chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Intense itching on evening of injection - lasted for 5 days to a week Hives (redness, swelling, intense itching) from injection site - upper arm to elbow (appeared day after injection)
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Limb discomfort
Clinical narrative: pt reports noticed after a few days from what he was saying some discomfort in left arm. no swelling no redness anywhere on arm or body. no warmth . no streaking reported. pt got vaccine on 11/3/2020 called clinic on 12/2/2020 for first time. pt reports no pain, no numbness, or tingling. able to use arm per pt. hadn't sought any tx or went anywhere. pt reports just notices some "discomfort" more in that arm with cerntain movements. when asked more about reporting like when turning sterring wheel of car notices sometimes. not worsening. was calling to look for suggestions. discussed if he had a PCP or ortho or PT. none per pt. told pt to let me look into further and call him back in meantime pt was going to try to see about assess with PT and get a PCP.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Gaze palsy, Injection site rash, Pyrexia, Thrombocytopenia
Clinical narrative: Rash & Thrombocytopenia at the site of Injection. Fever and Headache
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash approximately 1" square on upper back near left arm. Smaller rash near injection site.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: pt called and reported pain in the arm where she recieved the injection on 12/12/20. The pain has caused her to not be able to fully use her arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Impaired work ability
Clinical narrative: Patient states she was tired and week for about a week. She missed one day of work as well. She did recover.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: No reaction at this time, just reporting in case
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complain of left shoulder pain especially with cross arm over chest movement. 1 week of Naproxen and passive ROM exercises an ultrasound imaging if no improvement.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received a second dose of PCV-13 on 12/11/2020 in error.   She was due to receive her PPSV23 vaccine instead.  Patient had already received first dose of PCV-13 on 4/18/2018.
Sex: F
Vaccine: FLU4
Symptoms: Injection site discharge
Clinical narrative: she got home and removed the bandage, there was some clear liquid that came out, patient thinks it was the vaccine that came back out /no AE; she got home and removed the bandage, there was some clear liquid that came out, patient thinks it was the vaccine that came back out /no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist via The agency (Reference number- US-SANOFI-00333577) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 59 year old female patient who was administered an INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (underdose and injection site extravasation).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Pharmacist wants to know if a patient. Stated she was given FLUZONE QUAD (pre-filled syringes) on 10/13 but when she got home and removed the bandage, there was some clear liquid that came out, patient think it was the vaccine that came back out and wants to be re-vaccinated.  It was a case of an actual medication error due to she got home and removed the bandage, there was some clear liquid that came out, patient thinks it was the vaccine that came back out (latency same day).  At the time of reporting, patient had no 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.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient heard a loud pop as soon as the pharmacist administer the vaccine. Immediately upon standing the patient's arm was extremely sore.  Later the patient experienced pain, tingleness , and numbness going down into her elbow & hand.  After several weeks, the patient experienced pain radiating into her shoulder & neck. At this time, the patient did say her right arm is starting to hurt like the left arm .  The  patient went to see her doctor due to she thought she has rheumatoid arthritis but they wouldn't give her a referral.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Localized shoulder pain
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Rash
Clinical narrative: Patient describes turning black and blue at the injection site. Below on the inside of her arm she developed a rash.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient presented with hives, itching
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Fatigue, Induration, Pain
Clinical narrative: Chicken pox like, soreness, tenderness, red, hardness, she said cellulitis, swelling, red dots, tired
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling, Tenderness, Varicella
Clinical narrative: Chicken pox like, soreness, tenderness, red, hardness, she said cellulitis, swelling, red dots, tired
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient stated that adverse reaction to the pneumonia, extremely painful for over 5 days, could barely move the arm, did attempt to move the arm more after the shot.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Nausea, Neck pain
Clinical narrative: body aches, nausea, neck pain, low-grade fever to 100, right arm injection site warm red and itchy
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: body aches, nausea, neck pain, low-grade fever to 100, right arm injection site warm red and itchy
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Skin warm
Clinical narrative: swelling at injection site about the size of the palm of the hand per patient estimate, warm to the touch.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Mobility decreased, Myalgia
Clinical narrative: The patient reported extended pain at the injection site preventing her to rise her arm over head or higher than her shoulder. The pain is still present as of December 11 when the patient was in the pharmacy.  The patient does not recall  bruising at the injection site and states it is muscle pain (not joint related). I recommended the patient to contact her doctor for advice.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever, chills, body aches
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Immune thrombocytopenia, Platelet count decreased
Clinical narrative: After the first mandatory dose of influenza vaccine, annual healt check up revealed platelets of 13,000 Since then I have been under Drs care for ITP
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Aphonia, Dyspnoea
Clinical narrative: patient complains of lost of voice and pain when breathing
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Feeling of body temperature change, Hyperhidrosis, Visual impairment
Clinical narrative: about 3 minutes after injection. pt felt light headed, hot and cold sweating. felt weak. vision impairment. resolved after 20 minutes
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: trigeminal myalgia on the right side of the face and  lasted for 5 days and that happened about 2 weeks after she received the first dose
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: After receiving the vaccine, she went home. The next night woke up with extreme itching all over chest and neck. Had hives all over. The nurse and doctor saw it.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site scar, Pain, Pain in extremity
Clinical narrative: Intermittent left upper arm pain radiating up and down.  Scar at injection site.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: I was given the shot at my doctor's office by his nurse. Initially, my arm was just sore then the following day, my arm was sore and swollen with a red bump. The next few days, I also had a low fever, body chills and had problems moving my arm. Around the fourth day, my red bump had turned into a large welt from one side of my arm to the other side. This is when, I went to an online clinic and reported and sent a picture to the provider. A couple of days later the redness went away however, I still have a welt scar on my left arm.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: I was given the shot at my doctor's office by his nurse. Initially, my arm was just sore then the following day, my arm was sore and swollen with a red bump. The next few days, I also had a low fever, body chills and had problems moving my arm. Around the fourth day, my red bump had turned into a large welt from one side of my arm to the other side. This is when, I went to an online clinic and reported and sent a picture to the provider. A couple of days later the redness went away however, I still have a welt scar on my left arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Hives started on bottom of my feet that night, the next day i had them on my head and ears. i took benadryl every 4 hours. by the next day i had them all over. i thought my right hand was actually going to burst open it became so swollen. on 9/17 i had an urgent care visit and stated a steroid pack as well.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Limb discomfort, Nodule, Pain in extremity
Clinical narrative: On approximately October 12, after receiving the Gardasil 9 vaccine on September 30, I noticed that my "sore" left arm was not just sore but had a nodule in the tissue. I measured the nodule, and it was about 2 cm in diameter. I applied heat and massaged it, but it did not help. I messaged my provider's office on October 18 to ask if this was abnormal and if I should do anything else. My provider replied that I should continue to apply heat and that this was normal. I did apply heat as often as possible, and I even slept with heat for several hours at a time. This did not seem to speed up the resolution of the nodule. The nodule increased in size to 3 cm and swelled up to a round knot. I would say that it was 3 cm diameter by the end of October and increasingly sore and heavy. It gradually decreased in size in the latter half of November. Today I have no nodule but my left arm is still slightly sore. I still do not feel that I could receive another vaccine in the left arm without anxiety because of the soreness.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt called me today saying the imz (flu shot) she received on 10/02/20 caused her arm to be swollen and in pain. She said she gets pains that comes and go in that arm when she uses it since then that has not gone away. I told her she should really go see her pcp and get the arm checked out to make sure it is not something else going on and is the flu shot. Pt is going to see her pcp to get checked out.
Age: 1.75
Sex: M
Vaccine: FLU4, JEV1
Symptoms: Erythema multiforme, Pyrexia, Rash
Clinical narrative: patient diagnosed with Erythema Multiforme Minor. triamcinolone ordered. encouraged to continue Benadryl, Tylenol, and motrin PRN.  Rash flared and waned since august after first JEV, but fever and worsening rash after 2nd dose of the JEV.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: pt stated that after receiving the vaccine he got shingles, however, mild.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site paraesthesia, Injection site pruritus
Clinical narrative: The shot was painful, felt flu like the next day which I expected. However, I still feel a tingling at the injection site, slight itch, and soreness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site, redness and swelling at injection site, chills, slight fever, fatigue, headache.  Onset of symptoms was about 8-9 hours after injection.  Most symptoms cleared up within 48 hours, although some redness and soreness remained.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Pain at injection site, redness and swelling at injection site, chills, slight fever, fatigue, headache.  Onset of symptoms was about 8-9 hours after injection.  Most symptoms cleared up within 48 hours, although some redness and soreness remained.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient received the flu shot. Has gotten it every year and has experienced no issues. Patient asked for a copy of the vaccine, went to go receive it from the printer and patient passed out and fell to the ground. He regained consciousness within seconds. Patient was okay with no injury or bruising. checked blood pressure and it was within range: 126/72 with a heart rate of 79. Patient drank some water and said he was feeling much better,
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: pt received vaccine waited 15 minutes went to car and noticed she was all red in face/neck took a benadryl 25g and came back in store . Gave ice pack & water. She sat for 30 more minutes then went home.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: swelling, redness, to left arm. This reaction happen status post one day after vaccine. Also, prior to vaccine  mother applied ice pack to left arm and broke and leaked out onto the  left arm.
Age: 10.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 2x2 cm of induration of left arm at site of prior HPV vaccine. Tender to touch slight overlying warmth.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Immediate post-injection reaction, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Upon injecting patient she immediately felt "weird" - her aRm stiffened AND at the point I Removed needle from aRm and had patient RELAx (only 1/2 Dose was administerd) I had her Relax AND changed needle to finish giving Remaining shot but never got to do it as pt fainted. It happened so quickly. She was pail and passed out for about a minute or less. Called 911, but by the time help arrived, she felt better. Patient preferred to see her Doctor. EMT checked vital signs and all were within normal limits. I did give her orange juice before EMT got Here in case it was a hypoglycemic episode (no history of diabetes). Mother stated last time patient ate was over 3 hours. Patient Refused to go to the hospital And went to her doctor insteaD. Contacted her doctor AND informed her of the situation
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse event reported; MMR II and VARIVAX administered during a temperature excursion; This spontaneous report was received from an "HBP", referring to to a patient of unknown age and gender.The patient's pertinent medical history,  concomitant medications, previous drug reactions, or allergies were not provided.  On 23-SEP-2020 the patient was vaccinated with improperly stored dose of measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+)  live rHA (M-M-R II) at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection, and route of administration were not reported; lot number s006051, expiration date: 27-FEB-2021); and lot number S015427, that has been verified to be a valid lot number for measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+)  live rHA (M-M-R II), expiration date reported and stablished as as 20-MAY-2021, as prophylaxis (product storage error); and with  improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX) at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection, and route of administration were not reported; lot number S002740 has been verified to be a valid lot number, expiration date reported and stablished as 28-JAN-2021); and lot number 031494,  which is an invalid lot number for varicella virus vaccine live (Oka/Merck)(VARIVAX). Lot number 031494, does not match any Company product as confirmed by Lot Verification team, expiration date reported as 07-OCT-2021) as prophylaxis (product storage error). No other adverse event (AE) reported.  The vaccines that were administered, underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 14 hours, as recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; patient was inadvertently administered the second dose less than 2 weeks after the first one; This spontaneous report was received from a certified medical assistant (CMA) referring to a patient of unknown age and gender.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   CMA reported that on 03-DEC-2020, the patient was inadvertently administered a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported), less than two weeks after the first dose (inappropriate schedule of product administration). No adverse effects were reported.  The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Herpes zoster
Clinical narrative: Congestive Heart Failure; other zoster-related conditions; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) as prescribed for the long-term prevention of shingles and zoster-related condition. Subsequently, on an unknown date, the patient was treated by healthcare providers for congestive heart failure and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue to 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 would continue to suffer such losses, and damages in the future. The causality assessment between congestive heart failure, herpes zoster and other zoster-related conditions and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the event of congestive heart failure was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Blindness, Herpes zoster, Inappropriate schedule of product administration, Injury corneal, No adverse event
Clinical narrative: adverse reaction or side effect: none; every 5 years since 2005; This spontaneous report was received from a consumer, lawyer and a physician referring a female patient of unknown age. The pt's concomitant medications included spironolactone (ALDACTONE). The patient's concurrent conditions included failure congestive, orthostatic hypotension, osteoporosis, gastrooesophageal reflux disease (GERD), hypothyroidism, arteriosclerosis coronary artery, depression, anxiety and hypertension. The patient's historical conditions included chicken pox. The patient was an ex-tobacco user.   Since an unspecified date 2005, the patient has been vaccinated by a physician with pneumococcal vaccine (manufacturer unknown) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis every 5 years (inappropriate schedule of product administration) without experiencing any adverse reactions or side effects.  On an unspecified date in 2013, the pt experienced blindness, fall and vaccination failure; on 27-AUG-2013, the pt experienced injury corneal and herpes zoster; and on an unspecified day in October 2013, the pt experienced post herpetic neuralgia (captured in MARRS# 1812USA008155).; Sender's Comments:  US-009507513-1812USA008155:
Sex: F
Vaccine: PPV
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: adverse reaction or side effect: none; every 5 years since 2005; This spontaneous report was received from a consumer, lawyer and a physician referring a female patient of unknown age. The pt's concomitant medications included spironolactone (ALDACTONE). The patient's concurrent conditions included failure congestive, orthostatic hypotension, osteoporosis, gastrooesophageal reflux disease (GERD), hypothyroidism, arteriosclerosis coronary artery, depression, anxiety and hypertension. The patient's historical conditions included chicken pox. The patient was an ex-tobacco user.   Since an unspecified date 2005, the patient has been vaccinated by a physician with pneumococcal vaccine (manufacturer unknown) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis every 5 years (inappropriate schedule of product administration) without experiencing any adverse reactions or side effects.  On an unspecified date in 2013, the pt experienced blindness, fall and vaccination failure; on 27-AUG-2013, the pt experienced injury corneal and herpes zoster; and on an unspecified day in October 2013, the pt experienced post herpetic neuralgia (captured in MARRS# 1812USA008155).; Sender's Comments:  US-009507513-1812USA008155:
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: precancerous cells; lack of efficacy with GARDASIL; HPV; This spontaneous report was received from a 24 years old female pharmacist referring to herself. The patient's concurrent condition, medical history and concomitant therapy were not reported.  The pharmacist was the patient who received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On an unspecified date in 2008 (reported as when the patient was 12 years old), the patient was vaccinated with a complete series quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis (reported as routine vaccination). The patient was positive for human papillomavirus (HPV) as adult.  The patient reported a lack of efficacy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The patient sought medical attention with the physician. The patient was diagnosed with HPV on unknown date in 2018 when she had an abnormal PAP smear on routine visit. The patient said her PAP smear in 2019 was normal but the PAP smear in 2020 was also abnormal (Exact dates of PAP smears unknown). The patient had a colposcopy (with biopsy) on unknown date that showed precancerous cells but with no treatment as the physician said they were "not overly concerned and would continuing monitoring for now". The patient did not know what HPV type she tested positive for in 2018. The outcome of all events was not recovered. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs reported; Expired vaccine used; This spontaneous report was received from a Nurse Practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 09-DEC-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, subcutaneously, lot # S017237 and expiration date on 01-DEC-2020 (strength, frequency and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events reported.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: The only time  the patient ever had the flu was the only year that he/she had a flu shot; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via Social media.  This case involved a patient with unknown demographics who ever had the flu (Influenza) was the only year that he/she had a flu shot INFLUENZA VACCINE.  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 reported that he/she ever had the flu (Influenza) was the only year that he/she had a flu shot (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Chills, Malaise
Clinical narrative: cold chills; felt rough; Initial information regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional on 06-Nov-2020.  This case was linked to case 2020SA314521 (Cluster case).  This case involved patient (with unknown demographics) who reported of suffering from cold chills(chills) for which the patient had to lay down and also complained of feeling rough (feeling abnormal), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication 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 unknown route at aan unknown administration site for prophylactic vaccination.   On an unknown date, the patient reported of having cold chills (chills) for which the patient had to lay down and also complained of feeling rough for few hours (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory test was been reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was reported as unknown for all the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: each time I have gotten real sick afterwards; Initial information received on 08-Nov-2020 regarding an unsolicited valid non-serious case received from a patient.  This case involves a patient of unknown demographic who each time have gotten real sick afterwards (illness), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route and administration site unknown) for prophylactic vaccination.  On an unknown date, (unknown latency) after initiation influenza vaccine therapy time the patient had gotten real sick afterwards (illness) following the administration of influenza vaccine.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine, Near death experience
Clinical narrative: patient was extremely allergic to the flu shot, nearly died from it; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who was extremely allergic to the flu shot, nearly died from it (allergy to vaccine), while he/she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. At the time of the event, the patient was extremely allergic to egg.  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 was extremely allergic to the flu shot, nearly died from it (allergy to vaccine) (Unknown latency) following the administration of INFLUENZA VACCINE.  The patient was reported that he/she did not know it was incubated in egg white which he/she was extremely allergic to.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a patient of unknown age and gender who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's vaccination(s) included Influenza vaccine as prophylactic vaccination. The patient's medical history, past medical treatment(s), concomitant therapy 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sick (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.  On an unknown date, patient had recovered from the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient was so sick; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient) via Social media.  This case involved a patient with unknown demographics who was so sick (Illness), while he/she received INFLUENZA VACCINE.  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 was so sick (Illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  The patient was reported that he/she could not get off the floor, he/she had not had a shot since and had not had the flu.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: sick; arm swelled up with a knot in it; Knot in the arm; arm aches whole time; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who sick (illness), arm swelled up with a knot in it (peripheral swelling), knot in the arm (nodule) and arm aches whole time (pain in extremity), while the patient received 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 sick within two days (illness), arm swelled up with a knot in it (peripheral swelling), knot in the arm for three years (nodule) and arm aches whole time (pain in extremity) (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 events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had the flu; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via Social media.  This case involves patient (unknown demography) who had the flu (influenza), while the patient received 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 had the flu (influenza) (within 2 weeks) following the administration of INFLUENZA VACCINE.  It was reported that, every time after a flu shot within 2 weeks patient had the flu and after that stopped taking it and does not had the flu since.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 10-Nov-2020. This case involves a patient with unknown demographics who experienced sick (Illness), when received vaccine INFLUENZA VACCINE (flu shot). Relevant 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient experienced sick (Illness), unknown latency following the administration of INFLUENZA VACCINE. Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Myalgia, Pain in extremity
Clinical narrative: yesterday just a sore arm which is normal/woke up with sore muscles; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involved adult patient who had yesterday just a sore arm which is normal/woke up with sore muscles (Myalgia), while patient received INFLUENZA VACCINE.  The patient's 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 VACCINE produced by unknown manufacturer lot number not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient had yesterday just a sore arm which is normal/woke up with sore muscles (Myalgia), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise
Clinical narrative: May not give you the flu but it can certainly make you feel like you have the flu or worse; Was sick the entire winter; Initial information was received on 11-Nov-2020 and a live follow up was received on 08-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who felt like having the flu or worse (influenza like illness) and was sick the entire winter (sickness), after the patient received vaccine INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, 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 unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency), the patient was sick the entire winter (sickness) and was at the doctor weekly after getting INFLUENZA VACCINE (flu shot). The patient reported that the vaccine might not give the flu, but it could certainly make one feel like having the flu or worse (influenza like illness).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: sick; had a head cold; Initial information regarding this unsolicited valid non-serious social media  case received from a consumer (patient) on 12-Nov-2020.  This case involves a patient with unknown demographics who was sick (Illness) and had a head cold (Nasopharyngitis), when received INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date in November-2020 (reported last week), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in November-2020, (latency unknown) after administration of INFLUENZA VACCINE, the patient was sick (Illness) and then the patient went for a walk on the other day (unknown date in 2020) (latency unknown) and there the doctor had said that the patient had a head cold (Nasopharyngitis).  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient gets sick from the shot; Initial information was regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media and transmitted to Sanofi on 11-Nov-2020.   This case involves a male patient (unknown age) who got sick (Illness), after the patient received vaccine INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, 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, (Unknown latency) the patient got sick from the shot (illness) after getting the INFLUENZA VACCINE (flu shot).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Muscle discomfort, Pain
Clinical narrative: got sick; Unusual feeling in the muscle; aching and was so painful; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via social media on 12-Nov-2020.  This case was linked to case 2020SA322882 (Case for husband).  This case involved a female patient of an unknown age who got sick (Illness), and experienced unusual feeling in the muscle (Muscle discomfort) and was aching and was so painful (Pain), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer lot number not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got sick (Illness) and unusual feeling in the muscle (Muscle discomfort) and was aching so painful (Pain).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Muscle discomfort, Myalgia, Pain
Clinical narrative: got the flu from flu needle; aching so much and so painful; unusual feeling in muscles after taking the flu needle; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via Social media on 12-Nov-2020.  This case was linked to case 2020SA322867 (Case for Wife).  This case involved a male patient of an unknown age got the flu from flu needle (Illness), and experienced unusual feeling in the muscle (Muscle discomfort) and was aching and was so painful (Pain), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer lot number not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got the flu from flu needle (Illness) and unusual feeling in the muscle (Muscle discomfort) and was aching so painful (Pain).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu from taking the flu shot; Initial information regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient) via Social media on 12-Nov-2020.  This case involved an unknown age patient of an unknown gender who got the flu from taking flu shot (Illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer lot number not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient got the flu from taking flu shot (Illness).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the 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 haven't had the flu in over 30 years, except for the year patient got a flu shot; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient who have not had the flu in over 30 years, except for the year patient got a flu shot (influenza).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  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, the patient developed a non-serious patient havenot had the flu in over 30 years, except for the year patient got a flu shot (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for event.  There will be no information available on the batch number for this case.