chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Neuralgia, Shoulder injury related to vaccine administration
Clinical narrative: The patient elected to have the flu shot in her left arm, which has been amputated just below the elbow.  The patient is reporting nerve pain in the entire arm following the flu shot.  She also uses a diabetic freestyle libre sensor on this arm as well.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Head injury, Nausea, Pain in extremity, Syncope
Clinical narrative: Patient received flu shot.  A few minutes later while waiting to check out at register, she fainted.  When she fell she bumped her head above her eye.  She was unaware she had fainted, but she immediately regained consciousness.  She then claimed to feel "queezy". Patient was brought into back and laid down for around 30 minutes.  Was given water and an ice pack for her head wound.  Her pulse was normal and her blood pressure was normal.  She later explained she felt a pain in her arm before fainting.  She was planning to go to an urgent care facility to be checked when she left.
Age: 70.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Rash, Skin warm
Clinical narrative: The patient described a rash that was warm to the touch, and spread from arm to neck and breast areas. She gets the flu shot every year and never had a reaction in the past, so she believes it may be due to Boostrix. She will be following up with her PCP tomorrow to have rash checked.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient reported that he is having a hard time/discomfort raising his left arm when the vaccination was administered and having a soreness at the site of injection.
Age: 15.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Asthenia, Encephalitis autoimmune, Gait disturbance, Hypoaesthesia, Nausea
Clinical narrative: About 1/2 after receiving the shots my daughter started to complain that she was experiencing traveling numbness.  First her arm, then her leg.  She said the sensations kept moving around her body. Within an hour she was having blotches in her vision and felt extremely nauseated and was struggling to walk.  She became very weak and achy.   A doctor friend said it was somewhat normal and that she should lay down for a bit.  After about another hour she started to feel somewhat normal again.  She did complain of her hand bothering her several times on several different days.  Two months later she was at the ER 3 times for seizures and then hospitalized for 2 weeks.  Her diagnoses was anti-NMDA receptor encephalitis.  She is still in recovery.  The doctors do not know why or how the encephalitis occurred.  several of the symptoms mimicked what occurred after the vaccines were given but on a much more intense scale.
Age: 15.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pain, Pain in extremity, Seizure, Visual impairment
Clinical narrative: About 1/2 after receiving the shots my daughter started to complain that she was experiencing traveling numbness.  First her arm, then her leg.  She said the sensations kept moving around her body. Within an hour she was having blotches in her vision and felt extremely nauseated and was struggling to walk.  She became very weak and achy.   A doctor friend said it was somewhat normal and that she should lay down for a bit.  After about another hour she started to feel somewhat normal again.  She did complain of her hand bothering her several times on several different days.  Two months later she was at the ER 3 times for seizures and then hospitalized for 2 weeks.  Her diagnoses was anti-NMDA receptor encephalitis.  She is still in recovery.  The doctors do not know why or how the encephalitis occurred.  several of the symptoms mimicked what occurred after the vaccines were given but on a much more intense scale.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Redness, rash, warm to the touch, soreness all the way to the armpit. Patient was told to put a cold compress on the site as well as take Benadryl.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: patient presented to pharmacy 9-23-19 concerned with reaction having after vaccine.  She reported and showed visible signs of left arm swelling, pain and hot to the touch of vaccinated arm.  She also reported experiencing itching to arm vaccinated and left side of upper back.  I counseled patient that she appeared to be having an adverse event from the vaccination and should see a doctor to confirm as well as get further possible treatment.  Patient was seen in office at urgent care, given steroid injection and prescription for 5 day course of steroids.  I phoned patient to follow up and she informed me that the doctor believed she was having an allergic reaction to the vaccine as well and informed me of treatment.  As of now her symptoms remain the same, patient only received injection a few hours ago.
Age: 66.0
Sex: M
Vaccine: FLU3, HEPAB, VARZOS
Symptoms: Contusion, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Patient got bad 4.5 inch bruise in arm that he got a fluzone HD in. He could move his arm, but the pain made it hard to sleep. Pain is improving now. He ran a low grade fever for about a week which is gone now.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Patient reported severe chills (described by patient as "shaking the bed"), fever, headache, nausea, fatigue starting about 6 hours after administration of Shingrix and Fluzone High dose.  The  fatigue, fever and headache continued into the following day. The patient treated symptoms with over-the-counter ibuprofen.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rectangular red and puffy underneath injection site of Pneumovax 23 beginning 2 inches below injection site and ending 1 inch above the elbow crease. Slightly warm to the touch.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Large eyrthematous rash covering the entire deltoid area of the right arm. Upper area clearing up with the lower area still beefy red.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: Patient had no adverse reaction to the first Shingrix vaccine which was 1 year ago.  Her arm was very sore on Day 1 after the vaccine but no other symptoms.  On day 2 she noticed that it itched about 1 inch below and to the left of where the vaccine was given.  When she stopped by to see us today on day 3 the area was red and warm and was approximately 2 inches wide by 3 inches long.  It was itching and burning.  Advised her to use ice/cool pack on it and possibly try some topical hydrocortisone.  Will call her to follow up again in 2 days.  Explained that although this is not terribly common it is in the package literature.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient experienced erythema and swelling from his shoulder all the way down to his knuckles.  He said his shoulder was tender and he had a burning sensation.  When he came today (9-23-19), there was mild erythema with swelling;  the swelling near the wrist and hand was very pronounced.  The patient said he had the shot on 9-19-19 and the side effect occurred on 9-20-19.    He started an antibiotic on 9-21-19.   Today, he was evaluated by his pcp and they started him on a Medrol dose pack.  If his arm is not better tomorrow, he will be getting a Doppler done.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin discolouration
Clinical narrative: 09/20/2019 vaccine was delivered. 09/21/2019 patient noticed dark spots on the same arm but not at the injection site. About 7 dark spots looking like  burn spots dime to quarter size. No pain, no itching. Patient reported to the pharmacy on 09/23/2019. The spots did not change in size but started to become look not as dark as first day. Pharmacist recommended to call PCP. I am not sure if it is a side effect of vaccination or co-incidence. Injection site looks normal, no skin reaction, may be slightly swollen but it is hard to say because skin of the deltoid muscle looks absolutely normal.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient complained of rash on back that itches when in hot climate/setting for the past four days.  They look like 4 red bug bites.  I strongly recommended that he follow-up with his physician to determine if it is possibly something un-related to the vaccine components since he has been working outside.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscle pain, stomach pain, headache Tiredness
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sharp and throbbing pain upon certain  movement that has lasted from 8/8/19 till present time
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site reaction, Rash vesicular, Visual field tests
Clinical narrative: Bumpy blister type rash at injection site
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS AND SWELLING
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Confusional state, Hallucination, visual, Impaired driving ability, Joint swelling
Clinical narrative: Both my knees have swollen to a point where it is very painful to walk. Fever of 101.8 Sore throat. Mental confusion. Loss of sense of balance, seeing items that are not really there.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Both my knees have swollen to a point where it is very painful to walk. Fever of 101.8 Sore throat. Mental confusion. Loss of sense of balance, seeing items that are not really there.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient came in today to pick up a cephalexin antibiotic.  She was already at her dr's office today, and her arm was slightly swollen and red.  The dr. wasn't sure if she was developing an infection or not, so he just prescribed her the cephalexin to be safe.  The patient wasn't upset or bothered.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Fatigue, Injection site erythema, Injection site rash
Clinical narrative: 1 day after vaccination, the patient developed symptoms of severe fatigue, nausea, and malaise. The following morning, the patient awoke complaining of shortness of breath and chest pain. He also developed a red, angry rash that spread to cover most of the surface area of his upper arm around the injection site. The rash persisted for about 7-8 days after vaccination.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Nausea
Clinical narrative: 1 day after vaccination, the patient developed symptoms of severe fatigue, nausea, and malaise. The following morning, the patient awoke complaining of shortness of breath and chest pain. He also developed a red, angry rash that spread to cover most of the surface area of his upper arm around the injection site. The rash persisted for about 7-8 days after vaccination.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Premature menopause
Clinical narrative: I haven't had my period since I took the third shot after my HPV vaccine. And the medical report also shows that I have premature ovarian failure.d
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: redness, pain, itchy, heat in arm where injection was given, headache body aches all over
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: redness, pain, itchy, heat in arm where injection was given, headache body aches all over
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This patient received her second vaccine 13 days too soon. I have contacted GSK, the patient and the physician Per the CDC, the second dose is only considered invalid if it is given at less than 1 weeks after the first. This was 6-7 weeks after the first so the dose will not be repeated.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Pyrexia
Clinical narrative: Noted fever to 102.5 that night came down with tylenol. 2 days later noted (R) sided neck pain
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Says she believes she is having allergic reaction to Shingrix. Says that on 09/16/2019 she received the Shingrix  in her left arm and flu shot in her right arm at pharmacy. She said that the next day the area where she had this Shingrix injected became red, warm, and swollen. She was seen for this at urgent care on 09/18/2019. She was diagnosed with irritation of injection site. Shortly after that, she developed generalized itching with a rash on her trunk and extremities. She said that the redness in local reaction at the injection site has improved but the rash has worsened. She said she can think of nothing else new that she has come into contact with. She has had flu shots many times without problems. She denies any new foods, beverages, soaps, shampoos, laundry detergents, or dryer sheets. She denies any difficulty breathing or swallowing. No wheezing.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Local reaction, Pruritus, Rash
Clinical narrative: Says she believes she is having allergic reaction to Shingrix. Says that on 09/16/2019 she received the Shingrix  in her left arm and flu shot in her right arm at pharmacy. She said that the next day the area where she had this Shingrix injected became red, warm, and swollen. She was seen for this at urgent care on 09/18/2019. She was diagnosed with irritation of injection site. Shortly after that, she developed generalized itching with a rash on her trunk and extremities. She said that the redness in local reaction at the injection site has improved but the rash has worsened. She said she can think of nothing else new that she has come into contact with. She has had flu shots many times without problems. She denies any new foods, beverages, soaps, shampoos, laundry detergents, or dryer sheets. She denies any difficulty breathing or swallowing. No wheezing.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Ear pain, Eye pain, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Headache, nausea, Earache, sore throat, eye pain, severe Body aches.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain
Clinical narrative: Headache, nausea, Earache, sore throat, eye pain, severe Body aches.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Feeling hot, Flushing, Posture abnormal
Clinical narrative: Patient became flushed, hot, and lightheaded. Slumped to side but did not pass out. Symptoms resolved about 10 minutes after start.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Reports that 24 hrs after inj. of Pneumonia he had redness, warmth, swelling of upper arm down to elbow. Called Pharmacy was told to apply ice
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated her right arm was red and swollen after vaccine and there was pain. Patient applied ice pack and the redness did go down, but there was redness and warmth on interior side of arm starting from elbow and extending up to under arm area.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Skin warm, Swelling, Tenderness
Clinical narrative: Cellulitis, swelling, severe tenderness to touch, and warmth. Symptoms started approximately 30-45 minutes after injection, worse at 11 pm per patient. Started having chills the next morning.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Chills
Clinical narrative: Since taking shot, patient has experienced chills. Patient took temperature morning after shot, at 1:15 pm, and 99.1 degree F, chills resolved 9/10/19 Wed night.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Pyrexia
Clinical narrative: After midnight, I felt chills, headache and feverish. Then I had Fast heart rate. On Sept. 6, 2019 I called my doctor's office + reported on my situation. Nurse advised me to take Tylenol for headache that morning. No more chills, fever and fast heart rate in the morning of SepT. 6.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Talk to pt. She had flu like symptoms, body pain. Shivering after 3-4 hrs of vaccination on 9/22/19. on 9/23/19 at 2:30 PM she is feeling ok. No shivering, just body pain, Dr told to take Tylenol
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Skin warm
Clinical narrative: Red circular Rash, Raised, itchy, warm to touch treatment: tylonal, ice, hydrocortisone Cream, Benadryl for the itch.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Anxiety, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: 5 min after injection pt got hot and very sweaty and faint. I had pt lay down. Checked blood pressure 100/50, strong pulse, called 911, EMT determined pt had anxiety rxn. husband took pt home
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: Patient's daughter called stating her father has been having a really bloody nose for the past 30 minutes and was not stopping. He had received the Fluzone HD the day before. She believed it could have been the flu shot he got the previous day that was causing it, he usually does not get bloody noses. Recommended to call hospital to see if they would want him to come to be seen.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fEVER
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient was accidently given a 3rd dose of the meningococcal Vaccine - Menactra.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Pt experience, pain, fever and swelling of the entire arm and hand. Pt has difficulty moving her hand.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain; radiating pain; Back pain; This case was reported by a nurse via call center representative and described the occurrence of shoulder pain in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number 16B401, expiry date 28th February 2019) for prophylaxis.   On 3rd August 2018, the patient received the 1st dose of Bexsero. In August 2018, 10 days after receiving Bexsero, the patient experienced shoulder pain, radiating pain and back pain. On an unknown date, the outcome of the shoulder pain and radiating pain were recovered/resolved and the outcome of the back pain was unknown.   It was unknown if the reporter considered the shoulder pain, radiating pain and back pain to be related to Bexsero.  Additional information received were as follows: The registered nurse called to report a Bexsero adverse event. The patient experienced significant shoulder pain that radiates to the back The reporter reported that that the pain lasted a while as she spoke to the patient's mother about 10 days after the 1st dose. The patient's mother reported that he had the same reaction with 2nd dose. The reporter consented to follow up. For tolerance to 2nd dose, refer linked case US2019AMR163536.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: Product supply issue; Sore Arm; Swollen arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2018).   On 11th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 11th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm and swelling arm were not recovered/not resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional information received were as follows: The patient received 2nd dose of Shingrix late due to shortage, which led to product supply issue. The caller mentioned that an undisclosed amount of people had mentioned having flu-like symptoms following Shingrix vaccine, but the patient only had a slight sore and swollen arm that was getting better that was similar to when she received the flu shot. The reporter consented to follow up. The caller initially gave the okay to consent, but then said she would see her doctor soon.  No doctor information provided.  The caller mentioned an undisclosed amount of people had flu-like symptoms following Shingrix vaccine. The caller described reaction as similar to an unknown manufacturer of the flu shot she received each year. This case has been linked with US2019AMR147479, reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Product supply issue
Clinical narrative: Product supply issue; Sore Arm; Swollen arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2018).   On 11th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 11th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain in arm and swelling arm were not recovered/not resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional information received were as follows: The patient received 2nd dose of Shingrix late due to shortage, which led to product supply issue. The caller mentioned that an undisclosed amount of people had mentioned having flu-like symptoms following Shingrix vaccine, but the patient only had a slight sore and swollen arm that was getting better that was similar to when she received the flu shot. The reporter consented to follow up. The caller initially gave the okay to consent, but then said she would see her doctor soon.  No doctor information provided.  The caller mentioned an undisclosed amount of people had flu-like symptoms following Shingrix vaccine. The caller described reaction as similar to an unknown manufacturer of the flu shot she received each year. This case has been linked with US2019AMR147479, reported by the same reporter.
Age: 0.17
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse reactions reported; 2-month-old patient received GARDASIL 9 on 9/3/2019; This spontaneous report was received from a office manager referring to a 2 month old infant of unknown gender. The patient's medical history, current condition and concomitant drug were not provided.      On 03-SEP-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose and route were not provided, lot # R029117, expiration date 10-JUL-2021) (product administered to patient of inappropriate age). No adverse reactions reported.
Age: 0.17
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions reported; 2-month-old patient received GARDASIL 9 on 9/3/2019; This spontaneous report was received from a office manager referring to a 2 month old infant of unknown gender. The patient's medical history, current condition and concomitant drug were not provided.      On 03-SEP-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose and route were not provided, lot # R029117, expiration date 10-JUL-2021) (product administered to patient of inappropriate age). No adverse reactions reported.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Axillary pain, Immediate post-injection reaction, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced pain in arm immediately following vaccine. Pain radiating down arm to hand. No swelling, or redness near or around injection site. Fingers feel good ok to move as well as hand. Has "funny" feeling in hand, can't describe what it seems like but thinks its slight tingle in fingers. A little pain in axilla. No fevers or other symptoms. Instructed patient to takes tylenol & ibuprofen for pain. If tingle persists or if symptoms progress instructed patient to seek medical attention.
Age: 19.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Aggression, Borrelia test positive, Hair metal test abnormal, Helicobacter test positive, Incontinence
Clinical narrative: Aggression and worsened mental status, several episodes of incontinence. Aggression was treated with restraint and IM injections of Haldol
Age: 19.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Mental status changes, Patient restraint
Clinical narrative: Aggression and worsened mental status, several episodes of incontinence. Aggression was treated with restraint and IM injections of Haldol
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Fever, redness, swelling at injection site, hard lump. 24 hours later cellulitis formed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Fever, redness, swelling at injection site, hard lump. 24 hours later cellulitis formed.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphadenitis
Clinical narrative: I developed lymphadenitis right over my left collar bone on day after the vaccine. This never happened before with any vaccine.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood culture, Blood lactic acid, Chest X-ray, Chills
Clinical narrative: Fever of 104.2 rectal at 00:26, chills, weakness, vomiting and diarrhea.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Electrocardiogram, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Fever of 104.2 rectal at 00:26, chills, weakness, vomiting and diarrhea.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis, Vomiting
Clinical narrative: Fever of 104.2 rectal at 00:26, chills, weakness, vomiting and diarrhea.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Injection site erythema, Urticaria
Clinical narrative: Patient describes that she developed hives, facial redness, difficulty breathing, some redness at injection site.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Myalgia
Clinical narrative: Pain at injection site, muscle pain across shoulders involving previously stressed arm on opposite shoulder 24-36 hours after injection, muscle pain occurring in arm of original site of injection beginning 3-4 days after injection.  Pain was severe enough that it precluded sleep.  It tapered off beginning several days after onset.  At this time, a week after injection, pain is still quite noticeable and not responding well to acetaminophen.
Sex: F
Vaccine: HPV9
Symptoms: Fall, Injection site mass, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: reported the patient fell while ice skating with her "arms out-stretched; tender to touch but is not warm to touch; 1 inch by 1 inch seroma at the injection site; Medical Assistant reported the patient developed a walnut size swelling at the injection site.; soreness at the injection site for a few days / tender to touch but is not warm to touch; lump/mass/spot; This spontaneous report was received from a medical assistant and the physician, referring to a female patient of unknown age. Her concomitant medications included terbinafine hydrochloride (LAMISIL). The patient did not have any pertinent medical history, drug reactions or allergies.  On 01-AUG-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly in the lateral deltoid (exact dose dose and anatomical location were unknown) (lot # R017624 has been verified to be a valid lot number, expiration date 17-MAR-2021) to finish the dosing schedule. On an unknown date in August 2019, the patient fell with her arms out-stretched while ice skating. On an unknown date in August 2019, after the fall, the patient noted swelling at the injection site (also reported as walnut size swelling at the injection site). The patient sought medical attention and was seen by the physician, however she did not receive any treatment and had no lab diagnostics or studies performed. The physician informed that the patient developed 1 inch by 1 inch seroma at the injection site. According to the reporter the area was tender to touch, but it was not warm to touch and it seemed to be getting smaller. It was reported, that on an unspecified date, the patient would have an ultrasound performed.  The outcome of the events soreness at the injection site, area tender to touch and fall was unknown. The outcome of the other events was recovering. The causality assessment was not provided.  Follow up information has been received form the reporting physician on 04-SEP-2019, regarding the patient.  According to the physician, on 30-AUG-2019, the patient was doing fine and the spot went down.  On 04-SEP-2019, the physician contacted the patient and the mass was completely gone.
Sex: F
Vaccine: HPV9
Symptoms: Seroma
Clinical narrative: reported the patient fell while ice skating with her "arms out-stretched; tender to touch but is not warm to touch; 1 inch by 1 inch seroma at the injection site; Medical Assistant reported the patient developed a walnut size swelling at the injection site.; soreness at the injection site for a few days / tender to touch but is not warm to touch; lump/mass/spot; This spontaneous report was received from a medical assistant and the physician, referring to a female patient of unknown age. Her concomitant medications included terbinafine hydrochloride (LAMISIL). The patient did not have any pertinent medical history, drug reactions or allergies.  On 01-AUG-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly in the lateral deltoid (exact dose dose and anatomical location were unknown) (lot # R017624 has been verified to be a valid lot number, expiration date 17-MAR-2021) to finish the dosing schedule. On an unknown date in August 2019, the patient fell with her arms out-stretched while ice skating. On an unknown date in August 2019, after the fall, the patient noted swelling at the injection site (also reported as walnut size swelling at the injection site). The patient sought medical attention and was seen by the physician, however she did not receive any treatment and had no lab diagnostics or studies performed. The physician informed that the patient developed 1 inch by 1 inch seroma at the injection site. According to the reporter the area was tender to touch, but it was not warm to touch and it seemed to be getting smaller. It was reported, that on an unspecified date, the patient would have an ultrasound performed.  The outcome of the events soreness at the injection site, area tender to touch and fall was unknown. The outcome of the other events was recovering. The causality assessment was not provided.  Follow up information has been received form the reporting physician on 04-SEP-2019, regarding the patient.  According to the physician, on 30-AUG-2019, the patient was doing fine and the spot went down.  On 04-SEP-2019, the physician contacted the patient and the mass was completely gone.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient received an improperly stored dose of ROTATEQ on 09/12/2019. No adverse effect reported.; a patient received an improperly stored dose of ROTATEQ on 09/12/2019. No adverse effect reported.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 12-SEP-2019, the patient was vaccinated with and improperly storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, for prophylaxis, lot# S005874 with expiration date of 31-OCT-2020.  No adverse effects were reported.   It was stated that the vaccines underwent a temperature excursion lowest temperature below 2 degrees Celsius (1.2 C) for 24 hours 36 minutes. No previous temperature excursion was reported The call was not because of a "data logger".  No further information was provided. There was no Product Quality Complaint (PQC) involved in this case.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; the Patient received improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 11 year old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.  On 10-JUL-2019 the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R023513 with expiration date 16-AUG-2020; dose, frequency and route of administration were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (lot# reported as S000130 & expiration 23-AUG-2021). No adverse effects were reported.  The temperature excursion was ranged from -14 Celsius Degree to -10 Celsius Degree (-13.2 C) for 46 minutes. There was not previous temperature excursion. Data logger was involved. ; Sender's Comments:  US-009507513-1909USA007177: US-009507513-1909USA007512: US-009507513-1909USA007118:
Age: 1.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse effect; patient inadvertently received Proquad and varivax instead of the intended Varivax and MMR II; This spontaneous report was received from a licensed practical nurse refers to a 12 month old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-SEP-2019, the patient had inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) instead of the intended varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (anatomical location, route, lot# and expiry date were not reported for all the vaccines) for prophylaxis (wrong product administered). The nurse stated that the person administering the vaccines thought the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). Other suspect therapies included sterile diluent(STERILE DILUENT). No adverse effects were reported.
Sex: F
Vaccine: MENB
Symptoms: Contusion
Clinical narrative: small bruise; This case was reported by a other health professional via sales rep and described the occurrence of contusion in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of contusion (1st dose received on an unknown date and experienced small bruise).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced contusion. On an unknown date, the outcome of the contusion was unknown.   It was unknown if the reporter considered the contusion to be related to Bexsero.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced small bruise.
Sex: F
Vaccine: MENB
Symptoms: Contusion
Clinical narrative: small bruise; This case was reported by a other health professional via sales rep and described the occurrence of contusion in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced contusion. On an unknown date, the outcome of the contusion was unknown.   It was unknown if the reporter considered the contusion to be related to Bexsero.  Additional information received were as follows: This case was reported by the Medical assistant (MA). The age at vaccination was not reported. The patient had a small bruise. For tolerance to 2nd dose refer linked case US2019AMR150929.
Age: 65.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Emotional distress, Herpes zoster
Clinical narrative: Shingles on her back; This case was reported by a pharmacist and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) (batch number 260385, expiry date 30th April 2020) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD. In September 2019, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and Fluad in the right deltoid. Within less than a week after vaccination, the patient experienced shingles on back. The reporter stated that, the patient was upset and asked explaination to the reporter. The reporter gave permission to follow up. It was unknown if the reporter considered the shingles to be related to Fluad as well.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient experienced side effects after receiving the Shingrix vaccine.
Age: 66.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX
Symptoms: Chills, Headache, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Body aches; Severe headache; Chills; Both of arms are sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE)) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received about 2 months and 1 week ago, refer linked case US2019AMR163388).   On 5th September 2019, the patient received the 2nd dose of Shingrix and FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced general body pain, headache and chills. In September 2019, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the general body pain was not recovered/not resolved and the outcome of the headache and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, general body pain, headache and chills to be related to Shingrix.  Additional information received were as follows: A day before reporting date, the patient received Shingrix on unknown arm and Fluzone. At night before the reporting date, the patient started having body aches, a severe headache and chills overnight. The patient was still experiencing body aches at the reporting date. Both of his arms were also sore, where he got Shingrix and Fluzone. The Shingrix arm ached more than it did after the first dose.  The Fluzone arm ached more than he usually experiences after a flu vaccine. It was unknown if the reporter consider the events body aches, a severe headache, chills and arm aches to be related to the Fluzone as well. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Body aches; Severe headache; Chills; Both of arms are sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE)) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received about 2 months and 1 week ago, refer linked case US2019AMR163388).   On 5th September 2019, the patient received the 2nd dose of Shingrix and FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced general body pain, headache and chills. In September 2019, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the general body pain was not recovered/not resolved and the outcome of the headache and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, general body pain, headache and chills to be related to Shingrix.  Additional information received were as follows: A day before reporting date, the patient received Shingrix on unknown arm and Fluzone. At night before the reporting date, the patient started having body aches, a severe headache and chills overnight. The patient was still experiencing body aches at the reporting date. Both of his arms were also sore, where he got Shingrix and Fluzone. The Shingrix arm ached more than it did after the first dose.  The Fluzone arm ached more than he usually experiences after a flu vaccine. It was unknown if the reporter consider the events body aches, a severe headache, chills and arm aches to be related to the Fluzone as well. The reporter consented to follow up.
Sex: M
Vaccine: FLU4, VARZOS, FLUX
Symptoms: Chills, Headache, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Arm aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose about 2 months and 1 weeks ago from time of reporting and experienced arm ached), Shingrix with an associated reaction of pain (received 2nd dose on 5th September 2019 and experienced body aches, a severe headache and chills overnight) and INFLUENZA VIRUS VACCINE with an associated reaction of pain (received Fluzone on 5th September 2019 and experienced body aches, a severe headache and chills overnight).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in arm after receiving vaccine. This case has been linked with cases US2019AMR163388 and US2019162791 reported by the same reporter.
Sex: M
Vaccine: FLU4, VARZOS, FLUX
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Arm aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose about 2 months and 1 weeks ago from time of reporting and experienced arm ached), Shingrix with an associated reaction of pain (received 2nd dose on 5th September 2019 and experienced body aches, a severe headache and chills overnight) and INFLUENZA VIRUS VACCINE with an associated reaction of pain (received Fluzone on 5th September 2019 and experienced body aches, a severe headache and chills overnight).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in arm after receiving vaccine. This case has been linked with cases US2019AMR163388 and US2019162791 reported by the same reporter.