chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; body backs with back, hip, and knee pain limiting mobility; limiting mobility; Fatigue; chills; This is a spontaneous report from a contactable Other HCP (patient). A 30-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration in right arm, on 28Dec2020 03:30 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history included COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. The patient experienced Initially soreness in injection area on 29Dec2020 10:30 AM. At 19 hours after vaccination started to experience body backs with back, hip, and knee pain limiting mobility on 29Dec2020 10:30 AM. Fatigue and chills fan at 24 hour mark and are continuing now at 28 hours on 29Dec2020 10:30 AM. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Urticaria, Vaccination site swelling, Vaccination site warmth
Clinical narrative: welts around body, buttocks, arm, legs. vaccine site redness, puffiness, warm to touch
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Flushing, Heart rate increased, Supraventricular tachycardia, Urticaria
Clinical narrative: Patient had SVT; flushing; hives; heart rate increased to 160's (had been 180's earlier in the day); This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), via intramuscular, on 28Dec2020 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, it's unknown if the patient was tested for COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had SVT, flushing, hives 20 min after receiving vaccine on 28Dec2020. Patient was taken to ED and evaluated. SVT resolved. Patient sent home on heart monitor. Later that night while in bed, heart rate increased to 160's (had been 180's earlier in the day) and patient was admitted to hospital. Patient is a NP. Treatment received for the adverse event included cold water to face, vagal massage. The outcome of the event"Patient had SVT" was recovered on 28Dec2020 and of other events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events supraventricular tachycardia, flushing, hives, heart rate increased cannot be excluded based on the compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: foot pain 7/30/2019
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site haemorrhage, Weight
Clinical narrative: fair amount of bleeding after the needle was removed; good size bruise; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient started to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Other products, patient history and investigation assessment was No. There were no concomitant medications.She provided her weight as 140, 142, or 143 lbs. After administration of the COVID 19 vaccine there was a fair amount of bleeding after the needle was removed. It could have been the administration process. Another resident here had the same experience, but she was unsure if the resident received the Pfizer of Moderna vaccine. This was day 5 and the caller still had a bruise. The current caller said she developed a good size bruise, and she didn't bruise easily. She didn't have a prescribing doctor. She got it at the city hospital, where she worked. She was not on anticoagulants. She had not taken aspirin or Motrin. The outcome of the event bruise was not recovered, of other event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Urticaria
Clinical narrative: huge welt on her arm; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Medical history included covid-19 from end of Oct2020 to an unknown date. The patient's concomitant medications were not reported. The patient reported that she is an nurse in the ICU. She had received the 1st dose of the vaccine after she had covid the end of Oct2020. Her reaction to the vaccine was, she felt exactly how she did when she had covid. It lasted 3 days. She had a huge welt on her arm. Her pulmonologist suggested that she contact Pfizer for advice on if or when she should receive the 2nd dose, which is currently due 08Jan2021. Outcome of the event huge welt was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of giant urticaria due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: 1310:Pt received vaccine. 1315: Pt's husband honked horn as patient reports feeling dizzy, lightheaded, and nauseous. Pt has history of neurocardiogenic syncope and states this often happens to her with vaccine administration. HR 130 BP 120/70. Pt with seat reclined. 1320: Pt extracted from car by RNx2, assisted to cot to lay flat. Pt states feeling much better laying on cot. Pt observed 1:1 by this RN. Pt reports feeling better. Offered to call ambulance for patient, pt declines. States this is very normal for her. 1330: Pt able to sit up. 1345: Pt stands and assisted back to car with slow transition. Pt observed for additional 10 minutes in parking lot. Pt states she feels comfortable going home and resting. educa educated regarding reasons to go to Emergency Department or call 911, pt verbalizes understanding. education provided to patient's husband regarding things to monitor for. Both are agreeable and feel safe with plan. Pt encouraged to speak to Agency regarding second dose plan. Recommend patient recieves dose #2 at a healthcare facility while being continuously monitored by healthcare personnel and with the ability to provide immediate intervention. Pt verbalizes understanding.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis
Clinical narrative: Appendicitis / colic pain to her right midsection; This is a spontaneous report from a contactable Other-HCP (Nurse Practitioner).   A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 20Dec2020 for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  In Dec2020 3 days after vaccination she experienced colic pain to her right midsection. She was diagnosed with appendicitis. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The event appendicitis is most likely an intercurrent medical condition and is assessed as unrelated to BNT162B2.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Intensive care, Pyrexia
Clinical narrative: a high fever; extreme fatigue; have allergies; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the first of eight reports. Only this report is serious.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisaton. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient was admitted to the ICU. The patient had allergies, but it was unknown  what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number can not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520700 same reporter/drug/AE, different patients;US-PFIZER INC-2020520703 same reporter/drug/AE, different patients;US-PFIZER INC-2020520699 same reporter/drug/AE, different patients;US-PFIZER INC-2020520704 same reporter/drug/AE, different patients;US-PFIZER INC-2020520705 same reporter/drug/AE, different patients;US-PFIZER INC-2020520701 same reporter/drug/AE, different patients;US-PFIZER INC-2020520702 same reporter/drug/AE, different patients;US-PFIZER INC-2020520700 same reporter, drug, events, and different patients;US-PFIZER INC-2020520701 same reporter, drug, events, and different patients
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash all over body-itchy
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: extremely lightheaded; This is a spontaneous report from a contactable physician (patient's husband). The physician reported same events for 2 patients. This is 2nd of 2 reports. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 30Dec2020 at a single dose in deltoid left for Vaccination/COVID-19 vaccine. Medical history included COVID-19 in Jul2020, ongoing overweight. There were no concomitant medications. The patient experienced extremely lightheaded on 30Dec2020. Reporter seriousness for extremely lightheaded is medically significant. The reporter stated his wife (patient) was feeling about the same thing and believed his wife was feeling better. She got up and was walking around and is no longer beside him. No Emergency Room or Physician Office visited. The outcome of event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event dizziness cannot be excluded. ,Linked Report(s) : US-PFIZER INC-2020520760 same reporter/drug/event, different patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Palpitations, Throat tightness
Clinical narrative: About 4-5 minutes after receiving the shot, experienced heart racing (180 bpm), and feeling faint.  Breathing was fine.  Felt slightly tight in the throat.  Also experienced diarrhea twice within the 40 minutes following the vaccine.   The heart racing and faint feeling lasted about 5 minutes.  The throat tightness lasted closer to 1.5 hours, but was never severe- just noticeable.  Within 2 hours of the vaccine, was feeling much better.  Never experienced actual difficulty breathing.  I reported to employee health RN and personal physician.
Sex: M
Vaccine: FLUX
Symptoms: Neuralgic amyotrophy
Clinical narrative: Parsonage-Turner Syndrome; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via other company.  This case involves a male patient who experienced parsonage-turner syndrome (neuralgic amyotrophy), while he received vaccine INFLUENZA VACCINE.  At the time of report, patient was 54 year-old.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 1997, the patient developed non-serious parsonage-turner syndrome (neuralgic amyotrophy) (Unknown latency) following the administration of INFLUENZA VACCINE.  The patient could not ever receive influenza or any vaccine that contains the same ingredient and wanted to know if he was eligible to receive the COVID-19 vaccine and was asked to share about co-morbidities and the data.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: The patient had hives every day since then; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via media on 28-Dec-2020.  This case involves a 59-year-old female patient who had hives every day (Urticaria), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On 01-Dec-2020, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On 01-Dec-2020 in afternoon, the patient stated that she had one INFLUENZA VACCINE, and had hives every day since then (Urticaria).   The patient would like to know what the ingredients were of this vaccine so that she could trace it back to see what ingredient(s) that might had caused this reaction.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Discomfort, Injection site pain, Lethargy
Clinical narrative: dull injection site pain within 1 hour of injection. Moderate-severe injection site pain, minor chills, max temperature of 99.9F at 6 hours post injection.  At 15 hours post injection, moderate injection site pain and lethargy/discomfort were the only symptoms that remained. No redness or swelling at any point.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired PENTACEL given to an infant with no AE; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 3 months old female patient who received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and IMMUNOGLOBULIN ANTIHEPATITIS B (HEPATITIS B)  On 10-Nov-2020, the patient received 0.5 mL once daily dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE via intramuscular route in right vastus lateralis (lot number: UJ057AAA and expiry date: 07-Nov-2020) for prophylactic vaccination.  This was an actual medication error due to expired vaccine used (PT: expired product administered) (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 9 month old was given FLUZONE HD with no AE; a 9 month old was given FLUZONE HD with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency (Reference number- 00395603) and transmitted to Sanofi on 16-Dec-2020.  This case involves a 9 months old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, batch number: unknown, expiry date: unknown, via unknown route in unknown administration site) on an unknown date in Oct 2020 for prophylactic vaccination (overdose and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication, family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  At the time of reporting, no adverse event was reported.  Reporter stated that the patient was in the office at the time of call for his 2nd dose and wanted to know how to proceed and requested to callback today.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation
Clinical narrative: burning in her face, arms and legs; Initial information received on 16-Dec-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves an 80-year-old female patient who had burning in her face, arms and legs (burning sensation) while she was treated with Influenza Quadrival A-B High Dose Hv Vaccine (FLUZONE HIGH-DOSE QUADRIVALENT).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date in 2012, the patient received a dose of suspect quadrivalent influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose and frequency via unknown route and unknown site for prophylactic vaccination.  On -SEP-2012, (latency unknown) after starting the suspect vaccine therapy, the patient had burning in her face, arms and legs (burning sensation).  No laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: I woke up around 1:30 am on January 5th with a temperature of 99.9 degrees F.  By 3:00 am, my temperature spiked to 100.5 degrees F.  By 7 am, my temperature had returned to normal, around 98.6 degrees F and I have felt fine the rest of the day, besides some soreness at the injection site. I did not take any medications to help with the fever.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: expired IPOL being administered to patient; with no AE; Initial information received on 23-Dec-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 7 years old male patient who received expired IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 23-Dec-2020, the patient received a dose of suspect IPV (VERO) (with unknown strength, formulation, dose and frequency) (lot P1F541M and expiration date: 07-Dec-2020) via unknown route in unknown administration site for prophylaxis vaccination.    It was a case of actual medication error due to expired product administered.  At the time of report, no adverse event was reported.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: dizziness; Initial information was received on 23-Dec-2020 regarding an unsolicited valid non-serious case from the patient.  This case involves an 87 year old female patient who experienced dizziness, while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had not received other vaccine concomitantly.  On an unknown date of August-2020, the patient received unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, lot unknown and expiration date unknown) via an unknown route for prophylactic vaccination.  On 23-Dec-2020, the patient developed non-serious dizziness, immediately following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.
Sex: M
Vaccine: FLUR4
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: sick for 3-7 days; fever; aches; chills; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Agency (Reference number- 00406450) and transmitted to Sanofi on 24-Dec-2020.  This case involves a unknown age male patient who experienced fever (pyrexia), aches (pain), chills and was  sick for 3-7 days (illness), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Dec-2020, the patient received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot: QFAA2059; expiration date: 30-Jun-2021, strength-standard) once via intramuscular route in the left deltoid for prophylactic vaccination.  On 19-Dec-2020, the patient experienced non-serious fever (pyrexia), aches (pain), chills and was  sick for 3-7 days (illness), 2 days following administration of  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory data not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the event outcome was unknown for all events.  It was reported as product was used and no product technical complaint.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticarial rash on day 1, no progression on day 2.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Visual impairment
Clinical narrative: pain, ache behind his right eye, that is still there fuzzy vision that lasted for 30 minutes warmth on top of head and around his ear
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Tenderness, Urticaria
Clinical narrative: large 13-15 cm hive, itchy, tender, elevated and red
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Post vaccination x 1 week.  Sight is reddened/mod swelling/terrible intching
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Severe left Bell's palsy started 9 days after the 2nd Shingrix injection.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Injection site pain
Clinical narrative: weakness, headache, body aches, soreness at the injection site, warm injection site, dizziness, loss of appetite
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain
Clinical narrative: weakness, headache, body aches, soreness at the injection site, warm injection site, dizziness, loss of appetite
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia oral, Injection site pain, Migraine
Clinical narrative: Patient reported a "migraine headache at the back of the head within 5 minutes of receiving the Pfizer COVID 19 vaccine at 9:45am on 01/04/2021. Symptoms were quickly followed by itching of the head and ears. Within twenty minutes his tongue, lips, and throat felt tingly and numb. He stated he was taken by EMS to hospital where he was given Benadryl and monitored for 2 hours. Today he reports a mild headache, chills, soreness at the site of the injection with slight burning, and fatigue.  He stated, "I'm fine." Infection Prevention specialist for hospital reports that patient chart indicated he had no evidence of tongue or lip swelling. His vitals at the ER were stable and he was observed for over an hour. He was given oral zofran, acetaminophen, and benadryl.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Pruritus
Clinical narrative: Patient reported a "migraine headache at the back of the head within 5 minutes of receiving the Pfizer COVID 19 vaccine at 9:45am on 01/04/2021. Symptoms were quickly followed by itching of the head and ears. Within twenty minutes his tongue, lips, and throat felt tingly and numb. He stated he was taken by EMS to hospital where he was given Benadryl and monitored for 2 hours. Today he reports a mild headache, chills, soreness at the site of the injection with slight burning, and fatigue.  He stated, "I'm fine." Infection Prevention specialist for hospital reports that patient chart indicated he had no evidence of tongue or lip swelling. His vitals at the ER were stable and he was observed for over an hour. He was given oral zofran, acetaminophen, and benadryl.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: 23 yo male received COVID-19 Moderna vaccine at 11:04am , patient monitored x15 minutes, no complaint or adverse reactions noted, discharged at 11:19pm  Patient returned at 11:30am after going to his car, patient stated "I went to my car and took a sip of coffee, I felt like there was something in my throat".  Monitored Patient x 45 minutes, patient alert and oriented x 4, calm, skin color normal, no rash, BP 125/86, P 84, pulse ox 98, no complaint of worsening or change in condition.  Spoke with patient's father x 2, requested father to pick up son, but father felt not necessary.  Notified medical advisor, recommended discharge to immediate care or ED via self.  Parent agreed with self transport to ED after speaking with patient.  911 transport refused by patient.  Safety instructions reviewed with parent and patient, both verbalized understanding. Patient discharged to transport self to Emergency Room, parent aware.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient broke out in a rash and was diagnosed with shingles
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Developed itching at site and then in 24 hrs red area 9sunburn appearing color approx.  4 inch diameter circle  below the injection site, reddened area spread to part of deltoid and into antecubital at its maximum.   used ice packs and Ibuprofen initially and then took 1 dose Benadryl on 3rd day which has helped subside the spread and caused fading from sunburn red to very light red color.  itching milder
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Speech disorder, Stridor
Clinical narrative: Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg  given PO, cough worsening.  1122 second dose of Benadryl given, called for MD.  Brought pt to Private room via wheelchair.  Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126.  IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy.  1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given.  Lungs clear. 1140 Coughing stopped, pt able to speak now.  Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105  1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Fatigue, Headache, Malaise
Clinical narrative: a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac assistance device user, Cardiac pacemaker insertion, Chest pain, Dizziness, Tachycardia
Clinical narrative: Began experiencing tachycardia, dizziness, headache, and started shaking about 5 minutes after receiving the vaccine.  50 mg Benadryl given IM to R deltoid at 1000. Symptoms began to resolve. Started experiencing some chest pain. Individual states she has a pacemaker, which felt like it was "combating" the tachycardia. Was monitored for 45 additional minutes and all symptoms subsided. Individual was able to return to work.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Began experiencing tachycardia, dizziness, headache, and started shaking about 5 minutes after receiving the vaccine.  50 mg Benadryl given IM to R deltoid at 1000. Symptoms began to resolve. Started experiencing some chest pain. Individual states she has a pacemaker, which felt like it was "combating" the tachycardia. Was monitored for 45 additional minutes and all symptoms subsided. Individual was able to return to work.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Brain natriuretic peptide increased, COVID-19, Dyspnoea
Clinical narrative: Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer increased, International normalised ratio decreased, SARS-CoV-2 test positive, Troponin increased
Clinical narrative: Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Defaecation urgency, Hyperhidrosis, Loss of consciousness, Nausea, Road traffic accident
Clinical narrative: Pt received vaccination and left after 15 min. observation symptom free. He drove a short distance away from the clinical site when he felt profuse sweating and had syncope (seconds) crashing into curb. He was aroused from impact and was able to stop car. He then developed profuse nausea and sudden urge to defecate. He went to restroom. Given these events he returned to the clinical site in another vehicle. Upon arrival he denied chest pain, shortness of breath or ongoing nausea or abdominal pain. He reported his AM blood sugar was 72 and does not take insulin. No history of coronary disease or syncope. EMS was activated and assumed care.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Pt received vaccination and left after 15 min. observation symptom free. He drove a short distance away from the clinical site when he felt profuse sweating and had syncope (seconds) crashing into curb. He was aroused from impact and was able to stop car. He then developed profuse nausea and sudden urge to defecate. He went to restroom. Given these events he returned to the clinical site in another vehicle. Upon arrival he denied chest pain, shortness of breath or ongoing nausea or abdominal pain. He reported his AM blood sugar was 72 and does not take insulin. No history of coronary disease or syncope. EMS was activated and assumed care.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: Vertigo, nausea, vomiting
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Vertigo, Vomiting
Clinical narrative: Vertigo, nausea, vomiting
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Myalgia, Oropharyngeal pain
Clinical narrative: About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vertigo
Clinical narrative: Vertigo starting at 7pm the night of the vaccine.  The next morning woke with continued vertigo and fatigue.  Still in bed on 1/5/2021 at 12:30pm.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Unevaluable event
Clinical narrative: "Moderna COVID-19 vaccine EUA"
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Eye discharge, Eye swelling, Headache
Clinical narrative: Patient received the covid vaccine on 12/28/2020.  c/o new onset of bil eyelid swelling with "greenish" discharge on 1/1/2021 and stomach pain (relieved with BM - "little diarrhea") on 1/2/2021. Diarrhea improved after 24 hours but the eye swelling persists.  On 1/5/2021 new onset of headache, vomiting, "wet" cough, and nasal congestion.  Denies fever, chills, or body ache.    Covid test on 12/28/2020 was negative.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Productive cough, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Patient received the covid vaccine on 12/28/2020.  c/o new onset of bil eyelid swelling with "greenish" discharge on 1/1/2021 and stomach pain (relieved with BM - "little diarrhea") on 1/2/2021. Diarrhea improved after 24 hours but the eye swelling persists.  On 1/5/2021 new onset of headache, vomiting, "wet" cough, and nasal congestion.  Denies fever, chills, or body ache.    Covid test on 12/28/2020 was negative.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: acute, mild but obvious, swelling  of Right maxillary sinuses
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever up to 101, body aches, headache, chills
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient had vaccine and about an hour later began experiencing symptoms of dizziness, light-headed, and "woozy."  Was brought back to vaccine event by her manager.  Was advised to go to the ED but refused.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient's mom called 01/05/2021 @1106 to report that "she developed fever Sunday 12/27/20 of 102 gave Tylenol for fever and would only go down to 101, took her to the Dr. (Pediatrician) 12/28/20 and then continued Tylenol to treat fever" "Thursday 12/31 fever decreased to 100 and stayed down after that"  "and then last night (01/04/21) she got a rash "pinkish dots not really raised and were on her upper torso" Mom also reports, "she has decreased appetite and drinking in the last week" Mom denies any history of a vaccine reaction in the past. No complaints of nausea, vomiting or diarrhea; Mom also reports, "I called her doctor today but haven't heard back yet" 01/05/21 @1303 called Pediatrician Dr. regarding mom's concern "could she have reaction to measle vaccine?" LVM for the "Dr.'s nurse" @ 1330 Dr. Office nurse reports, "viral illness 12/28" they will follow up with mom.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness, headache
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chorioretinopathy, Optical coherence tomography, Vision blurred, Visual field defect
Clinical narrative: central serous retinopathy have small blurry spot in right lower quadrant visual field
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Throat irritation
Clinical narrative: About 5 minutes after receiving the vaccine, she began to experience a dry cough and tickling in the back of her throat. Also reported some shortness of breath. 25 mg of Benadryl was given IM in the R deltoid. Her symptoms subsided after approximately 15 minutes and she was able to return home.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Woke up with redness to the left eye.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: On the evening of 01/04/2021, I developed hives at the site of the shot.  (red welts)  I took a Benadryl and went to bed.  The swelling/hives went down the next morning, but it still feels itchy, thus I put hydrocortisone cream to see what happens.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in left hand
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nasal congestion, Pain
Clinical narrative: Left arm soreness and tenderness, onset approximately 6 hours after injection and lasting 4 days. Body muscle aches beginning about 6 hours after and progressing, lasting 3 days, but decreasing by day 2. Body chills beginning after about 11 hours and lasting for about 2 hours, resolving with Tylenol. Fever up to 101.1 beginning evening of injection and for full day following. General fatigue exacerbated day after injection and lasting 2 days(already experiencing some due to recent COVID infection). Mild nasal congestion day after injection and diminishing until resolved the day after beginning.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: Left arm soreness and tenderness, onset approximately 6 hours after injection and lasting 4 days. Body muscle aches beginning about 6 hours after and progressing, lasting 3 days, but decreasing by day 2. Body chills beginning after about 11 hours and lasting for about 2 hours, resolving with Tylenol. Fever up to 101.1 beginning evening of injection and for full day following. General fatigue exacerbated day after injection and lasting 2 days(already experiencing some due to recent COVID infection). Mild nasal congestion day after injection and diminishing until resolved the day after beginning.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: urticaria generalized and involving soft palate
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Nausea, lightheadedness, headache, fatigue, sore/swollen arm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Nausea, lightheadedness, headache, fatigue, sore/swollen arm
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Mobility decreased, Pain, Pain in extremity
Clinical narrative: I got my first dose 12/18/20, minimal symptoms, sore arm that lasted about 24 hours, consistent with every years flu shot.   2nd dose 1/4/21, completely different experience. I was forwarned that the first dose primes the immune system, 2nd can be worse, so I was taking 600 mg Motrin q6 hours. Despite that, my arm progressively hurt worse and worse until now I can?t lift it above my waist. Full body aches and pains. Horrible chills and so cold. 102.1 F is highest temp so far, but that?s on top of scheduled Motrin.   Still glad that I got it, but man does it suck right now.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I got my first dose 12/18/20, minimal symptoms, sore arm that lasted about 24 hours, consistent with every years flu shot.   2nd dose 1/4/21, completely different experience. I was forwarned that the first dose primes the immune system, 2nd can be worse, so I was taking 600 mg Motrin q6 hours. Despite that, my arm progressively hurt worse and worse until now I can?t lift it above my waist. Full body aches and pains. Horrible chills and so cold. 102.1 F is highest temp so far, but that?s on top of scheduled Motrin.   Still glad that I got it, but man does it suck right now.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain, Pyrexia, Rash erythematous
Clinical narrative: Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Decreased appetite, Dizziness, Dry skin, Dysphonia
Clinical narrative: No issue on date of vaccine. Minor muscle soreness in left arm the following day. No further issues following days. On 01/31/2020 at approximately 2130hrs, numbness and tingling of right side of face began while on work duty. Completed shift, drove home and went to bed. The following morning lips were covered in blisters, right cheek and under eye was extremely swollen. Attempted to drive to work and began experiencing brain fog and blurred vision. Returned home and facial swelling worsened along with severe headache and itchy dry skin. Took a bath and was unable to determine water temperature by touch. Intense leg muscle aches and nerve pain in right side of face. Remained calm and slept the following two days. Went to PCP as soon as possible on 01-04-2020 and was advised symptoms to be delayed adverse reaction to Moderna Vaccine. Patient was prescribed Alegra, Tylenol and methylprednisolone at this time. PCP advised inability to receive secondary dose on 01/28/2021 due to steroid treatment for allergic reaction to Moderna Vaccine. Swelling retreats and returns throughout the day following Dr visit. Voice changes occur during swelling (gurgled). The patient has no appetite but maintains a scheduled healthly diet. The patient has been unable to sleep for 24 hrs straight even after taking melatonin. There has been no shortness of breath however the patient experiences muscle spasms, dizziness and blurred vision while reading. The patient's right side of face  has slower reaction timing than the left, the right eye closes frequently (not in tandum with the left) and is unable to smile. The patient has not experienced vomiting nor stool issues. The patient is unable to return to work until 01-11-2021 or until symptoms remain undetected for 48 hrs.