chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: FLUR4
Symptoms: Rash, Rash erythematous, Rash pruritic, Scar, Skin discolouration
Clinical narrative: some slight irritation and scarring where the bumps were; bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach; bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 54 years old male patient who had bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach (rash erythematous and rash pruritic) and some slight irritation and scarring where the bumps were (scar) after he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  At the time of the event, the patient had ongoing high blood pressure.   On 01-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, Prefilled syringe, lot number not reported via intramuscular route in the right deltoid for prophylactic vaccination.  On 01-Oct-2020, the patient developed bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach (rash erythematous and rash pruritic) within a few hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient stated that he applied alcohol and calamine lotion to the area. He also reported taking Claritin which helped relieved symptoms. Patients stated that rash has gotten better, but still reported some slight irritation and scarring where the bumps were (Scar) unknown latency following vaccination.   Patient also reported that dark skin and rash was very red in comparison to his skin.  Relevant laboratory data was not reported.  The patient was recovering from rash erythematous and had not recovered from rash pruritic and Scar at the time of reporting.  There will be no information available on the batch number for this case.
Age: 54.0
Sex: M
Vaccine: FLUR4
Symptoms: Skin irritation
Clinical narrative: some slight irritation and scarring where the bumps were; bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach; bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 54 years old male patient who had bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach (rash erythematous and rash pruritic) and some slight irritation and scarring where the bumps were (scar) after he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  At the time of the event, the patient had ongoing high blood pressure.   On 01-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, Prefilled syringe, lot number not reported via intramuscular route in the right deltoid for prophylactic vaccination.  On 01-Oct-2020, the patient developed bright red, itchy bumps forming on the inside of his right arm, rash continued to worsen over the next few days and spread to his chest and stomach (rash erythematous and rash pruritic) within a few hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient stated that he applied alcohol and calamine lotion to the area. He also reported taking Claritin which helped relieved symptoms. Patients stated that rash has gotten better, but still reported some slight irritation and scarring where the bumps were (Scar) unknown latency following vaccination.   Patient also reported that dark skin and rash was very red in comparison to his skin.  Relevant laboratory data was not reported.  The patient was recovering from rash erythematous and had not recovered from rash pruritic and Scar at the time of reporting.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK given to a 17 year old patients in error with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via Medical Information(Reference number- 00322487) and transmitted to Sanofi on 19-Oct-2020.  This case involved a 17-year-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in error (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, vaccinations details, Concomitant medication and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, patient had not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: 4 yo with L arm redness swelling and pain. She had vaccines 2 days ago.  It was a little itchy. Acting well. No fever, no vomiting, no diarrhea, no sick contacts reported. Mom is not too worried but just wanted to make sure child was ok because this has not happened to her before. She tried a compress as advised by the nurse.  Likely a localized reaction at the injection site. May get a little worse before it gets better. Can use a cool compress. Can give motrin and benadryl for symptomatic relief. Advised mom to outline the area so she can tell if there are significant changes. Follow up for worsening or concerns such as worsening pain, streaking, swelling, fever.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Treponema test positive
Clinical narrative: Donated blood 10/29.  Informed today 11/4 blood was deferred due to antibodies for Syphilis.  Blood bank Staff asked me if I received a vaccination.  May have been cause of false positive?  Blood donated was unusable.  noteworthy.  Blood was sent to confirmatory.  Do not know anything else.md
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Blindness, Loss of consciousness
Clinical narrative: Patient described a Blackout or a  period of 3 seconds where she became unconscious. She experienced a lack of awareness and could not see.  This was 1 hour after her vaccination and lasted for 3 seconds.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received the flu immunization and then we proceeded over to the register to pick-up prescriptions.  The pharmacist was reveiwing the patients profile and when he looked up the patient was laying on the floor.  The pharmacist came around the counter and the patient was awake and alert.   The pharmacist elevated the patient's feet and had the patient lay on the floor for a few minutes prior to the patient standing up.  The patient did self report that he has fainted in the past and was operating on 3 hours of sleep from the night before.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram abnormal, Jaw fracture, Skin laceration, Syncope, Wound closure
Clinical narrative: Vasovagal fainting spell.  Patient fainted walking down the hall after having vaccine.  He hit his chin on the floor.  He had a laceration on the chin, that was repaired in the office. He was sent to an ENT who diagnosed with jaw fracture.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: X-ray abnormal
Clinical narrative: Vasovagal fainting spell.  Patient fainted walking down the hall after having vaccine.  He hit his chin on the floor.  He had a laceration on the chin, that was repaired in the office. He was sent to an ENT who diagnosed with jaw fracture.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site discomfort, Injection site nodule, Injection site warmth
Clinical narrative: Patient reports that his arm was sore immediately upon receiving the vaccine at 9:40 am on Nov, 2. States that he rubbed the area all morning and afternoon to try to ease the soreness. By evening of 11/02/20 a visible knot the size of a nickel had formed on the back of the left arm. He reported having chills that had went away by the next morning. Today, 11/04/20 he said that the arm is still sore and it is warm to touch 6 inches around the area.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV, TD
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: low grade fever for about 1 day; left arm was red, swollen, and warm to the touch starting 11/3/2020 and continued through 11/4/2020 (date of report); redness on back of neck and chest
Age: 95.0
Sex: F
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: Patient slipped and fell 15 mins after vaccine as she was leaving the pharmacy. Patient did not believe it was related to vaccine administration and that she just slipped.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: High fever 104+ 6 days after vaccine occurring for more than 3 days
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Headache, Pain
Clinical narrative: Severe heartburn, severe headache, body aches, started around 2am day after the vaccine.  Severe symptoms lasted for approx 24 hours, then less severe symptoms persisted for 4 days . Still have mild headaches.
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediately after receiving vax started having  general pain in arm and tingling in fingers. Started radiated to her neck . Has been constant for 2 wks. Reporter advised Pt to see MD.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Myalgia
Clinical narrative: Muscle pain initially within expected levels, but increased over a course of days to severe levels. Unable to raise my right arm over my head, arm strength has decreased by about 30 percent. Pain level has decreased over the last 24 hours but it is still at Level 7 out of 10.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Arm soreness one week after. Resolved with ibuprofen. After one week, patient attempted to stop ibuprofen and pain returned. Patient advised to see MD (who seen on 10/31/2020) and was diagnosed with frozen shoulder to be resolved with physical therapy.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: On 10/2 patient received flu shot at pharmacy. After patient reports heavy pain and no being able to move her arm upwards past her hips. Since some mobility has improved but the pain is debillitationg to patient. She can barely hold items heavier than a few pounds.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Patient says she has had radiating pain from her elbow to her ear on the same side as the administration site. She says it is aching and progressively worsening and started with the injection and radiated outwards. Patient is trying OTC meds but says none have alleviated the pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Erythema, Rash, Skin exfoliation
Clinical narrative: -Pt started noticing a reaction about a week after, started with a rash, went up to your hair that lead to hair loss, got into both feet (now it  is drying up now), also had red marks around the stomach, under the arms (scaly marks), elbows.. -Pt went to the doctor appt 11/03/2020 -Pt has been telling the nurse about the situation , but the nurse said to give it time to go away (pt stated she contacted nurse 1 month ago) - Md consulted to take bendaryl OTC
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Syncope
Clinical narrative: Received flu vax and started to drive home. about 10-15 minutes later started feeling dizzy and fainted while driving in the car. Only reaction had. Felt a little woozy for a while. Woke up fine the next day.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: 10/27/2020 Patient reports ever since having flu shot on 9/30/2020 she has had pain in the left arm. She reports it was sore and it now has progressively gotten worse. She feels that pain could be related to immunization. She had a right rotator cuff tear and repair and this feels similar. She denies any pain prior to the shot. She reports she has increased pain with a pulling motions and reaching out. What causes the most pain is reaching overhead. No pain just sitting still. Is slightly tender to press on deltoid at head of the hummerus. She feels pain is muscular in nature. The pain seems to be worsening with activity. No known alternative injury other than immunization. She has been sewing no other activities that include repetitive motion. No radiation of pain. Has not taken any OTC medication. No heat or ice on the area. Patient started on Naproxen delayed release tablet, 500mg, 1 tab(s), orally, 2 times a day, 7 days, 14 tablet, refills 0
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Rash, Skin exfoliation
Clinical narrative: -pt reported that she had this prevnar + shingrix and resulted in hair loss, started off as rash and went to her scalp, got into both feet (trying to dry up now), white scaly, under the arms/elbows/armpits -pt stated she called the nurse about 1 month ago, the nurse consulted her to give it time it will go away -Pt saw MD on 11/03/2020 and MD told pt she should not have received 2 shots at the same time, MD consulted pt to take benadryl
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: The patient does not report any issues when the vaccine was actually given (no pain at time of vaccination). Patient went on a 2.5 hour hike after the vaccination and afterwards had a nodule at the injection site. two days later (11/4) he reported warmness, redness, and swelling of his left arm. He went to the MD and they suspect cellulitus and prescribed doxycycline
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Discomfort, Joint range of motion decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Beginning the next morning after the injection :   Moderate Stiff neck, limited neck range of motion,  achy neck and upper back muscles on the left side for one week following injection.  Those symptoms retreated to mild.  Same symptoms appeared on right side of neck, upper back, and rhomboid  area., moderate discomfort.  Three weeks  now after injection the right side symptoms persist, reduced from moderate to mild\ moderate with  limited  but improving neck range of motion.   Left side symptoms persist with mild , and decreasing discomfort.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: a couple hours after getting the vaccine, patient had arm pain and could not move arm without pain. patient told her husband she thought she was injured. patient says is hurts in the joint, not in the muscle. patient says the bandaid was up higher than in past years. pain persisted for a full day at a high pain level and then decreased in pain for about 2 weeks. Then the pain start coming back in the same place on November 1st 2020. patient said it never completely went away but then noticed it getting worse on 11-1-20. Patient went to her MD on 11-2-20. per patient, at MD visit, MD said patient should rest for 3 days and not go to work for the rest of the week. MD told patient to use OTC anti-imflammatories and rest and to get back to MD on Monday 11-9-20 to decide if should get physical therapy.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Pallor
Clinical narrative: area of redness about 6 inches vertical and 3 inches horizontal around the injection site.  It is not itching and does not appear to have any fluid or blistering. it does blanch.  advised mom may apply warm compresses and give benadryl as directed, some redness as vaccine site not uncomon.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash vesicular
Clinical narrative: pt developed sciatic type pain one day after vaccine, then developed progression of pain down extremity and vesicular rash resembling shingles several days after vaccine given
Age: 20.0
Sex: M
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Anaphylactic reaction, Conjunctival hyperaemia, Dyspnoea, Urticaria
Clinical narrative: 20 yo M with anaphylactic reaction on 12 Jun following  immunizations including JEV, anthrax, typhoid, and yellow fever.  Patient presented approximately 20 min after receiving immunizations with urticaria, conjunctival injection, and difficulty breathing.  Epinephrine administered with relief of symptoms, and patient transported to Hospital Emergency Department by ambulance for additional treatment/observation.
Age: 2.92
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The vaccines were were given in the thighs at the request of mom at approximately 5 p.m. on Monday, October 5th, 2020. By bedtime at 8 p.m., patient had some swelling, reddness and pain in his left thigh to his knee and a temperature of 99.1 F. Mom gave Benadryl, Zertec, and iced thigh. Mom notified the pediatrician the next day and on Wednesday at 9 a.m., she brought patient to the ER. Patient was given a steroid injection and given 5 days of oral steroids. He was ambulating one hour post injection and better by that evening. The pain, reddness, and swelling resolved in one week. On Tuesday, October 13th, patient developed hives after completing the course of steroids which resolved in one week. The pediatrician told mom that he should not have any further flu shots. I spoke with mom today, 11/14/2020, who informed me that patient had swelling in his arm and into his chest after his flu shot last year. There was also some redness that was not reported on the screening form. Here is the list of influenza vaccines previously given to patient: Fluzone Quadrivalent pediatric given 3/12/2019 Lot UT63155A Expiration Date 6/30/2020 (thigh), Fluzone Quadrivalent pediatric given 04/09/2019 Lot UT63155A (thigh), Fluzone quadrivalent preservative free given on 10/07/2019 Lot U6648CA (arm).
Age: 68.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient came on 11/02/2020 telling that his arm was red and a little sored. I asked if it was hot and he answered it was a little hot. He said the symptoms developed the day after the vaccination. I suggested him to go to his doctor for an examination of the area.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea, Pain
Clinical narrative: patient does not appear having allergy but experience  symptoms on vis  handout  like nausea body ache headache and redness of injection site
Age: 17.0
Sex: F
Vaccine: FLUN4, HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Hypopnoea, Hypotonia, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: Within a minute of receiving last injection patient went limp and was lowered to the floor to avoid falling.  Her breathing was shallow but she maintained a heart rate of 58-62 and an SaO2 of 98-100% via pulse oximeter.  She awoke on her own spontaneously and tried to get up with help and also spoke a few words to her father when she again went limp and lost the ability to focus and did not respond when spoken to.  At 3:18 an emergency call was made.  At all times breathing, heartrate and oxygen levels were mainyained within normal limits.  She left via ambulance for the closest emergency room.  This patient spoke only a few words in English at all although her family does.  She smiled and seemed to respond when I told her that she was done and them had the syncopal episodes. Her father told her that she was a big girl and could do this and did not want to go into the room with her..  Epinephrine was drawn up but never given as breathing and heart rate were stable.  Patient had history of receiving vaccines at embassy before coming to this country but family does not have the record and does not know what she had.
Age: 17.0
Sex: F
Vaccine: FLUN4, HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Vision blurred
Clinical narrative: Within a minute of receiving last injection patient went limp and was lowered to the floor to avoid falling.  Her breathing was shallow but she maintained a heart rate of 58-62 and an SaO2 of 98-100% via pulse oximeter.  She awoke on her own spontaneously and tried to get up with help and also spoke a few words to her father when she again went limp and lost the ability to focus and did not respond when spoken to.  At 3:18 an emergency call was made.  At all times breathing, heartrate and oxygen levels were mainyained within normal limits.  She left via ambulance for the closest emergency room.  This patient spoke only a few words in English at all although her family does.  She smiled and seemed to respond when I told her that she was done and them had the syncopal episodes. Her father told her that she was a big girl and could do this and did not want to go into the room with her..  Epinephrine was drawn up but never given as breathing and heart rate were stable.  Patient had history of receiving vaccines at embassy before coming to this country but family does not have the record and does not know what she had.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysstasia, Fatigue, Feeling cold, Pain in extremity
Clinical narrative: Extreme pain in left arm, hot and swollen with rash. Cold chills, extremely weak, could barely stand.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash, Skin warm
Clinical narrative: Extreme pain in left arm, hot and swollen with rash. Cold chills, extremely weak, could barely stand.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site discomfort, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Upon waking this morning, left thigh very sore. Also noticeable swelling in a large portion of the thigh, not just injection site. Warm to the touch (oval shaped area about 1-2? out from injection site) and pink (oval shaped, only about an inch long at widest). Complains her leg hurts.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: The patient was inadvertently given the high dose flu vaccine instead of the regular age appropriate vaccine. The error was discovered after the patient had left and attempts were made to notify the patient and check in to see how she was doing, without success.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Headache, Injection site erythema, Nausea, Pain
Clinical narrative: patient didnot have allergy but experience  side effect wich is listed in vis handout  wich is nausea, headache, body ache redness on the site of injection
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Injection went normally, at about 3 hrs after injection noticed itching and hives on R arm and part of body.  Took Benadryl and started feeling better.  When woke up on 11/3 arm was swollen and hot from shoulder to elbow.  The swelling progressively got better through the day. On 11/4 it is still hot to touch and swollen with joint pain.
Age: 60.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: 102 degree F fever the night after injection. Left arm is still swollen and hot to touch, movement causes pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Limb discomfort, Magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: Patient is stating that his arm has been sore since he received the shot over a month ago and he thinks that we tore his rotator cuff.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient called on 11/4/2020 to report that after receiving the vaccine, she had fever for 2 days, arm was swollen down to the wrist, and that she felt pain in her arm; she said the pain was going away but arm was still swollen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia
Clinical narrative: Patient reported the onset of tingling, and sharp stabbing pain similar to a shingles outbreak along entire right posterior side of body from head (scalp) to pelvis.  She reported it radiated out along entire right arm as well.  No actual rash was reported and she stated it did not start until exactly one week later (10/26/20) after having received the first dose of Shingrix.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: HPI: She got a flu shot, high dose. This was 10/14/20. The injection site was hard and swollen and red. This resolved for the most part at this time )11/4/20). Hurt for 2.5 weeks and in the last day or 1 it's stopped hurting at the injection site but her whole upper arm is "a little bit more than an ache" and she can't "exactly use her arm" from the shoulder to the elbow but not involving the shoulder. The most difficult is "holding something" and trying to reach out and set it down. If there is any kind of weight in her arm, she can't extend it well. If she uses it a lot (like today picking up great grand baby), and she's using it a lot, now it hurts a lot without doing anything.  Will attempt treatment with Medrol dose pack for inflammation.  Treatment outcome pending
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: HPI: She got a flu shot, high dose. This was 10/14/20. The injection site was hard and swollen and red. This resolved for the most part at this time )11/4/20). Hurt for 2.5 weeks and in the last day or 1 it's stopped hurting at the injection site but her whole upper arm is "a little bit more than an ache" and she can't "exactly use her arm" from the shoulder to the elbow but not involving the shoulder. The most difficult is "holding something" and trying to reach out and set it down. If there is any kind of weight in her arm, she can't extend it well. If she uses it a lot (like today picking up great grand baby), and she's using it a lot, now it hurts a lot without doing anything.  Will attempt treatment with Medrol dose pack for inflammation.  Treatment outcome pending
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: patient complained arm soreness that lasted for 3 weeks post the initial injection. soreness to a point of not being able to raise the arm.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site bruising, Muscle tightness
Clinical narrative: tightness in trapezoid. bruised at injection  site
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Imaging procedure, Injection site movement impairment, Injection site muscle weakness, Injection site pain, Joint injection
Clinical narrative: Dose was given very high on the shoulder I have had pinching pain limited muscle mobility and muscle weakness ever since.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Rash macular
Clinical narrative: About 8 minutes after individual received vaccines, the individual experienced red blotchy areas on his face. Individual did NOT have a systemic reaction or have shortness of breath. Individual examined and assessed by his Health Care Provider (HCP). Per his HCP, given appropriate medication as treatment. Individual then remained in office for a period of time and inspected by a medical professional before leaving to ensure treatment was effective. Individual was doing well and in good health before leaving office.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient fainted immediately after receiving the vaccination.  He was still seated, and was gently lowered to the floor with his legs elevated.  He came around in about 30 seconds and was able to answer questions without difficulty.  He had perspiration on his forehead and face was drained of color.  BP was 115/79 and pulse 70 immediately after waking.  Patient was monitored for the next 15 minutes while hydrating, and no signs or symptoms were evident after that time.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Monoplegia
Clinical narrative: Paralysis to left foot and leg, numbness  GB symptoms
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Culture, Injection site induration, Injection site vesicles
Clinical narrative: 10cmX10cm area of induration and mild erythema of the left thigh. in the center there is a superficial blister. started on oral antibiotic course and antihistamines. bactrim prescribed after culture results came back.
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Malaise
Clinical narrative: Pain and redness at the injection site.  Patient reported feeling ill for days after vaccine administration.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Swelling
Clinical narrative: patient developed pain, swelling and a rash in arm that evening, it has increased in size a little bit the past two days, but she states it is feeling a little better today. Told her to take some benadryl and put a cold compress on it to relieve the pain. If no relief, pt needs to consult physician.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: High dose flu vaccine given, patient denies symptoms of flu after vaccine administration when contacted by phone on 11/4/2020.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site movement impairment
Clinical narrative: Patient received the vaccine on 10/13.  On 10/16, the patient returned to the pharmacy and he had just been to prompt care for decreased ROM of the right arm.  The doctor prescribed a course of steroids.  On 10/30, the patient returned to the pharmacy to let me know he had full ROM in the right arm.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Severe swelling, pain, and bruising at and surrounding the injection site, including inside the armpit. Increasing symptoms throughout the past 24 hours
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Cardiac flutter, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Immediate reaction of heart flutter, dizziness, near fainting, shortness of breath, rapid heart rate, nausea, neurological response of shaking, tingling and numbness up neck, swollen tongue, headache. Resolved at Urgent Care after 45 minutes of monitoring.  7 hours post even still experiencing dizziness, nausea, tiredness and heart flutters.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Nausea, Paraesthesia, Presyncope
Clinical narrative: Immediate reaction of heart flutter, dizziness, near fainting, shortness of breath, rapid heart rate, nausea, neurological response of shaking, tingling and numbness up neck, swollen tongue, headache. Resolved at Urgent Care after 45 minutes of monitoring.  7 hours post even still experiencing dizziness, nausea, tiredness and heart flutters.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Swollen tongue, Tremor
Clinical narrative: Immediate reaction of heart flutter, dizziness, near fainting, shortness of breath, rapid heart rate, nausea, neurological response of shaking, tingling and numbness up neck, swollen tongue, headache. Resolved at Urgent Care after 45 minutes of monitoring.  7 hours post even still experiencing dizziness, nausea, tiredness and heart flutters.
Age: 85.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Infection, Near death experience, Pain in extremity
Clinical narrative: pt began complaining of extreme pain in her left arm the evening of her injection, so much so that her son took her to the emergency room.  Morphine was given and pt still in extreme pain.  It was determined that pt had severe infection.  ER doctor, infectious disease doctor and pt's family doctor said she almost died. Upon discharge, pt is on antibiotic home infusion.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Patient's enter upper arm became bruised and swollen the morning after receiving the flu shot. It appears yellow closer to her shoulder and then purple/red closer to her elbow.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Patient returned 5 days after flu shot with a lesion on his arm where the flu shot was given.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: 2 weeks after receiving immunization patient complained of site pain, only when stretching or moving her arm
Age: 37.0
Sex: M
Vaccine: HEPAB, IPV
Symptoms: Expired product administered
Clinical narrative: Twinrix vaccine given was 1 day expired. No known adverse event.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: PT complained of shoulder pain indicating to us that administration was given too high in the deltoid.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: raised red area, itching
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Injection site urticaria
Clinical narrative: Patient with large red wheal at site of L injection taking up the entire lateral thigh
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out before walking out of pharmacy, then regained consciousness shortly after, and incident was reported by front store employees. I reached out to father who was with the patient when she came to get the vaccine, and said she is doing okay, and might make an appointment with the doctor to see if there are any issues and if she has any allergies. No allergies noted on vaccine consent form, but noted on her profile that she did pass out with the Fluzone vaccinee as documentation.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: About 4 hours after receiving vaccine the site around the injection began to swell to the size of half a tennis ball and was red in places and warm to the touch. 28 hours later it has not resolved.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis
Clinical narrative: 3 hours of extreme chills that night (Friday). Followed by 3 hours of extreme sweats the same night. Then woke up Saturday morning feeling fine.
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Contusion, Hypoaesthesia, Neuralgia, Pain, Swelling
Clinical narrative: nerve pain radiating from hands to the neck. numbness, swelling, bruising.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Long lasting muscle pain that slowly lessens.  Pain still there after 2 months of vaccine injection.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: Patient states that his arm and shoulder have continued to be sore ever since he received the second dose of the Shingrix vaccination in September.  He also states he started getting constant headaces soon after receiving the second dose of the Shingrix vaccination.  I recommended he go to see his physician and that I would report this to VAERS.  Patient has not reported back yet
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood glucose increased, Blood sodium decreased, Confusional state, Immature granulocyte count increased
Clinical narrative: Extreme pain to the left arm.  Inability to move left arm. Fever.  All over joint pain. Nauseated. Confused.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site movement impairment, Injection site pain, Monocyte count increased, Nausea, Pyrexia
Clinical narrative: Extreme pain to the left arm.  Inability to move left arm. Fever.  All over joint pain. Nauseated. Confused.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Extreme pain to the left arm.  Inability to move left arm. Fever.  All over joint pain. Nauseated. Confused.
Age: 1.83
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Condition aggravated, Injection site rash, Injection site urticaria, Rash
Clinical narrative: Rash, urticaria on the left thigh spread to whole body, improved. Residual rash urticaria on previous knee and left thigh
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Erythema, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Pt states Flu vaccine high in RT Deltoid. Typical initial discomfort in Rt arm when given. Pain has increased since then to include anterior shoulder and persists with any arm movement. No redness or swelling since 1st 2 hrs. Pt perceives weakness but no numbness or tingling - No prior Rt arm probs Rt hand dominant. No improvement
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: The pneumovax 23 vaccine was administered at  11:00 A.M 6/30/2020 - Around 1:00-1:30 left arm began to ache. the pain increased and was constant quickly. movement of arm was unbearable. fever, chills - started as well as body aches/joints 4:00 PM - vomiting started around 4:30 PM. Fever 101.9 Pain continued to increase + went to emergency room -
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: The pneumovax 23 vaccine was administered at  11:00 A.M 6/30/2020 - Around 1:00-1:30 left arm began to ache. the pain increased and was constant quickly. movement of arm was unbearable. fever, chills - started as well as body aches/joints 4:00 PM - vomiting started around 4:30 PM. Fever 101.9 Pain continued to increase + went to emergency room -
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Miliaria
Clinical narrative: Per patient report was seen for what she describes as a heat rash across her lower back on the day 2 weeks following her Shingrix injection. MD said it was shingles per patient and treated as such. Encourged patient to have administering pharmacy report to VAERS
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Morning after vaccine pt noticed arm swelling and hot right below injection site. Pt went to pcp. Dr diagnosed pt w/cellulitis at site of injection. Pt given cephalexin for treatment.
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 15 years old patient received FLUBLOK QUADRIVALENT vaccine with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00322459) and transmitted to Sanofi on 19-Oct-2020.  The case was linked to cases 2020SA295721 and 2020SA295712 (same reporter).  This case involves a 15 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringes (Lot: QFAA2051, expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (Product administered to patient of inappropriate age) (latency: same day). Pharmacist stated that 3 patients under the age of 18 received FLUBLOK QUADRIVALENT vaccine. Pharmacist would like to know if any adverse events have been reported in patients under the age of 18 that have received the FLUBLOK QUADRIVALENT. Also, would like to know if it was recommended that patients get re-vaccinated with an appropriate flu vaccine.  At the time of reporting, patient had not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: A 7 year old patient inadvertently received a dose of Flublok quadrivalent/no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (Reference number- 00300974) and transmitted to Sanofi on 05-Oct-2020.  This case is linked to case 2020SA278042 (same reporter).  This case involves a 7 year old male patient who was inadvertently vaccinated with a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number:UJ48AA, expiry date: 22-MAR-2021, strength: standard) once via intramuscular route in the left deltoid on 05-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of report, no adverse event reported.  Reporter stated that product was used for first time.  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: 7.0
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: 7 year old patient accidently received Flublok instead of Fluzone with no adverse event; 7 year old patient received a dose of Flublok no adverse event; the packaging for Flublok and Fluzone is very similar which causes confusion with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 12-Oct-2020.   This case is linked to case 2020SA284922.  This case involved an 7-years-old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2027, expiration date unknown) instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (Lot number and expiration date unknown) via unknown route in unknown administration site (Product administered to patient of inappropriate age) and (Wrong product administered) for prophylactic vaccination on an unknown date. The reporter also reported that the packaging for Flublok and Fluzone was very similar and believed this caused confusion to nurse (Product packaging confusion).  The patient's medical history, medical treatments, vaccinations and family history were not provided. No concomitant drug was reported.  This was a case of actual medication error as inappropriate age at vaccine administration, wrong vaccine administered and look alike packaging (Latency: Same day).  At the time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered Flublok Quadrivalent vaccine to 16-years-old patient/ No AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Regulatory Agency (Reference number- 00328380) and transmitted to Sanofi on 22-Oct-2020.  This case is linked to case 2020SA301262, 2020SA301304, 2020SA301293, 2020SA301312, 2020SA301276, 2020SA301284 and 2020SA301290 (same reporter).  This case involves a 16-years-old female patient who was inadvertently administered a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] prefilled syringe (lot number: QFAA2051, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 22-Oct-2020 (product administered to patient of inappropriate age).  Medical history, concomitant medications, medical treatments, vaccinations and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency on the same day).  At the time of reporting, patient had no adverse events.  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.