chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy developed 34 days following vaccine
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient reports that he had no abnormal symptoms until 2 weeks after vaccine, when he had some swelling and pain at vaccine site suddenly appear. He used a warm compress on the site, and the swelling went away. He states that his shoulder does not hurt, nor does his arm upon movement. The pain only occurs when touching the site of injection. It has gotten better a month later, but there is still some tenderness upon touching, other than that no pain upon movement or on any other area of the arm.
Age: 70.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Chest discomfort, Limb discomfort
Clinical narrative: Patient called on the phone and stated she had a reaction to the vaccine given on 11/20.  She said that it began the evening of 11/20 and into 11/21.  She said that it started with her arm and she got advice from a healthcare professional that told her to take Benadryl.   The adverse reaction got worse the next day 11/22 with patient stating it moved to her chest and prompted a ER visit (antibiotic prescribed) and she missed some days from work.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain
Clinical narrative: Patient experienced a localized reaction the following day in his right arm which was red, painful lump.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Mobility decreased, Pain, Pyrexia
Clinical narrative: Significant arm pain at the site of immunization. Couldn't lift my arm for 2 days. Fever. Extreme fatigue and body aches.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: patient reports upon waking in the morning that he is still have arm/shoulder pain at the injection site. He reports sometimes not being able to lift his left arm above his head
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Pain at approximate injection site when arm is moved in certain normal positions which subsides temporarily when the arm is forced through the discomfort. Pain and stiffness in the night. Other than certain movements (e.g. reaching for the toilet paper or hanging up clothes or exercising and inertia at night, there is no pain. Up to now my life has luckily  been pain free, but since the injection there's a little "sympathetic" twinge in the knee on the same side and the other arm, but I don't see how this can be related.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain at approximate injection site when arm is moved in certain normal positions which subsides temporarily when the arm is forced through the discomfort. Pain and stiffness in the night. Other than certain movements (e.g. reaching for the toilet paper or hanging up clothes or exercising and inertia at night, there is no pain. Up to now my life has luckily  been pain free, but since the injection there's a little "sympathetic" twinge in the knee on the same side and the other arm, but I don't see how this can be related.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu type symptoms,  bed rest,  still ill
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site joint discomfort, Injection site joint pain, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Within 30 minutes of the vaccination being administered in her right arm she had intense pain in discomfort within the right shoulder joint.  She then began to experience reduced range of motion and continued to have pain which has persisted, she was evaluated in clinic on November 28th and further evaluation was completed at that time.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Tendon disorder, Ultrasound scan abnormal
Clinical narrative: Within 30 minutes of the vaccination being administered in her right arm she had intense pain in discomfort within the right shoulder joint.  She then began to experience reduced range of motion and continued to have pain which has persisted, she was evaluated in clinic on November 28th and further evaluation was completed at that time.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient called this afternoon 12/1/2020 to let me know that her left arm/shoulder had been hurting since she received her flu shot on 9/16/2020. She said at first it felt like she couldn't move her arm and thought it would get better but it has not. She wakes up at night because it still hurts. She has a hard time picking up her infant grandson because of the pain., She said that her daughter researched her symptoms and it sounds a lot like SIRVA. She has tried taking ibuprofen, but gets no relief.  She called her provider today and will make an appointment for evaluation.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Soreness at injection site Tired/run down feeling body/muscle aches all over body upset stomach/ light nausea mild headache (no fever)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Soreness at injection site Tired/run down feeling body/muscle aches all over body upset stomach/ light nausea mild headache (no fever)
Age: 46.0
Sex: M
Vaccine: UNK
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient is complaining of pain and weakness on injection arm
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 101, body aches- too acetaminophen to treat.
Age: 27.0
Sex: M
Vaccine: FLUC4, TDAP
Symptoms: Dizziness, Emotional distress, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Patient to be immunized for both influenza and tetanus. Upon administration of Boostrix, patient began to feel lightheaded and dizzy. After a moments time, Flucelvax was administered in opposite arm and patient stated again was feeling nauseous and overwhelmed. Pharmacist monitored the patient for support. Patient became nauseated with minimal vomiting. Pharmacist guided for more support and aided to technicians for more support. Continuous monitoring occurred for about 5 minute and patient reported feeling less nausesous and alert. Emergent healthcare authorities not contacted to scene. Followed up with patient primary care provider of incident. Followed up with patient well-being.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Muscle/body aches Shivering  Took Extra Strength Tylenol and they went away. Shivering came back later in the day but was stopped by another dose of Tylenol.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient had arm soreness that extended from the upper arm and shoulder area, she had pain and some limitation with movement.  She said it was improving some over the last 5 days but was still sore and stiff.  The symptoms started about 24 hours after the shot
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Haematoma, Injection site muscle weakness, Injection site pain, Joint range of motion decreased, Laboratory test
Clinical narrative: Pt with severe hematoma 1 day after administration. hematoma and pain presisted 3 days after. One month since vaccine and pt with decreased ROM and muscle decrease in right arm with severe pain to the shoulder.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle atrophy, Pain, X-ray abnormal
Clinical narrative: Pt with severe hematoma 1 day after administration. hematoma and pain presisted 3 days after. One month since vaccine and pt with decreased ROM and muscle decrease in right arm with severe pain to the shoulder.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain (all over), headache, chills (but no fever), exhaustion.  Treatment - alternating tylenol and ibuprofen, which generally helped. Symptoms would come in waves.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site reaction, Administration site warmth, Injection site pruritus, Urticaria
Clinical narrative: 24 hours later developed a fist sized whelp at administration site along with itching and heat
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Localised infection, Peripheral swelling, Skin warm
Clinical narrative: Patient woke up on 10/20/2020 and her arm where she received the shot was swollen, red, and hot. She had a regular doctor visit scheduled that day so she mentioned it to her doctor. He said it looked like infection but no medication needed. Patient reported in took around 6 days to clear up.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Immediate post-injection reaction, Product administration interrupted
Clinical narrative: Patient was administered lot 5D4H4 exp 6/30/21 and experienced lightheadedness right after the vaccine was given.  This resolved in approximately 5 minutes.  Prior to receiving this, it was attempted to administer her vaccination with same vaccine lot 373H3 exp 6/30/21; however, there was an issue with the needle/syringe and the plunger would not depress.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: The morning after receiving the injection (15 hours after ) I experienced fatigue and soreness at the injection site and overall body aches.  I took two  Aleve but it didn't seem to help much. That evening I developed a fever of 102 . I took two more Aleve and went to bed. This morning my fever and general body aches were gone but there was still pain at the injection site and pain in my armpit area on the left side.  Now, 50 hours after the injection, there is still pain and tenderness at the injection site and  in my left armpit area .
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: PATIENT CALLED ON 12/01/2020 STATING  SHE GOT THE SHINGLES FROM THE VACCINE. SAID SHE HAD SHINGLE LIKE BUMPS COME UP ON HER ANKLES AND ELBOW. SHE HAS NOT CONTACTED HER PHYSICIAN.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: dizziness fainting vomiting  - onset within 15 seconds of admin
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient started experiencing normal arm pain for a few days after vaccine, however pain is still ongoing since 10/8, almost 2 months later. The pain decreased, now it is just when she is lifting her arm, she feels a sharp pain.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Severe, debilitating body aches at onset; chills for approx. 30 minutes. Less severe body aches on day 2; measured temperature (temporal) of 37.7 at noon on day 2, and (oral) 99.8 at 6 pm on day 2.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient reported not being able to lift arm after vaccine administration and also shoulder pain. Saw primary care provider who diagnosed possible rotator cuff tear, patient is going to physical therapy to try and help injury
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Patient came to the pharmacy on 12/1/2020 at 12PM expressing concerns about the area of injection on his left arm. After the shot on 10/12/2020, patient experienced soreness, difficulty in lifting items and decreased range of motion. He said he has not seek medical attention for this . He has tried compress but did not work. Suggest patient to try OTC NSAID to help with the pain and compress. Informed him to seek medical care if there are no improvement of symptoms after couple days.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swelling of eyelid
Clinical narrative: rash on forehead and eyelid swelling
Age: 58.0
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient messaged doctor 10 days after the vaccine on 11/30/20: "Arm is swollen and hot to the touch but skin doesn?t look affected. Temperature is normal, it?s just odd that it felt better on day 3 and then felt worse  on day 7. " Doctor spoke to patient on 12/1/2020, and reported "Improved arm swelling and no fever. Good range of motion now. Clearly had a reaction to vaccination. But recovering."
Age: 44.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient has had pain at injection site radiating down entire arm since vaccination. She says it becomes very stiff and she struggles to pick things up some times.
Age: 44.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient has had pain at injection site radiating down entire arm since vaccination. She says it becomes very stiff and she struggles to pick things up some times.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Fever 99.7F Body & muscule aches Fatigue Slight soar throat Light headed
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 99.7F Body & muscule aches Fatigue Slight soar throat Light headed
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site reaction, Neuralgia
Clinical narrative: First week after vaccination-flulike symptoms. Second week and to present  nerve pain around heart, waist, to left shoulder, now moving to right shoulder.  Three visits to the ER, three days in hospital.  First course of Valacyclovir resulted in improvement in left side symptoms, second course in progress to treat right side symptoms.  Patient has been diagnosed with internal shingles.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: No adverse event, pt received a 3rd Hep A
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain
Clinical narrative: Patient presents with prolonged injection site pain that spreads to her left upper arm/shoulder/neck area. The pain comes and goes away through out the day. The pain gets worse when she lifts her arm, and /or puts on clothes. She hasn't taken any medications or seen a doctor to help treat the pain. She has only been watching-waiting the pain hoping that it goes away.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Cheilitis, Glossitis, Inflammation, Pruritus
Clinical narrative: Severe inflammation (i.e. rash and hive) all over body, including face and eyes and lips and tongue with dramatic itching.  Lasted for over a week.  Anti-histamin and esteroid administered in 2 visits I had in the Urgent Care. Took it under control by taking medicine.  I was wary of the immunosuppressing impact of the esteroid (during the COVID-19 time). So it was debilitating to be sick and worry about getting sicker due to the medicine's side effect.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Contusion, Fatigue, Headache, Malaise
Clinical narrative: Left arm was very sore for 7 days, it was swollen and  had welts then turned into a bruise for a week.  I woke up the next morning and hurt all over, felt very fatigued, my joints hurt, had headache, and just felt bad. This lasted for 7 days!
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Left arm was very sore for 7 days, it was swollen and  had welts then turned into a bruise for a week.  I woke up the next morning and hurt all over, felt very fatigued, my joints hurt, had headache, and just felt bad. This lasted for 7 days!
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Flu shot caused soreness in the arm. Painful to lift arm above head.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Pallor
Clinical narrative: After patient received the vaccine, patient was informed to stay in the waiting area for 15 minutes. After about 5 minutes of giving the vaccine, patient started feeling dizzy and requested to be given water. Patient became a little pale. 911 was called and the paramedics arrived less than 10 minutes and took patient's vital signs. Patient was asked if she wants to go to the hospital but she declined. Patient left the pharmacy with her husband after she was evaluated by  the paramedics
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: This was a seasonal flu shot. It was a dark yellow brown color. Maybe 5cc or less
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Cyanosis, Fall, Gait disturbance
Clinical narrative: Child was in a deep sleep when I got her home, could not wake her up for 2 minutes, the outline of her lips was turning blue.  Kept her up for the rest of the day.   For the next five days she would be walking, and her legs would go out from under her like she was a raging alcoholic.  Progressively the falling subsided, and things got back to normal.  Worried that the allergy to the second dose of the mmr will be worse.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles 2 days after receiving first dose of Shingrix.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: After vaccine administered patient had an episode where she became stiff and very pale gray/white lasting a few seconds. Pt then back to normal consciousness
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash with red base on abdomen / Varicella Vaccine Rash
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Decreased activity, Pyrexia, Rash
Clinical narrative: Papular rash to neck and torso 5 days post vaccine. Fever present 8 days post vaccine Fever resolved with 2 days.
Age: 55.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Tinnitus
Clinical narrative: started with severe chills, migraine, severe pain at injection site, then fever and tinnitus   the tinnitus has never gotten better and got worse after the 2nd dose.  i was sick like the flu for a week.
Age: 55.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Chills, Influenza like illness, Injection site pain, Migraine, Pyrexia
Clinical narrative: started with severe chills, migraine, severe pain at injection site, then fever and tinnitus   the tinnitus has never gotten better and got worse after the 2nd dose.  i was sick like the flu for a week.
Age: 55.0
Sex: F
Vaccine: VARZOS, UNK
Symptoms: Tinnitus
Clinical narrative: started with severe chills, migraine, severe pain at injection site, then fever and tinnitus   the tinnitus has never gotten better and got worse after the 2nd dose.  i was sick like the flu for a week.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Arthralgia, Asthenia, Blood iron decreased, Cataract, Condition aggravated
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Feeling abnormal, Incorrect route of product administration, Loss of personal independence in daily activities, Malaise, Pain in extremity
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Visual impairment
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Bacterial infection, Blood test, Candida test negative, Cataract, Cervicitis trichomonal
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Deafness, Dizziness, Ear pain, Eye discharge, Fatigue
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Feeling abnormal, Headache, Herpes virus test, Hyperacusis, Injection site pain
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Magnetic resonance imaging, Nasal congestion, Ophthalmological examination abnormal, Pain, Pain of skin
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Pruritus, Secretion discharge, Sinusitis, Skin swelling, Skin wound
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS, FLU4, VARZOS
Symptoms: Swelling face, Tinnitus, Visual impairment
Clinical narrative: Patient felt 24 hrs after the shot soreness on injection site, body aches like body was angry at her. The next day symptoms got much worse, and some days later lots of mucus and white tissue coming out of the eyes, ophthalmologist said her cataracts have grown. Visited a 2nd ophthalmologist who stated vision changes in both eyes in 2 weeks. Sept 24th experienced a needle headache. Also experienced vaginal bacterial infection, sinus infection and headache for 4 weeks, dizziness, nasal congestion, facial skin swelled and felt sore/sensitive to touch, fatigue, hearing loss, skin was itchy and had sores, tinnitus, ear pain and sensitive to loud noises. Other specialists seen: ENT and ophthalmologist and Pharmacist.
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Headache, Myalgia, Paraesthesia
Clinical narrative: Ache/ joint pain in hand,wrist and forearm; Patient had tingling in hand; Bad headache; Initial information regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (MI) (Reference number- 00367104) and transmitted to Sanofi on 20-Nov-2020.  This case involves female of unknown age who had experienced tingling in hand (paraesthesia), bad headache (headache) and ache/joint pain in hand, wrist and forearm (arthralgia), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing autoimmune disorder concerned with antigen content.   On 21-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 21-Oct-2020, the patient developed non-serious events such as tingling in hand (paraesthesia) and bad headache (headache), on the night, vaccine was administered.  On an unknown date, the patient developed a non-serious ache/ joint pain in hand, wrist and forearm (arthralgia), exactly 2 weeks later the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the patient recovered from the events paraesthesia and headache on an unknown date. While did not recover from the event arthralgia.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Arthralgia, Headache, Paraesthesia
Clinical narrative: Ache/ joint pain in hand,wrist and forearm; Patient had tingling in hand; Bad headache; Initial information regarding an unsolicited valid non-serious case from a non-healthcare professional via Medical Information (MI) (Reference number- 00367104) and transmitted to Sanofi on 20-Nov-2020.  This case involves female of unknown age who had experienced tingling in hand (paraesthesia), bad headache (headache) and ache/joint pain in hand, wrist and forearm (arthralgia), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing autoimmune disorder concerned with antigen content.   On 21-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 21-Oct-2020, the patient developed non-serious events such as tingling in hand (paraesthesia) and bad headache (headache), on the night, vaccine was administered.  On an unknown date, the patient developed a non-serious ache/ joint pain in hand, wrist and forearm (arthralgia), exactly 2 weeks later the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the patient recovered from the events paraesthesia and headache on an unknown date. While did not recover from the event arthralgia.  There will be no information on the batch number for this case.
Age: 44.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Soreness in Left arm. The patient is having difficulty moving Left arm. Having sharp pain from shoulder to hand . The needle struck a nerve .
Age: 44.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness in Left arm. The patient is having difficulty moving Left arm. Having sharp pain from shoulder to hand . The needle struck a nerve .
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: a temperature excursion on RECOMBIVAX HB. This product was administered today.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's current condition, historical condition and concomitant medication were not provided.  On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot# R028528 with expiration date: 04-JUN-2021; formulation vial, 1 time dose, strength and route were unknown) for prophylaxis (product storage error).     The vaccine was stored above 47 Fahrenheit (F) for 1 hour. The previous temperature excursion was 50F for 45 minutes. The digital data logger was involved.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Wrong product administered
Clinical narrative: itching at the site; PENUMOVAX 23 was mistakenly given intradermally; PENUMOVAX 23 was mistakenly given instead of tuberculin PPD; This spontaneous report was received from a registered nurse concernign a 37-year-old non-pregnant female patient. The patient had no drug reactions or allergies. The patient's medical history, concurrent conditions, and concomitant medications were not reported.     On 03-NOV-2020 in the morning, the patient mistakenly received  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S009238, expiration date: 11-FEB-2021, 0.1 milliliter, intradermal, indication reported as vaccination) instead of tuberculin purified protein derivative(PPD). On the same date in the evening, the patient was contacted and she was complaining of itching at the site (injection site pruritus). The nurse stated the patient woudl come into trhe office on 05-NOV-2020 to get her PPD read (was placed in opposite arm after error) and they would recheck the patient's arm for any further issues.  At the time of reporting, the outcome of injection site pruritus was unknown.  The causality assessment between injection site pruritus and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: M
Vaccine: MMR
Symptoms: Syringe issue, Underdose
Clinical narrative: No other AE.; the vaccine sprayed into his face/eye; the vaccine sprayed into his face/eye; the vaccine sprayed into his face/eye; At time of exposure, the barrel came away from the needle and a small amount of the vaccine made contact with his face and eyes.; At time of exposure, the barrel came away from the needle and a small amount of the vaccine made contact with his face and eyes.; This spontaneous report was received from an unknown aged pharmacist referring to himself. His pertinent medical history, concomitant drugs and drug allergies were not reported.    On 09-NOV-2020 at 5:45 pm, he got the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number was R036581, expiration date was 17-DEC-2020, dose was 0.5 milliliter, strength and route was not reported) sprayed into his face and eye when the needle came off of the syringe. He confirmed the exposure to the vaccine on his face and eye did not occur while drawing up the medication from the vial. The pharmacist stated the exposure occurred at the end of administration. At time of exposure, the barrel came away from the needle and a small amount of the vaccine made contact with his face and eyes. The pharmacist went immediately to the eye flushing station and flushed his eyes. No further information provided. No other adverse events (occupational exposure to product, product leakage, product container issue, exposure via eye contact, exposure via skin contact and no adverse event). The pharmacist wanted to know if there were any precautions that needed to be taken.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Expired Recombivax HB was administered to a patient; Prior excursion of 49.2 F for 1 hour; This spontaneous report as received from a nurse referring to a 6-weel-old female patient. Information regarding patient's concurrent conditions, concomitant medications, drug allergies or reactions was not provided. Patient previous vaccinations include hepatitis B virus vaccine first dose.      On 12-NOV-2020, the patient was vaccinated with an expired and improperly stored second dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 0.5 milliliter, intramuscularly in the left leg thigh (LLT) lot # R012001 and expiration date 06-NOV-2020 for prophylaxis.      The vaccine had a excursion of 49.2 Fahrenheit degrees for 1 hour, no digital data logger was involved, no adverse effects were reported.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, shivering, fever, muscle aches persisted for 18 hours
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: No verbal Warning toward injection PAIN..!   Immediate severe headache....  Awakened 12 hours after injection with Chills and mild fever...  Severe pain at injection point...   Overall body aches, ringing in the ears....
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: No verbal Warning toward injection PAIN..!   Immediate severe headache....  Awakened 12 hours after injection with Chills and mild fever...  Severe pain at injection point...   Overall body aches, ringing in the ears....
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No adverse event; Improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On 16-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot # S005809, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 02-NOV-2021) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion 3 degrees Fahrenheit (F) for 3 hours and 30 minutes, as recorded by a data logger. There was no adverse effect reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Erythema, Inflammation, Muscular weakness, Pyrexia
Clinical narrative: Inflamation in upper arm and shoulder- red and hot to touch, cold sweats, low grade fever, severe weakness in legs - difficulty walking, nausea
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Inflamation in upper arm and shoulder- red and hot to touch, cold sweats, low grade fever, severe weakness in legs - difficulty walking, nausea
Age: 17.0
Sex: F
Vaccine: UNK
Symptoms: Swelling face, Urticaria
Clinical narrative: It was a flu shot but I'm not sure of the brand. I broke out into hives and my face swelled up. Was given benadryl and a steroid shot.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired PROQUAD administered; This spontaneous report was received from a nurse concerning a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, historical drug, drug reactions/allergies and concomitant were not provided.  On 20-NOV-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, lot number S012534 expiration date 20-OCT-2020 as prophylaxis. (Route of administration was not provided)  Lot No. S012534 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Body aches Slight headache
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine; A VFC contacted them and let them know what happened and that the product was actually received 2 days late/No patients reported any additional adverse experiences as a result of receiving the improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 03-NOV-2020, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T014309 and expiration date 24-APR-2022 administered as prophylaxis.  The improperly stored doses of the suspect vaccine experienced a temperature excursion on 27-OCT-2020, the reporter stated that the VFC contacted them and let them know what happened and that the product was actually received 2 days late. The temperature excursion was at an unknown temperature for an unknown timeframe; no previous temperature excursion were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: PPV
Symptoms: Syringe issue, Underdose
Clinical narrative: No additional adverse events reported; The pharmacist reports that a patient only received a partial dose of PNEUMO VAX 23; The pharmacist had no problem with the plunger it was when removing the needle from the arm that the "needle sheared off while when activating the BD safety glide on the needle".; some liquid (PNEUMOVAX 23) ran down the patient's arm; Information has been received from a pharmacist, referring to a female patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-NOV-2020, the patient was vaccinated with a partial dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T028093, expiration date on 24-APR-2022 (anatomical locations and administration route were not reported) for prophylaxis.  The reporting pharmacist stated that the patient only received a partial dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because when she withdrew the needle some of the vaccine "ran down the patient's arm". It was not known how much was actually received. No problem with the arm where the vaccine ran down. No additional adverse events were reported. A product quality complain filed as a precaution, however the pharmacist actually believed the issue was with the needle that was attached (not Merck) but could not be 100 % sure . The needle was not provided with the syringe and the pharmacist used a 25 gauge 1 inch needle. The pharmacist had no problem attaching the needle and the prefilled syringe looked fine. The pharmacist had no problem with the plunger it was when removing the needle from the arm that the "needle sheared off while when activating the safety glide on the needle". combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; dose of PROQUAD was administered to a patient on 11/18/2020 that had been involved in a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 18-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), 0.5 milliliter, lot number T015261, expiration date 31-OCT-2021 (route of administration was not provided) for prophylaxis. Sterile diluent(STERILE DILUENT) was used to reconstitute the vaccine. No additional adverse were reported.; Sender's Comments:  US-009507513-2011USA014866:
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; This spontaneous report was received from the patient's mother via a Company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (the dosage regimen information was not provided) for prophylaxis.  On an unknown date (also reported as "years later"), in her 20s, the patient developed rheumatoid arthritis.  At the time of the report, the outcome of rheumatoid arthritis was unknown. No causality assessment was provided.  Upon internal review, rheumatoid arthritis was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: swelling around my collar bone; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient experienced swelling around his/her collar bone, after receiving the dose of Shingrix. The reporter was asking if that sweeling was a side effect or not. No further information was available.
Sex: F
Vaccine: RAB, RAB, RAB, UNK
Symptoms: Therapeutic response decreased, Viral titre
Clinical narrative: Had the rabies shot 3 years ago / My antibody titer was 0.1 in the past; This case was reported by a consumer via licensee and described the occurrence of therapeutic response decreased in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for an unknown indication, rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for an unknown indication, Rabies NVS (RabAvert) for prophylaxis, rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis, rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis, Rabies NVS (RabAvert) for prophylaxis, rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis, rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for an unknown indication and immunoglobulin human anti-rabies (Hrig) for prophylaxis.   On an unknown date, the patient received the 1st dose of RabAvert, Rabavert Needle Device, Rabavert Pre-Filled Syringe Device, the 2nd dose of RabAvert, Rabavert Needle Device, Rabavert Pre-Filled Syringe Device, the 3rd dose of RabAvert, Rabavert Needle Device, Rabavert Pre-Filled Syringe Device and Hrig at an unknown dose and frequency. On an unknown date, unknown after receiving RabAvert, Rabavert Needle Device, Rabavert Pre-Filled Syringe Device, RabAvert, Rabavert Needle Device, Rabavert Pre-Filled Syringe Device, RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was related to pre exposure of Rabavert. The age at vaccination was not reported but the patient was in her 70s. It was reported that the patient had the rabies shot 3 years ago and with that round she got HRIG and Rabavert doses.  The antibody titer was 0.1 in the past. It was reported that many people were not very familiar with this rabies stuff. The patient was not sure if she was protected. For post exposure prophylaxis refer case US2020230715.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020230715:same patient