chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Headache, Neck pain, Palpitations, Sinus tachycardia
Clinical narrative: Sudden onset of headache approx. 24 hours after administration, dizziness, mildly slurred speech/stuttering described by patient (not seen on exam), neck pain, eye pain. Also c/o palpitations.
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Facial pain, Herpes zoster, Oral mucosal eruption
Clinical narrative: I received the shingles vaccine and a week later on 9/7/20 I started getting a rash on inside of my mouth and lip. I developed a stabbing pain in the left side of my face as well as my ear. I had an appointment with him on 9/9 so I mentioned the symptoms to him and he diagnosed me with shingles. My doctor prescribed medication for the shingles as well as pain medication.
Age: 53.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Pain, Swelling
Clinical narrative: 2 days after shots (both same arm), pt started experiencing swelling on shoulder. By end of day, swelled "larger than a softball." Pt instructed to ice and monitor and be seen if feels need at any time to but could start by seeing how icing does and then if worse or not getting better to be seen. Said is sensitive/painful to raise arm.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Body temperature increased, Headache, Hyperhidrosis
Clinical narrative: I had significant whole body aches, elevated temperature, sweating and weakness.  It started around 11 pm and lasted until 8 am.  When I got out of bed at 6 am, I was weak and unsteady on my feet.  When I checked my blood pressure at 8:30 am, it was SBP 97/ DBP 60 with a pulse of 96.  I felt weak and had a bad headache through out the day.  As the day progressed I felt better.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I had significant whole body aches, elevated temperature, sweating and weakness.  It started around 11 pm and lasted until 8 am.  When I got out of bed at 6 am, I was weak and unsteady on my feet.  When I checked my blood pressure at 8:30 am, it was SBP 97/ DBP 60 with a pulse of 96.  I felt weak and had a bad headache through out the day.  As the day progressed I felt better.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Patient called and said he had soreness, redness, swelling at the site of injection.  It also looked discolored at the site of injection.  He had a fever, body aches and a headache.  He received the flu shot on friday and showed all of the above symptoms overy saturday/sunday.  The brusing around the site of injection was still there on monday.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient called and said he had soreness, redness, swelling at the site of injection.  It also looked discolored at the site of injection.  He had a fever, body aches and a headache.  He received the flu shot on friday and showed all of the above symptoms overy saturday/sunday.  The brusing around the site of injection was still there on monday.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: body aches lasting about 18 hours shivering lasting about an hour
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: 38-year-old Program Director for the School received her mandatory flu shot on 10/21/2020 and reports that since she has had pain in the left arm since her injection. She reports that she has tried "everything:for pain which has not subsided. She reports having seen her Chiropractor, had acupuncture, used Ibuprofen and Tiger Balm and none of these modalities have give her relief. She points the lateral head of the tricep as the site of injection. with pain radiating towards her elbow. On presentation today she rates her pain as a 5/10 aching sharp throbbing pain made worse with overhead and over the shoulder reaching. She is tolerating full duty. She denies PMH,  illnesses in the last 2 months or prior reactions to vaccines. She takes an MVI and uses OCPs, she denies current pregnancy.
Age: 65.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumovax23 administered on 10-FEB-2012 and PREVNAR 13 on 29-MAY-2015; This spontaneous report was received from a 68year-old male patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 10-FEB-2012, the patient was vaccinated with  Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). Therefore, it was reported that on 29-MAY-2015 another dose of  pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) was administered to the patient (inappropriate schedule of product administration). No adverse event was reported.   This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1907USA012667:
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: exposed more and got a mild case occasionally/ flu; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves elderly female patient (unknown age) who got a mild case occasionally/ flu (influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got a mild case of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient and her husband every year got the vaccine. At 79 and 81, they get the high dose for senior adults. Her husband has never gotten flu but she was exposed more and got a mild case occasionally, but she would had expected to be seriously ill with her health issues.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: always got the flu, sometimes twice; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via social media.  This case involves a patient of unknown demographics, who always got the flu, sometimes twice (influenza), while he/she received influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine (batch number and expiry date unknown) at an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient got the flu shot gor years always got the flu, sometimes twice (influenza), No more flu shots for them. Haven't had the flu since.  No lab data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, event outcome was recovered for flu.  There will be no information available on the batch number for this case.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arms are sore; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (MI) via call-center (Reference number- 00342342) and transmitted to Sanofi on 02-Nov-2020.  This case is linked to cases 2020SA320485 and 2020SA307661 (same reporter).  This case involves a 47-years-old female patient who experienced arms are sore (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot number LUT7007NA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arms are sore (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, SARS-CoV-2 test negative
Clinical narrative: Loss of appetite; Diarrhea; Headache; Chills; Initial information regarding an unsolicited valid serious case was received from a Consumer/non-hcp (healthcare professional) via Medical Information (MI) (Reference number- 00349229) and transmitted to Sanofi on 06-Nov-2020.  This case involves a 65 years old female patient who experienced loss of appetite (decreased appetite), diarrhea (diarrhoea), headache (headache) and chills (chills), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, past medical treatments, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported) via unknown route in the left arm for prophylactic vaccination.  The patient did not get any other vaccines that day.  On an unknown date, the patient developed a non-serious headache and chills, three weeks following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date, the patient developed a non-serious loss of appetite (decreased appetite), diarrhea (diarrhoea), a couple of days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: On an unknown date SARS-CoV-2 test was negative.  It was not reported if the patient received any corrective treatment or not.  The patient was recovering from the events at the time of reporting.  There will be no information on the batch number for this case.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Malaise, Muscle discomfort
Clinical narrative: Fever 100.4F orally after waking that morning. Chills and sweats in the middle of the night. Fever symptoms started at maybe 1:00-2:00 am and lasted until 1:00-2:00 pm that day. Muscular stiffness/discomfort. General un-well feeling, fogginess, fatigue. Mild flu or cold like feelings. Contacted the clinic first thing after they opened at about 8:00 am, fearing Covid-19/ Was instructed to monitor myself and advised to call if conditions worsened, but was advised that it was most likely a reaction to the vaccine. General un-well feeling persisted for 3 days, but never worsened.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Night sweats, Pyrexia
Clinical narrative: Fever 100.4F orally after waking that morning. Chills and sweats in the middle of the night. Fever symptoms started at maybe 1:00-2:00 am and lasted until 1:00-2:00 pm that day. Muscular stiffness/discomfort. General un-well feeling, fogginess, fatigue. Mild flu or cold like feelings. Contacted the clinic first thing after they opened at about 8:00 am, fearing Covid-19/ Was instructed to monitor myself and advised to call if conditions worsened, but was advised that it was most likely a reaction to the vaccine. General un-well feeling persisted for 3 days, but never worsened.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Miliaria, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: Sudden onset of a Burning Hot Red Rash from head to toe with itching & tingling  that lasted about 1 &1/2 hours than slowly cleared up after taking a cool shower
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, C-reactive protein increased, Diplegia, Groin pain, Mobility decreased
Clinical narrative: Groin pain; Knee pain on the right side; Upper pain in his arms; Elevated c-reactive proteins; unable to move both arms; Diagnosed with Polymyalgia Rheumatica; Unable to move both arms; Myalgia; This case was reported by a nurse via call center representative and described the occurrence of polymyalgia rheumatica in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), paralysis of arms (serious criteria GSK medically significant), myalgia, groin pain, knee pain, pain in arm, c-reactive protein increased and mobility decreased. On an unknown date, the outcome of the polymyalgia rheumatica, paralysis of arms, c-reactive protein increased and mobility decreased were unknown and the outcome of the myalgia, groin pain, knee pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, paralysis of arms, myalgia, groin pain, knee pain, pain in arm, c-reactive protein increased and mobility decreased to be related to Shingrix.  Additional details were received as follows: The reporter was the wife of the patient and also a nurse.  Myalgia presented 2 to 3 days after the vaccine and continued throughout the month of October.  He visited a doctor on 15th September 20.  He had groin pain and knee pain on the right side.  He was referred to an orthopedist and had 4 appointments.  The knee pain was thought to be referred pain from the groin.  He had a shot in his knee on 2nd October 20 and 8th October 20.  On 15th Oct 20 and 28th October 20 he was seen for upper pain in his arms.  He was unable to move both arms.  He visited a rheumatologist  on 5h November 2020 and blood work showed elevated c-reactive proteins. He was diagnosed with Polymyalgia rheumatica. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: Groin pain; Knee pain on the right side; Upper pain in his arms; Elevated c-reactive proteins; unable to move both arms; Diagnosed with Polymyalgia Rheumatica; Unable to move both arms; Myalgia; This case was reported by a nurse via call center representative and described the occurrence of polymyalgia rheumatica in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), paralysis of arms (serious criteria GSK medically significant), myalgia, groin pain, knee pain, pain in arm, c-reactive protein increased and mobility decreased. On an unknown date, the outcome of the polymyalgia rheumatica, paralysis of arms, c-reactive protein increased and mobility decreased were unknown and the outcome of the myalgia, groin pain, knee pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, paralysis of arms, myalgia, groin pain, knee pain, pain in arm, c-reactive protein increased and mobility decreased to be related to Shingrix.  Additional details were received as follows: The reporter was the wife of the patient and also a nurse.  Myalgia presented 2 to 3 days after the vaccine and continued throughout the month of October.  He visited a doctor on 15th September 20.  He had groin pain and knee pain on the right side.  He was referred to an orthopedist and had 4 appointments.  The knee pain was thought to be referred pain from the groin.  He had a shot in his knee on 2nd October 20 and 8th October 20.  On 15th Oct 20 and 28th October 20 he was seen for upper pain in his arms.  He was unable to move both arms.  He visited a rheumatologist  on 5h November 2020 and blood work showed elevated c-reactive proteins. He was diagnosed with Polymyalgia rheumatica. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix. Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information received as follows: The age at vaccination was not applicable for this report.  The patient was diagnosed with multiple sclerosis. Till the time of reporting, the patient did not received the second dose of the Shingrix vaccine yet, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 14-Oct-2020 regarding an unsolicited non-valid non-serious case from a consumer/non-health care professional via social media.   This case is linked to case 2020SA293954 and 2020SA293953.  This case involves a female patient (age unspecified) who got the flu at the same time and it lasted 2 1/2 days (Influenza), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu at the same time and it lasted 2 1/2 days (influenza) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was recovered from flu.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm still hurts; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case was linked to case 2020SA300462.  This case involves patient (unknown demographic) whose arm still hurts (pain in extremity), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient's arm still hurts (pain in extremity) (non-serious, unknown latency) after the administration of INFLUENZA VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick as a dog; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves patient (unknown demographics) who got sick (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), past medical history, concomitant vaccination(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expired date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (non-serious), for 3 days (latency unknown), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient outcome was not reported.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: gotten the flu; Initial information received on 24-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves a patient (unknown demographics) who got flu (influenza), when received INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine for prophylactic vaccination with reaction of flu (influenza) (got the flu shot every year and have gotten the flu twice in the last five years).  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for flu.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick for over a week; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to case 2020SA314526 (same reporter).  This case involves a female patient (unknown age) who got sick for over a week (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious got sick for over a week (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Age: 65.0
Sex: F
Vaccine: FLUR4
Symptoms: Administration site pain, Chills, Erythema, Feeling abnormal, Malaise
Clinical narrative: administration site hurt and sore; Initial information was received on 09-Nov-2020 regarding an unsolicited valid serious case from a pharmacist.  This case involves a 65-year-old female patient (160 cm and 86.18 kg) who experienced administration site hurt and sore (vaccination site pain), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination and family history were not provided.  On 07-Nov-2020, the patient received a unknown dose of suspect PREVNAR 13 (not produced by Sanofi Pasteur, manufacturer: Pfizer) [Solution for injection in pre-filled syringe, lot number and expiry date not reported] via unknown route at the left arm muscle as concomitant medication.  On 07-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route at the right arm for prophylactic vaccination.  It was reported that, patient had no problem with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE given at same time in right arm on 07-Nov-2020 but on an unknown date, patient developed non serious administration site hurt and sore (right arm) (vaccination site pain) (unknown latency), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and PREVNAR 13. It was reported that, no problem or redness observed at the same site. It was reported that, the patient could breathe normally and did not have a rash on her body.  It was also reported that, On 07-Nov-2020, the patient developed hurting of left arm (about 3-inch width), on 08-Nov-2020, the patient developed redness and swelling of areas of the left arm (about 3-inch width), muscle stiffness with inflammation (all the way across the front of her arm) and skin over the muscle itself was very pale.  On 08-Nov-2020, in night, patient felt chills, feeling bad, did not feel very well.   On an unknown date, patient was recovered from vaccination site pain.
Age: 65.0
Sex: F
Vaccine: FLUR4
Symptoms: Musculoskeletal stiffness, Myositis, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: administration site hurt and sore; Initial information was received on 09-Nov-2020 regarding an unsolicited valid serious case from a pharmacist.  This case involves a 65-year-old female patient (160 cm and 86.18 kg) who experienced administration site hurt and sore (vaccination site pain), while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination and family history were not provided.  On 07-Nov-2020, the patient received a unknown dose of suspect PREVNAR 13 (not produced by Sanofi Pasteur, manufacturer: Pfizer) [Solution for injection in pre-filled syringe, lot number and expiry date not reported] via unknown route at the left arm muscle as concomitant medication.  On 07-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route at the right arm for prophylactic vaccination.  It was reported that, patient had no problem with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE given at same time in right arm on 07-Nov-2020 but on an unknown date, patient developed non serious administration site hurt and sore (right arm) (vaccination site pain) (unknown latency), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and PREVNAR 13. It was reported that, no problem or redness observed at the same site. It was reported that, the patient could breathe normally and did not have a rash on her body.  It was also reported that, On 07-Nov-2020, the patient developed hurting of left arm (about 3-inch width), on 08-Nov-2020, the patient developed redness and swelling of areas of the left arm (about 3-inch width), muscle stiffness with inflammation (all the way across the front of her arm) and skin over the muscle itself was very pale.  On 08-Nov-2020, in night, patient felt chills, feeling bad, did not feel very well.   On an unknown date, patient was recovered from vaccination site pain.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: arms are sore; Initial information regarding an unsolicited valid serious case was received from a pharmacist via call-center (Reference number- 00342292) and transmitted to Sanofi on 02-Nov-2020.  This case is linked to cases 2020SA320485 and 2020SA307661 (same reporter).  This case involves a 36-years-old female patient who experienced arms are sore (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot number LUT7007NA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arms are sore (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Dizziness
Clinical narrative: lack of appetite; dizziness; energy ever since; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via regulatory authority (Reference number- US-SANOFI-00336223) and transmitted to Sanofi on 28-Oct-2020.  This case involves a 71 year old female patient who had lack of appetite (decreased appetite), dizziness (dizziness) and energy ever since (asthenia), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications was not applicable.  On 20-Oct-2020, the patient received a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ512AA, expiry date 30-Jun-2021) once (standard) via intramuscular route in the right deltoid for prophylactic vaccination.  On 20-Oct-2020, the patient developed a non-serious lack of appetite (decreased appetite), dizziness(dizziness) and energy ever since (asthenia) (same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: patient administered an expired dose of Pentacel/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency via call-center (Reference number- 00339146) and transmitted to Sanofi on 30-Oct-2020.  This case involves a 6-months-old female patient who received expired 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency: once, strength: standard, lot number: UJ065AAA and expiry date: 16-Oct-2020) (expired vaccine used) on 23-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) and Menvale (study drug) for prophylactic vaccination.  This site is part of the vaccine study.  It was an actual medication error case due to due 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 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: 4.0
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: patient received Pentacel and Quadracel vaccine duplicate a couple days apart/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00341358) and transmitted to Sanofi on 02-Nov-2020 via call-center.  This case involves a 4-years-old female patient who received a vaccine duplicate a couple days apart  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ2678A and expiry date: 04-JUN-2021) on 22-Oct-2020 and 0.5 mL DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (strength: standard, frequency: once, lot number: C5772BA and expiry date: 17-Sep-2022 via an intramuscular route in left thigh) on 30-Oct-2020 (extra dose administered) 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 extra dose administered (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.
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: patient received an expired vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number- 00355051) via call center and transmitted to Sanofi on 11-Nov-2020.  This case involves a female patient (age not reported) who received vaccine IPV (VERO) [IPOL] (batch number: P1E70, expiry date: 09-Nov-2020) via an intramuscular route in right thigh on an unknown date for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HIB VACCINE (HIB); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event was reported.  Caller would like to know if the patient needed to be revaccinated.  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: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Menactra on 14th of November 2020 that had expired on the 30th of August 2020, No AE; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 12 years old female patient who was administered with 0.5 ml expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] ( lot number: U6346AA and expiry date:30-Aug-2020) via unknown route in left arm for prophylactic vaccination on 14-Nov-2020 (Expired product administered).  Medical history, past medical treatment(s), medical treatment(s), vaccination(s) and family history were not reported.  Concomitant medications included ADACEL and HPV VACCINE for prophylactic vaccination.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: 12/5/2020 about 15 -17 hours after Vaccine, Patient experienced fatigue, malaise. Temp was 99 and administered Tylenol at home. Temp at time of vaccine was 97.7. Patient felt better the following day after rest and sleep; 13 hours. Does have soreness at injection site.   Patient did not experience AE to first shingrix shot.   9/3/2020 - flu vaccine 9/9/2020 - 1st Shingrix shot
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Nausea, Pain
Clinical narrative: When I woke up this morning I felt nauseous, cold, very tired, and had serious body aches. As the day progressed, I continued to feel cold very tired,  had body aches and a heachache came on. My nausea turned into pain for the entire morning but was gone by 2:00 pm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Neck pain
Clinical narrative: redness and swelling at injection site -subsequent neck and shoulder pain
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large area of erythema, raised and warm to left thigh at vaccine site. Mildly pruritic.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dizziness
Clinical narrative: Patient exp adverse events on 12/6 night with having chills and stated din't check his temp. When he woke on 12/7 was light headed until the symptoms wore off. He stated since 12/7 afternoon around 4 pm he started to feel better and gain a appetite. Also stated he felt the same symptoms after the 1st dose Shingrix too couldn't recall the date.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Body temperature abnormal, Dizziness, Feeling cold, Flank pain
Clinical narrative: At 11:10 am, I came home after getting the flu shot, which was at 10:50 am. I felt light-headed and my face and lips turned pale. I had to lie on the floor and take deep breaths from passing out. I had to use the restroom, so I crawled towards the restroom and turned more pale and dry heaved. My heart rate slowed down dramatically and so did my temperature. I became weak, shaky, sweaty, and freezing cold. I had side pain while still in the restroom as well. This lasted for 10 minutes. After, I soon became better and gained color back in my face as well as my temperature. I reported what happened 10 minutes after my reaction to Primary Health to report this and to keep on my record.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait inability, Heart rate decreased, Hyperhidrosis, Pallor, Retching
Clinical narrative: At 11:10 am, I came home after getting the flu shot, which was at 10:50 am. I felt light-headed and my face and lips turned pale. I had to lie on the floor and take deep breaths from passing out. I had to use the restroom, so I crawled towards the restroom and turned more pale and dry heaved. My heart rate slowed down dramatically and so did my temperature. I became weak, shaky, sweaty, and freezing cold. I had side pain while still in the restroom as well. This lasted for 10 minutes. After, I soon became better and gained color back in my face as well as my temperature. I reported what happened 10 minutes after my reaction to Primary Health to report this and to keep on my record.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Tremor
Clinical narrative: At 11:10 am, I came home after getting the flu shot, which was at 10:50 am. I felt light-headed and my face and lips turned pale. I had to lie on the floor and take deep breaths from passing out. I had to use the restroom, so I crawled towards the restroom and turned more pale and dry heaved. My heart rate slowed down dramatically and so did my temperature. I became weak, shaky, sweaty, and freezing cold. I had side pain while still in the restroom as well. This lasted for 10 minutes. After, I soon became better and gained color back in my face as well as my temperature. I reported what happened 10 minutes after my reaction to Primary Health to report this and to keep on my record.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: shoulder pain
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity
Clinical narrative: After receiving the vaccine my arm was a little sore but thing to bad. Sunday rolled around and I couldn't move my arm without being in serious pain. The pain got worse as the day went on and ended up leading me to go to the ER. They said there was no infection and there is no reason for me to be in this much pain. They wrote me a prescription for Tylenol and Codeine however it is not helping at all. Its a constant painful ache and when I move it, it feels like a knife is stabbing me in my arm up to my shoulder blade.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Biopsy cervix abnormal, Human papilloma virus test positive, Loop electrosurgical excision procedure, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: At my first pap smear when I was around age 21, it came back abnormal. One year later at my next pap smear, it was abnormal again and we tested for HPV. The HPV test came back positive. I decided to come back after 6 months to monitor the situation as I was close to cervical cancer. After 6 months, my pap smear came back normal. I came back again after 6 months and this time, my pap smear was so abnormal that my OBGYN wanted to do a cervical biopsy that day. The results came back and I was extremely close to having cervical cancer. I had to have a  LEEP surgery to remove the abnormal cells. I will have difficulty getting pregnant now and may go into early labor. When we tested the strain of HPV I had, it was a strain that Gardasil is supposed to protect against.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Discomfort, Erythema, Pain in extremity, Pruritus
Clinical narrative: LARGE, RED, TENDER AREA IN THE RIGHT ARM, DESCRIBED AS ITCHY AND PAINFUL BY THE PATIENT.  AFTER EVALUATION BY THE PHARMACIST WHO ADMINISTERED THE VACCINE, A CELLULITIS WAS SUSPECTED AND THE PATIENT WAS REFERRED TO HER  PRIMARY DOCTOR. PRIMARY DOCTOR DID NOT CONSIDER THE REACTION TO BE A CELLULITIS AND PRESCRIBED DICLOFENAC GEL AND ACETAMINOPHEN TO TREAT THE PATIENTS SYMPTOMS AND DISCOMFORT.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Tenderness
Clinical narrative: LARGE, RED, TENDER AREA IN THE RIGHT ARM, DESCRIBED AS ITCHY AND PAINFUL BY THE PATIENT.  AFTER EVALUATION BY THE PHARMACIST WHO ADMINISTERED THE VACCINE, A CELLULITIS WAS SUSPECTED AND THE PATIENT WAS REFERRED TO HER  PRIMARY DOCTOR. PRIMARY DOCTOR DID NOT CONSIDER THE REACTION TO BE A CELLULITIS AND PRESCRIBED DICLOFENAC GEL AND ACETAMINOPHEN TO TREAT THE PATIENTS SYMPTOMS AND DISCOMFORT.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pruritus, Rash
Clinical narrative: Developed rash on torso, arms, legs and buttocks. Itching
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Patient had had injection site reaction at first dose. With second dose, patient had low-grade fever, body aches, and rash that spread to chest.
Age: 54.0
Sex: F
Vaccine: FLU4, FLU4, VARZOS, VARZOS
Symptoms: Condition aggravated, Migraine, Pain, Pain in extremity
Clinical narrative: Shooting pain into right or left hand; body aches (everywhere, especially back of neck); migraine;
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling, Tenderness
Clinical narrative: pt experienced a tender, palm sized raised bump next day. looks like it is resolving today (day 2)
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Pain, Rhinorrhoea, Skin warm
Clinical narrative: Body aches, runny nose and hoarse voice, felt warm for 3 weeks after flu shot same received on same day. Patient had 500mg tylenol prior to receiving flu shot
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Hot to touch, slight swelling about a quarter in size around injection area, low grade fever for approx. 24 hours
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient reports feeling warm sensation and tenderness to injection site area 4 hours after administration by MOA.  The area proceeded to become painful and formed an area of enduration.  Assessed today 12/8 site is approximately  4x4 inches erythema, area feels hot and enduration of most area of redness; after administration site gave her  depomedrol at 9am.   Dr. evaluated her at 2:30 and was given Rx for keflex 500mg TID for 7 days and topical steroid.  She was also administered 1gram of rocephin IM at 3PM Observed for reactions to antibiotic, no reaction after 15 minutes of observation
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: 24 hours after vaccination, I had a chill (not a shaking chill) and felt some aches -- just not normal 30 hours after vaccination I had a temp of 99.2.  42 hours after vaccination I felt fine
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Lymphadenopathy, Pruritus, Swelling
Clinical narrative: neck and lymph nodes swollen around 9:00 AM on 12/1/2020. Flushing + itching of neck. Patient was given steroids and zyrtec by her PCP.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Gaze palsy, Influenza like illness
Clinical narrative: Felt aches and pains day after vaccination.  Vaccination site was extremely tender and painful.  Had a serious chill in afternoon about 21 hours after vaccination.  Significant headache.  Felt like the flu.  Was very tired.  Took a nap. temperature was 100.9 when I went to bed.  I woke up the next morning Dec 8th feeling better, but still had the headache
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Felt aches and pains day after vaccination.  Vaccination site was extremely tender and painful.  Had a serious chill in afternoon about 21 hours after vaccination.  Significant headache.  Felt like the flu.  Was very tired.  Took a nap. temperature was 100.9 when I went to bed.  I woke up the next morning Dec 8th feeling better, but still had the headache
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headache, aches, low-grade fever (100.8); chills, fatigue
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Skin mass
Clinical narrative: Right thigh subcutaneous erythema.  After erythema resolved, a subcutaneous nodule remains.