chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: the patient having gotten a pneumonia vaccine and contracting pneumonia at a later time; the patient having gotten a pneumonia vaccine and contracting pneumonia at a later time; This is a spontaneous report from a contactable consumer reporting for her husband.  A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient's medical history and concomitant medications were not reported. it was reported the patient having gotten a pneumonia vaccine and contracting pneumonia at a later time. The reporter felt like the vaccine did not help prevent pneumonia for her husband. The outcome of the event was recovered on unknown date. Lot/batch number has been requested.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)  in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)  has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Cellulitis, Local reaction, Rash
Clinical narrative: It was a pretty significant local reaction where the patient was treated for cellulitis, she actually thought that it was because, the vaccine has been improperly administered; It was kind of like the high level, it was kind of like rash; This is a spontaneous report from a contactable nurse via a sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization and pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient medical history and concomitant medications were not reported. It was a pretty significant local reaction where the patient was treated for cellulitis, she actually thought that it was because the vaccine had been improperly administered. It was kind of like the high level, it was kind of like rash. She did believe it was potentially due to the vaccine, she didn't remember it was the Prevnar 13 or the Pneumovax 23. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event cellulitis with pneumococcal 13-valent conjugate vaccine can not be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Flu vaccine given 11/23/2018-no reaction or adverse event Patient reported had mandatory flu vaccine 10/14/2019, contacted employee health nurse1/7/2020 that she continues to have left shoulder pain from flu shot in her arm/shoulder area. States left side arm/shoulder: tender, hurts, does not impact her work, does wake up at night with pain. Taking Naprosyn over the counter per MD recommendations 1/15/2020. Doing home exercises. There is not anything phusical to see where the injection was given.
Age: 19.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Received the package of Oral Typhoid on 1/8/2020 but began taking the series of pills on 1/13/2020.  Within several hours of ingesting the first of four doses of the oral typhoid vaccine patient felt feverish and achiness.  took two Advil po. approximately 12 hours later, patient began to vomit.  remained in the bed for the remainder of that day and the following day.  On 1/15/2020 patient took the second of four doses at 6:30am.  Still feeling unwell, patient remained in bed until late morning .  Later in the day, around 4:30pm, patient experienced an episode of explosive vomiting which continued hourly for the next 12 hours.  Took Pepto-Bismol chewables. Patient is currently at home resting.  No medical/clinic visit made.
Age: 0.75
Sex: F
Vaccine: HIBV
Symptoms: Rash macular
Clinical narrative: Pt mother reported "red blotches all over her face, pink on her eyebrows, eyelids and she had a big huge blotch of red on the side of head"
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Loss of consciousness, Presyncope
Clinical narrative: Pt. received Rabies vaccine on 1/15/2020 for pre-exposure.  She received one previous dose 10/04/2017 after which she had a near syncopal episode.  She decided at that time not to continue with the remaining 2 doses of the series.  In 2017, pt. was also receiving immunotherapy for allergy desensitization which she discontinued as well due to multiple near syncopal/ syncopal episodes.  She is currently studying veterinary medicine and decided she wanted to finish the pre-exposure series due to the risk she is exposed to.  Pt. sent the following message to our clinic  today: "From: Sent: 01/16/2020 11:28 AM To: TRAVEL NURSE **** Subject: Rabies vaccine reaction? Hi, I received the rabies vaccine yesterday afternoon (3:40pm) and felt fine all day afterwards. However, this morning about (6am) 5 minutes after getting out of bed I passed out 3-4 times and it took about 30 minutes after the last episode for me to be able to get up and move around without feeling faint. Most of today I have felt dizzy and I have periods where I begin to feel light headed again. I felt that I should let someone know about this possible reaction to the vaccine and I am debating about not finishing the series.  I am not really sure what to make of what happened this morning and would like to speak with someone today if possible. I will be available by phone after 3pm today.  Thanks,  "
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Rotator cuff syndrome, Tendonitis, X-ray limb
Clinical narrative: Pain in shoulder starting on 10/30/19 causing pain at all times . Sent for a PT and ortho evaluation and diagnosed with Bursitis, impingement in the rotator cuff area, tendonitis are all presenting the same symptoms. Treated with PT starting in December and ongoing to the present.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelled, hot to the touch, deep red color, hurt to touch it, or to move it welts Diagnosis: Cellulitis due to reaction to shot Medication: Cephalexin 500mg 40 capsules (10 days - 4 per day) Both the pharmacist + Urgent Care provider said I had an extreme reaction to the shot
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Urticaria, Vaccination complication
Clinical narrative: Left arm swelled, hot to the touch, deep red color, hurt to touch it, or to move it welts Diagnosis: Cellulitis due to reaction to shot Medication: Cephalexin 500mg 40 capsules (10 days - 4 per day) Both the pharmacist + Urgent Care provider said I had an extreme reaction to the shot
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ammonia, Full blood count, Metabolic function test, Seizure like phenomena, Urine analysis
Clinical narrative: Seizure like activity, 10 episodes since receiving vaccines 1/7/20@11:35am onset appox.; pt referred to neuro, labs ordered
Sex: F
Vaccine: VARZOS
Symptoms: Pleuritic pain, Pneumonia
Clinical narrative: Pleuritic chest pain; pneumonia; Information has been received regarding a case in litigation, concerning a female (also reported as "his" (discrepant information)) patient of an unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. In or around 25-OCT-2017, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot #, expiration date, strength, dose, route of administration or anatomical location were not provided), as part of the routine health maintenance for prevention of shingles (herpes zoster). On an unspecified date, shortly after vaccination, she was hospitalized and diagnosed with pneumonia and pleuritic chest pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), she sustained severe and permanent personal injuries. Further as a tragic consequence she also suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of this report, the patient had not recovered from pneumonia or pleuritic chest pain. The events were related to zoster vaccine live (ZOSTAVAX). Upon internal review, the pneumonia was considered to be a medically significant event.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hypoaesthesia oral
Clinical narrative: dorsal numbness of the tongue; mild dizziness; posterior Headache for 5 days; This case was reported by a other health professional and described the occurrence of headache in a 33-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date unknown) for prophylaxis.   On 25th September 2019, the patient received FluLaval Tetra 2019-2020 season. On 29th September 2019, 4 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced headache (serious criteria hospitalization), numbness of tongue (serious criteria hospitalization) and dizziness (serious criteria hospitalization). On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the numbness of tongue and dizziness were unknown.   It was unknown if the reporter considered the headache, numbness of tongue and dizziness to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient has no known allergies. It was reported that 4 days after flu shot the patient experienced adverse reaction like posterior headache for 5 days, numbness of dorsal tongue and mild dizziness. Emergency room visit required. The patient was discharged by neurology. This was 1 of 5 cases reported by same reporter.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Dyspnoea, Pruritus
Clinical narrative: Patients brother called stating patient's whole body was itching, and she was coughing.  He was instructed to have Benadryl on hand, and asked if she was having difficulty breathing.  Brother stated the coughing was making it difficult for her to breath.  He was then instructed to take the patient to the ER if she was having difficulty breathing.  Patient was called the following morning.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest pain, Hypoaesthesia, Nipple pain, Pain of skin
Clinical narrative: PHN, severe surface skin pain on the front of body from collar bones down to the waist, nipples extremely sensitive, one numb spot on the left front just below ribs, internal stomach and chest area pains on both sides, BUT never had shingles!
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: PHN, severe surface skin pain on the front of body from collar bones down to the waist, nipples extremely sensitive, one numb spot on the left front just below ribs, internal stomach and chest area pains on both sides, BUT never had shingles!
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: injection site redness and warmth, redness inc on day 2
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Heart rate increased, Hyperhidrosis, Injection site discomfort
Clinical narrative: Patient developed discomfort in his left shoulder at the injection site.  At some point during the night he got very diaphoretic and realized that his heart was going very fast.  This morning still rapid so he decided to go to his physician's office to be checked out.  Was found to be in atrial fibrillation and sent here.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Troponin increased
Clinical narrative: Patient developed discomfort in his left shoulder at the injection site.  At some point during the night he got very diaphoretic and realized that his heart was going very fast.  This morning still rapid so he decided to go to his physician's office to be checked out.  Was found to be in atrial fibrillation and sent here.
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Musculoskeletal pain
Clinical narrative: Pain in shoulder beginning shortly after administration.  Pain ongoing as of 01/16/2020/.  Treatment initiated on 01/15/2020
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site mass, Injection site pain, Magnetic resonance imaging abnormal
Clinical narrative: greater than 2 months of pain at injection site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Burning sensation from the injection site of the deltoid down the arm to the wrist ongoing for 2 months.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Electroencephalogram, Hypotonia
Clinical narrative: No adverse reaction at the time.  Two days later pt had episode of apnea, went limp.  Lasted about 30 seconds
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Lethargy, Malaise, Muscular weakness, Pyrexia
Clinical narrative: First vaccine ever received: Vomiting x2 on 1/14/20 @ 4:00am and 12pm. Malaise. Lethargy. Headache. Muscle weakness. Low grade fever (100.3). Resolved.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: First vaccine ever received: Vomiting x2 on 1/14/20 @ 4:00am and 12pm. Malaise. Lethargy. Headache. Muscle weakness. Low grade fever (100.3). Resolved.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Hypersensitivity, Local reaction, Swelling
Clinical narrative: on 1/13/2020 began that night with redness and swelling. allergic local reaction to either vaccine or adhesive from bandaid.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Arm became painful and swollen that evening.  Swelling to greater than 4 inches around site, red and warm to touch.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: hot, swollen injection site Fever, body aches, chills, nausea
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: hot, swollen injection site Fever, body aches, chills, nausea
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Musculoskeletal stiffness, Myalgia, Pain, Panic attack
Clinical narrative: within 2 hours of the shot, throat swelled causing a panic attack.  After a few days the swelling did not go down so went to a convenient care down the road; was given antibiotics, inhaler and zyrtec.  After a week, muscles in arms started hurting.  Every week the pain became greater and traveled all over body including gums.  Local healthcare clinic agreed body was inflamed, gave steroid pack and made appointment with rheumatologist end of February 2020.  After one dose of the steroid, no pain at all.  Second pack was given to get me through the holidays. Within 24 hours after the last dose of steroid, pain and stiffness returned steadily.  I feel like my life has been ruined.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal swelling
Clinical narrative: within 2 hours of the shot, throat swelled causing a panic attack.  After a few days the swelling did not go down so went to a convenient care down the road; was given antibiotics, inhaler and zyrtec.  After a week, muscles in arms started hurting.  Every week the pain became greater and traveled all over body including gums.  Local healthcare clinic agreed body was inflamed, gave steroid pack and made appointment with rheumatologist end of February 2020.  After one dose of the steroid, no pain at all.  Second pack was given to get me through the holidays. Within 24 hours after the last dose of steroid, pain and stiffness returned steadily.  I feel like my life has been ruined.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized redness, swelling, and pain. Getting better as of 1/16/20
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Limb mass, Pruritus
Clinical narrative: 01/10/2020 On call notification. "Patient received 2 shots on Thursday and now there is a big circle/lump on arm".  Spoke with mother of child (MOC). Bump started yesterday. A little itchy. No pain. Mom just found out it was large tonight. No medicines given. Left arm. No other associated symptoms. No other rash, edema, oral changes, breathing changes, or fevers.  Vaccines given 1/8/20 (2 days ago). Wednesday. MOC confirms during conversation. 1 right arm (gardisil), 2 left arm (TDap and Menveo).   Advised benadryl dose tonight and every 6-8 hours as needed tomorrow. Monitor for improvement. Localized reaction will likely resolve with the next 2-3 days with treatment. Topically, may use OTC hydrocortisone cream and ice pack/cold compress for itch. Advised ED if any distress and urgent care if worsening skin symptoms or new concerns over the weekend.   Will refer patient to allergist.  01/13/2020: Call to parent for update. Symptoms resolved. Benadryl helped. No concerns.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed Zoster 17 days after the second Shingrix injection
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Patient started to have rash on the left upper arm that spread to chest, upper and lower back, and lateral left forearm; Had itchy ears and nose but no wheezing, or shortness of breath. Patient is advised to use non-drowsy lnog acting antihistamine such as Claritin or Allegra during the day and take Benadryl at night. Rx also given for Prednisone 20mg daily x 7 days
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Rash erythematous, Skin warm, Somnolence
Clinical narrative: Patient said she felt drowsy and malaise for 24 hours after the vaccine, then on 1/15/2020 she started to develop an irregular shaped rash on her vaccinated arm. The rash grew to double the size by mid day 1/16/2020 and was warm to the touch and red/erythmetous. Pharmacist suggested patient see nurse practitioner at urgent care clinic in our pharmacy location.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Hypersensitivity, Injection site cellulitis, Ultrasound scan
Clinical narrative: Patient had an allergic reaction that resulted in  cellulitis of right lower extremity
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Every muscle in my body ached badly, the larger the muscle, the worse and the longer period of time it ached.  I could not walk normally, and people who observed me on my daily neighborhood stroll were coming out of their houses and pulling over their cars to ask if I needed help.  I felt I had to move around, as inactivity would have prolonged the agony.  Moving my right foot from the accelerator to the brake required gritting my teeth.  This lasted about 10 days, then it was another 10 days before I felt appreciatively better.
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Injection site joint movement impairment, Myalgia, Vaccination complication
Clinical narrative: Pt reported that she had usual muscle soreness from flu vaccine administered that did not go away - sought evaluation in December 2019 due to limited range of motion in left arm.  Referred to PT.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: PT RECEIVED PNEUMOVAX 23 OM 1-9-20 AND ON 1-10-20 HAVE SLIGHT ITCHING REDNESS ON WHOLE ARM AND  SWOLLEN AND SORENESS AND VERY LOW GRADE FEVER, SHE WENT TO MD AND THEY GAVE HER CEPHALEXIN
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Shingles eruption with neuralgia, left side thorax.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: I received my pneumonia shot PPSv23 on 12/30/2019 in the early afternoon, At Pharmacy I since then have had  numbness and sever pain and weakness in my left arm. and dizziness. I have gone to the doctor and he gave me Hydrocodone 5-325mg for the pain and suggested to use heat for 15min at a time for the pain. My next appointment with the doctor is 1/24/2020
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: patient experience pain and swelling after immunization. used some warm compression and the swelling went away but the pain still exist. also can't rotate her hand backward, this start about an hour after immunization. per patient, went to see doctor 3 times, got some pain reliever over the counter but it doesn't help to relieve the pain. Patient have an exam on the should at 12/15 still pending for the result. pt did not complain of any fever
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Injection site pain
Clinical narrative: Upon left arm injection, I felt severe pain.  I believe the facility hit the bone and went too low on my arm.  I have had a bruise since at the injection site.  However, below the injection site i have had a large red patch.  Approximately 2 inches by 3 inches.  It grew to that size within a day of injection.  The pain still was so bad I went to the doctor. She looked at it and said they most likely hit lower on the arm than the muscle. But also I had an adverse reaction to the shot.  I documented photos as well.  There is no site to download them for you.  I also went to Pharmacy to tell them as well.
Age: 75.0
Sex: F
Vaccine: FLUC4, PNC13
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Laboratory test, Paralysis
Clinical narrative: Initial weakness, paralysis of extremities, Guilian Barre Syndrome with medical complications, hospital admission commencing 11.09.18 until death, 12.22.18.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Muscle disorder, Pyrexia
Clinical narrative: Two days after receiving MMR vaccine family noticed patient was not using the left side of his mouth when he talks.  Mother showed video to provider who confirmed he was able to use his mouth to eat/drink without difficulty or drooling and could close both eyes. He also developed fever 8 days after receiving the vaccine. Today (01/16/2020), mother contacted my office again as symptoms had not resolved.  Mother provided me with two videos that show depression of the orbicularis oris when face is at rest.
Age: 1.25
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: mother was told the shot given in the L thigh was Varicella, has a red circle around the injection site about 2 1/2 inches in diameter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, shivering, headache, body aches
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Retching, Scan brain, Sneezing, Tremor
Clinical narrative: Directly after vaccine administered, patient experienced shaking and general allergy symptoms. Patient called 1/16 to pharmacy saying that she is now experience chronic sneezing with clear liquid pouring from her face since the vaccine was administerd. Also is experiencing dry heaves that will not stop.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: TIREDNESS/ MUSCLE PAIN/ STOMACH PAIN/ HEADACHE/ HEART BEATING FAST/ SHIVERING/ FEVER/ NAUSEA
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: TIREDNESS/ MUSCLE PAIN/ STOMACH PAIN/ HEADACHE/ HEART BEATING FAST/ SHIVERING/ FEVER/ NAUSEA
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt reported redness and slight swelling of arm from deltoid to elbow, with no increased pain or limited mobility
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Approximately 4 hours after the Shingrix vaccination I began experiencing tightness in my chest and  a little trouble breathing. It lasted about 30 minutes. About 6 hours later the same incident occurred. I don?t have asthma and never had experienced difficulty in breathing.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Patient developed a red, raised, welt, 35mm in diameter. Patient noticed reaction about 20 hour after administration.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pyrexia, Rash pruritic
Clinical narrative: patient came in 2 days after 2nd dose with localized rash around injection site (3-4" diameter). Also had had a low grade fever overnight. Began taking Benadryl to relieve itching/rash. Next day I followed up w/phone call and pt. was better but still itching w/rash
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: -Since getting shot, Patient is having pain in the Arm -Can't pick up hand
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Genital rash, Rash, Swollen tongue
Clinical narrative: Patient called and stated that she was experiencing a rash spreading on her arm and groin. She stated that she did not have any swelling or difficulty breathing at that time. She was instructed to take Benadryl and go to her provider's office. The pharmacist called ahead to make them aware of the situation. Upon following up, the patient went to the ER because she started having mild swelling of the tongue. At the time of the call she had been given more Benadryl, Epinephrine, and a steroid and was being monitored.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Swollen tongue, Urticaria
Clinical narrative: Patient called and stated that she was experiencing a rash spreading on her arm and groin. She stated that she did not have any swelling or difficulty breathing at that time. She was instructed to take Benadryl and go to her provider's office. The pharmacist called ahead to make them aware of the situation. Upon following up, the patient went to the ER because she started having mild swelling of the tongue. At the time of the call she had been given more Benadryl, Epinephrine, and a steroid and was being monitored.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: Insomnia, Irritability, Vomiting
Clinical narrative: fussiness, not sleeping, vomiting still at 10 days post-injection
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Computerised tomogram, Dyspnoea, Dysstasia
Clinical narrative: I got the shot approximately the second friday of november 2017 and became sick a week laternwith influenza strand b, got better then i got sick again only with strand a. It was so much worse than strand b. I got better and about 2 weeks or so i began losing strengthnin my feet slowly working its way up from my feet to my legs to my arms then my fingers and at last it was harder to breath. When i began healing after a good while in hospital and in patient rehab i began gettinv better the opposite way as when i got sick like 1st my breathing then my fingers then arms and so on. My feet was the last part of me to "heal" and now i can no longer stand long periodsnof time or walk long anymore and i cant get more than a light jog i cant run anymore. I dont know why my legs just wont let me.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Influenza, Loss of personal independence in daily activities, Malaise, Muscular weakness
Clinical narrative: I got the shot approximately the second friday of november 2017 and became sick a week laternwith influenza strand b, got better then i got sick again only with strand a. It was so much worse than strand b. I got better and about 2 weeks or so i began losing strengthnin my feet slowly working its way up from my feet to my legs to my arms then my fingers and at last it was harder to breath. When i began healing after a good while in hospital and in patient rehab i began gettinv better the opposite way as when i got sick like 1st my breathing then my fingers then arms and so on. My feet was the last part of me to "heal" and now i can no longer stand long periodsnof time or walk long anymore and i cant get more than a light jog i cant run anymore. I dont know why my legs just wont let me.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological examination
Clinical narrative: I got the shot approximately the second friday of november 2017 and became sick a week laternwith influenza strand b, got better then i got sick again only with strand a. It was so much worse than strand b. I got better and about 2 weeks or so i began losing strengthnin my feet slowly working its way up from my feet to my legs to my arms then my fingers and at last it was harder to breath. When i began healing after a good while in hospital and in patient rehab i began gettinv better the opposite way as when i got sick like 1st my breathing then my fingers then arms and so on. My feet was the last part of me to "heal" and now i can no longer stand long periodsnof time or walk long anymore and i cant get more than a light jog i cant run anymore. I dont know why my legs just wont let me.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Induration, Pain, Pain in extremity, Swelling
Clinical narrative: Pt complained of pain that whole night he had the shot done and the next day. About 24 hours after he had the shot he said it felt like someone stepped on his arm. I looked and he had a big, raised patch of hives just below the injection site and fire red about the size of a baseball area on his arm and the area felt very firm and was a little swollen. I put Benadryl gel on the area. The area continued to hurt and was red that same size still until yesterday morning (1/16/2020) and by then the pain had subsided. When I looked last night (1/16/2020) it was no longer red but you could still see in light pink the area that size that had been red.
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Pt complained of pain that whole night he had the shot done and the next day. About 24 hours after he had the shot he said it felt like someone stepped on his arm. I looked and he had a big, raised patch of hives just below the injection site and fire red about the size of a baseball area on his arm and the area felt very firm and was a little swollen. I put Benadryl gel on the area. The area continued to hurt and was red that same size still until yesterday morning (1/16/2020) and by then the pain had subsided. When I looked last night (1/16/2020) it was no longer red but you could still see in light pink the area that size that had been red.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly store PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On 16-DEC-2019, the patient was vaccinated with improperly stored Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (dose and dosing schedule were unknown) (lot # S017430 with Expiration date: 18-MAY-2021) via subcutaneous route for prophylaxis. It was reported that the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was stored at a temperature of 30.78F with a time frame of 15 minutes. The previous temperature of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was lowest temperature below 36 degree Fahrenheit (30.78 F) 311 cycles. No digital data logger was involved. No adverse effects were reported. No product quality complaints were reported.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: No additional adverse events reported; The patient was accidentally given a second dose of PNEUMOVAX23; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient was vaccinated with a dose of pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) on 11-SEP-2017. There was no information regarding the patient's concurrent conditions, concomitant medications or drug reactions/allergies.  On 08-OCT-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not provided). On 09-JAN-2020, the patient was accidentally vaccinated with a second dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), because the office got a new computer system and the first dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not carried over to the new database.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; no adverse effect; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S021925, expiry date : 15-JUL-2021) for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). It was unknown if diluent used to reconstitute was stored at proper temperature.    It was reported that the vaccine experienced a temperature excursion total time in the range of 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to - 10 degrees C) for 30 minutes, 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) for 7 hours and 47 degrees F to 77 degrees F (9 degrees C to 25 degrees C) for 9 hours (product storage error). There was no previous temperature excursion and it was reported that this call was due to a digital data logger. The patient had no adverse events. There was no product quality compliant involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005586:Original Case : 2001USA005586
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; no adverse effect; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S021925, expiry date : 15-JUL-2021) for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). It was unknown if diluent used to reconstitute was stored at proper temperature.    It was reported that the vaccine experienced a temperature excursion total time in the range of 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to - 10 degrees C) for 30 minutes, 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) for 7 hours and 47 degrees F to 77 degrees F (9 degrees C to 25 degrees C) for 9 hours (product storage error). There was no previous temperature excursion and it was reported that this call was due to a digital data logger. The patient had no adverse events. There was no product quality compliant involved.   This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005586:Original Case : 2001USA005586
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine administered; no adverse effect; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S021925, expiry date : 15-JUL-2021) for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). It was unknown if diluent used to reconstitute was stored at proper temperature.    It was reported that the vaccine experienced a temperature excursion total time in the range of 6 degrees Fahrenheit (F) to 14 degrees F (-14 degrees Celsius (C) to - 10 degrees C) for 30 minutes, 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) for 7 hours and 47 degrees F to 77 degrees F (9 degrees C to 25 degrees C) for 9 hours (product storage error). There was no previous temperature excursion and it was reported that this call was due to a digital data logger. The patient had no adverse events. There was no product quality compliant involved.   This is one of the several reports received from the same reporter. Sender's Comments:  US-009507513-2001USA005586:Original Case : 2001USA005586
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Adverse reaction
Clinical narrative: had a reaction to GARDASIL 9; This spontaneous report was received from an office manager via a company representative referring to a 41 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 13-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, lot # and expiration date were not reported) intramuscularly for prophylaxis.     In January 2020, the patient had a reaction to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of the event was unknown. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was related.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Dose 2 she said hurt not as bad/ Pain in arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2020AMR003903).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient's injection hurted but not as bad as after the 1st dose and lasted for 3 days. The reporter stated all pain in arm resolved.  The reporter consented to follow up. For the tolerances of 1st dose, refer case US2020AMR003903, reported by same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Achy arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the vaccination left her with little more than an achy arm. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2020AMR004482.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was selected as adult as per vaccine indication. It was reported that the patient received 2nd dose and experienced headache. The patient knew the side effects but could not find out if the patient could take Ibuprofen for headache.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Nasopharyngitis, Pain, Throat irritation, Vaccine positive rechallenge
Clinical narrative: Scratchy throat; Head cold; Achy; Miserable/ felt poppy; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 5th August 2019 and experienced events, refer case US2020AMR000607). Concurrent medical conditions included sinus infection.   On 27th December 2019, the patient received the 2nd dose of Shingrix. On 28th December 2019, 1 days after receiving Shingrix, the patient experienced general body pain and feeling abnormal. On 29th December 2019, the patient experienced throat irritation and head cold. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)) and steroids nos (Steroid (Not Specified)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain and feeling abnormal were unknown and the outcome of the throat irritation and head cold were recovering/resolving.   It was unknown if the reporter considered the general body pain, feeling abnormal, throat irritation and head cold to be related to Shingrix.  Additional details were received as follows: The patient after vaccination was achy and miserable. The patient felt poopy and had a scratchy throat and a head cold. The patient already had a sinus infection going on before the second dose. The patient seen an ENT physician who instructed her to take an antibiotic and a steroid. The patient stated that the pharmacist pharmacist told her needed to wait to take the meds since she had the  Shingrix shot. The patient stated that she did not believe she had ever had chicken pox. The patient stated that the she felt the scratchy throat and head cold were getting better, but she still feels poopy. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence, Gastrointestinal sounds abnormal, Injection site erythema
Clinical narrative: injection site muscle pain; Injection site redness; stomach pain; stomach "rumbling" gas; Gas in stomach; diarrhea; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th January 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain, injection site erythema, stomach pain, borborygmus, gas in stomach, diarrhea and pain. On an unknown date, the outcome of the injection site muscle pain and injection site erythema were recovering/resolving and the outcome of the stomach pain, borborygmus, gas in stomach and diarrhea were resolved with sequelae and the outcome of the pain was unknown.   It was unknown if the reporter considered the injection site muscle pain, injection site erythema, stomach pain, borborygmus, gas in stomach, diarrhea and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient developed injection site muscle pain and redness and stomach rumbling gas, diarrhea and pain. The patient did not consent to follow up. This case has been linked to US2020004015, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: injection site muscle pain; Injection site redness; stomach pain; stomach "rumbling" gas; Gas in stomach; diarrhea; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th January 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain, injection site erythema, stomach pain, borborygmus, gas in stomach, diarrhea and pain. On an unknown date, the outcome of the injection site muscle pain and injection site erythema were recovering/resolving and the outcome of the stomach pain, borborygmus, gas in stomach and diarrhea were resolved with sequelae and the outcome of the pain was unknown.   It was unknown if the reporter considered the injection site muscle pain, injection site erythema, stomach pain, borborygmus, gas in stomach, diarrhea and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient developed injection site muscle pain and redness and stomach rumbling gas, diarrhea and pain. The patient did not consent to follow up. This case has been linked to US2020004015, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: injection site red hive; Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of injection site hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site hives and injection site erythema. On an unknown date, the outcome of the injection site hives and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site hives and injection site erythema to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that her sister received dose 1 of Shingrix and developed an injection site red hive that never went away. The reporter did not consent to follow up. This case has been linked to US2020004013, reported by the same reporter.