chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This spontaneous report from a contactable nurse reporting same events under the same suspect product for 19 patients. This is one of 19 reports. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced positive with COVID-19 on 03May2021. It was reported that 19 residents in the long term care facility where the reporter work were fully vaccinated and are positive with COVID-19. Some were not doing well at all. The events was serious for being hospitalization, life threatening. The events result in Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19 on 03May2021 with positive result. The outcome of the events 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 events of COVID-19 and suspected LOE.    There is limited information provided in this report.  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.,Linked Report(s) : US-PFIZER INC-2021548296 same reporter, vaccine and AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This spontaneous report from a contactable nurse reporting same events under the same suspect product for 19 patients. This is one of 19 reports. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced positive with COVID-19 on 03May2021. It was reported that 19 residents in the  facility where the reporter work were fully vaccinated and are positive with COVID-19. Some were not doing well at all. The events was serious for being hospitalization, life threatening. The events result in Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19 on 03May2021 with positive result. The outcome of the events 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 events of COVID-19 and suspected LOE.    There is limited information provided in this report.  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.,Linked Report(s) : US-PFIZER INC-2021548296 same reporter, vaccine and AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This spontaneous report from a contactable nurse reporting same events under the same suspect product for 19 patients. This is one of 19 reports. An elderly patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced positive with COVID-19 on 03May2021. It was reported that 19 residents in the long term care facility where the reporter work were fully vaccinated and are positive with COVID-19. Some were not doing well at all. The events was serious for being hospitalization, life threatening. The events result in Emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19 on 03May2021 with positive result. The outcome of the events 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 events of COVID-19 and suspected LOE.    There is limited information provided in this report.  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.,Linked Report(s) : PFIZER INC-2021548296 same reporter, vaccine and AE, different patient
Age: 1.5
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Quadracel vaccine given to 18 month old patient/ NO AE; Initial information received on 29-Apr-2021 regarding an unsolicited valid  non-serious case received from a nurse via call-center.  This case involves a 18 months old female patient who received 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (frequency: once, strength: standard, batch number: C5772AA and expiry date: 17-Sep-2022) (inappropriate age at vaccine administration) via an intramuscular route in left thigh for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  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: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, Product preparation issue
Clinical narrative: patient was given only the liquid portion of Pentacel with no reported AE; HPV vaccine was given by mistake; Initial information was received on 04-May-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (GMI Inquiry number: 00586863).  It was reported that a 6 months old male patient received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) (lot number: UJ440AA, expiry date: 29-May-2022)on 20-Apr-2021 via an unknown route at van unknown administration site for prophylactic vaccination (product preparation issue).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HPV VACCINE (HPV VACCINE).  HPV VACCINE was given by mistake (wrong vaccine administered).  It was a case of actual medication error due to inappropriate reconstitution technique and wrong product administered.  At the time of report, no adverse event 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 by the regulatory authority. 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: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Expired product administered
Clinical narrative: he gave a 2 day old expired PENTACEL vaccine to a patient with no reported adverse event; Initial information was received on 06-May-2021 regarding an unsolicited valid non-serious case from a other health professional in the  (GMI Inquiry number: 00590857).  It was reported that on 26-Apr-2021, a six month old male patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) (lot number: UJ162AB, expiry date: 24-Apr-2021) which was expired 2 days ago via intramuscular at an unknown administration site for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  At the time of report, no adverse event 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: M
Vaccine: TD
Symptoms: Expired product administered, Medication error
Clinical narrative: 14 year old patient was given an expired TENIVAC, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via agency (Reference number- 00592731) and transmitted to Sanofi on 07-May-2021.  This case involves a 14 year old male patient who was administered 0.5 ml dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6265AA; expiry date: 19-APR-2021) via unknown route in the left deltoid for prophylactic vaccination on 07-MAY-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  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.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, Product preparation issue
Clinical narrative: Pentacel was given without the Hib portion with no AE; Initial information was received on 12-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00598157).  It was reported that a six-month-old female patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without the hib portion via an unknown route for prophylactic vaccination (product preparation issue).  It was a case of actual medication error due to inappropriate reconstitution technique.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  At the time of report, no adverse event 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.  There will be no information available on batch number for this case.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAPIPVHIB, PNC13
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: one of their pediatricians had given a Daptacel and Pentacel vaccinations to a 15 month old on the same day. 0.5 ml Daptacel was given in the left thigh, today and 0.5 ml of Pentacel was given in the right thigh with no reported adverse event; Initial information was received on 12-May-2021 regarding an unsolicited valid non-serious case from a other health professional (Inquiry number: 00598178).  It was reported that a 15 month old female patient received 0.5 ml of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5765BA, expiry date: 28-Aug-2022)in the left thigh, today and 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and also received PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) (not produced by Sanofi Pasteur) via an unknown route for prophylactic vaccination (extra dose administered).  It was a case of actual medication error due to extra dose administered.  At the time of report, no adverse event 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: 1.25
Sex: F
Vaccine: DTAP, DTAPIPVHIB, PNC
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A patient received Daptacel and Pentacel on same day, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00598259) and transmitted to Sanofi on 12-May-2021.  This case involves a 15-month-old female patient who received 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ389ABA and expiry date not reported) via an unknown route in the right thigh, DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via an unknown route in the left thigh for prophylactic vaccination on 12-May-2021 (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect PREVNAR [PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)] (not produced by Sanofi Pasteur) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  This was a case of actual medication error case due to extra dose administered (latency same day).  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 the 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysarthria, Feeling drunk, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: Ran a fever for 2 days strait of around 102. Could not lift even the slightest things. I had slurred speech and I felt drunk. Was too weak to even get out of the bed for 2 days. My lymph nodes were swollen and still are. I still cannot lift my right arm over my head going on day 4.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Ran a fever for 2 days strait of around 102. Could not lift even the slightest things. I had slurred speech and I felt drunk. Was too weak to even get out of the bed for 2 days. My lymph nodes were swollen and still are. I still cannot lift my right arm over my head going on day 4.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Sensitive skin
Clinical narrative: The area around the injection site swelled and turned red. The red area was probably around 2-3 inches wide and lasted until the morning of May 22. The area was sensitive and sore to the touch.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Computerised tomogram head, Full blood count, Headache, Metabolic function test
Clinical narrative: Patient presented with headache rated at 8/10 on pain scale. Pain improved with acetaminophen. Labs, CT unremarkable (chronic changes noted on CT. Patient discharged with instructions to notify his PMD of  the reaction, but to plan to continue to receive the second dose of the vaccine as scheduled.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Breaking out in hives in random areas ever since 5/17.  This is not typical for my medical history.  Continues to occur daily one week after shot.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Severe, Additional Details: Patient experienced seizure. Called 911 and paramedics treated. Patient advised to see primary dr for seizures. she states she had hx of seizures w/o treatment at this time.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Mass, Oropharyngeal pain
Clinical narrative: Dizziness, headache, sore throat, tiredness Large painful lump near collarbone on left side notice the morning after when she woke up, still present.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Fire department perimedics got blood pressure of 85/50 and blood suger of 75? Started IV (content unknown) and transported via ambulance to local hospital. Called patient 7hours post incident. She was home and said she felt better. did not volunteer any specific diagnosis.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Dizziness, hot, sweaty right after vaccine administration. Patient has hx of vasovagal episodes. No nausea, vomiting, chest pain, shortness of breath nor trouble breathing. Patient felt better after laying down. Given water. Discharged to home
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Additional Details: Generalized/full body itching occured while pt shopping in-store after 15 min observation period (within 40-45 minutes after 2nd moderna dose). no other outlying symptoms occured. pt given 2 doses of benadryl and counseled to take prn (1-2 tab Q6hr) while at home. if worsening symptoms, advised to seek medical help.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling cold
Clinical narrative: About 4 hours after my shot I started experiencing cold chills and shortness of breath, I went to bed and the symptoms continued for another two hours and after a short nap(10-15 mins) the symptoms went away.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Feeling abnormal, Headache, Ophthalmological examination
Clinical narrative: Severe dizziness, headaches, blurred vision and brain fog. It is 5 weeks and still cannot drive
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Severe dizziness, headaches, blurred vision and brain fog. It is 5 weeks and still cannot drive
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Swelling, Urticaria
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: mild redness and singular hive/bump appeared on left arm 1 - 1 and 1/2 weeks after injection, 3 inches away from injection site. Arm felt bruised, sensitive and had a bump that is stillon the arm. bump appears like a big bite
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Aches all over, sore throat, headache, lethargy, chills, fever
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Tinnitus
Clinical narrative: April 15th started getting weak and off balance. April 25th developed tinnitus. 2021
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Laboratory test
Clinical narrative: Pt presenting with symptoms consistent with acute stroke within 24hr after receiving vaccine. Pt has hx of prior strokes before.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Product administered to patient of inappropriate age
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Pt felt dizzy after 10 minutes of sitting in the store. We decided to have the patient laid down for 10 extra minutes and she felt better after 20 mins. Pt was okay to leave the pharmacy with her parents.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Soreness and swelling at injection site, full body rash starting 24 hours after injection.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Depressed level of consciousness, Eye movement disorder, Fall, Pallor
Clinical narrative: Patient at 18:36 experienced a 1839 Syncopal episode 5-10 seconds, during 15min observation period. While seated patient eyes rolled back, and fell out of his chair onto his left side onto the floor, face down. Patient rolled over, semi-conscious, some- what confused at this time.   PCP and RN coordinator assessed patient. Irregular Pulse 48 noted, B/P 130/80 SPO2 88-90%. Patient extremely pallor but responsive. Confusion cleared after 5 minutes. Followed up vitals: Pulse 60 noted, B/P 128/86. Patient was walked out to vehicle.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse abnormal, Syncope
Clinical narrative: Patient at 18:36 experienced a 1839 Syncopal episode 5-10 seconds, during 15min observation period. While seated patient eyes rolled back, and fell out of his chair onto his left side onto the floor, face down. Patient rolled over, semi-conscious, some- what confused at this time.   PCP and RN coordinator assessed patient. Irregular Pulse 48 noted, B/P 130/80 SPO2 88-90%. Patient extremely pallor but responsive. Confusion cleared after 5 minutes. Followed up vitals: Pulse 60 noted, B/P 128/86. Patient was walked out to vehicle.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Early menstruation after the first and second dose and heavy bleeding
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Dizziness, Fatigue
Clinical narrative: 4/22/21 about 1:55 pm I got the shot,   2:45 got a bad headache, dizzy, feeling flush and upset sumac  I left work at 4 pm and when home.  around 6 pm i started to get joint pain in my arms, legs and hip.  by 730 pm I got the chills, shivers and got extremely tired.  I when to bed around 8 pm and woke up around 730 am on 4/23/21.   I felt like I was cold till Sunday (4/25/21), The headache remained till Wednesday (4/28/21).    I don't know if this is related but I would like to provided the information.  Prior to the shot my blood press was between 112 to 120/ 70 to 80.  after the shot my blood pressure has been 140 to 150/ 80 to 93.  am monitoring my blood pressure, adjusting my diet & trying to start a exercise regiment to address the blood pressure. I did have a epatch right before the shot  from 4/19/21 to 4/22/21.    .
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Flushing, Headache, Heart rate irregular, Loss of personal independence in daily activities
Clinical narrative: 4/22/21 about 1:55 pm I got the shot,   2:45 got a bad headache, dizzy, feeling flush and upset sumac  I left work at 4 pm and when home.  around 6 pm i started to get joint pain in my arms, legs and hip.  by 730 pm I got the chills, shivers and got extremely tired.  I when to bed around 8 pm and woke up around 730 am on 4/23/21.   I felt like I was cold till Sunday (4/25/21), The headache remained till Wednesday (4/28/21).    I don't know if this is related but I would like to provided the information.  Prior to the shot my blood press was between 112 to 120/ 70 to 80.  after the shot my blood pressure has been 140 to 150/ 80 to 93.  am monitoring my blood pressure, adjusting my diet & trying to start a exercise regiment to address the blood pressure. I did have a epatch right before the shot  from 4/19/21 to 4/22/21.    .
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Paraesthesia
Clinical narrative: Face hot tingly, headache for 2 days, dizzy light head, chills body aches hot one minute then cold just sick vomiting
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vomiting
Clinical narrative: Face hot tingly, headache for 2 days, dizzy light head, chills body aches hot one minute then cold just sick vomiting
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Loud ringing right ear.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Swelling in underarm area. Soreness from shoulder to elbow.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea/chills/low grade temp of 99.7  started around 8:00 pm, I took 2 Advil and went to bed for the night. Woke up at 11:30 pm with shivering chills, nausea, and 100.4 temp. Vomiting began shortly after that. I vomited 4 times during which my temp broke and I started sweating profusely.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extrasystoles, Heart rate irregular, Pain in extremity, Palpitations
Clinical narrative: I had no adverse effects at first, just a slight sore arm.  A couple of days after receiving the second dose, I started with heart palpitations, skipped beats, pounding and stopping at night when I laid down and after eating dinner.  I have no history of any heart conditions, problems of any sort.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site hypersensitivity, Injection site swelling, Pain
Clinical narrative: Started with chills and shakes, then full body aching and bad headache. Lasted for 24 hours. Significant swelling and sensitivity at injection site started in the evening and is still present.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Systemic: Bell's Palsy-Medium
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: Heart rate of 210 for over 30 minutes Then rate rate dropped to fluctuate between 130 and 160 At time of going to bed, 9 pm heart rate was still 110-125 As of 7 am on 5/22 rate rate is down to 90
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Shakiness-Mild, Additional Details: her boyfriend says she faints easily
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Ear swelling, Erythema, Impaired work ability, Pharyngeal swelling
Clinical narrative: Thursday, 05/20/2021 02:05PM received Janssen 0.5mL to left deltoid IM injection. 04:55PM Noticed a pin needle like rash on my chest, stomach, and neck. 05:00PM Took 50mg of Benadryl. 05:40PM Took another 50mg of Benadryl due to rash being more present on my chest, stomach, and neck. Itching began on the neck behind the ears. 05:50PM Noticed difficulty/restriction to swallowing.  06:20PM Checked into a facility. Waited an hour to be seen by a provider, Dr. He states only an acute reaction without examining my body of the rash; only examined my back & inside my mouth. I informed him that my rash was on my chest, stomach, neck, now my arms, and top of my thighs. He provided Prednisone and dismissed me. (I will be filing for malpractice)  08:00PM- Got home, still have rash with some difficulty swallowing. Friday, 05/21/21 06:00AM- Rash seems to subside and throat is fine, but swollen. 09:00AM While at work, coworker mentions my face is red. Rash came back to my arms and is now on my face. I took 50mg of Benadryl. 03:00PM Left work early since I could not take another dose of Benadryl to drive home.  03:20PM Rash has spread to whole entire body except lower than the knee. Took another 50mg of Benadryl. 09:00PM Took 25 mg of Benadryl went to bed. Saturday, 05/22/21  07:00AM Rash is more noticeable and red. Everywhere on the body, swelling to ears and throat. Took 50mg of Benadryl.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Throat tightness
Clinical narrative: Thursday, 05/20/2021 02:05PM received Janssen 0.5mL to left deltoid IM injection. 04:55PM Noticed a pin needle like rash on my chest, stomach, and neck. 05:00PM Took 50mg of Benadryl. 05:40PM Took another 50mg of Benadryl due to rash being more present on my chest, stomach, and neck. Itching began on the neck behind the ears. 05:50PM Noticed difficulty/restriction to swallowing.  06:20PM Checked into a facility. Waited an hour to be seen by a provider, Dr. He states only an acute reaction without examining my body of the rash; only examined my back & inside my mouth. I informed him that my rash was on my chest, stomach, neck, now my arms, and top of my thighs. He provided Prednisone and dismissed me. (I will be filing for malpractice)  08:00PM- Got home, still have rash with some difficulty swallowing. Friday, 05/21/21 06:00AM- Rash seems to subside and throat is fine, but swollen. 09:00AM While at work, coworker mentions my face is red. Rash came back to my arms and is now on my face. I took 50mg of Benadryl. 03:00PM Left work early since I could not take another dose of Benadryl to drive home.  03:20PM Rash has spread to whole entire body except lower than the knee. Took another 50mg of Benadryl. 09:00PM Took 25 mg of Benadryl went to bed. Saturday, 05/22/21  07:00AM Rash is more noticeable and red. Everywhere on the body, swelling to ears and throat. Took 50mg of Benadryl.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Heavy menstrual bleeding
Clinical narrative: My menstrual cycle was 10 days with heavy bleeding and my hair is falling out.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Starting about 2 hours after injection until 42 hours after injection Faintness - mild Headache - mild Fatigue - severe Injection site pain - mild Chills - Severe Brain fog - moderate
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Starting about 2 hours after injection until 42 hours after injection Faintness - mild Headache - mild Fatigue - severe Injection site pain - mild Chills - Severe Brain fog - moderate
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Galactostasis, Headache, Pain, Pyrexia
Clinical narrative: I began having a mild headache, body aches, and fatigue on the evening of my shot. That night my headache became extremely painful and the headache and fatigue continued to last through the following day. Then by the next day (48 hrs post vaccine) I felt fine again. In the afternoon, I started to develop a plugged duct in my right breast (I am nursing). And by that night I had developed a low grade fever and severe body aches. These have lasted into this morning (now  almost 72 hours post vaccine).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Myalgia, Paranasal sinus discomfort
Clinical narrative: Muscle aches - 14 hours Numbness - 14 hours Lightheaded - 12 hours Sinus pressure - 12 hours Headache - 12 hours
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Pateint got the shot at 3.0 PM She started feeling dizziness and light headache. Her BP was checked at 3.35 146/74 HR 83. She laid down and left her legs up for 15 mins. Her BP went down to 138/79 HR 85 at 3.50 pm. She felt better and called her cardiologist as well. She felt better afterward and called her relative to pick her up. She lef the store around 4.30pm
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Pain, Pyrexia, Sleep disorder, Vision blurred
Clinical narrative: Woke up in the middle of the night with 100.5 fever, cold sweats, aching all over and blurry vision
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Hyperthyroidism, Sinus tachycardia
Clinical narrative: Sinus Tachycardia from potential hyperthyroid, stopped Cytomel, stopped Synthroid for 2 days and resumed at same dose, Beta blocker prescribed, symptoms not resolve yet.  Appointment with Endocrinologist pending.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Severe pain in both hands, stiffness in hands
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Headache, Insomnia
Clinical narrative: Over the course of approximately 24 hrs starting at approximately 11p on the 20th: fever ranging from 101.2F to 102.4F, headache, muscle and body aches, body felt like one big bruise, exhaustion/lethargy, difficulty sleeping for more than 30 min at a time. The muscle aches, headache, bruised feeling, inability to sleep, and lethargy started to lessen around 1p the following day ( 21st) allowing for sleep. Fever was not noticed to go below 100 until the following morning (22nd). Last temperature on the 21st was taken at approximately 10:30p at 101.1F. During this entire time I was hydrated, had no appetite, and spent most of my time trying to rest and fall asleep.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Pain, Pyrexia
Clinical narrative: Over the course of approximately 24 hrs starting at approximately 11p on the 20th: fever ranging from 101.2F to 102.4F, headache, muscle and body aches, body felt like one big bruise, exhaustion/lethargy, difficulty sleeping for more than 30 min at a time. The muscle aches, headache, bruised feeling, inability to sleep, and lethargy started to lessen around 1p the following day ( 21st) allowing for sleep. Fever was not noticed to go below 100 until the following morning (22nd). Last temperature on the 21st was taken at approximately 10:30p at 101.1F. During this entire time I was hydrated, had no appetite, and spent most of my time trying to rest and fall asleep.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: felt light headed / dizzy after about 5 minutes of receiving vaccine. started to feel better after having his head down toward lap. monitored patient for 20 minutes before allowing him to go outside of observation area.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Aphonia, Blindness, Blood test, Cerebrovascular accident
Clinical narrative: I had a brain tia-stroke. Blood clots. Paralyzation.loss of vision. Loss of voice
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Paralysis, Thrombosis, Transient ischaemic attack
Clinical narrative: I had a brain tia-stroke. Blood clots. Paralyzation.loss of vision. Loss of voice
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: I had a brain tia-stroke. Blood clots. Paralyzation.loss of vision. Loss of voice
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: Onset of Zoster (Shingles) in the same (left) upper arm. Soreness at first on Tuesday evening, sharp pain by 1:30 am Wednesday, diagnosed at 11:45 Thursday morning.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Onset of Zoster (Shingles) in the same (left) upper arm. Soreness at first on Tuesday evening, sharp pain by 1:30 am Wednesday, diagnosed at 11:45 Thursday morning.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster (shingles) on forehead and scalp, left side. Prescribed valacyclovir for 7 days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lymphadenopathy
Clinical narrative: Fatigue, swollen lymph nodes, pain at injection site
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: After 5 hours when I got my moderna second dose shot. It feels like I?m getting cold for having a fever. My whole body feels like getting heavier because of body pain  and headache. My right arm was hurting when I touched it. It feels like I?m always cold sometime I?m shaking and make me sweat sometimes. It feels like I?m thirsty most likely, so I drink a lot of water.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Thirst
Clinical narrative: After 5 hours when I got my moderna second dose shot. It feels like I?m getting cold for having a fever. My whole body feels like getting heavier because of body pain  and headache. My right arm was hurting when I touched it. It feels like I?m always cold sometime I?m shaking and make me sweat sometimes. It feels like I?m thirsty most likely, so I drink a lot of water.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Hyperventilation, Nausea, Pallor, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Pt was looking pale 10 minutes after the injection. He looks to be in pain holding his stomach while hyperventilating. After another 5 minutes, he began to vomit and slowly recovered. He stated that his stomach was hurting. His heart rate is 90bpm.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Myalgia
Clinical narrative: I am 4 weeks pregnant; my due date is January 28. On May 20, I received the vaccine; on May 21, I experienced fatigue and muscle aches for the entire day.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Rash, Rash erythematous
Clinical narrative: Irritated Red bumpy rash from base of neck and covering whole face.    Fatigue and sore throat
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Feeling abnormal, Impaired work ability
Clinical narrative: Moderna COVID-19 Vaccine EUA  The 20th I started feeling bad all of a sudden. I was dizzy, weak, confuse, diarrhea, fever, just wasn't feeling well at all. I left work early and stayed home in bed for two days. I took Tylenol for the fever and sip ginger ale for the nausea. The 22 I'm still nausea, but feels a little better.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA  The 20th I started feeling bad all of a sudden. I was dizzy, weak, confuse, diarrhea, fever, just wasn't feeling well at all. I left work early and stayed home in bed for two days. I took Tylenol for the fever and sip ginger ale for the nausea. The 22 I'm still nausea, but feels a little better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Pruritus, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: EMS was contacted and dispatched to the site. Patient vital signs were checked. Patient refused to be taken to the hospital. Patient felt better and was brought home by family member
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt stated initially with the injection she felt the end of her tongue tingling and then a feeling throughout the body. it lasted about 10 minutes but subsided. she did not have any SOB/throat closing/ or anything needing an epi-pen. pt stayed for 45min to observe and she felt fine to leave.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever > 38 C, myalgias, and pain and redness at prior injection site.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Red rash at injection site. Warm to touch. 3?x6? rash
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient informed us prior to vaccination that she is prone to fainting and this happens when she receives vaccine or gets blood draw.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling of left supracervicle lymph nodes with pain and tenderness in left axillary region
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, muscle soreness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Hypertension, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Additional Details: Pt started off experiencing dizziness and shakiness. The dizziness subsided but pt was experiencing a possible anxiety atack. BP and pulse slightly elevated. Pt had not eaten all day and it was late afternoon so she was given chocolate and water. After 30 minutes, pt was able to leave on their own with friend.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Tinnitus
Clinical narrative: Loud ringing in the ears.  Moderately severe headache (not quite migraine but the first shot was).  Sore arm.  Tired.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had trouble walking 5 minutes after vaccine injection.  Sat patient down.  She fainted and was unresponsive for over 1 minute.  911 called and emergency team came to check vitals.  NP on duty also assisted checking vitals.  Patient became conscious 1 minute after fainting.  Her and her mom stayed in the store for an extra 30 minutes and decided to leave.  Patient feeling normal.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Uveitis
Clinical narrative: Uveitis
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: sudden onset of continuous, constant Tinnitus
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Immediate post-injection reaction, Lethargy, Seizure
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: seizure-Mild, Systemic: Seizure-Mild, Additional Details: immediately after administratn, patient had a seizure. His hands,arms, and legs had uncontrolled jerking movements.  The occurence lasted approximately 1 minute.  Afterwards, patient was alert and indicated that he was very tired and was sweating.  Patient was seated on a chair; his head did not hit anything.  911 was called and emergency response personnel was at the premise within 5 to 10 minutes.  Patient was taken to hospital.  Patient stated to EMS that he did not lose consciousness.
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Eye haemorrhage, Fatigue, Mouth haemorrhage, Penile haemorrhage
Clinical narrative: Tired, sneeze
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased, Rectal haemorrhage, Sneezing
Clinical narrative: Tired, sneeze
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, chest pressure,