chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Product administered at inappropriate site, Spinal pain, Vaccination error
Clinical narrative: Immediate pain upon injection. Severe burning feeling. Left with severe pain in shoulder, back, and spine. Injection site was too high and given at the wrong angle. I was seated while pharmacist administering the injection stood above me. Still experiencing pain.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: At 9:10 AM - given Menactra LD. 9:11 AM, gave Bexsero RD. Patient slumped over in chair, lost consciousness x approximately 60 seconds. Awoke with a "jerk", asked what happened and said she had a terrible headache and nausea. BP was 129/78. 9:20 patient reported "feel ok except for HA." BP 109/63. Call on 9/20/19 - patient reports she is doing just fine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On an unknown date, an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), subcutaneously, with lot # S007069 and expiration date on 06-SEP-2020, for prophylaxis (dose, dose number and anatomical injection site were not reported) was administered to the patient. It could not be verified if the sterile diluent (strength, dose, dose number, route of administration, anatomical injection site, lot number and expiration date were not reported) was properly stored.   It was reported that on 15-OCT-2019, the vaccines were exposed to a temperature excursion of -11.5 degrees Celsius (C) degrees for 76 hours. There was no previous temperature excursions. The call was placed because of a Digital Data logger report. No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune hepatitis
Clinical narrative: autoimmune hepatitis; This spontaneous report was received from a nurse and refers to about 18-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, lot# and expiration date were nor reported) for vaccination.  On an unknown date, the patient was diagnosed with autoimmune hepatitis. The patient was told that she would be lucky if her liver would last for another 10 years.At the time of the report, the patient was still receiving unspecified infusion as a treatment for the autoimmune hepatitis at unspecified hospital. The outcome of autoimmune hepatitis was reported as not recovered/not resolved. The reporter considered autoimmune hepatitis to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).  Upon internal review, the event of autoimmune hepatitis was considered to be medically significant.
Sex: F
Vaccine: FLUX
Symptoms: Deafness, Hypersensitivity
Clinical narrative: Hearing loss; Allergic reaction to a flu vaccine; This is a spontaneous case reported by other non-health professional to agency (Case: SEQ19-05065) and initially retrieved on 18-Oct-2019, concerning a female patient of unspecified age.  The patient's medical history included drug allergy to amikacin, low blood pressure and gastrointestinal related (as reported).   The patient's concomitant medications included intravenous unspecified steroids.  On an unspecified date in 2017, the patient was administered INN Flu Vaccine [Influenza Vaccine, anatomical location: right arm, dose, route of administration, batch number, expiry date: not reported] for unknown indication.  On an unspecified date in 2017 after vaccination, the patient developed an allergic reaction to a flu vaccine.  On an unspecified date in 2017, 24 hours after vaccination, patient lost her hearing. Six months, later she was receiving intravenous steroids for low blood pressure and her hearing returned. At that time, she was pending Cochlear transplant, but that was not needed since her hearing returned.  On an unspecified date, the outcome of the allergic reaction was recovered/resolved.  The case was assessed as serious.  Company comment: The patient experienced deafness and allergy to vaccine after vaccination with the suspect product INN flu vaccine. Chronology is plausible. Medical history of low blood pressure may have contributed to development of the event deafness. Causality was also confounded by therapy with concomitant medications, intravenous unspecified steroids. Considering all the above mentioned, causal role of the suspect product is assessed as related.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt states she received the influenza vaccine at pharmacy at approx. mid-day on 9/17.  Pt states by that afternoon she was unable to lift her right arm due to pain.  Patient presented to her PCP's  office on 10/17/2019 where she was instructed to increase fluids, take Ibuprofen, and use warm compresses.  As of 10/28/2019 patient states her arm is feeling much better.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Injection site swelling, Joint fluid drainage, Pain
Clinical narrative: Swelling to Right Deltoid and shoulder in general.  Pain increasing in severity over the course of 4 days.  Pain and swelling reached point that patient reported to the ER for further evaluation.  Imaging of involved area completed and draining of fluid from involved area completed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Energy increased, Headache, Pruritus
Clinical narrative: DAY OF INJECTION:  PATIENT DESCRIBED FEELING STIMULATED, ENERGETIC, "LIKE ON SPEED",  DAY 2 :  PATIENT DEVELOPED DIZZINESS, HEADACHE, HIVES FROM HEAD TO TOE.  CONTACTED LOCAL EMERGENCY ROOM BY TELEPHONE AND WAS TOLD TO TAKE BENADRYL.  PATIENT TOOK BENADRYL AND HIVES AND ITCHING WERE RELIEVED.  DAY 3:  SYMPTOMS MOSTLY RESOLVED WITH THE EXCEPTION OF EXPERIENCING LOOSE STOOLS.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: DAY OF INJECTION:  PATIENT DESCRIBED FEELING STIMULATED, ENERGETIC, "LIKE ON SPEED",  DAY 2 :  PATIENT DEVELOPED DIZZINESS, HEADACHE, HIVES FROM HEAD TO TOE.  CONTACTED LOCAL EMERGENCY ROOM BY TELEPHONE AND WAS TOLD TO TAKE BENADRYL.  PATIENT TOOK BENADRYL AND HIVES AND ITCHING WERE RELIEVED.  DAY 3:  SYMPTOMS MOSTLY RESOLVED WITH THE EXCEPTION OF EXPERIENCING LOOSE STOOLS.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Oedema peripheral
Clinical narrative: Patient had edema in left arm that led her to seek medical care.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Musculoskeletal pain, Pain in extremity
Clinical narrative: PATIENT HAD A PAIN FROM LEFT SHOULDER DOWN TO LEFT LEG.  SHE HAD HEADACHE, FELT LIKE FLU SYMPTOM WITHOUT  FEVER,  AND HAD NO ENERGY.
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Body aches, sore throat, headache, fatigue
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Periorbital oedema, Urticaria
Clinical narrative: Returned to office approx. 2 hours after vaccine was given with  Urticarial rash on neck and periorbital edema. Benadryl 25 mg given by mouth. Rash and edema resolved within 20 minutes of taking medication.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb mass, Pain, Peripheral swelling, Pruritus
Clinical narrative: Redness & swelling immediately, progressing  down left arm daily for 5 days to just above the elbow.  It was painful and felt like a lump when touched. It was also very hot to the touch.  Symptoms went away after 6 days. Then it began to itch.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Redness & swelling immediately, progressing  down left arm daily for 5 days to just above the elbow.  It was painful and felt like a lump when touched. It was also very hot to the touch.  Symptoms went away after 6 days. Then it began to itch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Condition aggravated, Diplopia, Dizziness
Clinical narrative: I had flu-like symptoms within an hour of getting the Shingrix vaccine, which lasted for 10 days. I had muscle weakness in entire body, weak, tired, headache and overall sick feeling. Then I started to get back my symptoms from my TBI, which had been under control with vision therapy. I have been getting progressively worse with my vestibular system since receiving the Shingrix vaccine. I am now constantly dizzy, have balance problems again, have visual problems where my eyes are not focusing properly. I have been under a doctor's care for the TBI and have been doing vision therapy for over three years. My symptoms were under control and I have a weekly routine of vision therapy 3 times a week. The therapy had gotten me to having a basically normal life, but after getting the Shingrix vaccine, I have regressed significantly.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Malaise, Muscular weakness
Clinical narrative: I had flu-like symptoms within an hour of getting the Shingrix vaccine, which lasted for 10 days. I had muscle weakness in entire body, weak, tired, headache and overall sick feeling. Then I started to get back my symptoms from my TBI, which had been under control with vision therapy. I have been getting progressively worse with my vestibular system since receiving the Shingrix vaccine. I am now constantly dizzy, have balance problems again, have visual problems where my eyes are not focusing properly. I have been under a doctor's care for the TBI and have been doing vision therapy for over three years. My symptoms were under control and I have a weekly routine of vision therapy 3 times a week. The therapy had gotten me to having a basically normal life, but after getting the Shingrix vaccine, I have regressed significantly.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vestibular disorder, Vision blurred, Visual impairment
Clinical narrative: I had flu-like symptoms within an hour of getting the Shingrix vaccine, which lasted for 10 days. I had muscle weakness in entire body, weak, tired, headache and overall sick feeling. Then I started to get back my symptoms from my TBI, which had been under control with vision therapy. I have been getting progressively worse with my vestibular system since receiving the Shingrix vaccine. I am now constantly dizzy, have balance problems again, have visual problems where my eyes are not focusing properly. I have been under a doctor's care for the TBI and have been doing vision therapy for over three years. My symptoms were under control and I have a weekly routine of vision therapy 3 times a week. The therapy had gotten me to having a basically normal life, but after getting the Shingrix vaccine, I have regressed significantly.
Age: 72.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient had edema and erythema in left arm.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Two hours after she received her vaccine, she experienced extreme pain (pain scale 1 to 10 she described it as a 10), could not lift her arm.  It gradually decreased over the next 5 days until it was gone.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: approx 1 day after administration of vaccine patient developed significant rash, soreness in arm
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Culture, Dry mouth, Tongue discomfort
Clinical narrative: A few days after receiving the flu vaccine the patient started experiencing dry mouth and burning tongue syndrome. She does not know if it is related to the vaccine but wanted to report it.
Age: 44.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Injection site pain
Clinical narrative: Patient called on 10/28/2019 to report an adverse event. Patient reports that she received the flu shot on Saturday 10/26/19 in the afternoon. She received the vaccine in the left deltoid. She reports that her left shoulder feels weak and hurts like it hit her bone or muscle. The patient has received flu shots in the past and denies past adverse events. The patient reported pain when getting dressed, putting hair up in a ponytail and using any movement of her arm above her elbow. She denies pain when arm is rested. Patient reports that it feels like her shoulder has popped. She reports that the pain has stayed relatively stable since yesterday, 10/27/19. She was encouraged to continue to monitor her pain and other symptoms. This pharmacist called her primary care physician and left a voicemail to explain the situation.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Pain in extremity, Tenderness
Clinical narrative: Patient presented to our clinic on 10/24/19 with complaints of soreness, redness, and tenderness to right arm.  Patient reported she received her flu shot 2 days ago on her right arm. Patient showed our PA where the Pharmacist gave her the shot. The PA prescribed Keflex 500mg BID x 7 days for treatment of cellulitis.   We received documentation from the pharmacy who administered the vaccine, there documentation indicates the flu vaccine was given in the left arm, however patient insists it was right arm.  When I spoke to the RPH she reports it is possible the documentation on their end could be wrong as sometimes they give multiple flu shots back to back right now and could have not circled the correct location on their consent.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: 2.5 days of Chills, severe headache, aches, very sore arm.  Sore arm still apparent on the 4th day.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Caesarean section, Electromyogram, Exposure during pregnancy, Fatigue
Clinical narrative: Given Tdap (unsure which manufacture- documented by OB) while pregnant with second child on 7/25/2019. Received Tdap during first pregnancy on 5/10/2018 with no adverse reaction. Due date was 9/29/2019. Diagnosed with Guillian-Barre Syndrome 9/5. Emergent c-section at 36w4d. Birth weight 6lbs 13oz. Plasmapheresis started, and continued until mid october. Partial paralysis and decreased mobility and sensation. Pain, numbness, decreased sensation and tingling continues as of 10/28. Decreased mobility continues 10/28. Fatigue continues 10/28. Gabapentin prescribed for pain. Prednisone prescribed for inflammation. PT/OT and speech therapy multiple times per week.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Inflammation, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Given Tdap (unsure which manufacture- documented by OB) while pregnant with second child on 7/25/2019. Received Tdap during first pregnancy on 5/10/2018 with no adverse reaction. Due date was 9/29/2019. Diagnosed with Guillian-Barre Syndrome 9/5. Emergent c-section at 36w4d. Birth weight 6lbs 13oz. Plasmapheresis started, and continued until mid october. Partial paralysis and decreased mobility and sensation. Pain, numbness, decreased sensation and tingling continues as of 10/28. Decreased mobility continues 10/28. Fatigue continues 10/28. Gabapentin prescribed for pain. Prednisone prescribed for inflammation. PT/OT and speech therapy multiple times per week.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain, Paraesthesia, Paralysis, Plasmapheresis
Clinical narrative: Given Tdap (unsure which manufacture- documented by OB) while pregnant with second child on 7/25/2019. Received Tdap during first pregnancy on 5/10/2018 with no adverse reaction. Due date was 9/29/2019. Diagnosed with Guillian-Barre Syndrome 9/5. Emergent c-section at 36w4d. Birth weight 6lbs 13oz. Plasmapheresis started, and continued until mid october. Partial paralysis and decreased mobility and sensation. Pain, numbness, decreased sensation and tingling continues as of 10/28. Decreased mobility continues 10/28. Fatigue continues 10/28. Gabapentin prescribed for pain. Prednisone prescribed for inflammation. PT/OT and speech therapy multiple times per week.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Premature delivery, Sensory loss
Clinical narrative: Given Tdap (unsure which manufacture- documented by OB) while pregnant with second child on 7/25/2019. Received Tdap during first pregnancy on 5/10/2018 with no adverse reaction. Due date was 9/29/2019. Diagnosed with Guillian-Barre Syndrome 9/5. Emergent c-section at 36w4d. Birth weight 6lbs 13oz. Plasmapheresis started, and continued until mid october. Partial paralysis and decreased mobility and sensation. Pain, numbness, decreased sensation and tingling continues as of 10/28. Decreased mobility continues 10/28. Fatigue continues 10/28. Gabapentin prescribed for pain. Prednisone prescribed for inflammation. PT/OT and speech therapy multiple times per week.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Head banging, Pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme injected arm pain, fever (101.9), severe headache, body aches and chills.  Severe for approx. 36 hours, then decreasing until gone 4 days after injection.
Age: 85.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Rash
Clinical narrative: Rash over legs and torso, and severe muscle pain in bilateral arms started shortly after vaccination and symptoms have not resolved 2 weeks later.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain
Clinical narrative: pt complained of chest pain on left side starting the night after flu shot. still having pains on 10/28/19
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pyrexia, Rash
Clinical narrative: Immediate shoulder pain right after injection, 101degree fever at 4am on 10/09/19, rash on upper chest neck area, persistent shoulder pain continue regardless ibuprofen intake and reported shoulder popping on 10/23
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Patient given flucelvax in left deltoid and pneumovax 23 in right deltoid. Patient reported waking up on 10/27/19 with right shoulder joint stiffness and limited arm mobility along with overall cold chills. Patient called to report reaction to pharmacy on 10/28/19 at 1015AM. Patient stated some relief from the intensity of reaction when waking upon 10/28/19.  Patient directed to take NSAIDS OTC therapy and report back to pharmacy and/or physician if mobility or cold chills do not improve or worsen within 48 hours. Patient PCP office notified. Left message with employee to update patient data.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Musculoskeletal chest pain, Pyrexia
Clinical narrative: pt had extreme chills, shivers late the day. slight temp of 100.5.  sore ribs the next day ( possibly from shivers?)
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: I had hives appear on both right and left shoulders. The inflammations where very itchy and stayed inflamed for two weeks and continues to itch even today.
Age: 37.0
Sex: F
Vaccine: DTAP, FLU4, HEP, HEPA, MMR
Symptoms: Feeling abnormal
Clinical narrative: SHE CALLED HER DOCTOR OFFICE AFTER SHE LEFT PHARMACY SHE TOLD NURSE SHE  DOES NOT NOT FEEL GOOD
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiovascular disorder, Immediate post-injection reaction, Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: I experienced left shoulder joint pain immediately after the vaccination was administered. Over the course of the day, the pain traveled up through my shoulder into the left side of my neck. My left arm became weak and it  was difficult to lift it above my head. The pain also traveled down my left arm into my left hand and became more intensely painful that night and the following day and a half.  My left hand became stiff and blood vessels ruptured in my left fingers. Three days out from time of vaccination pain is beginning to subside, but I?m still sore and am experiencing prickly pains in my left arm.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: I experienced left shoulder joint pain immediately after the vaccination was administered. Over the course of the day, the pain traveled up through my shoulder into the left side of my neck. My left arm became weak and it  was difficult to lift it above my head. The pain also traveled down my left arm into my left hand and became more intensely painful that night and the following day and a half.  My left hand became stiff and blood vessels ruptured in my left fingers. Three days out from time of vaccination pain is beginning to subside, but I?m still sore and am experiencing prickly pains in my left arm.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Vaccine given too high in the arm and was given in the joint, employee was unable to raise arm and has extreme pain to the right arm.  Was treated with steroids and physical therapy at a clinic.
Age: 47.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed Cellulitis below the shot area.  He was traveling out of the country immediately following the shot so he was unable to report until he was back.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient received the Afluria and Shingrix vaccines on 09/16/19 in the same arm 1 inch apart.  Patient reports muscle pain at injection site for the last 1.5 months with interference with daily activities such as putting on clothes.  Patient reports that there is no external swelling or redness at the site of injection.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Anxiety, Chest pain, Computerised tomogram, Dyspnoea, Hypoaesthesia
Clinical narrative: 57-year-old who presents to the emergency room with a 5-6 day history of progressive weakness in his extremities and painful tingling and numbness as well.  He first developed the symptoms 5-6 days ago in the left upper extremity which was associated with chest pain and secondary anxiety and shortness of breath.  Patient was admitted to the hospital overnight.  He also complained of generalized weakness in his legs as well as a near syncopal episode in the emergency room at the time.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Lumbar puncture, Magnetic resonance imaging, Mechanical ventilation, Muscular weakness, Pain in extremity
Clinical narrative: 57-year-old who presents to the emergency room with a 5-6 day history of progressive weakness in his extremities and painful tingling and numbness as well.  He first developed the symptoms 5-6 days ago in the left upper extremity which was associated with chest pain and secondary anxiety and shortness of breath.  Patient was admitted to the hospital overnight.  He also complained of generalized weakness in his legs as well as a near syncopal episode in the emergency room at the time.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Paraesthesia, Presyncope
Clinical narrative: 57-year-old who presents to the emergency room with a 5-6 day history of progressive weakness in his extremities and painful tingling and numbness as well.  He first developed the symptoms 5-6 days ago in the left upper extremity which was associated with chest pain and secondary anxiety and shortness of breath.  Patient was admitted to the hospital overnight.  He also complained of generalized weakness in his legs as well as a near syncopal episode in the emergency room at the time.
Age: 57.0
Sex: M
Vaccine: UNK, FLUR4
Symptoms: Dyspnoea, Malaise, Paraesthesia, Paralysis
Clinical narrative: 57-year-old who presents to the emergency room with a 5-6 day history of progressive weakness in his extremities and painful tingling and numbness as well.  He first developed the symptoms 5-6 days ago in the left upper extremity which was associated with chest pain and secondary anxiety and shortness of breath.  Patient was admitted to the hospital overnight.  He also complained of generalized weakness in his legs as well as a near syncopal episode in the emergency room at the time.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness
Clinical narrative: Patient reported dizziness / lightheadedness after receiving the vaccine through today, 10/28/2019
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Tremor
Clinical narrative: Patient stated that five hours after dose felt like she had the flu, shaking, shivers, and nausea, and lasted few days
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: STUDENTS SHOULDER AND ARM RED/HOT TO THE TOUCH.  WENT TO THE DR AND DR STATED IT WAS JUST A LOCALIZED REACTION.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site next day.
Age: 76.0
Sex: U
Vaccine: UNK
Symptoms: Contusion
Clinical narrative: THE VACCINATION WAS DONE 10-09-2019 AS OF 10-19-2019 I STILL HAVE A LARGE BRUISE AS IF MY SKIN WAS BURNED
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient came in around 3pm this afternoon on 10-22-19 with his grandmother and she wanted the nurse to look at his arm because he received a Pneumovax 23 this morning around 9:00 am and it looked swollen. When looking at the patient arm it was visibly swollen and was warm to touch and hard with an induration of about 3" wide and 4" long. Patient had a temp of 100.6 and b/p 90/40. Told grandmother to take child to the E.R. or Primary Care Physician as soon as she leaves the Health Department. Grandfather came and took child to the E.R. Talked with grandparents around 4:35 or 4:40 pm the child was being seen at the E.R. Between 6 and 6:20pm the grandmother contacted supervisor, RN and stated the child had been released and was doing fine and that he received medication for his fever and benadryl for the swelling. Grandmother contacted supervisor, RN on 10/23/2019 in the am and stated the child had been to his regular pediatrician and stated that the swelling had went down and the child would be fine just to give him medication for his fever and plenty of rest.
Age: 3.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Gastroenteritis viral, Laboratory test, Vomiting
Clinical narrative: Vaccines given 10/17/19 on 10/19/19 pt vomited 2x called office triage and was advised to go to ER due possible dehydration DX: viral gastroenteritis
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Urticaria
Clinical narrative: Hives to face that spread to back and chest rapidly. Possible allergic reaction after receiving flu shot/red whelting on face noted/gave him 7.5ml of Benadryl/parents were called/12:10-whelting has spread to neck, arms, legs, stomach, and back-no improvement/gave him another 7.5ml of Benadryl/Mom arrived at 12:35/Mrs. is on the phone interpreting form me with Mom/Mom gave permission to go ahead and use the Epi-Pen and she is taking him straight to the hospital/12:40 Epi-0.15 was given in left thigh/tol. well.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Local reaction (soreness/redness/itching swelling at injection site  told to put ice (10/26/19) & Tylenol/go to urgent care 10/27/19 10/27/19 - went to urgent care given prednisone  Thamanolone cream 10/28/19 - spoke to patient. Arm still hurts a little Patient has headache. Swelling has gone down  but still a little itchy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Pain in extremity
Clinical narrative: Local reaction (soreness/redness/itching swelling at injection site  told to put ice (10/26/19) & Tylenol/go to urgent care 10/27/19 10/27/19 - went to urgent care given prednisone  Thamanolone cream 10/28/19 - spoke to patient. Arm still hurts a little Patient has headache. Swelling has gone down  but still a little itchy.
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; administration of an expired ROTATEQ vaccine; This spontaneous report was received from a medical assistant concerning to a 2 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 03-OCT-2019 at 16:30, the patient was seen for a well-child check and weighed 12 pounds, 6 ounces. On that day, he was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) per oral route (dose unspecified) lot# R002806 expiration date 29-SEP-2019 for prophylaxis. Later on the same date, the medical assistant realized that the vaccine given had expired days ago. No adverse effect was reported.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Extra dose administered, Gait inability, Influenza, Injection site pain
Clinical narrative: Shortly after that, I had flu symptoms, aching; Shortly after that, I had flu symptoms, aching; I was weak, couldn't nagivate; I had to stay in bed for days, I was so sick; She subsequently experienced my arm got swollen, huge; Two shots, five days apart; Two shots, five days apart; This past winter I had the flu and pneumonia twice; This past winter I had the flu and pneumonia twice; The injection site was sore; This spontaneous report was received from a currently 85 year-old female patient regarding herself. The patient  concurrent conditions included blood pressure abnormal and had no pertinent medical history, drug reactions, and allergies. The patient's concomitant therapies included blood pressure pill.  On unspecified date (reported as 20 years ago  or more), the patient was vaccinated Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 2 injections (reported as 2 shots) (extra dose administered) five days apart (inappropriate schedule of product administration) for pneumonia (lot number, and expiration date were not reported).   Shortly after she subsequently experienced that her arm got swollen, huge (injection site swelling). Shortly after that, she had flu symptoms(influenza), aching (pain). She stated, she was weak, and could not navigate (asthenia). She had to stay in bed for days, she was so sick (malaise). The injection site was sore (injection site pain). It was reported that the patient recovered on unspecified date (reported as a week later) of the events injection site swelling, influenza, pain, asthenia, malaise, and injection site pain. Then, in 2018 (reported as the past winter), she had the flu (influenza) and pneumonia twice in 18 months. The patient talked to the doctor, and no laboratories and studied were performed.    The outcome of the events influenza and pneumonia was not provided.   The causal relationship between the aforementioned events and vaccine Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23)  was not provided.   Upon internal review, the event pneumonia was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Pain, Pneumonia
Clinical narrative: Shortly after that, I had flu symptoms, aching; Shortly after that, I had flu symptoms, aching; I was weak, couldn't nagivate; I had to stay in bed for days, I was so sick; She subsequently experienced my arm got swollen, huge; Two shots, five days apart; Two shots, five days apart; This past winter I had the flu and pneumonia twice; This past winter I had the flu and pneumonia twice; The injection site was sore; This spontaneous report was received from a currently 85 year-old female patient regarding herself. The patient  concurrent conditions included blood pressure abnormal and had no pertinent medical history, drug reactions, and allergies. The patient's concomitant therapies included blood pressure pill.  On unspecified date (reported as 20 years ago  or more), the patient was vaccinated Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 2 injections (reported as 2 shots) (extra dose administered) five days apart (inappropriate schedule of product administration) for pneumonia (lot number, and expiration date were not reported).   Shortly after she subsequently experienced that her arm got swollen, huge (injection site swelling). Shortly after that, she had flu symptoms(influenza), aching (pain). She stated, she was weak, and could not navigate (asthenia). She had to stay in bed for days, she was so sick (malaise). The injection site was sore (injection site pain). It was reported that the patient recovered on unspecified date (reported as a week later) of the events injection site swelling, influenza, pain, asthenia, malaise, and injection site pain. Then, in 2018 (reported as the past winter), she had the flu (influenza) and pneumonia twice in 18 months. The patient talked to the doctor, and no laboratories and studied were performed.    The outcome of the events influenza and pneumonia was not provided.   The causal relationship between the aforementioned events and vaccine Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23)  was not provided.   Upon internal review, the event pneumonia was considered to be medically significant.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse affects; first dose of VAQTA was given to patient on 4/18/2019 and a second dose was given on 5/24/19; This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy details were not reported. On 18-APR-2019, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength and dose were not reported) intramuscularly for prophylaxis. Second dose was given on 24-MAY-2019 (inappropriate schedule of product administration). No adverse event was reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: Localized reaction; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs).   A 65-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced localized reaction. The pharmacist was informed that there may be corn in the product and she stated maybe that was why the patient had a reaction so she wanted to know if there was any corn derived products in the vaccine.  Information on the batch number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: severe arm soreness; had a difficult time showering for a few days without assistance.; This is a spontaneous report from contactable Pharmacist via Pfizer Sales Representative.   A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation .  The patient medical history  and concomitant medications were not reported.  The patient experienced severe arm soreness  on an unspecified date with outcome of unknown , had a difficult time showering for a few days without assistance on an unspecified date with outcome of unknown.    The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Pneumonia pneumococcal, Product quality issue
Clinical narrative: Double pneumococcal pneumonia; Double pneumococcal pneumonia; Received a contaminated batch; Received a contaminated batch; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for routine vaccination. Medical history included HIV from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced double pneumococcal pneumonia on an unspecified date. The reporter reported that there were two patients received the same vaccine and got double pneumococcal pneumonia after receiving it, both patients received a contaminated batch. The outcome of double pneumococcal pneumonia was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019457002 same reporter/drug, different patient/event.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Influenza virus test negative, Injection site pain, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: pain and stiffness in the neck.; pain and stiffness in the neck.; Today she is experiencing more joint pain at neck, fingers, back, and hips./muscle and joint aches; muscle and joint aches; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient received second dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration in left arm on 18Oct2019 around 10:00AM at single dose for immunization/ meningitis prevention. The injection was given at a physician's office or private clinic. The patient received the first dose of meningococcal group b rlp2086 in Sep2019 ("over a month ago, or 5 weeks ago") for immunization. After first injection the patient just had arm pain, or pain at the site of the injection. There were no other relevant medical history or concomitant medications. On 20Oct2019 the patient started experiencing pain and stiffness in the neck, having muscle and joint aches, and had been increasing since then. The patient went to urgent care where they did a flu swab and strep swab, which both were negative. In urgent care, the patient was given muscle relaxers. The patient was told to take ibuprofen (ADVIL) for the joint pain, but it was worse on 22Oct2019. The outcome of events pain and stiffness in the neck was unknown, the outcome of events muscle and joint aches was not recovered.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Neck pain, Pain in extremity, Streptococcus test negative
Clinical narrative: pain and stiffness in the neck.; pain and stiffness in the neck.; Today she is experiencing more joint pain at neck, fingers, back, and hips./muscle and joint aches; muscle and joint aches; This is a spontaneous report from a contactable consumer (patient's mother). A 21-year-old female patient received second dose of meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration in left arm on 18Oct2019 around 10:00AM at single dose for immunization/ meningitis prevention. The injection was given at a physician's office or private clinic. The patient received the first dose of meningococcal group b rlp2086 in Sep2019 ("over a month ago, or 5 weeks ago") for immunization. After first injection the patient just had arm pain, or pain at the site of the injection. There were no other relevant medical history or concomitant medications. On 20Oct2019 the patient started experiencing pain and stiffness in the neck, having muscle and joint aches, and had been increasing since then. The patient went to urgent care where they did a flu swab and strep swab, which both were negative. In urgent care, the patient was given muscle relaxers. The patient was told to take ibuprofen (ADVIL) for the joint pain, but it was worse on 22Oct2019. The outcome of events pain and stiffness in the neck was unknown, the outcome of events muscle and joint aches was not recovered.
Sex: M
Vaccine: PNC13
Symptoms: Joint noise, Joint range of motion decreased, Pain, Pain in extremity, Swelling
Clinical narrative: My left arm still hurts and I have limited range of motion; My left arm still hurts and I have limited range of motion; crunching sound in my arm; pain; swelling; This is a spontaneous report from a contactable consumer (patient).  An elderly (turned 65 in 2018) male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date in Oct2018 for immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced his left arm still hurt and he had limited range of motion (limited arm movement after a year), he had crunching sound in my arm, pain, swelling on an unspecified date. The outcome of the events was unknown. The CDC decided not to recommend this vaccine this past July2019.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: arm pain; pain at the site of the injection; This is a spontaneous report from a contactable consumer (patient's mother).  A 21-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date in Sep2019 at single dose for immunization/ meningitis prevention.  The patient's medical history concomitant medications were not reported.  it was reported that for the first injection the patient just had arm pain, or pain at the site of the injection. The outcome of the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Swollen arm; Swollen arm and difficulty lifting it; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm and difficulty lifting it on an unspecified date with outcome of unknown.   Information on the batch number has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: arm swollen; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who experienced arm swollen (peripheral swelling), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious arm swollen (peripheral swelling) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other lab data was not reported.  Final diagnosis was arm swollen (peripheral swelling).   It was not reported if the patient received a corrective treatment.  Outcome of event was unknown.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient received expired Daptacel with no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional via a phone call.  This case involves a 30 months old male patient who received expired daptacel (expired product administered), while he received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (FLU); and HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was an actual medication error due to expired product administered.  On 15-Oct-2019, the patient received 0.5 ml (frequency 1) dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5281AA via intramuscular route in the left thigh.  On 16-Oct-2019, the patient received expired daptacel (expired product administered) 1 day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. It was reported that the reporter was not sure which dose this was in the series and see if the child was behind on vaccines. The child last checkup was at 18 months.  No lab data was provided.  Final diagnosis was not applicable received expired daptacel.   It was not reported if the patient received a corrective treatment.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; fever that left him in bed for 1-2 days; aches/pain; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to 2019SA290956 (same reporter).  This case involves a 75 years old male patient who experienced flu like symptoms, while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRIOha kyaN VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on concomitant therapy.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AA via intramuscular route in the arm upper.  On an unknown date, The patient developed a non-serious flu like symptoms(influenza like illness), fever that left them in bed for 1-2 days (pyrexia) and aches/pain (pain) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab test reported.  Final diagnosis was flu like symptoms, fever and pain.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovered / Resolved on an unknown date for the events.