chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Erythema, Headache
Clinical narrative: PT STATES THE EVENING AFTER INJECTION HER ARM BECAME EXTREMELY RED, HOT, AND PAINFUL AND HAS NOT IMPROVED. THE FOLLOWING DATE SHE BEGAN TO EXPERIENCE NAUSEA, STOMACH, NECK, AND BACK PAIN AND HEADACHE. ON DAY 2 POST INJECTION SHE ADDED DIARRHEA TO HER SYMPTOMS AS WELL AS CONTINUING "FLU LIKE" SYMPTOMS. ON DAY 3 SHE RETURNED TO PHARMACY STATING HER SYMPTOMS HAD NOT IMPROVED AND SHE COULD NOT EAT AND FELT HORRIBLE. SHE SAID SHE DID NOT EXPERIENCE THESE SAME EFFECTS WITH 1ST INJECTION. SHE SHOWED A PICTURE OF THE REDNESS ON HER LEFT DELTOID AND SAID SHE COULD HARDLY LIFT HER ARM. SHE HAS NOT SOUGHT MEDICAL TREATMENT TO MY KNOWLEDGE.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site erythema, Nausea, Neck pain
Clinical narrative: PT STATES THE EVENING AFTER INJECTION HER ARM BECAME EXTREMELY RED, HOT, AND PAINFUL AND HAS NOT IMPROVED. THE FOLLOWING DATE SHE BEGAN TO EXPERIENCE NAUSEA, STOMACH, NECK, AND BACK PAIN AND HEADACHE. ON DAY 2 POST INJECTION SHE ADDED DIARRHEA TO HER SYMPTOMS AS WELL AS CONTINUING "FLU LIKE" SYMPTOMS. ON DAY 3 SHE RETURNED TO PHARMACY STATING HER SYMPTOMS HAD NOT IMPROVED AND SHE COULD NOT EAT AND FELT HORRIBLE. SHE SAID SHE DID NOT EXPERIENCE THESE SAME EFFECTS WITH 1ST INJECTION. SHE SHOWED A PICTURE OF THE REDNESS ON HER LEFT DELTOID AND SAID SHE COULD HARDLY LIFT HER ARM. SHE HAS NOT SOUGHT MEDICAL TREATMENT TO MY KNOWLEDGE.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Skin warm
Clinical narrative: PT STATES THE EVENING AFTER INJECTION HER ARM BECAME EXTREMELY RED, HOT, AND PAINFUL AND HAS NOT IMPROVED. THE FOLLOWING DATE SHE BEGAN TO EXPERIENCE NAUSEA, STOMACH, NECK, AND BACK PAIN AND HEADACHE. ON DAY 2 POST INJECTION SHE ADDED DIARRHEA TO HER SYMPTOMS AS WELL AS CONTINUING "FLU LIKE" SYMPTOMS. ON DAY 3 SHE RETURNED TO PHARMACY STATING HER SYMPTOMS HAD NOT IMPROVED AND SHE COULD NOT EAT AND FELT HORRIBLE. SHE SAID SHE DID NOT EXPERIENCE THESE SAME EFFECTS WITH 1ST INJECTION. SHE SHOWED A PICTURE OF THE REDNESS ON HER LEFT DELTOID AND SAID SHE COULD HARDLY LIFT HER ARM. SHE HAS NOT SOUGHT MEDICAL TREATMENT TO MY KNOWLEDGE.
Age: 1.33
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: All vaccines were administered at 1355, MMRV vaccine as administered on the L leg. 5 minutes later, at 1400, pt experienced a small reaction including redness around injection site and three small hives clustered together near injection site. The patient primary care provider was notified of the reaction and came to assess the patient. Primary care provider ordered a dose of diphenhydramine to be administered to the patient with no other treatments needed at the time.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Periarthritis, X-ray limb abnormal
Clinical narrative: left shoulder pain since flu shot reported on 3/22/18 noted capsulitis in left humeral joint on XR. offered recheck with XR shoulder and PT or Ortho referral -pt refused.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever, dizziness, lowered blood pressure; Symptoms persisted for more than 24 hours.
Age: 15.0
Sex: F
Vaccine: DTAPIPV, HPV9, MMRV
Symptoms: Injection site erythema, Rash, Vaccination site swelling
Clinical narrative: Rash on bilateral hands, Right foot, and bilateral inner arms. BENADRYL 25 mg, TYLENOL 650 mg, and triamcinolone to rash.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Aches, fever, fatigue.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site scab, Lymphadenopathy, Pain, Pain of skin, Papule
Clinical narrative: Patient received primary SPV on 3/26/2019 alone. He is a medical technician. He had normal body aches and site progression and about 4/5/2019 noted onset of small papules to both hands, elbows, forearms that progressed to pictures sent (pictures taken day 4). Patient advised pictures of his hands were taken with elbows yesterday (will track them down). Patient advised he had some axillary nodal swelling, and skin itched to point of being painful, so he took OTC Zyrtec and Benadryl at night. He denied any chest pain, sob, fever or other systemic symptoms. He denied any rash elsewhere on body and no history of any eczema, atopic derm, etc or any immunosuppressive disorders. He was on no routine medications using Zyrtec for allergic rhinitis (uses meds more for spring pollen/grass). He advised hx of hives/rashes and allergic rhinitis when contacting grasses, pollen as a child that he was given allergy shots for but doesn't recall specifics and has not required shots for years. He advised only new contact was with a new detergent for cloths, otherwise nothing else new. He is driving home and will send me updated pictures of hands (both sides), elbows, and SPV site (describes as umbilicated lesion with new scab forming in center). He states hands/forearms are much better after 3 doses of steroids, is using Zyrtec/Benadryl at night, and MD prescribed lidocaine 5% topical patch and 2.5% cream, clobetasol prop 0.05% topical cream and prednisone 20 mg (3 tab x 7 days) and then f/u on Monday before stopping steroids). He is keeping all sites covered with dressings
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus
Clinical narrative: Patient received primary SPV on 3/26/2019 alone. He is a medical technician. He had normal body aches and site progression and about 4/5/2019 noted onset of small papules to both hands, elbows, forearms that progressed to pictures sent (pictures taken day 4). Patient advised pictures of his hands were taken with elbows yesterday (will track them down). Patient advised he had some axillary nodal swelling, and skin itched to point of being painful, so he took OTC Zyrtec and Benadryl at night. He denied any chest pain, sob, fever or other systemic symptoms. He denied any rash elsewhere on body and no history of any eczema, atopic derm, etc or any immunosuppressive disorders. He was on no routine medications using Zyrtec for allergic rhinitis (uses meds more for spring pollen/grass). He advised hx of hives/rashes and allergic rhinitis when contacting grasses, pollen as a child that he was given allergy shots for but doesn't recall specifics and has not required shots for years. He advised only new contact was with a new detergent for cloths, otherwise nothing else new. He is driving home and will send me updated pictures of hands (both sides), elbows, and SPV site (describes as umbilicated lesion with new scab forming in center). He states hands/forearms are much better after 3 doses of steroids, is using Zyrtec/Benadryl at night, and MD prescribed lidocaine 5% topical patch and 2.5% cream, clobetasol prop 0.05% topical cream and prednisone 20 mg (3 tab x 7 days) and then f/u on Monday before stopping steroids). He is keeping all sites covered with dressings
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Exercise tolerance decreased, Headache, Injection site pain
Clinical narrative: Significant swelling of lymph node of right underarm. Continued significant pain at site of injection and throughout the right arm, right shoulder and right side of neck even 4 days after vaccine. Pain was most intense starting the day after vaccine and lasting through third day after vaccine accompanied by a strong headache on the day after vaccine. My endurance has been significantly reduced to the point that I have gotten out of breath and felt a bit dizzy while climbing stairs, particularly starting the second day after the vaccine (Monday 4/8) through the current day (4/10). I feel that I can rule out an unassociated virus or infection because I have no fever, no runny nose, no diarrhea or symptoms other than those described above.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: Significant swelling of lymph node of right underarm. Continued significant pain at site of injection and throughout the right arm, right shoulder and right side of neck even 4 days after vaccine. Pain was most intense starting the day after vaccine and lasting through third day after vaccine accompanied by a strong headache on the day after vaccine. My endurance has been significantly reduced to the point that I have gotten out of breath and felt a bit dizzy while climbing stairs, particularly starting the second day after the vaccine (Monday 4/8) through the current day (4/10). I feel that I can rule out an unassociated virus or infection because I have no fever, no runny nose, no diarrhea or symptoms other than those described above.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Headache, Insomnia
Clinical narrative: I experienced the following: shoulder pain and soreness; fever, shivering (I could not get warm even with lots of blankets and clothes) headache and fatigue. In addition to the side effects outlined above, what I consider the real adverse event was the phantom pain. I experienced severe or what I would describe, violent phantom pain in my left amputated limb. The phantom pain was so severe, that I often cried out, my entire body tightened as i felt the jolt, and I did not sleep from 12 am until the next evening. I have had phantom pain before, but nothing this severe, or continuous. This was not normal.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle tightness, Musculoskeletal pain, Phantom limb syndrome, Pyrexia
Clinical narrative: I experienced the following: shoulder pain and soreness; fever, shivering (I could not get warm even with lots of blankets and clothes) headache and fatigue. In addition to the side effects outlined above, what I consider the real adverse event was the phantom pain. I experienced severe or what I would describe, violent phantom pain in my left amputated limb. The phantom pain was so severe, that I often cried out, my entire body tightened as i felt the jolt, and I did not sleep from 12 am until the next evening. I have had phantom pain before, but nothing this severe, or continuous. This was not normal.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrex given to a two year old which is not licensed for the age group
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Injection site bruising
Clinical narrative: Approximately 5 hours after receiving the injection I developed a fever of 101 degrees, had chills and shivering, redness and pain at the injection site. 24 hours after the injection the initial reactions subsided with the injection site pain and swelling remaining.  36 Hours after the injection, joint pain and fatigue were experienced and that lasted 7 days with the redness and swelling at the injection site increasing to about 3 inches in diameter around the actual injection site. After about 14 days the redness and swelling gave way to a bruise. Bruising is still slightly noticeable at 34 days since the injection.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Approximately 5 hours after receiving the injection I developed a fever of 101 degrees, had chills and shivering, redness and pain at the injection site. 24 hours after the injection the initial reactions subsided with the injection site pain and swelling remaining.  36 Hours after the injection, joint pain and fatigue were experienced and that lasted 7 days with the redness and swelling at the injection site increasing to about 3 inches in diameter around the actual injection site. After about 14 days the redness and swelling gave way to a bruise. Bruising is still slightly noticeable at 34 days since the injection.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Rash
Clinical narrative: EMPLOYEE STATES SHE BECAME DIZZY APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF VACCINE (4/7/19)  WHICH LASTD ABOUT 5 MINUTES OR SO THEN AGAIN TWO DAYS LATER (4/9/19) LASTING 20MINUTES. RASH NOTED ON LEFT ARM FOUR INCHES BELOW INJECTION SITE. INTERMITTENT DIZZY EPISODES ON AND OFF TODAY (4/10/19).
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Patient came into the pharmacy on 4/10/19 and reported a rash all over her body - red with raised areas similar to hives. She said it started on 4/9/19, the day after she received her first dose of SHINGRIX. BENADRYL was recommended and patient was referred to her physician.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Mom called around 4:30 stating that clients leg  started to swell and has become worse and that client may have a fever because she feels warm but has not taken clients temperature. Nurse at Public Health asked if client was having any wheezing, problems breathing, or swelling of the face. Nurse explained to mom that client is having a local reaction which may take about 3-5 days before it goes away. That mom can call her provider and find out if she can give client anything like Tylenol or Benedryl. Nurse also explained to mom that if client is having any respiratory problems or any facial swelling that she should seek emergency help as soon as possible. Mom stated she understood.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Hypoaesthesia, Nodule, Pain, Skin discolouration
Clinical narrative: The day after the SHINGRIX vaccine was administered, patient felt number in his left arm, radiating through his fingers then occaisionally felt numbness in his right fingers. There's a egg size knot- bruised color on his left shoulder blade area. Painful and bruised and still present until today.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Autism spectrum disorder, Developmental delay, Diagnostic procedure
Clinical narrative: Asd (autism spectrum disorder) in process of complete severity and diagnosis, and developmental delay.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Patient's husband reported patient having pain, soreness at site of injection, headache, muscle aches, and fatigue and gotten worse so he took patient to emergency room. Both patient's Dr. and hospital doctors agreed and told patient that she had an adverse reaction to the second SHINGRIX vaccine shot. The first dose given 2 months prior she did not have this significant reaction just arm swelling and pain for few days. Patient was treated for adverse reaction in emergency room. Patient said she had chills, headache, every bones in her body hurts, hot/cold, shaking, sweating.  The following day on 2/14/19 she went to emergency room for few hours and was discharged.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Myalgia, Tremor
Clinical narrative: Patient's husband reported patient having pain, soreness at site of injection, headache, muscle aches, and fatigue and gotten worse so he took patient to emergency room. Both patient's Dr. and hospital doctors agreed and told patient that she had an adverse reaction to the second SHINGRIX vaccine shot. The first dose given 2 months prior she did not have this significant reaction just arm swelling and pain for few days. Patient was treated for adverse reaction in emergency room. Patient said she had chills, headache, every bones in her body hurts, hot/cold, shaking, sweating.  The following day on 2/14/19 she went to emergency room for few hours and was discharged.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Pt stated on 04/08/19 she began to have a massive headache that she has never had before, and on 04/09/2019, and large red rash developed in the area where the vaccine was administered. It is bright red, and hot to the touch. She stated she can feel the heat radiating through her arm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Asphyxia, Secretion discharge
Clinical narrative: The morning after the vaccines Patient suffocated on lots of mucus for no other apparent reason than having shots the previous day.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bone pain, Fatigue, Gait inability, Influenza like illness
Clinical narrative: I don?t know which flu shot I got but I was a young healthy fit person and felt like I had horrible case of flu, extreme malaise, bone joint muscle pain extreme exhaustion not being able to walk pain. Dr said I had a reaction to flu. I also am compound hetero mthfr gene mutation and never been the same
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Myalgia, Vaccination complication
Clinical narrative: I don?t know which flu shot I got but I was a young healthy fit person and felt like I had horrible case of flu, extreme malaise, bone joint muscle pain extreme exhaustion not being able to walk pain. Dr said I had a reaction to flu. I also am compound hetero mthfr gene mutation and never been the same
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mild/Moderate fever and vomiting
Age: 54.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: pain and soreness in arm, resulted in ER visit and pain meds prescribed
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Massive Headache, Fever up to 101 for 12 hours, Shivers/chills, Nausea, pain in left leg muscle, pain all over.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Massive Headache, Fever up to 101 for 12 hours, Shivers/chills, Nausea, pain in left leg muscle, pain all over.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Choking, Cough, Dyspnoea, Pain in extremity, Pyrexia
Clinical narrative: Pain in left arm. Difficulty breathing. Coughing and choking. Wheezing. Intermittent fevers. The pain in arm subsided after two days. The fevers are still occurring. Coughing is still occurring.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: Pain in left arm. Difficulty breathing. Coughing and choking. Wheezing. Intermittent fevers. The pain in arm subsided after two days. The fevers are still occurring. Coughing is still occurring.
Age: 1.67
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Nodule
Clinical narrative: Patient has developed a Rash on left thigh and knot on Right thighh 1 day post-vaccination patient was given KEFLEX 250mg and asked to come back to rechecked on also called mom few time to check up on patient but patient got better.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure, Headache, Photophobia, Photosensitivity reaction, Tremor
Clinical narrative: One month after 1st Administration 6/12/17-Pt developed tremors in hands that continued. Also developed a few headaches. One month after 2nd 6/27/18 pt had a gran mal seizure. Severe headaches, photosensitivity, sensitivity to flashing lights.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient developed Rash on left thigh. Patient was prescribed cephalexin at urgent care before coming to office.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received Boostrix vaccine and was waiting at the pharmacy afterwards. He reported feeling dizzy then fainted. Emergency services were contacted and arrived shortly. The patient felt fine after the event and refused services from emergency services.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Induration, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness and swelling remote from the injection site. Fever marked induration and fatigue. Facial redness.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Pain, redness and swelling remote from the injection site. Fever marked induration and fatigue. Facial redness.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt. complain about pain from shoulder to elbow started 2 days after injection and today is 7th day and pain is getting worse, injection site is swollen, red, hot to touch, and itchy. Spoke to patient she saw her primary care on 4/2/19 for swelling & redness MD gave her Prednisone. 4/10/19 No pain & redness & swelling cleared up. she is doing ok now.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (716060). This spontaneous report as received from a regulatory authority refers to a 12 year old male patient with fire ants allergy. Acetaminophen, FLONASE, ZYRTEC and SINGULAIR were reported as other medications. On 28-SEP-2017 the patient was vaccinated with GARDASIL 9 lot # N017832 dose 2, intramuscular in the right arm for prophylaxis. Other suspect therapies included meningococcal conj vaccine (unspecified), VARIVAX and ADACEL. On 29-SEP-2017, 2 days after onset of therapy the patient experienced cellulitis on the left arm in the location where vaccines were administered. There was no induration or fluctuance was observed. Erythema and warmth measuring 14 cm x 14 cm. Not any laboratory test was performed. The outcome of erythema, vaccination site cellulitis and skin warm was reported as not recovered/not resolved. The patient presented no other illness at time of vaccination. No information was provided regarding the patient's medical history or current illnesses. Follow-up information was received from the registered nurse on 10-APR-2019. The nurse stated that she would not be able to assist in providing the requested information without patient identifiers. The nurse agreed to continue research event and if the requested information becomes available, she will call back or fax. Additionally, nurse mentioned that another patient, teenage male, who was vaccinated with an unknown vaccination and developed cellulitis at injection site in 2019. She stated that she could recall any other details and was not able to recall the patient's name.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 720967), on 31-JAN-2018, referring to a 12 year old male patient with no concurrent illnesses and a medical history of asthma. On 09-OCT-2017, the patient was vaccinated with GARDASIL 9 (lot/batch number 70003014800, expiration date not provided), dose 2, intramuscularly, in the left arm for prophylaxis. There were no other concomitant medications. On 09-OCT-2017, the patient experienced a short syncopal episode - on table, as laying down, passed out but came to almost immediately. Later on the same date, the patient experienced vomiting, 100.8 oral fever (units not provided), headache, achy. On the next day, 10-OCT-2017, the patient experienced fatigue. The patient was out of school for 3 days (loss of personal independence in daily activities) and felt "out of it". The patient recovered from syncope and loss of consciousness, on 09-OCT-2017, and from loss of personal independence on 12-OCT-2017. The outcome of the events of pain, feeling abnormal, vomiting, fatigue, headache and pyrexia was reported as recovered, on an unspecified date. The agency considered this case as non-serious. The agency did not give the causality assessment between the events and the suspect vaccine. Lot number 70003014800 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow up information has been received from a physician via a line listing obtained on request by the Company from the FDA under the Freedom of Information Act on 25-FEB-2019 concerning the 13 year old (previously reported as 12 year old) not Hispanic white patient with asthma and no allergies. The patient was not taking any medication at the time of vaccination. Historical vaccination included influenza. The physician reported that on 09-OCT-2017 at 10:00, the patient was vaccinated with GARDASIL 9. The physician stated that the patient recovered from the adverse events and returned to school the following Thursday. Follow-up information was received from physician on 05-APR-2019: The reporter stated that they were unable to locate the patient without name or date of vaccination. Later the details were provided to a physician and he stated that they will attempt to locate patient information. The patient was a 14 years old male patient (also reported as 15 years old and previously reported as 13 years old). On 09-OCT-2017, other suspected vaccines included influenza vaccine (dose and frequency unknown) lot# U1829AC, dose number 9, intramuscularly given for prophylaxis. The event syncope occurred 21 minutes post vaccination and it was a brief episode for a duration of less than 1 minute. The onset date of events pain, vomiting, pyrexia and headache was reported as 10-OCT-2017 (previously reported as 09-OCT-2017). The patient received no prescription drug as treatment for the events. There were no temperature excursions and no digital data logger involved.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a patient who received 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX and had a very unpleasant reaction and reluctant to get the second, which was now available. The patient wanted to know whether what was the percentage of protection from shingles after just getting the initial injection. The patient was on insurance which does not cover the injection. The patient requested to send any coupon that would help with that cost, and asked whether he should decide to proceed.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: Chills, fever x2 days, Bodyaches, nausea redness/soreness around injection site.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever x2 days, Bodyaches, nausea redness/soreness around injection site.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: This case was reported by a consumer and described the occurrence of generalized pruritus in a patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 18th October 2018). On 8th March 2019, the patient received the 2nd dose of SHINGRIX. On 9th March 2019, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus, allergy, rash and pain. The patient was treated with Steroids and methylprednisolone. On an unknown date, the outcome of the generalized pruritus, allergy, rash and pain were unknown. It was unknown if the reporter considered the generalized pruritus, allergy, rash and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. After vaccination with 2nd dose of SHINGRIX, the patient experienced severe itching over entire body, rash and severe pain that causes the patient to seek medical aid. The patient directed by emergency room for steroid and methylprednisolone tablet. The patient was seek for the fair compensation and legal assistance from Glaxosmithkline.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Pain, Pruritus generalised, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of generalized pruritus in a patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 18th October 2018). On 8th March 2019, the patient received the 2nd dose of SHINGRIX. On 9th March 2019, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus, allergy, rash and pain. The patient was treated with Steroids and methylprednisolone. On an unknown date, the outcome of the generalized pruritus, allergy, rash and pain were unknown. It was unknown if the reporter considered the generalized pruritus, allergy, rash and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via pharmacy claims management company. After vaccination with 2nd dose of SHINGRIX, the patient experienced severe itching over entire body, rash and severe pain that causes the patient to seek medical aid. The patient directed by emergency room for steroid and methylprednisolone tablet. The patient was seek for the fair compensation and legal assistance from Glaxosmithkline.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Pain, Pain in extremity, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On 26th March 2019, the patient received SHINGRIX (intramuscular). On 28th March 2019, 2 days after receiving SHINGRIX, the patient experienced shingles, lower legs erythematous, pain and papular rash. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles and lower legs erythematous were not recovered/not resolved and the outcome of the pain and papular rash were unknown. It was unknown if the reporter considered the shingles, lower legs erythematous, pain and papular rash to be related to SHINGRIX. Additional details were reported as follows: The patient got SHINGRIX on Tuesday. On Thursday the patient developed a red area with raised spots that were very painful on her left ankle. The pain would wake her up during the night. The patient went to the emergency room on Sunday and it was diagnosed as shingles. The patient was started on valacyclovir. Consented to follow up. The emergency room visit required. The reported batch number 32Z64 for SHINGRIX did not exist and was updated to 32ZG4 as per the sales database.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Rash papular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On 26th March 2019, the patient received SHINGRIX (intramuscular). On 28th March 2019, 2 days after receiving SHINGRIX, the patient experienced shingles, lower legs erythematous, pain and papular rash. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles and lower legs erythematous were not recovered/not resolved and the outcome of the pain and papular rash were unknown. It was unknown if the reporter considered the shingles, lower legs erythematous, pain and papular rash to be related to SHINGRIX. Additional details were reported as follows: The patient got SHINGRIX on Tuesday. On Thursday the patient developed a red area with raised spots that were very painful on her left ankle. The pain would wake her up during the night. The patient went to the emergency room on Sunday and it was diagnosed as shingles. The patient was started on valacyclovir. Consented to follow up. The emergency room visit required. The reported batch number 32Z64 for SHINGRIX did not exist and was updated to 32ZG4 as per the sales database.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Anxiety, Asthenia, Body temperature increased, Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, muscle pain, chills, upset stomach and stomach pain. On 1st April 2019, the patient experienced tiredness. On 2nd April 2019, the patient experienced weakness, appetite absent and feeling bad. On an unknown date, the outcome of the erythema of extremities, swelling arm and muscle pain were recovering/resolving and the outcome of the chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm, muscle pain, chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, after receiving SHINGRIX the first three days were the worst with redness and swelling of the arm, muscle aches, chills, shivers, and upset stomach. After those three days, she has felt somewhat better but has continued to have stomach aches and chills which comes and goes. On 1st April 2019, after 7 days of vaccination the patient had a little tiredness and chills but otherwise felt well.  On 2nd April 2019, after 8 days of vaccination the patient felt weak, tired, lack of energy, no appetite, chills, and felt lousy. Did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased appetite, Diarrhoea, Influenza like illness, Injection site erythema, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, muscle pain, chills, upset stomach and stomach pain. On 1st April 2019, the patient experienced tiredness. On 2nd April 2019, the patient experienced weakness, appetite absent and feeling bad. On an unknown date, the outcome of the erythema of extremities, swelling arm and muscle pain were recovering/resolving and the outcome of the chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm, muscle pain, chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, after receiving SHINGRIX the first three days were the worst with redness and swelling of the arm, muscle aches, chills, shivers, and upset stomach. After those three days, she has felt somewhat better but has continued to have stomach aches and chills which comes and goes. On 1st April 2019, after 7 days of vaccination the patient had a little tiredness and chills but otherwise felt well.  On 2nd April 2019, after 8 days of vaccination the patient felt weak, tired, lack of energy, no appetite, chills, and felt lousy. Did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, muscle pain, chills, upset stomach and stomach pain. On 1st April 2019, the patient experienced tiredness. On 2nd April 2019, the patient experienced weakness, appetite absent and feeling bad. On an unknown date, the outcome of the erythema of extremities, swelling arm and muscle pain were recovering/resolving and the outcome of the chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm, muscle pain, chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, after receiving SHINGRIX the first three days were the worst with redness and swelling of the arm, muscle aches, chills, shivers, and upset stomach. After those three days, she has felt somewhat better but has continued to have stomach aches and chills which comes and goes. On 1st April 2019, after 7 days of vaccination the patient had a little tiredness and chills but otherwise felt well.  On 2nd April 2019, after 8 days of vaccination the patient felt weak, tired, lack of energy, no appetite, chills, and felt lousy. Did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Chills, Decreased appetite
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, muscle pain, chills, upset stomach and stomach pain. On 1st April 2019, the patient experienced tiredness. On 2nd April 2019, the patient experienced weakness, appetite absent and feeling bad. On an unknown date, the outcome of the erythema of extremities, swelling arm and muscle pain were recovering/resolving and the outcome of the chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm, muscle pain, chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, after receiving SHINGRIX the first three days were the worst with redness and swelling of the arm, muscle aches, chills, shivers, and upset stomach. After those three days, she has felt somewhat better but has continued to have stomach aches and chills which comes and goes. On 1st April 2019, after 7 days of vaccination the patient had a little tiredness and chills but otherwise felt well.  On 2nd April 2019, after 8 days of vaccination the patient felt weak, tired, lack of energy, no appetite, chills, and felt lousy. Did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Feeling abnormal, Myalgia, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, muscle pain, chills, upset stomach and stomach pain. On 1st April 2019, the patient experienced tiredness. On 2nd April 2019, the patient experienced weakness, appetite absent and feeling bad. On an unknown date, the outcome of the erythema of extremities, swelling arm and muscle pain were recovering/resolving and the outcome of the chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm, muscle pain, chills, upset stomach, stomach pain, tiredness, weakness, appetite absent and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, after receiving SHINGRIX the first three days were the worst with redness and swelling of the arm, muscle aches, chills, shivers, and upset stomach. After those three days, she has felt somewhat better but has continued to have stomach aches and chills which comes and goes. On 1st April 2019, after 7 days of vaccination the patient had a little tiredness and chills but otherwise felt well.  On 2nd April 2019, after 8 days of vaccination the patient felt weak, tired, lack of energy, no appetite, chills, and felt lousy. Did not consent to follow-up.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: redness and tenderness  posterior to the shot in the forarm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Malaise
Clinical narrative: Severe headache, hive like redness surrounding injection site, severe malaise, chills lasting approximately 24 hrs.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Severe chills.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: 3/22/19 c/o of continued left arm pain with certain movement since flu vaccine given in Nov.  Offered shoulder XR with PT or Ortho consult -pt declined.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PLASMA DONOR REPORTED BY PHONE TODAY(APRIL 11, 2019) . DONOR COMPLAINED PAIN/TENDERNESS AT THE INJECTION SITE (LEFT ARM)  A DAY AFTER THE INJECTION WAS GIVEN. NO FEVER NOTED . DONOR UNABLE TO RAISE HIS  ARM FREELY. ADVICED TO SEEK MEDICAL ATTENTION AS SOON AS POSSIBLE
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Unknown number of patients have received improperly stored doses of VARIVAX.; no adverse events; This spontaneous report as received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On unknown dates, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Strength, route, dose, frequency, and anatomical location were unknown) with lot # R017642 and expiration date 20-JUN-2020. The administered doses of the vaccine experienced the temperature excursion of 25.5 F  degrees Fahrenheit  for 1hour and 30 minutes. There was a digital data logger invloved, but there was no previous temperature excursion.  Follow-up information was received from the medical assistant on 09-APR-2019, regarding a male patient who is reported to be under 10 years of age. There were no reported adverse events following the administration of varicella virus vaccine live (oka/merck)(VARIVAX) (No adverse event).  This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect was reported.; Nurse reports that one dose of an improperly stored vaccine, VARIVAX (Lot #  R010466 / Expiration Date:  4/10/2020), was administered to one patient with the initials "AB" on 3/18/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information of concomitant medication, pertinent medical history and drug reactions/allergies was not provided. Concomitant therapy included sterile diluent.   On 18-MAR-2019, the patient was administered with one improperly stored dose only of varicella virus vaccine live (oka/merck)(VARIVAX) (route: subcutaneous(reported as SQ); lot # R010466 with expiration date 10-APR-2020; strength and dose detail were not provided) to the arm for prophylaxis (product storage error). The varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to temperature excursion of 10.6 fahrenheit degree for 9 hours and previous temperature excursion of 9.5 fahrenheit degree for 5 hours and 15 minutes and 10.8 fahrenheit degree for 7 hours. No adverse effect was reported. Data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient were vaccinated with improperly stored MMR II; Information has been received from a nurse referring to a 19 months old patient of unknown gender. Concomitant therapy included sterile diluent. The patient's drug reactions/allergies and pertinent medical history were not provided.  On 20-MAR-2019, the patient was vaccinated with improperly stored mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R028003, expiration date 01-OCT-2020 for prophylaxis (strength, dose, frequency and route were not provided). The sterile diluent used to reconstitute mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was stored properly. The outcome of the event was unknown. The storage temperatures of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was reported as -11.9 degrees Celcius for a time frame of 1 hour and 45 minutes. There was no previous temperature excursion. The call was due to a data logger. No adverse effects reported. No product quality compliance provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA004568: US-009507513-1904USA004569: US-009507513-1904USA004570: US-009507513-1904USA004571: US-009507513-1904USA004572:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No known adverse effects; A patient received a dose of M-M-R II via the intramuscular route in error.; Information has been received from a medical assistant referring to a patient of unknown and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 21-MAR-2019 the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# and expiration date unknown), intramuscularly, for prophylaxis (inappropriate route of vaccination). No adverse effects were reported.No product quality compliant (PQC) involved.
Sex: F
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects were reported; Interchange of vaccine products; Inappropriate schedule of product administration; This spontaneous report was received from a pharmacist concerning to a 70-year-old female patient. The patient's historical conditions, concurrent condition and concomitant medications were not provided.  In December 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis.  After this on 28-MAR-2018, the patient was inadvertently vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR), lot number W519243 and expiration date in March 2020 (strength, frequency, route of administration and anatomical location were not provided) for prophylaxis. No adverse effects were reported.