chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Feeling of body temperature change, Pyrexia
Clinical narrative: Reaction: 12 hours after receiving the injection, I started to get the chills. I went to bed and literally felt I was on fire all night. I went from burning up to freezing and not until 12 hours later did the fever go away.   Although I don't have the specifics on the first shot, I felt "horrible" with that shot too for 12 hours but did not have the fever like I had the second time.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Feeling cold, Pyrexia
Clinical narrative: Reaction: 12 hours after receiving the injection, I started to get the chills. I went to bed and literally felt I was on fire all night. I went from burning up to freezing and not until 12 hours later did the fever go away.   Although I don't have the specifics on the first shot, I felt "horrible" with that shot too for 12 hours but did not have the fever like I had the second time.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: Skin Rash, Rash, Erythema Multiform & Urticaria Pruritus
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Facial pain, Fall, Headache, Oral pain, Skin laceration
Clinical narrative: About 10 seconds after receiving the flu and Gardasil 9 vaccines, the patient had a syncopal episode. She was seated on the exam table for the vaccines and during the syncopal episode, she fell forward off the exam able and onto the floor. She landed on her face and the front of her body. She was coherent 5 seconds after the event and could state her name and recognized where she was in the doctor's office. After the fall, she complained of pain on her chin, in her mouth and a headache. She had a deep 2 cm laceration on her chin. The wound was cleaned and gauze was applied. I Inspected her mouth but saw no bleeding or teeth abnormalities. After 15 min of monitoring, she was sent to the ER for further evaluation.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: About 10 seconds after receiving the flu and Gardasil 9 vaccines, the patient had a syncopal episode. She was seated on the exam table for the vaccines and during the syncopal episode, she fell forward off the exam able and onto the floor. She landed on her face and the front of her body. She was coherent 5 seconds after the event and could state her name and recognized where she was in the doctor's office. After the fall, she complained of pain on her chin, in her mouth and a headache. She had a deep 2 cm laceration on her chin. The wound was cleaned and gauze was applied. I Inspected her mouth but saw no bleeding or teeth abnormalities. After 15 min of monitoring, she was sent to the ER for further evaluation.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None known
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: C-reactive protein normal, Culture urine negative, Decreased activity, Decreased appetite, Differential white blood cell count normal
Clinical narrative: Patient had decreased feeding and activity from the day after vaccines until calling 911 on 12/13/19  at 5pm and being taken by rescue to the ED due to non responsiveness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electrocardiogram normal, Full blood count normal, Influenza virus test negative, Metabolic function test, Respiratory syncytial virus test negative
Clinical narrative: Patient had decreased feeding and activity from the day after vaccines until calling 911 on 12/13/19  at 5pm and being taken by rescue to the ED due to non responsiveness.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Unresponsive to stimuli, Urine analysis normal
Clinical narrative: Patient had decreased feeding and activity from the day after vaccines until calling 911 on 12/13/19  at 5pm and being taken by rescue to the ED due to non responsiveness.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pain radiating from point of injection up toward neck and down through the arm, severely restricting movement for over two months.  Though my arm is still sore today, movement is much better and pain has decreased.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Feeling abnormal, Injection site pain, Joint stiffness
Clinical narrative: Right arm  became increasingly sore and stiff starting approximately 4 hrs. post vaccination.  The pain and stiffness progressed to all joints  of the body.  I developed a fever and chills during the night and had trouble rising  from the bed during the night.  I was in extreme pain and wished that I could die.  I have never felt so miserable following a vaccination.  I took 650 mg Naproxen Sodium at 3:30 p.m. which did nothing to relieve the joint and muscle pain.  I was somewhat improved by 5:30 a.m., but no longer having chills.  My right shoulder is still sore 26 hrs. later, but I can now raise my elbow above my head.  All of my joints are still painful.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Right arm  became increasingly sore and stiff starting approximately 4 hrs. post vaccination.  The pain and stiffness progressed to all joints  of the body.  I developed a fever and chills during the night and had trouble rising  from the bed during the night.  I was in extreme pain and wished that I could die.  I have never felt so miserable following a vaccination.  I took 650 mg Naproxen Sodium at 3:30 p.m. which did nothing to relieve the joint and muscle pain.  I was somewhat improved by 5:30 a.m., but no longer having chills.  My right shoulder is still sore 26 hrs. later, but I can now raise my elbow above my head.  All of my joints are still painful.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, induration, soreness, skin hot to touch, area around vaccine with positive swelling (width -  2x 4  " Length)  to be monitored x 24 hours .   Emergency room if symptoms worsens.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Patient came into the pharmacy on 12/14/19.  She said her flu shot was very painful.  She said she has had  nerve pain in her right arm since receiving immunization.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Influenza like illness, Respiratory tract congestion
Clinical narrative: 1:17 PM shot 10PM EST could not breathe Went to ER 9:24 CST 3 weeks after Senior shot. I sick w/flu like-Congestion, Coughing-went to Dr - Did not have flu but badley congested. Gave me medicine 3 weeks later I was ok
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Numbness to right side of face, Hives/bloches red to face & chest. Heaviness to chest, shortness of breath, dizziness, headaches.
Age: 46.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash macular, Urticaria
Clinical narrative: Numbness to right side of face, Hives/bloches red to face & chest. Heaviness to chest, shortness of breath, dizziness, headaches.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got first dose at 15 years of age, second dose at 17 years of age; This spontaneous report has been received from a registered nurse, concerning a 17- years-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date (reported as when the patient was 15 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. Furthermore, on an unknown date (reported as when the patient was 17-years-old), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration).
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Patient did not experience an adverse reaction. A pediatric dosage of Hep B was given to an adult patient.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I have been diagnosed with Shingles on 12/17/2019 after having the Shingle shot on 12/11/2019.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Lethargy, Pyrexia, Vomiting
Clinical narrative: vomiting and diarrhea for about 8 hours, lethargy, fever
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Slight fever, chills, body aches
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Pain in extremity, Wrong technique in product usage process
Clinical narrative: She said her arm been hurting and haven't been able to move it.  She said she got an MRI today and the MRI says it there is damaged do to the vaccine going too deep.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had edema in injection site w/ swelling, redness, and warmth down to elbow.  Edema in Deltoid area resolved with in 4 days but continued to have mild edema and light pink to red area in elbow area with normal skin temp,  4 days after injection when seen in office.  Swelling is not resolved after 4 days but is resolving without additional treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Intermittent burning sensation in a circular area approximately 4" in diameter on client's right upper side between axillary and subscapular areas. Client denies erythema or other discoloration, rash, or induration; reports skin to be intact. Client reports sensation to be improving; worsened when clothing rubs against impacted area.   Initial side effects experienced starting 12/3/19 and resolved by 12/4/19 included: Feeling feverish, fatigue, erythema & induration at injection site, and flu-like symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Intermittent burning sensation in a circular area approximately 4" in diameter on client's right upper side between axillary and subscapular areas. Client denies erythema or other discoloration, rash, or induration; reports skin to be intact. Client reports sensation to be improving; worsened when clothing rubs against impacted area.   Initial side effects experienced starting 12/3/19 and resolved by 12/4/19 included: Feeling feverish, fatigue, erythema & induration at injection site, and flu-like symptoms.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Middle insomnia, Pain
Clinical narrative: Patient called the pharmacy and stated that she developed increasing levels of pain in her left shoulder after receiving the Boostrix.  She stated that the pain radiates from the shoulder down the front of her bicep from the should to elbow joint causing severe discomfort.  She also stated that she is having trouble raising her arm and the pain wakes her up at night.  Patient has not received medical attention for this problem.
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: pt has ahd arm related pain since a few days after her vaccine was administered and it is not getting better
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased eye contact, Lethargy, Unresponsive to stimuli
Clinical narrative: The baby was lethargic and would only sleep and breastfeed for 5 days following the vaccines. He also wouldn't make eye contact, smile or interact/respond to verbal stimuli for approximately 5 weeks. He did not respond to his parents, noises, toys, etc. Prior to the administration of the vaccines he had started to smile and make eye contact.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Injection site rash
Clinical narrative: I became tired already about 15-30 minutes after the IM injection, and then had to lie down and sleep, for 3-4 hours, immediately after my 15 minute drive home from the Dr. visit.  I developed a fever, up to 102 degrees, that evening and the next day.  I was tired, weak, and lost appetite for the next 24 hours. A rash developed and covered my right upper arm (see photo), centered on the injection site. I had a mild headache. At 48 hours after the vaccination, I started feeling a little better, and on the 4th day after the vaccination I could take a short walk outside the house. The skin rash disappeared after 4-5 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Somnolence
Clinical narrative: I became tired already about 15-30 minutes after the IM injection, and then had to lie down and sleep, for 3-4 hours, immediately after my 15 minute drive home from the Dr. visit.  I developed a fever, up to 102 degrees, that evening and the next day.  I was tired, weak, and lost appetite for the next 24 hours. A rash developed and covered my right upper arm (see photo), centered on the injection site. I had a mild headache. At 48 hours after the vaccination, I started feeling a little better, and on the 4th day after the vaccination I could take a short walk outside the house. The skin rash disappeared after 4-5 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Chills, fatigue, nausea, muscle soreness
Sex: F
Vaccine: VARZOS
Symptoms: Acute disseminated encephalomyelitis, Brain injury, Herpes zoster, Loss of personal independence in daily activities, Pain
Clinical narrative: ADEM; The patient suffered debilitating injuries including an outbreak of painful shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. On 12-AUG-2012, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster) in a pharmacy. Approximately in February 2013, six months after receiving zoster vaccine live (ZOSTAVAX), the pt suffered debilitating injuries including an outbreak of painful shingles and a diagnosis of acute disseminated encephalomyelitis (ADEM) as a result of the vaccine. These injuries caused severe brain injuries which incapacitated Plaintiff and caused her to be housed at an assisted living center where she received 24-hour supervision and caregiving. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Additionally, the pt sustained severe and permanent personal injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of ADEM and shingles were considered as not recovered. The reporter considered ADEM and shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of ADEM was determined to be medically significant. The reporters considered ADEM and shingles to be disabling.
Age: 46.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: possible expired dose of Typhim Vi was administered to patient, No AE; expiry date illegible on syringe label, no AE; Initial information received on 29-Oct-2019 and additional information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 46 years old male patient who received an expired 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The medical history, medical treatments, vaccinations and family history were not provided.   On 25-Oct-2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Injection Suspension, lot N1K811M Expiry date: 19-Nov-2019) via unknown route in the left deltoid.  It was a case of an actual medication error due to expired vaccine used.  It was also a case of Product expiration date illegible.  At the time of report no adverse event was reported.  PTC Number: 100005853 Batch number: N1K811M Expiry date: 19-Nov-2019 Sample Status: Not Available. Issue status: in process  The nurse reported that the administering Medical Assistant (MA) did not know the expiration date due to the date on the syringe appeared to be smudged and the box the syringe was taken out of was not located; that the date was either 19Oct2019 or 29Oct2019; that the MA reported the date to be smudged but the syringe was disposed before anyone else could see the syringe; that the date was looked at after the injection was given.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Urticaria, Vaccination site inflammation
Clinical narrative: they had injection site redness, with warmth to touch and one of them said that the redness; injection site warmth; injection site redness; hives spread down their arm; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case from a consumer (Office Staff).  This case is linked to cases 2019SA322706 and 2019SA327309.  This case involves female (age not reported) patient who had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation) with its symptoms injection site redness (vaccination site erythema), injection site warmth (vaccination site warmth) and hives spread down their arm (vaccination site urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6719KA and expiry date: 30-Jun-2020) via unknown route in unknown administration site.  On an unknown date, the patient who had injection site redness, with warmth to touch and one of them said that the redness (vaccination site inflammation) with its symptoms injection site redness (vaccination site erythema), injection site warmth (vaccination site warmth) and hives spread down their arm (vaccination site urticaria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  (Other relevant tests included No lab data..)  Final diagnosis was vaccination site urticarial and vaccination site inflammation.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for all events.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: severe hives; Initial information received on 25-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient who experienced severe hives (urticaria), while she received vaccine INFLUENZA VACCINE..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing corn allergies.  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 unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious severe hives (urticaria) (Unknown latency) following the administration of INFLUENZA VACCINE. It was reported that, The reaction drives her crazy and therefore she did not receive another flu shot.  No lab data was reported.  Final diagnosis was urticarial.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for urticarial.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: sore arm after receiving a flu shot; Their arm is sore and hard to lift up; felt the injection burning; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case from a consumer (Physicians Assistant).  This case involves a 70 years old female patient who experienced sore arm after receiving a flu shot (pain in extremity), arm is sore and hard to lift up (injected limb mobility decreased) and injection burning as it went in and it has not gone away (vaccination site pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ285AB and expiry date: 06-May-2020) via unknown route in unknown administration site.  On an unknown date, the patient experienced sore arm after receiving a flu shot (pain in extremity), felt the injection burning as it went in and it has not gone away (vaccination site pain) and arm is sore and hard to lift up (injected limb mobility decreased) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab data was reported.  Final diagnosis was pain in extremity, injected limb mobility decreased and vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as not recovered for all events.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: an expired dose of IPOL was given/no AE; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demography who received vaccine IPV (VERO) [IPOL] and reported that an expired dose of Ipol was given/no AE (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 04-Dec-2019, the patient received a dose of suspect 0.5 ml IPV (VERO) lot N1K921M and expiry date: 14-Nov-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was not reported whether the patient had any adverse effect.  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: U
Vaccine: HIBV, IPV
Symptoms: Product storage error
Clinical narrative: excursion involved UnOpened Vaccine Ipol given to a patient, excursion was 50.4 degrees F. x 30 minutes; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves the patient of unknown demography who she received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] and reported that excursion involved unopened vaccine Ipol given to a patient, excursion was 50.4 degrees F. x 30 minutes (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 22-Oct-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ076AAA and expiry date: 21-Aug-2020 via unknown route in unknown administration site.  On 22-Oct-2019, the patient received a dose of suspect IPV (VERO) lot P1A251M and expiry date: 02-May-2020 via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse event.  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: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm was really sore; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient (age not reported) who experienced really sore arm (Pain in extremity), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Dec-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious arm was a little sore (Pain in extremity), unknown latency following the administration of INFLUENZA VACCINE. It was reported that her arm was a little sore the first day. On day 2, she reported that her arm was really sore, causing her concern.  Other relevant tests not reported.    Final diagnosis was Pain in extremity.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for Pain in extremity.  Information on the batch number was requested.
Sex: M
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dysuria, Micturition urgency, Muscular weakness
Clinical narrative: aggravating his COPD; aggravating his COPD; rash on his torso, arm and the back of his shoulders; felt the need to urinate but could not, , he had a burning feeling; prostate stated giving trouble; bronchial problems; muscle weakness; stomach is queasy; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 73 years old male patient who experienced aggravating his COPD (Chronic obstructive pulmonary disease), rash on his torso, arm and the back of his shoulders (rash), muscle weakness (Muscular weakness), felt the need to urinate but could not, had a burning feeling (Dysuria), stomach is queasy (nausea) and prostate stated giving trouble (Prostatic disorder NOS), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious aggravating his COPD (chronic obstructive pulmonary disease), rash on his torso, arm and the back of his shoulders (rash), muscle weakness (muscular weakness), felt the need to urinate but could not, he had a burning feeling (dysuria), stomach is queasy (nausea), prostate stated giving trouble (Prostatic disorder NOS) and bronchial problems (bronchial disorder) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was Chronic obstructive pulmonary disease, rash, Muscular weakness, Dysuria, nausea and Prostatic disorder NOS.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Prostatic disorder, Rash, Urinary retention
Clinical narrative: aggravating his COPD; aggravating his COPD; rash on his torso, arm and the back of his shoulders; felt the need to urinate but could not, , he had a burning feeling; prostate stated giving trouble; bronchial problems; muscle weakness; stomach is queasy; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 73 years old male patient who experienced aggravating his COPD (Chronic obstructive pulmonary disease), rash on his torso, arm and the back of his shoulders (rash), muscle weakness (Muscular weakness), felt the need to urinate but could not, had a burning feeling (Dysuria), stomach is queasy (nausea) and prostate stated giving trouble (Prostatic disorder NOS), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious aggravating his COPD (chronic obstructive pulmonary disease), rash on his torso, arm and the back of his shoulders (rash), muscle weakness (muscular weakness), felt the need to urinate but could not, he had a burning feeling (dysuria), stomach is queasy (nausea), prostate stated giving trouble (Prostatic disorder NOS) and bronchial problems (bronchial disorder) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was Chronic obstructive pulmonary disease, rash, Muscular weakness, Dysuria, nausea and Prostatic disorder NOS.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for all the events.  Information on the batch number was requested.
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Parkinson's disease
Clinical narrative: Patient suffered an exacerbation of her Parkinson's after receiving this season's Fluzone Quadrivalent; Initial information was received on 05-Dec-2019 regarding an unsolicited valid serious case from a pharmacist.  This case involves female patient (age unknown) who experienced exacerbation of Parkinson's (parkinsonism), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history included Parkinson's disease. The patient's past vaccination included FLUZONE QUADRIVALENT.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number lot number and other dosing details were not reported] via unknown route in unknown administration site.  On an unknown date, the patient experienced exacerbation of Parkinson's (parkinsonism), (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  Final diagnosis was exacerbation of Parkinson's.   It was not reported if the patient received a corrective treatment.  The patient outcome was unknown for exacerbation of Parkinson's.  Information on the batch number was requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: 4-year old consumer that received the Fluzone Quadrivalent in subcutaneously with a one-inch needle, no AE; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UJ305AA via subcutaneous route in the right arm on 09-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was a case of actual medication error due to Inappropriate route of vaccination.  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: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site paraesthesia
Clinical narrative: TINGLING FROM THE INJECTION SITE RADIATING DOWN TO THE ELBOW HAPPENING INTERMITTENTLY FROM 10/8/19 AND CONTINUING THROUGH THE TIME OF REPORTING THE EVENT (12/17/19)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Soreness, Swelling, Redness
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: redness and swelling at the site, warm to the touch, no fever, some itching
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Hypopnoea, Mydriasis, Pallor
Clinical narrative: Pt became light headed, pale, diaphoretic. Pt eyes became dilated and fixed and unresponsive to external stimuli. . Breathing rapid and shallow. Pulse weak and thready.  Assisted to floor, feet elevated. P-72 BP 106/70. Recovered after few minutes. Pt observed in health department for approx. 20 minutes before release home with mother.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pulse abnormal, Pupil fixed, Respiratory rate increased, Unresponsive to stimuli
Clinical narrative: Pt became light headed, pale, diaphoretic. Pt eyes became dilated and fixed and unresponsive to external stimuli. . Breathing rapid and shallow. Pulse weak and thready.  Assisted to floor, feet elevated. P-72 BP 106/70. Recovered after few minutes. Pt observed in health department for approx. 20 minutes before release home with mother.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: arm became red, swollen, and very painful-lasted for about 4 days then gradually improved
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Insomnia, Limb discomfort, Pain
Clinical narrative: Patient's arm via phone picture was very red and inflammed around injection site (area was large, covered most of arm above elbow) for more than 7 days. Patient stated it was very painful, and she could not sleep because of pain. She also said that her hand on that arm felt "very heavy". It has gone away now.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: lip swelling 20 minutes after receiving vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Patient stated that Shingrix caused a swollen, red spot on her arm that was slightly painful.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A Kinrix was given instead of a Pediarix.  Does was fine, pt was fine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Impaired work ability, Injection site pain
Clinical narrative: Fatigue bad enough to miss 2 days off work.  Strong muscle soreness at injection site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Ear pain, Nasal congestion, Oropharyngeal pain, Urticaria
Clinical narrative: Experienced urticaria on neck, axillas, waist resolved on own after 24 hours.  Concurrent respiratory complaints of nasal congestion , cough , ear pain, sore throat which began 2 days after vaccine
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: pt had redness and swelling on right arm described as hives per the provider, kids Benadryl 12.5mg was given.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Patient came in 12/17/19 complaining  of pain after the shot which radiates down his arm and up to his neck sometimes; said it started after he had the shingles vaccine. He did not notice any bruising, just pain.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: PATIENT DEVELOPED SWELLING AND DISCOLORED RIGHT ARM AND FEVER ON 10/21/2019
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Dizziness, Feeling abnormal
Clinical narrative: Shooting aches and pains in joints, general malaise, headache, shivers, fever, dizzy, stomach upset. Felt very bad all night the first night, all day the second day.  Worse than a flu feeling.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Shooting aches and pains in joints, general malaise, headache, shivers, fever, dizzy, stomach upset. Felt very bad all night the first night, all day the second day.  Worse than a flu feeling.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abnormal behaviour, Decreased eye contact, Diarrhoea, Feeling abnormal, Pain
Clinical narrative: Approximately 5 hours after my son, 6 weeks old at the time, had his wellness visit and all his vaccines, he started to sleep very heavily, he was unresponsive, he woke to projectile vomit and it was highly unusual, he was burning up with a fever (the fever was below the offices recommended rate at when you would bring him to the emergency room), he was having projectile diarrhea. He was obviously having severe reactions to the vaccines, I didn't know it until I asked fellow mothers who have gone through this same experience. I called the emergency line at approximately midnight, nearly 10 hours after the vaccines, at this point he was not waking up without me forcefully waking him so he wouldn't fall into a deep sleep, at times he would not wake up even to me saying his name and gently nudging him and patting his back, etc, he is an exclusively breast fed baby that has ALWAYS nursed on demand, he has ALWAYS woke every 2 hours to nurse, this is how I knew immediately that something was very, very wrong during the first 5 to 10 hrs, when I got through to the emergency doctor on the emergency line, she shrugged off all my concerns, she told me THIS WAS NORMAL, she said I was a "first time mom" and that I was over reacting and panicking for no reason etc, I told her this is not normal and I know my son's patterns, behavior, and his routine. She told me to give him Tylenol which is known to cause more extreme and adverse side effects after vaccines. I told her it didn't seem right, she told me to do it and he would be fine, I did not give him Tylenol because his immune sytem would not be able to fight the fever or clear the new toxins present if I gave him that dose of Tylenol as she suggested. They still have that recording and I will ask them to pull that recording if need be, to prove that this doctor dismissed these huge issues, she downplayed his adverse reactions to the vaccines, she mocked me, then proceeded to tell me she's "been doing this for 40+ years" that she knows what she's talking about, etc.. I did not bring my son to the E.R., I nursed him and I stayed away the entire week, I did not sleep, because I knew if I slept that my son would not wake back up ever again, he was very close to death after these vaccines, it took a full week for him to slowly come back to normal, he would not look us in the eyes like he did prior to the vaccines, he was groggy and zombie like, he was sluggish and unresponsive, he would do blood curdling screams towards the end of the week, as if he was in pain, my poor son went through more than any child should endure at the young age of 6 weeks, it's sad our family went through this and my son endured this after we knew that this seemed wrong.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Screaming, Sluggishness, Somnolence, Unresponsive to stimuli
Clinical narrative: Approximately 5 hours after my son, 6 weeks old at the time, had his wellness visit and all his vaccines, he started to sleep very heavily, he was unresponsive, he woke to projectile vomit and it was highly unusual, he was burning up with a fever (the fever was below the offices recommended rate at when you would bring him to the emergency room), he was having projectile diarrhea. He was obviously having severe reactions to the vaccines, I didn't know it until I asked fellow mothers who have gone through this same experience. I called the emergency line at approximately midnight, nearly 10 hours after the vaccines, at this point he was not waking up without me forcefully waking him so he wouldn't fall into a deep sleep, at times he would not wake up even to me saying his name and gently nudging him and patting his back, etc, he is an exclusively breast fed baby that has ALWAYS nursed on demand, he has ALWAYS woke every 2 hours to nurse, this is how I knew immediately that something was very, very wrong during the first 5 to 10 hrs, when I got through to the emergency doctor on the emergency line, she shrugged off all my concerns, she told me THIS WAS NORMAL, she said I was a "first time mom" and that I was over reacting and panicking for no reason etc, I told her this is not normal and I know my son's patterns, behavior, and his routine. She told me to give him Tylenol which is known to cause more extreme and adverse side effects after vaccines. I told her it didn't seem right, she told me to do it and he would be fine, I did not give him Tylenol because his immune sytem would not be able to fight the fever or clear the new toxins present if I gave him that dose of Tylenol as she suggested. They still have that recording and I will ask them to pull that recording if need be, to prove that this doctor dismissed these huge issues, she downplayed his adverse reactions to the vaccines, she mocked me, then proceeded to tell me she's "been doing this for 40+ years" that she knows what she's talking about, etc.. I did not bring my son to the E.R., I nursed him and I stayed away the entire week, I did not sleep, because I knew if I slept that my son would not wake back up ever again, he was very close to death after these vaccines, it took a full week for him to slowly come back to normal, he would not look us in the eyes like he did prior to the vaccines, he was groggy and zombie like, he was sluggish and unresponsive, he would do blood curdling screams towards the end of the week, as if he was in pain, my poor son went through more than any child should endure at the young age of 6 weeks, it's sad our family went through this and my son endured this after we knew that this seemed wrong.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vaccination complication, Vomiting projectile
Clinical narrative: Approximately 5 hours after my son, 6 weeks old at the time, had his wellness visit and all his vaccines, he started to sleep very heavily, he was unresponsive, he woke to projectile vomit and it was highly unusual, he was burning up with a fever (the fever was below the offices recommended rate at when you would bring him to the emergency room), he was having projectile diarrhea. He was obviously having severe reactions to the vaccines, I didn't know it until I asked fellow mothers who have gone through this same experience. I called the emergency line at approximately midnight, nearly 10 hours after the vaccines, at this point he was not waking up without me forcefully waking him so he wouldn't fall into a deep sleep, at times he would not wake up even to me saying his name and gently nudging him and patting his back, etc, he is an exclusively breast fed baby that has ALWAYS nursed on demand, he has ALWAYS woke every 2 hours to nurse, this is how I knew immediately that something was very, very wrong during the first 5 to 10 hrs, when I got through to the emergency doctor on the emergency line, she shrugged off all my concerns, she told me THIS WAS NORMAL, she said I was a "first time mom" and that I was over reacting and panicking for no reason etc, I told her this is not normal and I know my son's patterns, behavior, and his routine. She told me to give him Tylenol which is known to cause more extreme and adverse side effects after vaccines. I told her it didn't seem right, she told me to do it and he would be fine, I did not give him Tylenol because his immune sytem would not be able to fight the fever or clear the new toxins present if I gave him that dose of Tylenol as she suggested. They still have that recording and I will ask them to pull that recording if need be, to prove that this doctor dismissed these huge issues, she downplayed his adverse reactions to the vaccines, she mocked me, then proceeded to tell me she's "been doing this for 40+ years" that she knows what she's talking about, etc.. I did not bring my son to the E.R., I nursed him and I stayed away the entire week, I did not sleep, because I knew if I slept that my son would not wake back up ever again, he was very close to death after these vaccines, it took a full week for him to slowly come back to normal, he would not look us in the eyes like he did prior to the vaccines, he was groggy and zombie like, he was sluggish and unresponsive, he would do blood curdling screams towards the end of the week, as if he was in pain, my poor son went through more than any child should endure at the young age of 6 weeks, it's sad our family went through this and my son endured this after we knew that this seemed wrong.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient said her whole upper arm was red and swollen. It was not hot. She also said her arm hurt. The injection was given on Sunday the 8th. The reaction was there when she woke up on the 9th and was gone on the the 11th.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Flu like symptoms, very sore arm, feverish and the next day my arm tingles and has since then.  Feels like it's going to sleep many times per day.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hypersensitivity, Paraesthesia
Clinical narrative: Patient had an allergic reaction to the flu immunization and had to receive treatment at the ER. She was given prednisone and Benadryl. After vaccination patient reported feeling light headed and tingling in her arm.