chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: inadvertently administered the DTap-IPV portion and not the hib portion, no AE; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 4 months old patient who was inadvertently administered the dtap-ipv portion and not the hib portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (2 dose, 0.5 ml, lot number and expiration date not reported) via unknown route in unknown administration for prophylactic vaccination on 19-Nov-2020 (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication were given to patient.  It was a case of actual medication error due to inappropriate reconstitution technique (same day latency).  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.  There will be no information on the batch number for this case.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: increased redness, warmth to right deltoid, pain.  Pain shooting down arm from deltoid area
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: patients were administered with FLUZONE HIGH DOSE QUADRIVALENT that was NOT viable due to temperature excursion, no AE; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case from another health professional.    This case involves 20 patients of unknown demography who were administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number not reported via unknown route in unknown administration site that was not viable due to temperature excursion, on an unknown date.   Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.   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.  There will be no information on the batch number for this case.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Influenza A virus test, Nausea
Clinical narrative: chills, body aches, skin hurt, nausea, lack of appetite and diarrhea (along with sore arm)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Norovirus test, Pain, Pain in extremity, Pain of skin, SARS-CoV-2 test
Clinical narrative: chills, body aches, skin hurt, nausea, lack of appetite and diarrhea (along with sore arm)
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Product preparation issue
Clinical narrative: administered PENTACEL without the ACTHIB diluent (with no adverse event); Initial information was received on 23-Nov-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 5 months old female patient who was administered Pentacel without the Acthib diluent (with no adverse event) (Product administration error), while she received vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV (MRC5)/HIB(PRP/T) vaccine (Pentacel).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar) and rotavirus vaccine.  On an unknown date, the patient received a dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV (MRC5)/HIB(PRP/T) vaccine at a dose of 0.5 mL once via unknown route (lot: U6540AA, expiry dates were unknown) for immunization in unknown administration site.  On an unknown date (latency unknown)  after taking the suspect, the patient who was administered Pentacel without the Acthib diluent (with no adverse event) (Product administration error) (intensity: not applicable).  No laboratory test was reported.   Action taken was reported as not applicable. Therapy status was unknown. Corrective treatment was not reported. Outcome was reported as not applicable for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.    No further information was reported.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Vertigo
Clinical narrative: 24 hours after injection developed muscle aches and fatigue. Approximately 36 hours developed severe vertigo with nausea. Headache present. Continued 12/19 to present. Taking Dramamine for symptoms which on 12/21/2020 is helping with vertigo and nausea. Fatigue, headache and muscle aches continue 12/21/2020.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Impaired work ability, Nausea, Vertigo
Clinical narrative: 24 hours after injection developed muscle aches and fatigue. Approximately 36 hours developed severe vertigo with nausea. Headache present. Continued 12/19 to present. Taking Dramamine for symptoms which on 12/21/2020 is helping with vertigo and nausea. Fatigue, headache and muscle aches continue 12/21/2020.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Vertigo
Clinical narrative: Fatigue: 18 hours after injection to current time. Dizziness: 24 hours to current time, Vertigo: 36 hours to current time, subsiding with use of Dramamine Nausea: coincides with the dizziness/vertigo Spoke with PCP office 3 times who referred me back to hospital, the provider of the vaccination.  Hospital COVID-19 Incident Command pulled me from employment until I get a back to work note from my PCP.  PCP states this is a Hospital issue, they pulled you, they need to reinstate you. Hospital Occupational Health agrees in principal and is working on an outcome.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Impaired work ability, Nausea, Vertigo
Clinical narrative: Fatigue: 18 hours after injection to current time. Dizziness: 24 hours to current time, Vertigo: 36 hours to current time, subsiding with use of Dramamine Nausea: coincides with the dizziness/vertigo Spoke with PCP office 3 times who referred me back to hospital, the provider of the vaccination.  Hospital COVID-19 Incident Command pulled me from employment until I get a back to work note from my PCP.  PCP states this is a Hospital issue, they pulled you, they need to reinstate you. Hospital Occupational Health agrees in principal and is working on an outcome.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: at 1805; associate c/o lightheaded and noted to be diaphoretic. BP was 138/92 with HR 85 and room air sat 98%. at 1830; reported feeling better. BP 127/83. HR 76. room air sat 100%. at 1845: felt better 143/101 1905: discharged to home. BP 136/92
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 18 years old patient was administered Fluzone Quadrivalent High Dose, no AE; 18 years old patient was administered Fluzone Quadrivalent High Dose, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via the Medical Information (Reference number- 00370404) on 24-Nov-2020.    This case involves an 18 years old female patient who received a 0.7ml standard dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] once (lot number, expiration date not reported) via intramuscular route at unknown administration site for prophylactic vaccination (Product administered to patient of inappropriate age and overdose) on 11-Nov-2020.  Medical history, past medical treatment(s), vaccination(s), family history were not provided.  No other vaccine was administered concomitantly  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose (latency-same day).  Reporter stated that a staff member administered the incorrect doses due to not paying attention to what was being given and to who it was being given to and that there was limited information available. It was reported as Fluzone Quadrivalent High Dose medication error with 4 patients described as the patients being under the age of 65 at time of vaccination  It was a case of actual medication error due to incorrect dose administered.  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 holders 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 on the batch number for this case.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Product preparation issue
Clinical narrative: DTaP-IPV fluid had not been administered to the patient; Initial information regarding an unsolicited valid non-serious case was received from a Other health care professional via Agency (Reference number- 00374983) and transmitted to Sanofi on 30-Nov-2020.  This case involves a 6-months old female patient who received PENTACEL  (Batch number UJ349AAA, expiry dates 22-Jun-2021) via an Intramuscular route in an left leg (left thigh) for prophylactic vaccination, on 23-Nov-2020. The reporter said, It was later discovered that the DTaP-IPV fluid had not been administered,(Inappropriate reconstitution technique).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patients concomitant medication includes flu vaccine (ROTAVIRUS VACCINE, Batch unknown and expiry date not repoted).  It was an actual medication error due to Inappropriate reconstitution technique (Latency 1 day)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms and  legs  . resolved after taking a dose of Benadryl
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired dose of TENIVAC was inadvertently administered, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00375578) and transmitted to Sanofi on 30-Nov-2020.    This case involves a 37 years old male patient who received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number U6101AA and expiry date 23-Oct-2020) via an Intramuscular route in an in the  Left Deltoid for prophylactic vaccination (Expired product administered).    The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    This was an actual medication error case due to Expired vaccine used (latency same day) on 30-Nov-2020.    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 holders 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 on the batch number for this case.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Blood glucose, Full blood count, Laboratory test, Pregnancy test, Presyncope
Clinical narrative: pre-syncopal episode approximately 11 hours later
Age: 1.58
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: 19 month old female patient administered expired dose of ActHib, no AE; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 month old female patient who was vaccinated with an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  On 01-Dec-2020, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ135ABA and expiry date: 26-Nov-2020) via an unknown route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional), product used: used and still using product: no  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching, Taste disorder
Clinical narrative: The reaction to the shot was that she had alcohol taste, nausea, wretching, and a rapid response team was called and she was taken to the ED.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Presyncope, Vomiting
Clinical narrative: Pfizer-BioNTech COVID 19 Vaccine  42 y.o. female had just received her vaccine when she became very lightheaded, was placed on a stretcher and brought to ED further evaluation. Patient has hx of rheumatoid arthritis.  Stated that she has not eaten since earlier this morning, did have some nausea vomiting earlier that is now resolved, feels that it was related to "an adrenaline rush just prior to her vaccination.  Upon arrival to ED she is denying any headache, fever, sweats, chills, cough, shortness of breath, angioedema, chest pain, palpitations, vomiting, edema, claudication, urticarial.  Diagnosed with near syncope.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Peripheral swelling, Pruritus, Skin warm, Sluggishness
Clinical narrative: SHE NOTICED EARLY IN THE MORNING HER ARM WAS TENDER. IT WAS SWOLLEN AND HOT, AND WAS ITCHY. SHE DID NOT HAVE A FEVER, BUT FELT A LITTLE SLUGGISH ALL DAY. SHE WENT TO SEE A NURSE IN OUR ER THAT DREW A LINE AROUND THE REACTION AREA. IT WAS ABOUT 5 INCHES IN DIAMETER. WHEN SHE REPORTED THE REACTION TO ME TODAY IT IS NOW ABOUT 7 INCHES IN DIAMETER. WITH WHITE DIFFUSE EDGES, A  RED CIRCLE RADIATING OUT FROM THE INJECTION SPOT ABOUT 2 TO 2 1/2 INCHES .
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: SHE NOTICED EARLY IN THE MORNING HER ARM WAS TENDER. IT WAS SWOLLEN AND HOT, AND WAS ITCHY. SHE DID NOT HAVE A FEVER, BUT FELT A LITTLE SLUGGISH ALL DAY. SHE WENT TO SEE A NURSE IN OUR ER THAT DREW A LINE AROUND THE REACTION AREA. IT WAS ABOUT 5 INCHES IN DIAMETER. WHEN SHE REPORTED THE REACTION TO ME TODAY IT IS NOW ABOUT 7 INCHES IN DIAMETER. WITH WHITE DIFFUSE EDGES, A  RED CIRCLE RADIATING OUT FROM THE INJECTION SPOT ABOUT 2 TO 2 1/2 INCHES .
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: a 61 year-old female patient received expired Tenivac without adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional (Nurse) via Agency (Reference number- 00379109) and transmitted to Sanofi on 02-Dec-2020.    This case involves a 61 years old female patient who received a dose of 0.5 ml expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (produced by unknown manufacturer, lot number LU6101AA, expiry date 23-Oct-2020) vaccine via intramuscular route in an unknown administration site for prophylactic vaccination, on 02-Dec-2020 (Expired product administered).    The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    This was an actual medication error case due to expired vaccine used (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 holders 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: HIBV, MNQ
Symptoms: Wrong product administered
Clinical narrative: 1 year old patient received Menactra instead of the ActHIB without adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (Nurse) via Agency (Reference number- 00380738) and transmitted to Sanofi on 03-Dec-2020.    This case involves a 1 year male patient who received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) instead of the HIB (PRP/T) VACCINE (Powder and solvent for solution for injection,  , ) ActHIB (produced by unknown manufacturer lot number U6690AB, expiry date 21-Aug-2023) via an unknown route in an unknown administration site for prophylactic vaccination, on 03-Dec-2020 (wrong vaccine administered).    The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    This was an actual medication error case due to wrong vaccine 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 holders 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: Approximately 10 to 15 minutes after vaccination, patient reported feeling dizzy with slight headache. Also reported tingling starting on the left fingers and hand that progressed to tingling (not numbness) up both arms and both sides of the upper body.   Body felt "weird".  Headache progressed to a "pounding headache" with pain in the eyes because the headache is "so bad".  Patient reports feeling tired and "drained".    Patient being frequently monitored by nursing staff.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Approximately 10 to 15 minutes after vaccination, patient reported feeling dizzy with slight headache. Also reported tingling starting on the left fingers and hand that progressed to tingling (not numbness) up both arms and both sides of the upper body.   Body felt "weird".  Headache progressed to a "pounding headache" with pain in the eyes because the headache is "so bad".  Patient reports feeling tired and "drained".    Patient being frequently monitored by nursing staff.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: 20 year old male patient administered expired dose of Menactra, no AE; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 20 year old male patient who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Patient did not received other vaccines.  On 03-Dec-2020, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6346AA and expiry date: 30-Aug-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional), product used: used, first time product used: yes and still using product: no  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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: fatigue, weakness
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient experienced no ill side effects.  it was an expired vaccine by 3 months.
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered an expired dose of Acthib/No AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00381689) and transmitted to Sanofi on 04-Dec-2020.  This case involves a 15 months old male patient who inadvertently administered an expired dose of acthib/no adverse event, while he received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number# UJ175AA, expiry date: 26-Nov-2020) via Intramuscular route in right thigh for prophylactic vaccination, on 04-Dec-2020 (expired product administered).  The patient concomitant medications diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and influenza vaccine (FLU).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  This was an actual medication error case due to expired vaccine used (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 holders 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Dysgeusia, Pain, Pyrexia
Clinical narrative: The night of vaccination patient had a metal taste in mouth and lost all sense of taste. 12/19/2020 she developed a fever, body aches, and chills. 12/20/20 Continued to be febrile, then was told to follow up with PCP.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: intense arm pain radiates up into shoulders and down other arm.  Very painful.  Lasted 2 weeks
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: vaso vagal reaction. client lowered to floor when apparent he was having the reaction. Legs elevated.  Head not hit. Sternal rub x 3 times during first minute to keep him awake. Each time he would say, "I'm OK, I'm OK".  BP monitor brought to room by, RN. BP taken at 11:18 106/74 pulse 63.  client now alert. BP at 11:24 106/69, pulse 85.  BP at 11:31 103/63, pulse 85. Client stands and walks well to waiting room at 11:35.  Leaves clinic at 11:45 with no further problems.  Stated he had not eaten anything for breakfast. Crackers given.
Sex: M
Vaccine: FLU4
Symptoms: Adverse drug reaction, Unevaluable event
Clinical narrative: adverse event; Initial information regarding an unsolicited valid non-serious case was received from a patient via Medical Information (Reference number- 00383487) on 07-Dec-2020.   This case involves male patient who experienced side effects of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose  of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient reported non-serious event the patient experienced side effects (latency same day).   Action taken reported as not applicable.  It was unknown the patient received any corrective treatment.  Event outcome reported as unknown for the event.  Reporter causality reported as related with respect to the event and company causality reported as Unassessable.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Periarthritis
Clinical narrative: Frozen shoulder pain... went to ER treated with steroid and pain meds.
Sex: U
Vaccine: FLU3, FLU4, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Lowest temperature reached 23.7 degrees Fahrenheit and total time out of range unknown with no AE; Initial information regarding an unsolicited Non-valid non-serious case was received from a Other Health Professional via The Company (Reference number-00384919) and transmitted to Sanofi on 08-Dec -2020 via call-center.  This case involves a patient with unknown demographic detail was received vaccine QUADRIVALENT INFLUENZA VACCINE [FLUZONE QUADRIVALENT] (lot and expiry date were unknown), POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot and expiry date were unknown) and INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE] (lot and expiry date were unknown) 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 product storage error (latency: unknown).  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: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient has rash and pruritus on legs and arms the day after receiving the shot. She was instructed by the pharmacist and her doctor to take oral benadryl every 4 hours. As of today (12/21/20), 12 days after immunization, patient's rash in resolving and pruritus is not as bad as it was on 12/10/20.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Myalgia, Nausea
Clinical narrative: fatigue, muscle soreness and weakness, headache, nausea
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: fatigue, muscle soreness and weakness, headache, nausea
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Palpitations
Clinical narrative: I had heart palpitations and extreme fatigue for 48 hours.
Age: 24.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Wrong product administered
Clinical narrative: stated patient was given TENIVAC but should have received ADACEL instead with no AE; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 24 years old female patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection)(ADACEL) (wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  On 14-Dec-2020, patient received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection)(ADACEL) (lot number: not reported, expiry date: unknown) via unknown route and site for prophylactic vaccination (wrong product administered). Nurse Practitioner wants to know how long they have to wait before administering ADACEL.  It was an actual medication error due to the Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  No laboratory date was reported.  The event outcome not applicable.  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.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eye pain, Fatigue, Headache
Clinical narrative: Fatigue, mild fever, joint ache, muscle ache, headache, eye pain (had underwent LASIK recently, date of vaccination was LASIK POD#18, but that eye pain had entirely resolved at least a week ago, now recurring), mild chills.  (Instructed by employer to include this in Item 18: Pfizer-BioNTech COVID-19 Vaccine EUA)
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fatigue, mild fever, joint ache, muscle ache, headache, eye pain (had underwent LASIK recently, date of vaccination was LASIK POD#18, but that eye pain had entirely resolved at least a week ago, now recurring), mild chills.  (Instructed by employer to include this in Item 18: Pfizer-BioNTech COVID-19 Vaccine EUA)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: 5 in red spot underneath the injection site
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dyspnoea, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Approximately 15 minutes after injection, patient reported nausea/vomiting, difficulty breathing, being clammy and having numbness/tingling in the L side of face and L arm.  Cold packs were applied, BP 165/104 obtained at that time, O2 sats 99% on RA.  O2 via facemask applied.  Sats continued in upper 90's throughout event.  Rapid response called at onset of symptoms.  They connected to monitor upon arrival.  HR maintained 70's-80's throughout event.  At 2304 BP 165/102, HR 85, patient reported feeling better.  At 1108, BP was 159/100.  Patient reported feeling well enough to go home at that time and did so.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Approximately 15 minutes after injection, patient reported nausea/vomiting, difficulty breathing, being clammy and having numbness/tingling in the L side of face and L arm.  Cold packs were applied, BP 165/104 obtained at that time, O2 sats 99% on RA.  O2 via facemask applied.  Sats continued in upper 90's throughout event.  Rapid response called at onset of symptoms.  They connected to monitor upon arrival.  HR maintained 70's-80's throughout event.  At 2304 BP 165/102, HR 85, patient reported feeling better.  At 1108, BP was 159/100.  Patient reported feeling well enough to go home at that time and did so.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Feeling hot, Palpitations, Pruritus
Clinical narrative: Pfizer/BioNTech COVID 19 vaccine EUA C/O "heart coming out of chest", itching, and hot feeling approximately 10-15 minutes after injection. She took 25mg Benadryl PO one hour before vaccine. Was given 25 mg oral Benadryl at 1410. HR and blood pressure returned to normal and pt was released within 20  minutes of reaction.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dyspnoea, Electrocardiogram normal, Hypertension, Metabolic function test normal
Clinical narrative: Hypertension (220/110) and shortness of breath after Pfizer-BioNTech COVID-19 0.3 IM injection in the right deltoid.  Presented to ED within 6 minutes of injection for evaluation. Symptoms resolved within 10 minutes in the ED except BP remained in 160s/90s. Blood glucose, CMP, and ECG normal. No medications given. Patient asked to leave following resolution of symptoms.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nausea, Pallor
Clinical narrative: became dizzy, nauseated, pale, weak and almost fainted 5 minutes after the injection.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Activated partial thromboplastin time, Chest X-ray, Full blood count, Influenza virus test negative
Clinical narrative: general malaise and abdominal discomfort after vaccine,  three days later started with facial rash and fever Treatment: Famotidine, Benadryl
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Metabolic function test, Mycoplasma test negative, Prothrombin time, Pyrexia
Clinical narrative: general malaise and abdominal discomfort after vaccine,  three days later started with facial rash and fever Treatment: Famotidine, Benadryl
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: general malaise and abdominal discomfort after vaccine,  three days later started with facial rash and fever Treatment: Famotidine, Benadryl
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Exposure to SARS-CoV-2, Myalgia, Sinus congestion
Clinical narrative: The night patient got vaccination she had abdominal pain, muscle aches and sinus congestions. She was also exposed to a positive covid 19 case and is going for testing 12/21/2020.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood triglycerides increased, Cough, Pyrexia
Clinical narrative: I have had symptoms of a low grade fever on and off and a cough  has developed that sounds like "whooping cough" .  This is the 4th day. Is this normal or does it get better .  do you need to see a dr??
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Neck pain, Pain
Clinical narrative: Felt achy, headache, neck sore, possible low grade fever, tired, chills occasionally. Treated with motrin and rest.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor, Tachycardia
Clinical narrative: Approximately 10 minutes after the vaccine, patient became tachycardia hr 110, diaphoretic, and pale. Felt back to normal around 12:30 pm. Patient did not develop any additional symptoms until Saturday evening around 5pm when similar symptoms developed but milder.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Throat irritation
Clinical narrative: Approximately 30 minutes after receiving the vaccination, patient reports itching started on left arm, then the head, then both arms and then lower back.  No redness, erythema, or hives.  Itching progressed  to the ears and throat started to feel "sticky/funny" within 1 hour of receiving the vaccine.  Diphenhydramine 50 mg and Famotidine 20 mg administered.  Itchiness resolved 15 to 30 minutes after receiving diphenhydramine and famotidine.  However, lips and tongue feel "tingly".
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Slight difficulty with exhalation.  Denies difficulty with inhalation, swelling of face or throat, palpitations, rash, or dizziness and weakness. Advised to continue to monitor. Strict UC/ER precautions advised.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: 1813: reported feeling nauseated and was noted to diaphoretic. HR 110. BP 142/82. Room Air sat 100%. 1830: reports feeling better HR 89. BP 141/75. Room air Sat 100% 1840: symptoms resolved. associate sent home per request. HR 86 no interventions done.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Injection site pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches 24 hours.  Continues 72 hours later to have swollen axillary lymph right arm.  Pain at injection site.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Injection site pain, Lymphadenopathy, Myalgia
Clinical narrative: Fever, chills, body aches 24 hours.  Continues 72 hours later to have swollen axillary lymph right arm.  Pain at injection site.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, body aches 24 hours.  Continues 72 hours later to have swollen axillary lymph right arm.  Pain at injection site.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Hello to all. Patient reported feeling dizzy right after sitting down for the 15 minute wait period. I asked her if she would like to lay down. I took her in the side room to lay on the hospital bed. Her bp was 177/115. She is a physician and so is her husband. He was with her. He suggested we had a bad cuff , and he wanted a manual one. Staff went to the ER to retrieve it.  Her husband took her BP and BP was elevated with the manual cuff as well. I provided juice and water for the patient and got her rags. Her blood pressure stayed elevated for the whole 30 minutes she was there. Her husband wanted to know what I had to give her. He wanted lisinopril 5mg. I explained that we only had benadryl and epipens for allergic reactions. He decided to take her home. He stated he would give her one of his blood pressure pills and that she would be fine. She was able to get up and walk out without assistance
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Patient states that a day after she received the vaccine she started running a fever and since receiving the vaccine she suffers from severe fatigue, dizziness and body aches daily.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Approximately 30hrs. post vaccine I experienced hearing loss in my right ear. I could hear very little and it became worse within the next few hours. 12hrs after this began, my hearing came back and I then acquired a ringing in my right ear. This progressively lessened, and about 24 hrs after the initial hearing loss started,  all the symptoms dissapated.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient received the TDAP vaccine on 12/15/2020. Patient called 12/21/2020 to the health department and reported that her arm at the injection site is round,  size of a naval orange, red, and really hot. Patient reported these symptoms started 12/17/2020. She also stated she experienced nausea on 12/16/2020 for a couple of hours.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: flushing, felt dizzy. given Benadryl 50mg and resolved in 15 minutes
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: The day after vaccination, her "injection" arm became red/swollen/painful.  It lasted about a week.  She did not seek treatment for it.  She took aleve at home.  Note, she had Fluad the same day in the same arm, however, she has had Fluad before without issue.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Confusional state, Dyskinesia, Flushing, Headache
Clinical narrative: During the 15-minute observation period the patient became flushed and began complaining of a headache.  She then went unconscious and had tonic-like activity for approximately 2 minutes.  The patient subsequently stopped the seizure-like activity and woke up but was confused and was acting in a postictal fashion.  She was evaluated emergently upon arrival in the ED and noted to have an altered mental status.  Physician noted that this does not appear to be an allergic or anaphylactic reaction.  There was no evidence of rash and lung sounds were clear with no wheezing.  Subsequent CT showed a diffuse subarachnoid hemorrhage and patient was transferred to the Medical Center for further treatment.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Mental status changes, Postictal state, Seizure like phenomena, Subarachnoid haemorrhage
Clinical narrative: During the 15-minute observation period the patient became flushed and began complaining of a headache.  She then went unconscious and had tonic-like activity for approximately 2 minutes.  The patient subsequently stopped the seizure-like activity and woke up but was confused and was acting in a postictal fashion.  She was evaluated emergently upon arrival in the ED and noted to have an altered mental status.  Physician noted that this does not appear to be an allergic or anaphylactic reaction.  There was no evidence of rash and lung sounds were clear with no wheezing.  Subsequent CT showed a diffuse subarachnoid hemorrhage and patient was transferred to the Medical Center for further treatment.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Approximately 2 hrs 30 min post administration I experienced mild parasthesia in my left ring finger and pinky finger and mild left arm muscle weakness and mild lady hand grasp weakness.  This episode lasted about 40-45 min, self resolved completely with no intervention.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Paraesthesia
Clinical narrative: Approximately 2 hrs 30 min post administration I experienced mild parasthesia in my left ring finger and pinky finger and mild left arm muscle weakness and mild lady hand grasp weakness.  This episode lasted about 40-45 min, self resolved completely with no intervention.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling and warm to touch.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Woke up middle of night, severe muscle aches/cramps, chills/fever, debilitating headache.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Woke up middle of night, severe muscle aches/cramps, chills/fever, debilitating headache.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: Woke up middle of night, severe muscle aches/cramps, chills/fever, debilitating headache.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient reported feeling dizzy shortly after the vaccine. Symptoms resolved after she laid down and we got her a drink.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature increased, Cough, Diarrhoea
Clinical narrative: Pt experienced temp of 103.8 at 3am on 12/18/20.  Temp decreased to 100 on 12/19-12/20.  As of 9am on 12/21 temp was 99.3.  On 12/19 pt began experiencing diarrhea, cough and stomach pain.  Cough and stomach pain continued to report of 12/21.  Pt had COVID + test on 10/11/2020.  She stated that it was as if the symptoms she had in October were back.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypertension, Oedema, Rash macular, Throat irritation
Clinical narrative: Patient presents to the emergency department less than 20 minutes after getting her first COVID-19 vaccine, feels like there is a tickle in her throat, patient has some blotchy erythema on the front of her neck and chest. Patient very hypertensive on arrival here to the ED.    Patient was given IM epi 300 mcg, was also given Solu-Medrol 125 mg IV, Pepcid 20 mg IV, and Benadryl 50 mg IV. Patient reexamined at 9:45 AM, states that symptoms are better. Blood pressure actually has improved down to 172/91. She no longer has the erythema edema on the front of her neck and chest, feels as though symptoms are improving.   We will continue to observe patient here for the next 2 hours after epi.  Pt. asymptomatic by 1230.  Discharged to home and advised to not get the second COVID-19 vaccine shot in three weeks.