chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: The patient had checked about need of receiving second shingrx shot but patient was hesitant because of event experienced after 1st shot.; severe itching on arms and legs; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pruritus and incomplete course of vaccination. On an unknown date, the outcome of the pruritus was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but patient could be 64 or 63 years old at time of vaccination. The patient received 1st shot one and a half years ago from date of reporting and  had severe itching on arms and legs for 3 months. The patient had checked about need of receiving second shingrx shot but patient was hesitant because of event experienced after 1st shot. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm is sore; Running a fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional case details were reported as follows: The patient reported arm was sore and was running a fever after vaccination and asked was that normal. No coughing or shortness of breath. There was no nausea either The patient had not traveled either.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Chills; Arm is so unbelievably sore; Muscles ache; This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th March 2020, the patient received Shingles vaccine. In March 2020, less than a day after receiving Shingles vaccine, the patient experienced chills, pain in arm and muscle pain. On an unknown date, the outcome of the chills was unknown and the outcome of the pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chills, pain in arm and muscle pain to be related to Shingles vaccine.  Additional case details were reported as follows: The patient received shingles shot yesterday (the day of reporting) and all night was having the chills. The patient arm was so unbelievably sore and muscles ache.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: experienced an event which was not known at the time of this report; This case was reported by a physician via sales rep and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced an event which was not known at the time of this report.   The physician did note that this event was unlike he experienced using Shingrix previously. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: experienced "severe reactions; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 21st June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse reaction. The action taken with Shingrix was unknown. 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 reported as follows: The age at vaccination was not reported. Several patients received the first dose of Shingrix and did not receive the second dose after a two to six months period. Pharmacist mentioned that 4 patients received the first dose in the pharmacy where she works but she only provided the details of one patient.  She did not provide his initials.  After call was transferred, the pharmacist told second line agent the reason patients delayed taking the second dose was because they experienced severe reactions which she described as having problems getting out of bed for three days. She stated she had already provided the information to the first line agent. No further details or information provided, other than what was documented. This case is one out of 4 cases reported by the same reporter.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PPV, RV5
Symptoms: Rash macular
Clinical narrative: Diffuse macular rash located on forehead, torso, and extremities
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: tired; aching/soreness; shivering; flu-like symptoms; stomach cramps; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on unknown date).   On 28th February 2020, the patient received the 2nd dose of Shingrix. On 2nd March 2020, 3 days after receiving Shingrix, the patient experienced tiredness, pain, shivering, influenza-like symptoms and stomach cramps. On an unknown date, the outcome of the tiredness, pain, shivering, influenza-like symptoms and stomach cramps were unknown.   It was unknown if the reporter considered the tiredness, pain, shivering, influenza-like symptoms and stomach cramps to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. The patient's side effects were much more severe than he was led to believed they would be according to his pharmacist
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Pain
Clinical narrative: joint pain all over her body / beginning in the feet and working its way upwards towards the rest of the body; began to experience flu like symptoms; fatigue; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 30th September 2019, the patient received the 2nd dose of Shingrix. On 30th September 2019, 8 hrs after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue and general body pain. On 2nd October 2019, the patient experienced joint pain. On an unknown date, the outcome of the influenza-like symptoms, fatigue and general body pain were resolved with sequelae and the outcome of the joint pain was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, general body pain and joint pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. The patient experienced  flu like symptoms described as body aches and fatigue that resolved after a few days. The patient also experienced  joint pain all over her body, which was described as intermittent, beginning in the feet and working its way upwards towards the rest of the body. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pruritus, Swelling
Clinical narrative: urticaria all over body; itching on hands; chills; nausea; swelling; fatigue; This case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 4th March 2020, the patient received the 2nd dose of Shingrix. On 5th March 2020, 1 days after receiving Shingrix, the patient experienced generalized urticaria, itching both hands, chills, nausea, swelling and fatigue. On an unknown date, the outcome of the generalized urticaria, itching both hands, chills, nausea, swelling and fatigue were recovering/resolving.   It was unknown if the reporter considered the generalized urticaria, itching both hands, chills, nausea, swelling and fatigue to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient  experienced generalized urticaria, itching both hands, chills, nausea, swelling and fatigue.  The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: urticaria all over body; itching on hands; chills; nausea; swelling; fatigue; This case was reported by a nurse via call center representative and described the occurrence of generalized urticaria in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 4th March 2020, the patient received the 2nd dose of Shingrix. On 5th March 2020, 1 days after receiving Shingrix, the patient experienced generalized urticaria, itching both hands, chills, nausea, swelling and fatigue. On an unknown date, the outcome of the generalized urticaria, itching both hands, chills, nausea, swelling and fatigue were recovering/resolving.   It was unknown if the reporter considered the generalized urticaria, itching both hands, chills, nausea, swelling and fatigue to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient  experienced generalized urticaria, itching both hands, chills, nausea, swelling and fatigue.  The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Pain
Clinical narrative: experienced sporadic chest pain; on day 8 he developed Shingles; Pain in his  back; Pain in his left side; This case was reported by a nurse via call center representative and described the occurrence of chest pain in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2020, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced chest pain, shingles, back pain and pain. On an unknown date, the outcome of the chest pain, shingles, back pain and pain were unknown.   It was unknown if the reporter considered the chest pain, shingles, back pain and pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. On day 5 and 6 after vaccination he experienced sporadic chest pain, on day 8 he developed Shingles and he now has mild pain in his left side and back. Nurse did not provide lot number and expiration date but she provided the mailing address of where her husband received the dose. She mentioned that they went to the hospital and checked his kidneys and they were okay. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: 6 MONTH OLD WITH  LOCALIZED VACCINE REACTION VERSUS CELLULITIS GIVEN AT THAT SITE -LEFT THIGH.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Decreased appetite, Erythema, Headache
Clinical narrative: Initially, left arm warm, red, small white circle at injection site.  On March 18, 2020, noticed severe pain in lower head, neck and shoulders. Shivers, night sweats, awakened by neck pain, Temperature ranged anywhere from 100 to 102. While pain and other symptoms appear to be diminishing, they still exist to date (March 24, 2020).  Arm has slight discoloration in inoculation area but no longer is red.  Appetite is diminished.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Musculoskeletal pain, Neck pain, Night sweats, Skin warm
Clinical narrative: Initially, left arm warm, red, small white circle at injection site.  On March 18, 2020, noticed severe pain in lower head, neck and shoulders. Shivers, night sweats, awakened by neck pain, Temperature ranged anywhere from 100 to 102. While pain and other symptoms appear to be diminishing, they still exist to date (March 24, 2020).  Arm has slight discoloration in inoculation area but no longer is red.  Appetite is diminished.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Initially, left arm warm, red, small white circle at injection site.  On March 18, 2020, noticed severe pain in lower head, neck and shoulders. Shivers, night sweats, awakened by neck pain, Temperature ranged anywhere from 100 to 102. While pain and other symptoms appear to be diminishing, they still exist to date (March 24, 2020).  Arm has slight discoloration in inoculation area but no longer is red.  Appetite is diminished.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain and swollen to area
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; Received first dose in 2013 and the second dose on 3/20/2020; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  In 2013, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 20-MAR-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient described a rash that appeared one day after getting the vaccine. She experienced a rash and itching on the arm that she had the vaccine. The rash and itching did not spread to her full body, but it took several days to begin subsiding.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Rash
Clinical narrative: Rash developed 1 week after vaccination to  bilateral arms,  no redness at site, no, sob, no elevated temperature. As of today 03/24/2020 rash to bilateral legs and stomach and itching to site . No other complaints. Treatment at home consisted of alovera and other home remedies.  Advised for patient to contact a provider in town for treatment /evaluation of rash and itching. Again no other complaints was mentioned.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal disorder, Musculoskeletal pain
Clinical narrative: Shoulder is in pain,  cannot lift arm. I cannot use arm at all.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Patient received a Pneumovax 23 2/08/20. Pt called the pharmacy on 3/21/20 to report the adverse reaction. Pt stated he experienced swelling at the injection site along with numbness on the feet a little over 24hrs after administration. Pt stated we went to the hospital where he was treated with steroids and an unknown injected or IV medication. Pt stated intensity of numbness, reported as pins and needles, worsened 2-3 weeks prior to 3/21/20.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Autism spectrum disorder, Condition aggravated, Crying, Dairy intolerance, Diet refusal
Clinical narrative: Fever of 104.5, inconsolable crying for hours, high pitched screams, irritability, red lump at vaccination site, red rash on his abdomen, and refusing to eat.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eczema, Encephalopathy, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Fever of 104.5, inconsolable crying for hours, high pitched screams, irritability, red lump at vaccination site, red rash on his abdomen, and refusing to eat.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Rash, Rash erythematous, Screaming, Vaccination site mass
Clinical narrative: Fever of 104.5, inconsolable crying for hours, high pitched screams, irritability, red lump at vaccination site, red rash on his abdomen, and refusing to eat.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Initially, patient reported soreness at the injection site.  On 03/13/2020 at ~0900, the patient fainted at home while walking out of the bathroom. Patient reported feeling  "strange" for the rest of the day. Patient also reported a low-grade fever reported at this time. The patient reported that the injection site was raised and red.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Initially, patient reported soreness at the injection site.  On 03/13/2020 at ~0900, the patient fainted at home while walking out of the bathroom. Patient reported feeling  "strange" for the rest of the day. Patient also reported a low-grade fever reported at this time. The patient reported that the injection site was raised and red.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Rash, Vomiting
Clinical narrative: Pt started vomiting the within 18hrs and developed flat rash not itchy 24 hrs after vaccine. Rash went away within 48hrs after vaccine administration.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Product administered at inappropriate site, Tendon rupture, X-ray
Clinical narrative: Patient states that the vaccine was given higher than normally, in the shoulder area. It was very painful and the needle was not in all the way so she asked the Pharmacist to take the needle out and redo.  So the  pharmacist went a little lower in the arm and gave the shot. It was still very painful. Patient went to the doctor next day and the arm was examined by Dr. Dr suspects a tendon rupture from vaccine and ordered X rays. Still waiting to get x ray reports back. Patient was started on Prednisone and anti-inflammatory drugs.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives all over body
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Burning sensation, Injection site pain, Joint range of motion decreased, Middle insomnia, Musculoskeletal pain
Clinical narrative: PATIENT ON: (A) 11/20/2019 time 9:12am while standing up received in his right shoulder & arm the influenza vaccine flu shot that NURSE injected, and approx. 2-hours later (11:30am) his shoulder & arm hurts like it never hurt before, like its in boiling water & tingles, his right shoulder hurts when he lift his arm up, it was so bad that he seen colors too; (B) 11/21/2019 was seen by STAFF & given (1) Plastic Bag for Ice; (2) IBUPROFEN (#24 200mg Tablets); and (3) APAP NON-ASPIRIN (#24 324mg Tablets); (C) 12/2/2019 was given (1) IBUPROFEN (#60 400mg Tablets); and (2) MUSCLE RUB; (D) 12/11/2019 was given a lower bunk restriction until 6/8/2020; (E) 12/12/2020 started Physical Therapy with Dr.; (F) 12/26/2019 Dr. issued patient a TENS (ProM-300) & PROM-013 Machine; (G) 02/20/2020 told staff that this chronic pain in his right shoulder & arm wakes him up in the middle of his sleep each night since 11/20/2019, and he also told Dr. many times; (H) 02/23/2020 asked APNP & Nurse: The LENGTH OF THE NEEDLE that Nurse used 11/20/2019 to inject his right deltoid with the influenza vaccine flu shot while he was standing up. And as of to date NO ANSWER TO THIS QUESTION; (I) 03/7/2020 asked staff: Is his right shoulder & arm chronic pain with the decreased range of motion caused by the injection 11/20/2019 of the influenza vaccine flu shot into the shoulder capsule rather that the muscle? Staff replied: Please discuss at your upcoming appointment with Physical Therapy; (J) 03/12/2020 asked Dr. was he aware of the SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) report, and Dr. said no he was not aware of the SIRVA report nor never heard of SIRVA, then Dr. looked SIRVA up on his computer & read same info regarding SIRVA. Dr. said he will do some more research into SIRVA. Dr. mention maybe increasing patient's milligrams of IBUPROFEN; (K) 03/16/2020 NURSE (female) increase patient IBUPROFEN to 600mg (milligrams) Tablets after he told Nurse that on 03/15/2020 time 2:00am the chronic pain in his right shoulder & arm was really bad & made him jump up to his feet in the middle of his sleep rubbing his shoulder. THE END FOR NOW. COPIES FILED.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity, Paraesthesia, Peripheral nerve neurostimulation, Shoulder injury related to vaccine administration
Clinical narrative: PATIENT ON: (A) 11/20/2019 time 9:12am while standing up received in his right shoulder & arm the influenza vaccine flu shot that NURSE injected, and approx. 2-hours later (11:30am) his shoulder & arm hurts like it never hurt before, like its in boiling water & tingles, his right shoulder hurts when he lift his arm up, it was so bad that he seen colors too; (B) 11/21/2019 was seen by STAFF & given (1) Plastic Bag for Ice; (2) IBUPROFEN (#24 200mg Tablets); and (3) APAP NON-ASPIRIN (#24 324mg Tablets); (C) 12/2/2019 was given (1) IBUPROFEN (#60 400mg Tablets); and (2) MUSCLE RUB; (D) 12/11/2019 was given a lower bunk restriction until 6/8/2020; (E) 12/12/2020 started Physical Therapy with Dr.; (F) 12/26/2019 Dr. issued patient a TENS (ProM-300) & PROM-013 Machine; (G) 02/20/2020 told staff that this chronic pain in his right shoulder & arm wakes him up in the middle of his sleep each night since 11/20/2019, and he also told Dr. many times; (H) 02/23/2020 asked APNP & Nurse: The LENGTH OF THE NEEDLE that Nurse used 11/20/2019 to inject his right deltoid with the influenza vaccine flu shot while he was standing up. And as of to date NO ANSWER TO THIS QUESTION; (I) 03/7/2020 asked staff: Is his right shoulder & arm chronic pain with the decreased range of motion caused by the injection 11/20/2019 of the influenza vaccine flu shot into the shoulder capsule rather that the muscle? Staff replied: Please discuss at your upcoming appointment with Physical Therapy; (J) 03/12/2020 asked Dr. was he aware of the SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) report, and Dr. said no he was not aware of the SIRVA report nor never heard of SIRVA, then Dr. looked SIRVA up on his computer & read same info regarding SIRVA. Dr. said he will do some more research into SIRVA. Dr. mention maybe increasing patient's milligrams of IBUPROFEN; (K) 03/16/2020 NURSE (female) increase patient IBUPROFEN to 600mg (milligrams) Tablets after he told Nurse that on 03/15/2020 time 2:00am the chronic pain in his right shoulder & arm was really bad & made him jump up to his feet in the middle of his sleep rubbing his shoulder. THE END FOR NOW. COPIES FILED.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Pain in extremity
Clinical narrative: Mother of the patient refers that after vaccines were administered, she started complaining of pain in the left arm but the mother didn't think much of it and thought the patient was exaggerating and it was normal because of the vaccine. Then after a few days the area was red and the mother thought it would go away in a few days, seeing that it had lasted a week, and it was red and hot, then the mother decided to call our vaccine clinic on 3/5/20. Around 3pm we asked if she had called the patient's primary care doctor and the mother said no. She was advised to take the patient to be evaluated by her pediatrician. The pediatrician's office was closed that day so the office manager gave the option for them to go in early in the morning the next day, to which the mother replied it would be the patient's first day of school but that she would still take the patient to the Peds. Mother was advised the situation got worse to take to the ER the same day. Next day, Friday 3/6/20, we received at the vaccination clinic, from the pediatricians office to get the recent vaccination records since the patient was having a localized allergic reaction per physical exam.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Inflammation, Injection site mass, Injection site pain, Joint range of motion decreased
Clinical narrative: On 10/10/2019 I was administered a influenza vaccine into my Left deltoid at approximately 2:40pm. The vaccine was Given with my shirt collar pulled down off my shoulder and was very high up on my arm. It hurt when I got it. A bandaid was placed and I left. Upon trying to close my car door my arm was very painful. I went home and removed the bandaid to find the bloody spot from the injection was about and inch to and inch and a half higher than the bandaid. Later I tried to go to the gym and found I couldn't lift weights. A thick band of tissue running from my shoulder down vertically through my deltoid was in a big lump and making noises when I moved my arm. My shoulder only wanted to move in certain directions. I went home and took Aleve assuming the pain would subside. Every week afterwards it was getting worse and I lost range of motion which was painful to move in certain directions and do simple tasks. On 11/27/19 I returned to Health Care to be evaluated for shoulder pain due to a flu shot. The doctor stated she doubted it was from my flu shot and that it wouldn't hurt me six weeks plus later. She sent me for X-rays and I was referred to an orthopedist. I was evaluated given a cortisone injection, told I got tendonitis/bursitis, and also told if the injection and physical therapy didn't fix it I would likely need surgery to clean it out. I have seen Physical therapy for six weeks as of now and still have limited range of motion mobility with my Left arm, pain, nausea, and my arm feels like its going to pop out of the socket. I have been given two Ionto pain patches at PT and have been Kinesiology taped. I have two more visits and then to be re-evaluated at PT to make 8 weeks I have requested a referral to the orthopedist/shoulder specialist. I am a dental hygienist and this has affected my ability to work more days than I am currently working due to pain and limited motion. I also had an MRI done on 12/31/2019 which showed inflammation and fluid in the muscle, as well as a possible labral tear. I am currently still in treatment with no resolution. I Have inquired if ligaments or tendons were hit during the injection only to not be given a straight answer. I still can not go to the gym and use my upper body due to this issue.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Magnetic resonance imaging, Musculoskeletal pain, Pain in extremity, Tendonitis, X-ray
Clinical narrative: On 10/10/2019 I was administered a influenza vaccine into my Left deltoid at approximately 2:40pm. The vaccine was Given with my shirt collar pulled down off my shoulder and was very high up on my arm. It hurt when I got it. A bandaid was placed and I left. Upon trying to close my car door my arm was very painful. I went home and removed the bandaid to find the bloody spot from the injection was about and inch to and inch and a half higher than the bandaid. Later I tried to go to the gym and found I couldn't lift weights. A thick band of tissue running from my shoulder down vertically through my deltoid was in a big lump and making noises when I moved my arm. My shoulder only wanted to move in certain directions. I went home and took Aleve assuming the pain would subside. Every week afterwards it was getting worse and I lost range of motion which was painful to move in certain directions and do simple tasks. On 11/27/19 I returned to Health Care to be evaluated for shoulder pain due to a flu shot. The doctor stated she doubted it was from my flu shot and that it wouldn't hurt me six weeks plus later. She sent me for X-rays and I was referred to an orthopedist. I was evaluated given a cortisone injection, told I got tendonitis/bursitis, and also told if the injection and physical therapy didn't fix it I would likely need surgery to clean it out. I have seen Physical therapy for six weeks as of now and still have limited range of motion mobility with my Left arm, pain, nausea, and my arm feels like its going to pop out of the socket. I have been given two Ionto pain patches at PT and have been Kinesiology taped. I have two more visits and then to be re-evaluated at PT to make 8 weeks I have requested a referral to the orthopedist/shoulder specialist. I am a dental hygienist and this has affected my ability to work more days than I am currently working due to pain and limited motion. I also had an MRI done on 12/31/2019 which showed inflammation and fluid in the muscle, as well as a possible labral tear. I am currently still in treatment with no resolution. I Have inquired if ligaments or tendons were hit during the injection only to not be given a straight answer. I still can not go to the gym and use my upper body due to this issue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fall, Hyperhidrosis, Loss of consciousness
Clinical narrative: Woke up went into bathroom - began to sweat & chills fell to floor - also was dizzy - pasted out. Don't know how long I was out -- came to got a cold compress for my head & went to bed.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 71-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in January 2014, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), on 13-FEB-2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: Redness that spread to the inside of her arm/Erythema at the injection site; Area was warm to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2022) for an unknown indication.   On 19th February 2020, the patient received Shingrix (intramuscular). On 19th February 2020, less than a day after receiving Shingrix, the patient experienced erythema of extremities and injection site warmth. On an unknown date, the outcome of the erythema of extremities and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and injection site warmth to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported a patient received Shingrix and later that day developed erythema at the injection site and redness that spread to the inside of her arm that was about the size of a baseball.   Also stated the area was warm to the touch.  Patient reported the redness got better and then seemed to spread again.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Redness that spread to the inside of her arm/Erythema at the injection site; Area was warm to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number TJ35Z, expiry date 1st December 2022) for an unknown indication.   On 19th February 2020, the patient received Shingrix (intramuscular). On 19th February 2020, less than a day after receiving Shingrix, the patient experienced erythema of extremities and injection site warmth. On an unknown date, the outcome of the erythema of extremities and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities and injection site warmth to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported a patient received Shingrix and later that day developed erythema at the injection site and redness that spread to the inside of her arm that was about the size of a baseball.   Also stated the area was warm to the touch.  Patient reported the redness got better and then seemed to spread again.
Age: 64.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Discomfort, Insomnia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Frozen shoulder. Unable to raise or rotate left arm. Constant low-grade pain and severe pain when trying to raise or rotate arm. Intensity of pain increases dramatically in a reclining position. Unable to sleep. Acetaminophen provides no relief. Heat provides minimal relief. Currently out of country  and it is not possible to receive any medical services except due to life-threatening events as a result of the Coronavirus situation.
Age: 64.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injected limb mobility decreased, Insomnia, Pain, Periarthritis
Clinical narrative: Frozen shoulder. Unable to raise or rotate left arm. Constant low-grade pain and severe pain when trying to raise or rotate arm. Intensity of pain increases dramatically in a reclining position. Unable to sleep. Acetaminophen provides no relief. Heat provides minimal relief. Currently out of country  and it is not possible to receive any medical services except due to life-threatening events as a result of the Coronavirus situation.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; the patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse concerning to patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 03-MAR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (unspecified), orally, (frequency not provided; lot # 1660942, expiration date 06-FEB-2021), for prophylaxis. There was a data logger issue involved. There were multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 minutes (reported as hours). No previous temperature excursion were reported. No additional adverse effects were reported.  This was one of several reports received from the same source.; Sender's Comments:  US-009507513-2003USA005842: US-009507513-2003USA005917: US-009507513-2003USA005962:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored Varivax; no additional adverse event reported; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 12-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live)Oka/Merck)(VARIVAX) (dose, frequency and route were not provided; Lot number reported as S025608 has been verified to be valid; expiration date reported and validated as 18-AUG-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).    The vaccine underwent a temperature excursion of - 8.6 degree Celsius (° C) for a period of 24 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The office manager reported that the patient did not experience any adverse event.   This is one of several reports received from the same source; Sender's Comments:  US-009507513-2003USA005878:
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional effects noted; Patient may have accidentally received an MMRII vaccine intramuscularly as opposed to subcutaneously; the pharmacist however gave the MMRII vaccine to the patient in the deltoid and utilizing a technique for intramuscular administration; This spontaneous report was received from a pharmacist referring to a 43-year-old female patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 13-MAR-2020, the patient was accidentally vaccinated intramuscularly as opposed to subcutaneously (incorrect route of product administration) with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) in the deltoid left arm for prophylaxis (strength was not provided, lot # S005251 had been verified to be a valid number; expiration date reported as February 20201, and upon internal validation established as 20-FEB-2021). Also it was reported the pharmacist utilized a technique intended for intramuscular administration (Wrong technique in product usage process). No additional effects noted.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he was administered both PNEUMOVAX 23 and PREVNAR 13; This spontaneous report was received from a pharmacist concerning a family member, who was a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 19-MAR-2020 the patient was vaccinated for prophylaxis with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (dose, route, lot# and expiration date were not provided for any suspect therapy).
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Insomnia, Pain in extremity, Streptococcus test
Clinical narrative: PNEUMOV AX 23 vaccine "every 5 years".; painful redness down the arm and into the chest; painful redness down the arm and into the chest; painful redness down the arm and into the chest; cant go to bed or sleep; This spontaneous report was received from a consumer refers to a 21-year-old female patient. The patient's concurrent conditions include allergy to animal, dust and mold. The patient's medical history included splenectomy in approximately June 1984 and deep vein thrombosis.   Concomitant therapies included fexofenadine hydrochloride, pseudoephedrine hydrochloride(ALLEGRA-D) and triamcinolone acetonide(NASACORT).    On 1984, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose 1 in the left arm for protection as she had no spleen, lot 3 and exp dat were not provided, the patient was vaccinated every 5 years.   The patient reported that "after a few hours, after getting the vaccine, she got pain down her arm to her elbow and also into her chest. The patient reported the "pain was so bad she could not go to bed and sleep." The patient reported this happened the first time she got the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in 1984 and every subsequent administration of the vaccine. The patient reported an unspecified physician gave the patient unspecified medication that alleviates the pain on unspecified dates. The patient reported that she recovered from the redness and pain on unspecified dates after each administration of the vaccine on unspecified dates. The patient was not hospitalized due to the events.  On an unspecified date the patient had a Streptococcus pneumoniae test was result was not provided. The relatedness of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the reporting events was not provided.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Vaccine positive rechallenge
Clinical narrative: today I am having dizzy spells; I have chills all night; This case was reported by a consumer and described the occurrence of chills in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (for tolerance to the 1st dose, refer case US2020AMR045702).   On 11th March 2020, the patient received the 2nd dose of Shingrix. On 12th March 2020, 1 days after receiving Shingrix, the patient experienced dizzy spells. In March 2020, the patient experienced chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills was unknown and the outcome of the dizzy spells was not recovered/not resolved.   It was unknown if the reporter considered the chills and dizzy spells to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix late morning and was fine all day and had chills all night. On the day of reporting, the patient had dizzy spells and wanted to know was this normal.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: I have chills all night, which I was expecting based on my reaction to the 1st shot; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had chills all night, with reaction to the 1st shot. This case is linked to the case US2020AMR045696, reported for the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Malaise, Pyrexia, Rash, Rash erythematous
Clinical narrative: rash was red, hot to the touch, elevated, and blotchy; rash was red, hot to the touch, elevated, and blotchy; Red rash on the right side of her face; severe arm discomfort at the injection site; Fever; Malaise; This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a adult female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date unknown) for prophylaxis.   On 5th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th February 2020, less than a day after receiving Shingrix, the patient experienced injection site discomfort. On 10th February 2020, the patient experienced skin warm, localized maculopapular rash and red rash. In February 2020, the patient experienced fever and malaise. On 15th February 2020, the outcome of the localized maculopapular rash and red rash were recovered/resolved. On an unknown date, the outcome of the injection site discomfort, fever, malaise and skin warm were recovered/resolved.   It was unknown if the reporter considered the injection site discomfort, fever, malaise, skin warm, localized maculopapular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 64 or 65 years old. The patient received Shingrix vaccine in the right deltoid at approximately 12:00 noon. The patient experienced severe arm discomfort at the injection site within four hours of receiving the vaccine. She could not sleep on her right arm due to the discomfort. She experienced fever and general malaise that lasted for 48 hours. On Monday, 10th February 2020, she woke up with a red rash on the right side of her face. The rash was red, hot to the touch, elevated, and blotchy. She said it looked like hives. Tuesday and Wednesday the rash was on both sides of her face and was evident for 2-3 hours in the morning and then gone for the rest of the day. She went to her physician on Thursday, 13th February 2020, but the physician did not know what was causing the rash, she swabbed the area and would be going to run tests. On Saturday, 15th February 2020, she woke up and the rash was gone. No further information was provided.