chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Autonomic nervous system imbalance, Malaise, Mental disability, Physical disability
Clinical narrative: dysautonomia; permanently mentally disabled; permanently physically disabled; sick; Initial information received on 23-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who experienced dysautonomia (autonomic nervous system imbalance), permanently mentally disabled (mental disability), permanently physically disabled (physical disability), sick (illness) when received INFLUENZA VACCINE.  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 VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious dysautonomia (autonomic nervous system imbalance) 2-months following the administration of INFLUENZA VACCINE.   On an unknown date, the patient developed a serious permanently mentally disabled (mental disability), permanently physically disabled (physical disability), sick (illness) unknown latency following the administration of INFLUENZA VACCINE.   These events were leading to disability.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of the events were not recovered (now permanently physically and mentally disabled).   Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who suffered from autonomic nervous system imbalance, mental disability, physical disability and illness after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was compatible. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Crying, Decreased appetite, Diarrhoea, Fatigue, Irritability
Clinical narrative: My baby was not drinking the next day, he was very tired and was crying for the entire day. Very irritable, he was vomiting and had a lot of diarrhea. He was getting worse by the day and on the 17th of July I took him to the hospital and they found out he had rotavirus.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Rotavirus infection, Vomiting
Clinical narrative: My baby was not drinking the next day, he was very tired and was crying for the entire day. Very irritable, he was vomiting and had a lot of diarrhea. He was getting worse by the day and on the 17th of July I took him to the hospital and they found out he had rotavirus.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: The patient got the symptoms and also got guillian barre in some instances; Initial information was received on 23-Oct-2020 regarding an unsolicited valid serious social media case from a consumer via social media.    This case involves a patient who got the symptoms and got Guillian Barre in some instances (Guillain-Barre syndrome), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, vaccinations, 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious gullain-barre (Guillain-Barre syndrome), unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented social media case concerns a patient with unknown demography who got Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient didn't have any adverse reactions. Patient was given an extra dose of these vaccines as it was not yet in System and mother of child did not have patients vaccine record.
Age: 73.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Blood test normal, Pain, Pain in extremity
Clinical narrative: Pain in both arms after injections. Patient states pain has increased over the past 2 months since vaccinations. Has pain when lifting even small objects. She states pain is not constant, but comes and goes.
Sex: M
Vaccine: FLU4
Symptoms: Injection site abscess
Clinical narrative: abscess at injection site; Initial information was received on 26-Oct-2017 regarding an unsolicited valid serious case from a other health professional.  This case involves a 50 year old male patient who had an abscess at injection site (vaccination site abscess), while he received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 27-Sep-2017, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT5911NA, expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  On 02-Oct-2017, the patient developed a serious abscess at injection site (vaccination site abscess) 5 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was hospitalized for this event.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the event was recovering.; Sender's Comments: This case concerns 50 year old male patient who had vaccination site abscess after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies, safety of the vaccination procedure would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Myalgia, Nausea, Thirst
Clinical narrative: approximately 12 hours after injection developed flu like symptoms- rigors, chills, myalgia, malaise, nausea, excessive thirst, but what concerned her more was she had a presyncopal episode. did no lose consciousness but describes acute onset "tunnel vision, ringing in ears" so laid on the ground on her side and the symptoms subsided after 20 minutes or so
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Tunnel vision
Clinical narrative: approximately 12 hours after injection developed flu like symptoms- rigors, chills, myalgia, malaise, nausea, excessive thirst, but what concerned her more was she had a presyncopal episode. did no lose consciousness but describes acute onset "tunnel vision, ringing in ears" so laid on the ground on her side and the symptoms subsided after 20 minutes or so
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was reconstituted only with the liquid portion, no AE; Initial information regarding an unsolicited valid non-serious case received from other healthcare professional via The Agency (Reference number- 00328233) and transmitted to Sanofi on 22-Oct-2020.  This case involves a patient (age and gender not reported) who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number U6841SAA and expiry date 22-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination where PENTACEL was reconstituted only with the liquid portion (product preparation issue), in Oct-2020.  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  This was an actual medication error case due to inappropriate reconstitution technique (latency same day).  It was reported that medical assistant (MA) called with concern if Pentacel was reconstituted only with the liquid portion. MA had a follow up question how can she obtain a proper diluent. MA was advised that there was no recommendation in obtaining proper diluent. MA also asked how are they going to make sure it was documented properly now because when she enter another HIB dose, it does not count as first one because Pentacel was documented, unless they document it separately. She then proceeded to say that she has other doses of HIB like PVAX HIB and asked that if she gives the dose, was the consumer protected or was the dose valid.   At the time of reporting, no adverse event was reported.  Disclaimer: 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: 12.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, VARCEL
Symptoms: Disorientation, Dyskinesia, Eye movement disorder, Hyperhidrosis, Syncope
Clinical narrative: Pt. fainted when leaving office. Noted on floor by nurse.  No notification of changes in feeling to staff or visitors prior to fainting. Jerking movements , eye roll, sweating, disorientation noted.  Duration less than one minute.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Fluzone HD by mistake today and she is only 64 yrs old with no AE; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years old female patient who received a 0.7 ml dose of an INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ512AB, expiry date: 30-Jun-2021) via intramuscular route in the left arm on 23-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  Disclaimer: 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: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain, Vaccination site warmth, Wrong product administered
Clinical narrative: this one hurt more than ever; the whole area is hot to the touch; patient recieved Fluzone High Dose Quadrivalent  instead of Fluzone Quadrivalent; patient recieved Fluzone High Dose Quadrivalent  instead of Fluzone Quadrivalent; Initial information received on 04-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 57 years old female patient who experienced hurt more than ever (vaccination site pain) and the whole area is hot to the touch (vaccination site erythema), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccinations included flu shot every year and used to get allergy shots and it hurts her .  Medical history, medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Hepatic cancer 7 years ago. She has experienced two recurrences of the cancer with the last recurrence being 3.5 years ago..   On 02-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE instead of INFLUENZA QUADRIVAL A-B VACCINE (0.5/ 0.7 ml [unclear], lot number not reported via unknown route in the right arm for prophylactic vaccination.  It was also a case of actual medication error due to wrong vaccine administration and  inappropriate age at vaccine administration (PT: Wrong product administered and product administered to patient of inappropriate age) (same day latency).  On an unknown date, the patient developed non-serious events of hurting (vaccination site pain) and the whole area is hot to the touch (vaccination site warmth) (unknown latency)  following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: C-reactive protein increased, Full blood count normal, Lymphadenopathy, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient reported experiencing a severely painful, stiff neck two hours after the injection on 11/30/20. She then started experiencing swollen neck lymph nodes as well as a sore throat and fever that started on Tuesday morning (12/1/2020). She had 100.8 fever (at it's highest) that lasted until the evening of 12/3/20.  Patient has been taking OTC Tylenol q6h, which helped with the pain, but not her fever. Patient presented to her Primary care physician's office on Wednesday (12/2/20). She was tested for strep at that time, it was negative. Bloodwork (Including C-reactive protein-5.1, CBC-normal, Sedimentation Rate-7.0) was also done at that time. Patient is to follow up with her PCP on  the afternoon of 12/4/20
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test
Clinical narrative: Patient reported experiencing a severely painful, stiff neck two hours after the injection on 11/30/20. She then started experiencing swollen neck lymph nodes as well as a sore throat and fever that started on Tuesday morning (12/1/2020). She had 100.8 fever (at it's highest) that lasted until the evening of 12/3/20.  Patient has been taking OTC Tylenol q6h, which helped with the pain, but not her fever. Patient presented to her Primary care physician's office on Wednesday (12/2/20). She was tested for strep at that time, it was negative. Bloodwork (Including C-reactive protein-5.1, CBC-normal, Sedimentation Rate-7.0) was also done at that time. Patient is to follow up with her PCP on  the afternoon of 12/4/20
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pyrexia
Clinical narrative: Patient developed a large knot about the size of a softball she says and developed a fever lasting 2 days, she notified me about this today.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1-2 inches below injection site, small red swollen patch of skin. Warm to the touch, raised, and tender like a bruise. Size of the affected area began to grow over next 24-48 hrs, to about 3 inches in diameter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Temperature of 101 degrees F, Body Aches. Patient took Tylenol and symptoms relieved in the morning.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration unknown) for the long-term prevention of shingles and/or zoster-related conditions at the pharmacy. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2015, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Dysphagia
Clinical narrative: The customer reported they had a 2 month old patient who received a dose of ROTATEQ (date unknown) and had difficulty swallowing the oral dose.; No other AE.; This spontaneous report was received from a medical assistant via a company representative, referring to a 2-months-old female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered by oral route, as prophylaxis (formulation, strength, vaccination scheme, lot number and expiration date were not reported), at this time; the patient had difficulty swallowing the oral dose (product use complaint). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE; was inadvertently administered an expired dose of ROTATEQ; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not reported.  On 02-DEC-2020, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliters (ml) by oral route lot # 1660951, with an expiration date on 11-NOV-2020 for prophylaxis (strength was not reported).   No additional adverse event was reported.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: My arm is still really sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In November 2020, the patient received the 2nd dose of Meningococcal B vaccine. In November 2020, less than a week after receiving Meningococcal B vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Meningococcal B vaccine and experienced sore arm.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia / which lasted 6 months; This case was reported by a physician via call center representative and described the occurrence of post herpetic neuralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was recovered/resolved.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient had shingles or post herpetic neuralgia. At the time of vaccination the post herpetic neuralgia had completely resolved. The day after her first dose of Shingrix she experienced a recall of her post herpetic neuralgia in the exact same area, which lasted 6 months. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves patient (unknown demographics) who got sick (illness), when received INFLUENZA VACCINE.  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 VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (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 illness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to cases 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173, 2020SA294125 and 2020SA294145 (same reporter).  This case involves a patient of unknown demographics who got flu (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, 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 (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu (Influenza) (non-serious event) 12 hrs 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 report, the outcome was unknown for the event.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick so many times; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to cases 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173 and 2020SA294145 (same reporter).  This case involves a patient of unknown demographics who got sick so many times (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), 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 (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick so many times (illness) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient was recovered from the event.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA300020.  This case involves a female patient age not reported who experienced flu (influenza), while she received INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, 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 (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) one week following the administration of INFLUENZA VACCINE.  It was reported that she lived 83 years without getting the flu, but got a flu shot got the flu a week and only reason she got one then because she was in nursing home.  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: very sick for a week or more.; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA306301, 2020SA302198, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308033 and 2020SA308034 (same source).  This case involves elderly patient (unknown age and gender) who was very sick for a week or more (illness), while the patient 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 was very sick for a week or more (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: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Gaze palsy, Myalgia, Pyrexia
Clinical narrative: 18 hours after injection - light fever, headache, and minor muscle aches in back of thighs. Patient has had similar reactions to other vaccines previously. Taking bed rest with increased protein and fluid intake.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: flu-type symptoms for 2 weeks ( exhaustion, vomiting, headache, loss of appetite, fever- accompanied w pain in left arm around the injection site, Today the pain can escalate  to a 8 out of 10, off and on during the day and will wake her at night.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: flu-type symptoms for 2 weeks ( exhaustion, vomiting, headache, loss of appetite, fever- accompanied w pain in left arm around the injection site, Today the pain can escalate  to a 8 out of 10, off and on during the day and will wake her at night.
Age: 50.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Impaired work ability, Night sweats, Pruritus, Pyrexia
Clinical narrative: Mild fever, night sweats, tiredness, raised itchy red welts all over the body.  Effects lasted 2 days.   No treatment used other than time off from work and lots of sleep.
Age: 50.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Mild fever, night sweats, tiredness, raised itchy red welts all over the body.  Effects lasted 2 days.   No treatment used other than time off from work and lots of sleep.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: get sick as a dog; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient (unknown demography) who get sick as a dog (illness), while the patient received vaccine INFLUENZA VACCINE.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA307452, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308033, 2020SA306301 and 2020SA302198 (same source).  The patient's past vaccination(s) included INFLUENZA VACCINE. Medical history, medical treatment(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 developed non-serious get sick as a dog (illness) (about a month later) following the administration of INFLUENZA VACCINE.  It was reported that, if patient not take flu shot get a mild case of flu if at all that's why patient was not taking flu  shot from last 33 years.  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: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Laboratory test normal, Sinus tachycardia, Vertigo
Clinical narrative: Did not have AE to first Shingrix shot.  Patient administered 2nd Shingrix to L arm on 12/01/2020. By 16:30, patient heartrate increased. Went for a run and never got the taccycardia down; above 140BPM. Have never had experienced event like this. Patient went to ER. They administered medication to lower heart rate. BP 155/100. Sinus Taccycardia, vertigo. Heartrate was in and out of taccycardia on 12/2/2020. By 12/4/2020 it was much better;Resting HR has been in the 80's (normal is the 50's). Patient 'slowly feeling like going back to normal'.   Had flu shot well before 30 days shingrix, 2nd dose.
Sex: U
Vaccine: FLU3
Symptoms: Illness, Influenza like illness, Malaise
Clinical narrative: It sure felt like the flu when I was so, so sick after I took one; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient) via Media through social media.  This case involves a patient of unknown age who was sure felt like the flu when patient was so, so sick after patient took one (illness), while patient was treated with influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient who was sure felt like the flu when patient was so, so sick after patient took one (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: almost die from it after I got the shot; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious social media case from the patient via Social medial.  This case involves a patient of unknown demographics who reported of dying from it after the shot (vaccination complication) while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient who reported of dying from it after the shot (vaccination complication), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Coronavirus infection, Cough, Dyspnoea
Clinical narrative: Corona virus infection; hardly breath; coughing every breath; Initial information received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had corona virus infection (coronavirus infection), hardly breath (dyspnea) and coughing every breath (cough), when received vaccine 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (reported as within a few days), the patient had non-serious event corona virus infection (coronavirus infection), hardly breath (dyspnea) and coughing every breath (cough)  following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   Patient was received breathing treatment, steroid shot, antibiotic shot, prescribed 10 days of antibiotics and a inhaler. It was rough. The patient was due for flu shot, not looking forward to it.  At the time of report, the outcome of events was unknown.   There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu; Initial information was received on 25-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer (Patient).  This case involves a patient of an unknown demographics who got flu (influenza), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, 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 not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got sick; Initial information was received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient (age unspecified) who got sick (illness), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, 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 not reported] via an unknown route  at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (non-serious event) immediately following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.     It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: severe reaction; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse (patient) via call center.   This case involves a female patient (age unspecified) who experienced severe reaction (adverse reaction), while she received INFLUENZA VACCINE.  Medical history, 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) [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 a non-serious severe reaction (adverse reaction) unknown latency, following the administration of INFLUENZA VACCINE.  It was reported that recently had a flu shot through a local pharmacy with the larger dose due to my age. I have had flu shots over the last 7 years without any reaction through my work place. I am wondering if there was any preservative in my recent flu shot. I have the lot number. Please contact me.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for the event.  There will be no information available on lot number for this case.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: (Rt) shoulder & arm pain came in 1 week after vaccine with continued (Rt) shoulder & arm pain - given Ibuprofen 600mg TID / disc ice packs to shoulder - patient went to ER next day - given Rx Lidocaine patch
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got flu; Initial information was received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case is linked to cases 2020SA296404 (same reporter).  This case involves patient (age and gender unspecified) who experienced flu (influenza), while patient received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, 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 not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product administered at inappropriate site
Clinical narrative: Menactra and  Adacel were not given in deltoid; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient grandmother) via call center and transmitted to Sanofi on 03-Nov-2020.  This case involves a 12 years old male patient for whom it was reported DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] were not given in deltoid (Product administered at inappropriate site) Lot number unknown via unknown route in the left arm for prophylactic vaccination.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and both these vaccines were not given in deltoid, reporter was saying that the vaccine was given to low from deltoid muscles and The patient was thin. Reporter said giving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lower for a thin child only means lesser muscle mass. Reporter said that she also called Merck and Glaxo and they told her the same thing. Reporter did not mention any other vaccine names. Reporter said it was given in left arm. Reporter did not had any other information for the template.   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: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram abdomen normal, Delivery, Echocardiogram normal, Exposure during pregnancy, Hypertension
Clinical narrative: at 37 weeks into pregnancy developed hypertension.  sent to the ER for observation, blood pressure improved.   Three days after delivering the baby blood pressure went up again.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Scan with contrast normal, Ultrasound kidney normal
Clinical narrative: at 37 weeks into pregnancy developed hypertension.  sent to the ER for observation, blood pressure improved.   Three days after delivering the baby blood pressure went up again.
Age: 18.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Abdominal pain upper, Capsule endoscopy, Colonoscopy, Crohn's disease, Diarrhoea
Clinical narrative: In August of 2018 (around a month after getting the shot), i started having diarrhea and mild stomach pain. . The stomach pain got worse. Instead of it occuring just when i ate food, it was constant stomach pain. I lost 65 pounds, have diarrhea 3-4 times a day. It continued to go on and i eventually got an ultrasound on September 28th, 2018. From there I was referred to a GI specialist had a series of labs and colonoscopy/endoscopies and was diagnosed with an autoimmune disease (Crohn's). It took almost a year and a half to receive a diagnosis.
Age: 18.0
Sex: F
Vaccine: MNQ, UNK
Symptoms: Endoscopy, Laboratory test, Ultrasound scan, Weight decreased
Clinical narrative: In August of 2018 (around a month after getting the shot), i started having diarrhea and mild stomach pain. . The stomach pain got worse. Instead of it occuring just when i ate food, it was constant stomach pain. I lost 65 pounds, have diarrhea 3-4 times a day. It continued to go on and i eventually got an ultrasound on September 28th, 2018. From there I was referred to a GI specialist had a series of labs and colonoscopy/endoscopies and was diagnosed with an autoimmune disease (Crohn's). It took almost a year and a half to receive a diagnosis.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Dizziness, Dysarthria, Dysstasia, Laboratory test
Clinical narrative: Pt experienced dizziness, slurred speech, couldn't stand up. Ambulance called to take her in. Doesn't remember being in ambulance at 11 am. Memory came back about 3 pm.  Patient taken to  Hospital ER.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging
Clinical narrative: Pt experienced dizziness, slurred speech, couldn't stand up. Ambulance called to take her in. Doesn't remember being in ambulance at 11 am. Memory came back about 3 pm.  Patient taken to  Hospital ER.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Discomfort, Herpes zoster, Hypoaesthesia, Inflammation, Lethargy
Clinical narrative: severe swelling of the lymph nodes in  my left arm - the arm I received the shot in.  The outside edge of my left hand was numb and the #4 & 5 fingers were numb.    ON Saturday I felt lethargic and achy.   The swelling began to recede on Sunday but when I had a previously scheduled mammogram on Tuesday, Sept. 29 the scans showed significant inflamation in my left breast and lymph nodes.   I still have one node that is inflamed.  I had a follow up on Nov. 18.  Swelling is less but still uncomfortable.       I ALSO HAD, WHAT MY PHYSICIAN  BELIEVE TO BE, SHINGLES ON THE LEFT SIDE OF MY FACE.  THEY PERSISTED FOR 2 WEEKS.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Lymphadenopathy, Pain, Ultrasound breast abnormal
Clinical narrative: severe swelling of the lymph nodes in  my left arm - the arm I received the shot in.  The outside edge of my left hand was numb and the #4 & 5 fingers were numb.    ON Saturday I felt lethargic and achy.   The swelling began to recede on Sunday but when I had a previously scheduled mammogram on Tuesday, Sept. 29 the scans showed significant inflamation in my left breast and lymph nodes.   I still have one node that is inflamed.  I had a follow up on Nov. 18.  Swelling is less but still uncomfortable.       I ALSO HAD, WHAT MY PHYSICIAN  BELIEVE TO BE, SHINGLES ON THE LEFT SIDE OF MY FACE.  THEY PERSISTED FOR 2 WEEKS.