chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Dyspnoea, Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On 6th April 2019, 3 days after receiving SHINGRIX, the patient experienced axillary pain and injection site pain. On 7th April 2019, the patient experienced fatigue, shortness of breath and knee pain. On an unknown date, the outcome of the axillary pain, injection site pain, fatigue, shortness of breath and knee pain were not reported. The reporter considered the axillary pain, injection site pain, fatigue, shortness of breath and knee pain to be related to SHINGRIX. Additional details were provided as follows: On 3rd April 2019, Wednesday, the patient received 1st dose of SHINGRIX in her left arm, bicep. SHINGRIX batch and lot number was not available. On 6th April 2019, the patient started to develop lot of pain and tenderness underneath the arm and had difficulty applying deodorant. The patient also experienced pain at the injection site. On 7th April 2019, Sunday, the patient ran a half marathon and at three-fourths of the race, she started to experience fatigue, shortness of breath, and hip and knee pain and had to walk at the end of the marathon. The patient stated that, she had trained for the race and used to exercise a lot and was not expecting these side effects, hence attributed all the side effects to the SHINGRIX vaccine. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 3rd April 2019, the patient received the 1st dose of SHINGRIX. On 6th April 2019, 3 days after receiving SHINGRIX, the patient experienced axillary pain and injection site pain. On 7th April 2019, the patient experienced fatigue, shortness of breath and knee pain. On an unknown date, the outcome of the axillary pain, injection site pain, fatigue, shortness of breath and knee pain were not reported. The reporter considered the axillary pain, injection site pain, fatigue, shortness of breath and knee pain to be related to SHINGRIX. Additional details were provided as follows: On 3rd April 2019, Wednesday, the patient received 1st dose of SHINGRIX in her left arm, bicep. SHINGRIX batch and lot number was not available. On 6th April 2019, the patient started to develop lot of pain and tenderness underneath the arm and had difficulty applying deodorant. The patient also experienced pain at the injection site. On 7th April 2019, Sunday, the patient ran a half marathon and at three-fourths of the race, she started to experience fatigue, shortness of breath, and hip and knee pain and had to walk at the end of the marathon. The patient stated that, she had trained for the race and used to exercise a lot and was not expecting these side effects, hence attributed all the side effects to the SHINGRIX vaccine. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Haemoptysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sputum bloody in a 67-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingle during holiday). Previously administered products included ZOSTAVAX (received in April 2015). On 28th February 2019, the patient received the 1st dose of SHINGRIX. On 1st March 2019, 1 days after receiving SHINGRIX, the patient experienced sputum bloody. On an unknown date, the outcome of the sputum bloody was not recovered/not resolved. It was unknown if the reporter considered the sputum bloody to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right deltoid and the next morning he coughed up blood. The condition repeated for the next to days and he was clear for the next 2 days. The symptoms returned and had occurred on various days since then. The patient also experience the symptom this morning. His healthcare professional said that his lungs sound clear, so he was ruling out pneumonia. The patient had a chest x-ray and it was negative.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site joint pain, Pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a 77-year-old male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site joint pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site joint pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site joint pain, injected limb mobility decreased and vaccine administered at inappropriate site to be related to SHINGRIX. Additional details were reported as follows: The reporter was a patient. The patient experienced shoulder pain in the same arm where he received the injection and that it persists now. The patient was unable to lift his arm up to shoulder level without experiencing a tremendous amount of pain and that exercise had not helped it. The nurse giving him the shot told him that she does not give it in the muscle, and caller was unsure if the shot was administered in his muscle or not, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blister, Pain
Clinical narrative: C/o pain in RUQ of abdomen. Dull, burning and constant x 4 days. On exam, in RUQ abdomen a group of about 25 small vesicles and smaller group of vesicles around side and back. Rx for VALTREX 1 gm TID x 7 days, Prednisone 40 mg x 7 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Muscle pain, headache, does not go away with ADVIL.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Peripheral swelling
Clinical narrative: Pt experienced swelling in arm, pain, and itchy rash surrounding injection site
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Musculoskeletal pain
Clinical narrative: shoulder erythema and pain, no fever
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pain in extremity
Clinical narrative: 2 days after receiving the shot, the patient says her arm is red and there is a large swollen circle around the injection site, as well as arm soreness.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: There was some pain at the injection site almost immediately; It remained painful for several days. A red area developed around the injection site - approximately 5 inches by 3 inches and the skin was warm with a slight welting. More importantly, during the 12 hours immediately following the injection, my entire body ached - every muscle seemed to be affected and I was very tired. I felt feverish; however, I did not measure a temperature. I took three ibuprofen to relieve the muscle ache. I had several matters to accomplish during the day immediately following the vaccination, which I did manage to complete, albeit not up to par. The muscle ache resolved within 24-48 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain, Pyrexia, Urticaria
Clinical narrative: There was some pain at the injection site almost immediately; It remained painful for several days. A red area developed around the injection site - approximately 5 inches by 3 inches and the skin was warm with a slight welting. More importantly, during the 12 hours immediately following the injection, my entire body ached - every muscle seemed to be affected and I was very tired. I felt feverish; however, I did not measure a temperature. I took three ibuprofen to relieve the muscle ache. I had several matters to accomplish during the day immediately following the vaccination, which I did manage to complete, albeit not up to par. The muscle ache resolved within 24-48 hours.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: Patient became very nauseous the evening he received the immunization (last night), and today he is extremely tired and weak - not wanting to get out of bed.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests, Deafness unilateral
Clinical narrative: Patient describes loss of hearing in one ear.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Eczema, Erythema, Pyrexia, Screaming
Clinical narrative: Around five hours after receiving vaccines patient became distraught, and unconsolable.  He presented a low grade fever and cried, whimpered and screamed for about three and a half hours. Later that night I saw two eczema spots on his chest, which had already been there, but they were bright red and more noticeably raised than before.  He also on both of his arms from about slightly above his elbows to about middle of his forearms round, red, rings, which looked eczema like presented. They are still present no longer red, but still there when he never had them before.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Dizziness x 5 days.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Lethargy, Pain in extremity
Clinical narrative: Fatigue, headache, sore arm (6"dia), backache, fever, lethargy, yes, I'm tired!
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue, headache, sore arm (6"dia), backache, fever, lethargy, yes, I'm tired!
Age: 10.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Nodule, Pain, Pruritus
Clinical narrative: Pt had a large red knot to come up the day after vaccination. Complaints of itching and hurting. Cold compresses and TYLENOL given.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT DEVELOPED ABOUT 9CM REDNESS SWELLING WITH MODERATE ITCHING TO RIGHT DELTOID AND HOT TO THE TOUCH. MOTHER GAVE PATIENT BENADRYL AND BY THE 4TH DAY THE SWELLING HAD GONE DOWN AND ONLY HAD REDNESS AND MILD ITCHING TO AREA. DR. INSTRUCTED PARENT TO CONTINUE GIVING BENADRYL AND MOTRIN FOR DISCOMFORT.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: ARM PAIN, FELT WARM AND LITTLE SWOLLEN
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-JUN-2014, at age 50, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: vaccine was administered before the recommended booster schedule; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves unknown age and gender of patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was actual medication error due to inappropriate schedule of product administration. On an unknown date, the consumer began experiencing vaccine was administered before the recommended booster schedule.  Final diagnosis was vaccine was administered before the recommended booster schedule.  It was not reported whether the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: expired dose of Fluzone High-Dose vaccine was inadvertently administered; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 77 years old male patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] inadvertently.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy received.   On 11-Apr-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB (expiry date: 28-Mar-2019) via unknown route.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: expired Imovax vaccine was given to patient; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 year old female patient who was vaccinated with 0.5 ml expired RABIES (HDC) VACCINE [IMOVAX RABIES] (formulation: Powder and solvent for suspension for injection) (lot: N1B901M, expiry date: 18-Mar-2019) via intramuscular route, on 12-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used (expired Imovax vaccine was given to patient).  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, FLU4, MNQ
Symptoms: Product storage error
Clinical narrative: Pentacel, Menactra, Fluzone "Pediatric" or Quadrivalent 0.25 mg, and Fluzone Quadrivalent 0.5 mg that was too cold (29-33 ºF for 20 days); Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 3 patients (kids) of unknown demography who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that Pentacel, Menactra, Fluzone "pediatric" or Quadrivalent 0.25 mg, and Fluzone Quadrivalent 0.5 mg that was too cold (29-33 ºf for 20 days).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect 0.25 mg INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. 1 other doses were administered on unknown dates for suspect 0.5 mg INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient who was administered a dose of Menactra that expired on 03/05/2019; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case from  a Nurse.  This case involves a patient of unknown demography who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that patient was administered a dose of Menactra that had already expired on 03/05/2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (expiry date: 05-Mar-2019) lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was not reported if any adverse event occurred following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 83.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient's daughter reported on 4/17/2019 the patient has had a raised bump on patient's left arm with continuous pain and soreness. Patient's primary MD has been treating the pain with lidocaine patches and meloxicam and will be seeing a physical therapist in the near future to try and bring the the bump on her arm down. Daughter states MD believes the vaccine administered back in October could have hit a nerve on that specific arm and caused the reaction. Documents from the vaccine indicate FluBlok was administered on the left arm.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Injection site erythema, Injection site warmth
Clinical narrative: Patient reported facial flushing and red injection site and injection site hot to the touch. Requested treatment at clinic and was given RX for Triamcinolone .1% twice daily for 2 weeks and instructed to get OTC ZYRTEC once daily. Facial symptoms resolved with TYLENOL at home on 04/16/2019.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, painful swelling all around the site, itching, bad headache, tiredness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Redness, painful swelling all around the site, itching, bad headache, tiredness.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: ARM PAIN, SWELLING AND WARMTH AT THE TOUCH LOW GRADE TEMP 99.0
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Muscle spasms, Nausea, Pain
Clinical narrative: Apr11: Ache began in Rt. arm, aprox. 3PM, and traveled through whole body by late evening followed by chills so intense that I could not stop shaking. The chills began shortly before 8:30PM. (Some nausea, not too bad though); Apr 12: Woke up feeling better, just not myself yet, so took it slow all day. Apr.13: Woke feeling much better, took shower and while drying off my lower back started being very painful with any movement to the extent that I could barely walk without hanging onto something. This lasted all day. I have experienced spasms in that area before, but never this severely. Apr 14: I was much improved and began feeling like my body belonged to me once again. I took it easy being cautious. I will see Dr. Apr 24th.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Apr11: Ache began in Rt. arm, aprox. 3PM, and traveled through whole body by late evening followed by chills so intense that I could not stop shaking. The chills began shortly before 8:30PM. (Some nausea, not too bad though); Apr 12: Woke up feeling better, just not myself yet, so took it slow all day. Apr.13: Woke feeling much better, took shower and while drying off my lower back started being very painful with any movement to the extent that I could barely walk without hanging onto something. This lasted all day. I have experienced spasms in that area before, but never this severely. Apr 14: I was much improved and began feeling like my body belonged to me once again. I took it easy being cautious. I will see Dr. Apr 24th.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza, Malaise
Clinical narrative: Pt thought she was going to die and describes herself being so extremely sick with flu for 32 days beginning the day after the vaccine was administered.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Decreased appetite, Influenza, Myalgia, Nausea
Clinical narrative: Pt thought she was going to die and describes herself being so extremely sick with flu for 32 days beginning the day after the vaccine was administered.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Pt thought she was going to die and describes herself being so extremely sick with flu for 32 days beginning the day after the vaccine was administered.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza, Malaise
Clinical narrative: Patient stated that the day after she received the vaccine she experienced symptoms of the flu including muscle pain, weakness, nausea, fever, as well as a decreased appetite that lasted 32 days. She states that due to the vaccine she lost approximately 30 pounds. When asked if she sought medical attention she stated that she did not.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Decreased appetite, Influenza, Myalgia, Nausea
Clinical narrative: Patient stated that the day after she received the vaccine she experienced symptoms of the flu including muscle pain, weakness, nausea, fever, as well as a decreased appetite that lasted 32 days. She states that due to the vaccine she lost approximately 30 pounds. When asked if she sought medical attention she stated that she did not.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Patient stated that the day after she received the vaccine she experienced symptoms of the flu including muscle pain, weakness, nausea, fever, as well as a decreased appetite that lasted 32 days. She states that due to the vaccine she lost approximately 30 pounds. When asked if she sought medical attention she stated that she did not.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Routine vaccination. Pt recently had a newborn enter the family and wanted to get vaccinated to protect the newborn baby.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye infection, Herpes zoster
Clinical narrative: Patient developed infection of eye, untreatable with antibiotics. Belief is that it was shingles/zoster virus and related to vaccine. Recommended by MD to not receive second dose.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: pt had red, hot arm,some swelling, from shoulder to elbow, had fever and chills, took about 3 days until fever broke and she felt better
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Child developed injection site redness and swelling. Over the next day after the vaccine started to get fevers. Fevers as high as 105 on the second day after the vaccine was administered.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Presyncope
Clinical narrative: Vasovagal, blood pressure increase, heart rate increased to 187, dizzy, light head.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MMR, VARCEL
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: 10:33 am Client felt dizzy with cold clammy skin and pale immediately after last vaccine was administered.  VS BP 100/70, R 24 P 76 sitting with head between legs 10:41 Feeling better, color better, cool compress applied to neck and face 10:50am Feeling better,  color returned, BP 110/80, P 64 R 32 rechecked R 29  10:56 Left walking out of clinic accompanied by father
Age: 14.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, HPV9, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event noted - was instructed to report as an error; pt should have received Td and IPV separately but since the dtap was considered valid the combination vaccine was administered.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Papule, Rash
Clinical narrative: Patient stated she developed a rash @ forehead and upper chest the next day after receiving the MMR vaccine . Patient stated went to a dermatologist , being treated with cortisone .  Provider noted multiple papules @ forehead and upper chest , no redness, no oozing
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Spotty rash over torso and most of today beginning on 13th day after vaccination
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Full blood count, Hypotonia, Metabolic function test, Pyrexia, Respiratory arrest
Clinical narrative: She started with symptoms of not breathing,turning purple,turning limp on 07/01/2018  when they were out in the swimming pool with mom and the 3  older siblings. She had a tactile fever and mom blew in her mouth.The episode lasted a few minutes?? Was seen at ER and treated as a case BRUE..
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Skin discolouration
Clinical narrative: She started with symptoms of not breathing,turning purple,turning limp on 07/01/2018  when they were out in the swimming pool with mom and the 3  older siblings. She had a tactile fever and mom blew in her mouth.The episode lasted a few minutes?? Was seen at ER and treated as a case BRUE..
Age: 24.0
Sex: M
Vaccine: HEP, HPV9, TYP
Symptoms: Dyskinesia, Syncope
Clinical narrative: Syncope after injecting HPV vaccine followed by jerking movements lasting ~  10 seconds.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Induration, Myalgia
Clinical narrative: Hard, red, swollen upper arm; Muscle Aches, fever, headache, shivering.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Hard, red, swollen upper arm; Muscle Aches, fever, headache, shivering.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Lethargy, Pain, Pain in extremity
Clinical narrative: SORENESS IN ARM; DIARRHEA; FULL BODY ACHES; LOW GRADE FEVER; LETHARGY; ERYTHEMA ACROSS UPPER ARM -- ALL X 48 HOURS MAX.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: SORENESS IN ARM; DIARRHEA; FULL BODY ACHES; LOW GRADE FEVER; LETHARGY; ERYTHEMA ACROSS UPPER ARM -- ALL X 48 HOURS MAX.
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Computerised tomogram head normal, Headache, Pain, Pyrexia
Clinical narrative: Body aches, chills, fever, severe headache at the base of my skull, that required an emergency room visit. Pain was excruciating. This headache lasted most of the second day after getting the vaccination. ER was able to help with the pain and the next morning (3rd day after getting the SHINGRIX shot.) I felt better. I had also received a pneumonia vaccination (PNEUMOVAX) the same day as the Shingles vaccination. But, the ER felt it was from the SHINGRIX vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Electroencephalogram normal, Full blood count, General physical condition abnormal, Metabolic function test, Musculoskeletal stiffness
Clinical narrative: She had a stiff body, looked weird and purple just like the previous episode in July 2018. She had a stare and the whole episode lasted for about 3-4 minutes. 911 was called and she was taken to ER and evaluated. CBC, Metabolic profile was done. She was referred to a neurologist and he admitted her at Hospital and a Video EEG was done. It was interpreted as a normal EEG. Seizure diagnosis was considered.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Skin discolouration, Staring
Clinical narrative: She had a stiff body, looked weird and purple just like the previous episode in July 2018. She had a stare and the whole episode lasted for about 3-4 minutes. 911 was called and she was taken to ER and evaluated. CBC, Metabolic profile was done. She was referred to a neurologist and he admitted her at Hospital and a Video EEG was done. It was interpreted as a normal EEG. Seizure diagnosis was considered.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope
Clinical narrative: After 3rd injection (HPV-9), child became pale and stated he felt dizzy. Child fainted and regained consciousness after approx. 20-30 seconds. Child was sitting. He did not fall. He did not hit head.  EMS was called to evaluate child. It was determined that he was stable and could go home. Mother advised to watch child and to call EMS or to take child to the ER if any issues or concerns. Child alert and oriented and denied complaints, upon leaving Clinic.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Infection
Clinical narrative: PATIENT STATES THAT SHE GOT AN INFECTION FROM THE INJECTION
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Patient called this evening stating that she has ankle and leg swelling. She said it started around the time that she received the vaccine but is unsure if it started before the vaccine or after and doesn't know the date swelling started. I recommend that she should contact her physician.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Malaise, Product administered at inappropriate site
Clinical narrative: Vaccine given too high- in the shoulder instead of the deltoid muscle. Per patient, he experienced significant pain at the time of the injection. Shoulder continued to hurt even to the present time over a month later. The next 2.5 days after vaccine administration he experienced fever and didn't feel well. Went to his PCP Dr. after he noticed a swelling in the front of his shoulder (5-10 days after injection) who sent him for ultrasound and he was told he would need a biopsy which he has not done.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Ultrasound scan abnormal
Clinical narrative: Vaccine given too high- in the shoulder instead of the deltoid muscle. Per patient, he experienced significant pain at the time of the injection. Shoulder continued to hurt even to the present time over a month later. The next 2.5 days after vaccine administration he experienced fever and didn't feel well. Went to his PCP Dr. after he noticed a swelling in the front of his shoulder (5-10 days after injection) who sent him for ultrasound and he was told he would need a biopsy which he has not done.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness
Clinical narrative: patient was given the prevnar 13 walked a way for 2 minutes then came back and sat on are bench and said she was feeling dizzy, she also stated that she had been working out for 45 minutes prior to the shot, i told her to sit down for 15 mins, and gave her some cold water, she recovered and felt she was dehydrated from working out and that might have made her dizzy, i called later to check up on her and she recovered fully.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Erythema, Pain, Secretion discharge, Swelling, Tenderness
Clinical narrative: red area, pain when touching, hot, mucus it was putting in passing the most large and painful days of 2 weeks.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: After receiving the first of two shingles vaccine injections. Fever of 99.4  Normal heart rate 52. Heart rate now 64
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Teen came to office for immunizations on 4/15/19 - imms were ordered correctly but placed using a sub Q technique resulting in a site reaction on BL 48 hours later. Right arm - 4 x 5 cm area of diffuse pink swelling at posterior mid arm. Left arm - 2 x 3 cm area of well circumscribed pink swelling.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pain in extremity, Rheumatoid arthritis, Tenderness
Clinical narrative: patient had tinder arm starting the same day when he got the vaccine. net day pain in shoulder arms and hands. then he was diagnosed with rheumatoid Arthritis, been on steroid course to help with the pain.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Skin oedema, Skin warm
Clinical narrative: 4/16/19 about 2hrs after vaccine noted pain and redness on left deltoid; progressed today. Seen in clinic 48 hrs after reaction. Erythematous warm, no significant edema no fluctuance 2x10cm area of redness dermal edema.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Hypoaesthesia, Injected limb mobility decreased, Injection site haemorrhage, Injection site pain
Clinical narrative: Patient said as soon as needle went in there was pain & lots of bleeding - down arm. She can't lift arm up above shoulder - lots of numbness/throbbing pain
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient said as soon as needle went in there was pain & lots of bleeding - down arm. She can't lift arm up above shoulder - lots of numbness/throbbing pain
Age: 0.5
Sex: F
Vaccine: HEP, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: ~ 1am localized redness around injection sites; redness surrounds both sides. Small lump with warmth at site
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Rash maculo-papular, Target skin lesion
Clinical narrative: Rash maculopapular with some target lesions. Started 1 day post vaccine. No treatment needed. Improving
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a  female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-JAN-2007, at age 61, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster is unknown.  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 29th March 2019, the patient experienced shingles, pruritus, red rash and vesicles. The patient was treated with valacyclovir hydrochloride and lidocaine. On an unknown date, the outcome of the shingles, pruritus, red rash and vesicles were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the shingles, pain in arm, pruritus, red rash and vesicles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in the left arm. On 25th March 2019, the patient reported that she had left arm pain and left arm soreness the same day of vaccination. The patient reports, 4 days after vaccination, itching inside her left shoulder blade. After 4 days of vaccination, there was a rash that looked like volcanoes. They were red and filled with fluid. The diameter of the rash on the shoulder blade was about that of an egg. The patient was seen on 2nd April 2019 by their physician, who diagnosed possible shingles. The patient was prescribed valacyclovir and lidocaine for the affected area.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 29th March 2019, the patient experienced shingles, pruritus, red rash and vesicles. The patient was treated with valacyclovir hydrochloride and lidocaine. On an unknown date, the outcome of the shingles, pruritus, red rash and vesicles were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the shingles, pain in arm, pruritus, red rash and vesicles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in the left arm. On 25th March 2019, the patient reported that she had left arm pain and left arm soreness the same day of vaccination. The patient reports, 4 days after vaccination, itching inside her left shoulder blade. After 4 days of vaccination, there was a rash that looked like volcanoes. They were red and filled with fluid. The diameter of the rash on the shoulder blade was about that of an egg. The patient was seen on 2nd April 2019 by their physician, who diagnosed possible shingles. The patient was prescribed valacyclovir and lidocaine for the affected area.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 12th April 2019, the patient received the 3rd dose of SHINGRIX. On 12th April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and extra dose administered. On an unknown date, the outcome of the injection site swelling and extra dose administered were unknown.  It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The nurse reported that his wife received a third dose of SHINGRIX, which led to extra dose administered. The reporter gave consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 12th April 2019, the patient received the 3rd dose of SHINGRIX. On 12th April 2019, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and extra dose administered. On an unknown date, the outcome of the injection site swelling and extra dose administered were unknown.  It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The nurse reported that his wife received a third dose of SHINGRIX, which led to extra dose administered. The reporter gave consent to follow up.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Adverse drug reaction, Chest pain, Colitis ulcerative, Colonoscopy, Erythema
Clinical narrative: I experienced frequent bowel movements on October 14, 2013 and had gotten worse throughout the years.  As for treatment, I started with Prednisone, Lialda, Imuran, and Humira.  I had experience negative side effects with Imuran such as fatigue, muscle aches and chest pain to name a few.  And with Humira I had also experienced negative side effects such as skin rashes all over the body, itchy skin, red, swollen, and painful skin at times mostly during the night, and did not sleep well.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Frequent bowel movements, Laboratory test, Myalgia, Poor quality sleep
Clinical narrative: I experienced frequent bowel movements on October 14, 2013 and had gotten worse throughout the years.  As for treatment, I started with Prednisone, Lialda, Imuran, and Humira.  I had experience negative side effects with Imuran such as fatigue, muscle aches and chest pain to name a few.  And with Humira I had also experienced negative side effects such as skin rashes all over the body, itchy skin, red, swollen, and painful skin at times mostly during the night, and did not sleep well.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pruritus, Rash, Rash generalised, Skin swelling
Clinical narrative: I experienced frequent bowel movements on October 14, 2013 and had gotten worse throughout the years.  As for treatment, I started with Prednisone, Lialda, Imuran, and Humira.  I had experience negative side effects with Imuran such as fatigue, muscle aches and chest pain to name a few.  And with Humira I had also experienced negative side effects such as skin rashes all over the body, itchy skin, red, swollen, and painful skin at times mostly during the night, and did not sleep well.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: 101.5 fever
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Psoriasis, Skin swelling
Clinical narrative: 10/14/2018  I notice I had small bump on my Whole body
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: At site of injection: swollen, red, pain, soreness, Overall feeling of tiredness and feeling blah, loss of appetite, mild headache, pain radiating down length of injected arm, low grade fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: At site of injection: swollen, red, pain, soreness, Overall feeling of tiredness and feeling blah, loss of appetite, mild headache, pain radiating down length of injected arm, low grade fever.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pyrexia, Syncope
Clinical narrative: Significant swelling of arm. Extensive redness. More than 'typical'. Fever like symptoms (more than first dose). Syncope.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported.; one dose of expired VARIVAX (M033905 7/20/2018) that was administered to one patient on 3/20/2019; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history was not provided.   On 20-MAR-2019, the patient was vaccinated with one dose of expired varicella virus vaccine live (oka/merck)(VARIVAX) (lot # M033905, expiration date  20-JUL-2018, subcutaneous; dose detail and anatomical location were not reported) for prophylaxis. The sterile diluent that was used to reconstitute the varicella virus vaccine live (oka/merck)(VARIVAX) was not expired. No adverse effect was reported.