcome of the events left eye swollen and painful and watery, arm was swollen and felt hot to the touch were not recovered.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vertigo
Clinical narrative: dizziness; vertigo or feeling of spinning; Extreme headache; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included multivitamin (GNC) for an unknown indication and from an unknown date. The patient previously received her 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 12:00 (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 COVID-19 vaccine. On 31Mar2021 at 23:00 (also reported one day after), the patient had experienced extreme headache and nausea. On 02Apr2021 (reported as began on third day of vaccination), she had dizziness/vertigo or feeling of spinning. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events nausea, vertigo or feeling of spinning, extreme headache and dizziness were not recovered 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: Lymph node pain, Lymphadenopathy
Clinical narrative: Severe pain in lymph node(s) under left arm, in arm pit; Severe swelling and pain in lymph node(s) under left arm, in arm pit.; 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: EK6213) via an unspecified route of administration in the left arm on 29Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) from an unknown date and allergy to sulfa's. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 08Mar2021 at 14:15 (at the age of 61-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 at 07:00, the patient experienced severe swelling and pain in lymph node(s) under left arm, in arm pit. The patient received shot on Monday and had absolutely no reaction, not even a sore arm, until she woke up on Friday morning. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe swelling and pain in lymph node(s) under left arm, in arm pit and included application of heat and massage (as tolerable). The clinical outcome of the events severe swelling and pain in lymph node(s) under left arm, in arm pit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Fatigue, Headache
Clinical narrative: tired and spacey; Chills; felt light headed; thirsty; headache; back ache; fever; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 26Mar2021 at 11:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) , calcium carbonate (CALTRATE), ascorbic acid, tocopheryl acetate, zinc oxide, cupric oxide, betacarotene (PRESERVISION) and diphenhydramine hydrochloride (BENADRYL) from started on unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the left arm on 05Mar2021 at 14:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 01:00, the patient experienced chills, started in the middle of the night, felt light headed and really thirsty when she got up. Then at about noon on 27Mar2021, she had a really bad headache, back ache, fever nausea and vomiting that lasted until morning. The next day on 28Mar2021, the patient, was tired and spacey. On third day the patient felt more like herself, but tired. On fourth day she felt great and back to happy normal self. The patient did not receive any treatment. 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 event headache, back ache, fever, nausea, vomiting, chills, felt light headed, thirsty and tired was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Thirst, Vomiting
Clinical narrative: tired and spacey; Chills; felt light headed; thirsty; headache; back ache; fever; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 26Mar2021 at 11:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) , calcium carbonate (CALTRATE), ascorbic acid, tocopheryl acetate, zinc oxide, cupric oxide, betacarotene (PRESERVISION) and diphenhydramine hydrochloride (BENADRYL) from started on unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6203) via an unspecified route of administration in the left arm on 05Mar2021 at 14:45 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 01:00, the patient experienced chills, started in the middle of the night, felt light headed and really thirsty when she got up. Then at about noon on 27Mar2021, she had a really bad headache, back ache, fever nausea and vomiting that lasted until morning. The next day on 28Mar2021, the patient, was tired and spacey. On third day the patient felt more like herself, but tired. On fourth day she felt great and back to happy normal self. The patient did not receive any treatment. 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 event headache, back ache, fever, nausea, vomiting, chills, felt light headed, thirsty and tired was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash starting day after and continued to 2nd day. Rash is up and down arms and legs and on back; 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: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 12:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included knee surgery. The patient had no known allergies. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) twice daily, received after knee surgery. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 12:15 (at the age of 61-year-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 (day after vaccine), the patient experienced rash which continued to second day (03Apr2021). It was stated that the rash was up and down arms and legs and on back. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event rash was not recovered at the time of this report.   No follow-up attempts are needed; information about lot or batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID symptoms developed 4 days later; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 28Mar2021 at 12:45 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included sciatica. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) 800mg from an unknown date for an unknown indication. The patient previously received cefaclor (CECLOR) and experienced allergy. The patient did not receive any other 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 had been tested for COVID-19.  On 01Apr2021 at 15:00, 4 days after the vaccination, the patient experienced COVID symptoms and was tested positive for COVID five days later. The patient did not receive any treatment for the reported event. On 02Apr2021, the patient underwent a nasal swab test (SARS-CoV-2 test) and the result was positive. The clinical outcome of the event COVID symptoms developed 4 days later was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Soreness and swelling at injection site; Soreness and swelling at injection site; Red spot at exact injection site; Soreness in lymph nodes at arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 (at the age of 40-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 02Apr2021 at 23:00 the patient experienced soreness and swelling at injection site (7 days after the first injection), red spot at exact injection site and soreness in lymph nodes at arm pit. 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 adverse events. The clinical outcome of the events soreness and swelling at injection site, red spot at exact injection site and soreness in lymph nodes at arm pit were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Worsening SOB; cough; This is a spontaneous report from a contactable healthcare professional via COVID-19 Adverse Event Self-Reporting Solution .     A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration on 22Mar2021 as a single dose for COVID-19 immunization.  Medical history included psoriatic arthritis and asthma from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Concomitant medications included acetylsalicylic acid (ASA), taken for an unspecified indication, start and stop date were not reported; secukinumab (COSENTYX) taken for an unspecified indication, start and stop date were not reported; gabapentin (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; lysine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; meloxicam (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; nicotinic acid (NIACIN) taken for an unspecified indication, start and stop date were not reported; cyproheptadine hydrochloride (PERIACTIN) taken for an unspecified indication, start and stop date were not reported; calcium, magnesium (MANUFACTURER UNKNOWN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  The patient previously took lidocaine and experienced drug allergy.  The patient experienced worsening shortness of breath (SOB)  and cough on 23Mar2021 with outcome of unknown.  Details were as follows: On 23Mar2021, the patient experienced worsening SOB and cough. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The clinical outcome of worsening SOB and cough was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; Low grade fever 100.2 and chills also sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 03:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included sinusitis (reported as sinus) and reflux. The patient had no known allergies. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), pantoprazole sodium sesquihydrate (PROTONIX) and loratadine (CLARITIN) all for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 10:00 the patient experienced low grade fever 100.2 (units unspecified) and chills also sore arm at injection site. The patient did not receive any treatment for the events. The adverse 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 low grade fever 100.2 and chills also sore arm at injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia oral, Vaccination site pain
Clinical narrative: tingling in tongue; nausea; body aches; soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8730) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included retinol (VITAMIN A), cetirizine hydrochloride (ZYRTEC) and paracetamol (TYLENOL) from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 16:00 the patient experienced soreness at injection site(vaccination site pain). On 02Apr2021 the patient experienced nausea and body aches(general body pain). On 03Apr2021 the patient experienced tingling in tongue. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event soreness at injection site, nausea, body aches and tingling in tongue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Salivary gland enlargement, Toothache
Clinical narrative: I had giant sublingual glands; I noticed because one of my backteeth hurt and I looked in the mirror.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on an unknown date in Apr2021, (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient did not have allergies to medications, food, or other products. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) from an unknown date and for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On an unknown date in Apr2021 the patient experienced giant sublingual glands under the lower jaw of teeth and tongue and back teeth hurt (tooth ache). It was reported that within about 8 hours of getting the first dose the patient noticed about giant sublingual glands under his lower jaw teeth and tongue because one of his back teeth was hurt, when he looked in the mirror. 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 the reported adverse events. The clinical outcome of the events giant sublingual glands and toothache (back teeth hurt) were not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Pyrexia
Clinical narrative: Fever; chills; stomach upset; tired; This is a spontaneous report from a contactable consumer. An adult female patient (unknown if pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration on 27Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any medication within two weeks of vaccination. It was unknown if any other vaccines received within four weeks prior to the COVID-vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. On 28Mar2021, the patient experienced fever and chills 2 days, stomach upset next 24 hours, tired for additional days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any treatment for the reported events. The clinical outcome of fever and chills was recovered on 30Mar2021, stomach upset was recovered on 29Mar2021 and tiredness was recovered in 2021. This report was reported as non-serious by reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 02Apr2021 at 09:00(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date 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 03Apr2021 at 12:00 the patient experienced itching all over. The patient did not receive any treatment for the reported adverse event. 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 event itching all over was recovering at the time of this report   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vertigo, Vomiting
Clinical narrative: Extreme acute case of vertigo; Vomit; diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and batch/lot number and expiration date were not reported), via an unspecified route of administration in left arm on 19Mar2021 at 12:00 (at the age of 52-year-old) as dose number unknown, single for COVID-19 immunization. The patient's medical history included diverticulitis. The patient had no allergies 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. Concomitant medications included omeprazole, birth control pills and ascorbic acid (VITAMIN C); All drugs received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 at 16:00, the patient experienced extreme acute case of vertigo, she was in bed for 12 days, also had vomit and diarrhea. The patient visited to physician or other healthcare professional office/clinic visit due to adverse events. The patient was treated with a shot of meclizine (ANTIVERT) and 3 pills a day for vertigo. The outcome of the events was resolving.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Night sweats, Pruritus
Clinical narrative: Headache; Night sweats; Swollen lymph node in armpit; Mild all over body itching; This is a spontaneous report from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 11Mar2021 at 14:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included escitalopram oxalate (LEXAPRO), bupropion hydrochloride (WELLBUTRIN SR), calcium (MANUFACTURER UNKNOWN), vitamin b 12 (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) all for unknown indication, from unknown date within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. In Mar2021, the patient experienced headache, night sweats, swollen lymph node, armpit and mild all over body itching. No therapeutic measures were taken as a result of reported 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 headache, night sweats, swollen lymph node, armpit and itching all over body were recovered.   No follow-up attempts are needed. No further information is expected.