chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient. On an unknown date in 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-DEC-2011, a healthcare provider at a health system administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 23-JAN-2017, the patient was treated by a physician at a health system for shingles and postherpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Herpes zoster, Neuropathy peripheral
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In February 2015, the patient was treated by a physician for Guillain-Barre syndrome and peripheral neuropathy. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Arthritis, Gait disturbance, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: Initial information received on 02-Jan-2019 regarding an unsolicited valid serious case received from a nurse. This case is linked to case 2019SA005285 (same patient) This case involves a 59 years old female patient who experienced arthritis such as pain in her joints in her arms and hips (Rheumatoid Arthritis) and barely walk, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Tobacco user. It was unclear which Flu Shot she received last year. The patient complained of Left Shoulder pain and she stated it was placed in her bursa of her left arm last Flu Season. She did obtain an MRI. Her HCP stated that she is getting old and experiencing chronic changes. Her HCP stated it wasn't a side effect of the Flu shot. The patient's past medical treatment(s) and family history were not provided. On 18-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6302AA, Expiration Date: 30-Jun-2019 via intramuscular route in the arm nos. On an unknown date, the patient developed a serious arthritis such as pain in her joints in her arms and hips (rheumatoid arthritis) 2 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. On an unknown date, the patient developed a serious arthritis such as pain in her joints in her arms and hips (arthralgia) 2 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient developed a serious barely walk (gait disturbance) 2 weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. (Other relevant tests included she had a Rhematoid Arthritis panel in the middle of Nov2018 and she definitely has Rheumatoid Arthritis.) Final diagnosis was barely walk and arthritis such as pain in her joints in her arms and hips. The patient is receiving Water Therapy to move better. The outcome of the event was reported as Unknown. Documents held by sender: none. Sender's Comments: This case concerns a 59 years old female patient who presented with Rheumatoid Arthritis such as pain in her joints in her arms and hips and gait disturbance 2 weeks after vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible with the role of the vaccine. Patient's past medical history included Tobacco user, Musculoskeletal pain (Left Shoulder pain) and Bursa disorder with bursa of her left arm. She did obtain an MRI. Moreover, HCP stated that she is experiencing chronic changes due to old age and did not consider events as side effect of the Flu shot. Additional information regarding patient's condition at the time of vaccination, lab//radiological test excluding other degenerative factors are needed for complete assessment of the case. Based upon the reported information, no conclusion can be drawn regarding the role of the vaccination.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Back pain, Burning sensation, Chest pain, Influenza like illness
Clinical narrative: Feeling like I had a mild flu: Fever, Body Aches and then started having burning sensation and pain in the armpit area that radiated under and above the breast and into the back.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Feeling like I had a mild flu: Fever, Body Aches and then started having burning sensation and pain in the armpit area that radiated under and above the breast and into the back.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Throat irritation, Urticaria
Clinical narrative: Patient came to clinic one hour after receiving HPV vaccine, stating throat felt itchy with hives on face and arms. Patient was given SOLU-MEDROL 125mg im, BENADRYL 50mg IM, and 150mg ZANTAC oral. Patient watched for1 hour with full recovery of symptoms. Orders at discharge: continue ZANTAC PO 150mg twice a day 7 days, start ZYRTEC PO 10mg daily for 7 days, prednisone po 40mg once a day for 5 days.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Mass
Clinical narrative: Hard lump, no redness, no fever, no temp, no pain. Instructed to apply warm compress to area.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Myalgia, Skin warm
Clinical narrative: Patient received 2 vaccines in Left arm. MENACTRA/BEXSERO at 16 yr visit. Pt. came in a week later complaining of muscle pain and unable to lift her arm that vaccines were given in. Per physician: Tender to palpation just inferior to tip of shoulder and over deltoid muscle. Slightly warm, not red or swollen. Can actively abduct past 90 degrees then starts to use neck muscles.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to LAT.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chills, Dizziness, Erythema
Clinical narrative: After the shot my arm was very sore, swollen, very red and painful. Used ice and took ADVIL. Lasted 4 days. That same night, I was dizzy, hot and cold was sweaty and had chills. Upset stomach (for over a month). Severe joint pain - stayed in bed for two days. Had headaches for over a month, around my eyes and temples. They lasted for over a month and then decreased. I went to my Dr. for advice as to whether I should get the second shot. I have not decided. I get a flu shot every year - no problem. I got the first shingles shot when I was 60 yrs old no problem. I had two pneumonia shots - no problem.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Headache, Hyperhidrosis, Pain in extremity, Peripheral swelling
Clinical narrative: After the shot my arm was very sore, swollen, very red and painful. Used ice and took ADVIL. Lasted 4 days. That same night, I was dizzy, hot and cold was sweaty and had chills. Upset stomach (for over a month). Severe joint pain - stayed in bed for two days. Had headaches for over a month, around my eyes and temples. They lasted for over a month and then decreased. I went to my Dr. for advice as to whether I should get the second shot. I have not decided. I get a flu shot every year - no problem. I got the first shingles shot when I was 60 yrs old no problem. I had two pneumonia shots - no problem.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Skin fissures, Skin warm
Clinical narrative: Hot spots-rashes-hives-redness of skin when touched - cracked fingertips - extreme itching. There occur at different times, and not all at once. Was told to use BENADRYL. I need to know how long this will last. And what to do about 2nd shot. Who to contact. This is important, as it affects my life.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hot spots-rashes-hives-redness of skin when touched - cracked fingertips - extreme itching. There occur at different times, and not all at once. Was told to use BENADRYL. I need to know how long this will last. And what to do about 2nd shot. Who to contact. This is important, as it affects my life.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on the left side of my body. From my mouth all the way down my left side to my foot.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Dysphagia, Herpes simplex
Clinical narrative: Pt. got SHINGRIX on 12/27/18 and on 1/2/19 pt. developed difficulty swallowing and was diagnosed with Herpes Simplex.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Inflammation, Musculoskeletal pain, Pain
Clinical narrative: Severe inflammation and pain in the shoulder, resulting in difficulty moving the arm without a lot of pain.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Low grade fever for 8 hours the following day.
Age: 3.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At the injection site, a 7x10 cm area of erythema with minimal swelling. No systemic symptoms.  Treated with oral steroids. Parent to re-check with us if not improving.
Age: 3.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: At the injection site, a 7x10 cm area of erythema with minimal swelling. No systemic symptoms.  Treated with oral steroids. Parent to re-check with us if not improving.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Local reaction
Clinical narrative: Local reaction, no secondary infection. Provider ibuprofen for inflammation and warm compresses to affected area.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient has developed chickenpox 23 days after receiving Varicella vaccine.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: At site of HIBERIX after shot, see a small needle size black dot. No treatment. No sign of infection.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-MAY-2011, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 23-MAR-2015, the patient was treated by a healthcare provider for herpes zoster ophthalmicus. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Upon internal review herpes zoster ophthalmicus was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-MAY-2011, a physician administered the ZOSTAVAX to the patient. On or about 21-OCT-2011, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the his injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. In March 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Balance disorder, Dizziness, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 10-APR-2010, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (dose, route, and lot # not provided).  Shortly thereafter, the patient began to experience muscle weakness, hip pain, dizziness, equilibrium issues, and an unsteady gait. In or around June 2012, the patient presented to his physician for the issues and he was diagnosed with Guillain-Barre syndrome. As a direct and proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using the product. He also experiences mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. The patient sustained serious personal injuries and related losses including, but not limited to, the following: Patient required and will continue to require healthcare and services; patient incurred and will continue to incur medical and related expenses; and patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of Guillain-Barre syndrome was not resolved. Causality assessment was related. The lawyer considered Guillain-Barre syndrome to be disabling. Upon internal review, Guillain-Barre syndrome was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 10-APR-2010, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (dose, route, and lot # not provided).  Shortly thereafter, the patient began to experience muscle weakness, hip pain, dizziness, equilibrium issues, and an unsteady gait. In or around June 2012, the patient presented to his physician for the issues and he was diagnosed with Guillain-Barre syndrome. As a direct and proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using the product. He also experiences mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. The patient sustained serious personal injuries and related losses including, but not limited to, the following: Patient required and will continue to require healthcare and services; patient incurred and will continue to incur medical and related expenses; and patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of Guillain-Barre syndrome was not resolved. Causality assessment was related. The lawyer considered Guillain-Barre syndrome to be disabling. Upon internal review, Guillain-Barre syndrome was considered to be medically significant. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: High fever, chills, headache, dizziness, sore arm.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Onset of itching at the sig right after getting the injection, then swelled and is itching and burning. No SOB or throat swelling. Hx flu shots with ever a reaction. No hx other allergic reaction, no egg allergies.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: The monthly temperature logs were not done for the Month of October for both the manual temp logs and digital logs. Due to no temperature log not being done all vaccines are considered and deemed unviable.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Due to the temperature for the month of October 2018 not being done on the data logger and manual temp logs the vaccines will be deemed unviable.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Joint range of motion decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT HAD SEVERE PAIN AND NO RANGE OF MOTION FROM 1ST DOSE OF SHINGRIX GIVEN 9/07/2018, ADDED ABOVE DETAILS. SHE HAD TO GET A CORTICOSTEROID SHOT FROM HER DR'S OFFICE. SHE FORGET TO MENTION THIS YESTERDAY WHEN SHE CAME IN FOR HER 2ND SHOT, 1/8/19. SHE SAID YESTERDAY HER ARM STARED TO GET PAINFUL AND PUFFY. THE PAIN IS ALL DOWN HER ARM AND IN HER ARMPIT. SHE HAS BEEN PUTTING ICE ON IT AND WILL TAKE SOME IBUPROFEN. SHE HAS MORE RANGE OF MOVEMENT THAN LAST TIME, BUT IT IS VERY PAINFUL.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient states that approx 2 days after receiving vaccine, her inner arm had redness, swelling, and warmth to the touch. She said that she felt weak. The weakness lasted for 2 days. She said the issue was completely resolved after approx 5 days. She did not have a reaction to the first dose she received.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: There are no symptoms to report, however the temperature not working or the data logger were not working for the Month of October 2018 due to the temperatures not being logged for the month all vials of immunizations were deemed unviable.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Mom did not report the adverse event to our clinic until the next week when she was here for another reason. She reported that the morning of the day after the child had her flu vaccine, she developed hives. Mom did not give any medication but gave her a bath, and the hives disappeared and did not return. There were no other symptoms, no fever and no difficulty breathing.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain at site of injection, muscle pain through whole body, tiredness, shivering.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient parent called child right leg was red and swollen painful to walk, patient was seen the next day by the PA, and was given mupirocin 2% cream.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Pain, Pain in extremity
Clinical narrative: Patient had first SHINGRIX shot (9/14/2018) in left arm and experienced soreness for 3-4 days. In this case, patient received the 2nd SHINGRIX vaccine (12/05/2018) in the right arm and patient first contacts pharmacy on 12/21/2018 complaining of redness, limited use of arm, soreness mainly between shoulder and elbow but also under the arm. She states the pain occurs at different places at different times, and patient states on 01/08/2018 that symptoms still remain except the redness which has since resolved.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9, TDAP, FLU4, HPV9, TDAP
Symptoms: Blood glucose normal, Computerised tomogram head normal, Generalised tonic-clonic seizure
Clinical narrative: Patient had a tonic clonic seizure during the night after receiving his immunizations. It self resolved. He has no history of seizure. He went via EMS to the ER where he had a normal work up.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9, TDAP, FLU4, HPV9, TDAP
Symptoms: Blood glucose normal, Computerised tomogram head normal, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging brain normal, Seizure
Clinical narrative: Patient had a tonic clonic seizure during the night after receiving his immunizations. It self resolved. He has no history of seizure. He went via EMS to the ER where he had a normal work up.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Patient did not have any reactions to the vaccine due to the inaccurate use of the temperature the vaccine was deemed unviable in the month of October 2018 because not temperature logs were found.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, Tendon pain
Clinical narrative: Left rotator cuff injury and pain, starting after the shot was administered and continues to date (now two months after the shot).
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Tenderness
Clinical narrative: Headache, achy feeling like the flu, tender on bottoms of feet, sore arm at injection site.
Age: 19.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rashes and hives on neck and chest. No breathing issues. BENADRYL given for itching and hives.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Blood lactic acid, Body temperature increased, Chills, Electrocardiogram abnormal, Fatigue
Clinical narrative: Within 1 hour of vaccine, arm became red and a hard knot formed at injection site and a headache. By 2100 that evening I had a temp of 100.2F, slight muscle aching, chills and a headache. Sunday 1/6/2019 right shoulder and neck pain, injection site was hot to touch, redness and hard knot was larger. Muscle aches, fatigue remained. Temp was still around 100.2F. Monday, 1/7/2019 Muscle aches, fatigue were worse. Temp was 99.9, Tuesday, 1/8/2019 shoulder pain, neck pain and jaw pain began around 0500am. I went to the ER.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Full blood count, Headache, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Within 1 hour of vaccine, arm became red and a hard knot formed at injection site and a headache. By 2100 that evening I had a temp of 100.2F, slight muscle aching, chills and a headache. Sunday 1/6/2019 right shoulder and neck pain, injection site was hot to touch, redness and hard knot was larger. Muscle aches, fatigue remained. Temp was still around 100.2F. Monday, 1/7/2019 Muscle aches, fatigue were worse. Temp was 99.9, Tuesday, 1/8/2019 shoulder pain, neck pain and jaw pain began around 0500am. I went to the ER.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth, Metabolic function test, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Within 1 hour of vaccine, arm became red and a hard knot formed at injection site and a headache. By 2100 that evening I had a temp of 100.2F, slight muscle aching, chills and a headache. Sunday 1/6/2019 right shoulder and neck pain, injection site was hot to touch, redness and hard knot was larger. Muscle aches, fatigue remained. Temp was still around 100.2F. Monday, 1/7/2019 Muscle aches, fatigue were worse. Temp was 99.9, Tuesday, 1/8/2019 shoulder pain, neck pain and jaw pain began around 0500am. I went to the ER.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Pain in jaw, Ventricular extrasystoles
Clinical narrative: Within 1 hour of vaccine, arm became red and a hard knot formed at injection site and a headache. By 2100 that evening I had a temp of 100.2F, slight muscle aching, chills and a headache. Sunday 1/6/2019 right shoulder and neck pain, injection site was hot to touch, redness and hard knot was larger. Muscle aches, fatigue remained. Temp was still around 100.2F. Monday, 1/7/2019 Muscle aches, fatigue were worse. Temp was 99.9, Tuesday, 1/8/2019 shoulder pain, neck pain and jaw pain began around 0500am. I went to the ER.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain, Autism spectrum disorder, Condition aggravated, Crying, Discomfort
Clinical narrative: High fever. Colic and crying in pain and could not sleep. Acid reflux and gagging with sounds. Went back to pediatrics office and met with another doctor later in the same day  who asked why all these vaccines were given on the same day? Administer Tylenol for relief. Long term issues (surfaced immediately after 1st round of vaccines). Patient developed food intolerance to most of the foods that mom was eating. Severe sleep issues due to discomfort.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Food intolerance, Gastrooesophageal reflux disease, Immediate post-injection reaction, Insomnia, Pain
Clinical narrative: High fever. Colic and crying in pain and could not sleep. Acid reflux and gagging with sounds. Went back to pediatrics office and met with another doctor later in the same day  who asked why all these vaccines were given on the same day? Administer Tylenol for relief. Long term issues (surfaced immediately after 1st round of vaccines). Patient developed food intolerance to most of the foods that mom was eating. Severe sleep issues due to discomfort.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Retching
Clinical narrative: High fever. Colic and crying in pain and could not sleep. Acid reflux and gagging with sounds. Went back to pediatrics office and met with another doctor later in the same day  who asked why all these vaccines were given on the same day? Administer Tylenol for relief. Long term issues (surfaced immediately after 1st round of vaccines). Patient developed food intolerance to most of the foods that mom was eating. Severe sleep issues due to discomfort.
Age: 0.33
Sex: F
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Vaccine was mixed with sterile diluent instead of the provided Saline Diluent. This was discovered the next business day when an extra bottle of Saline Diluent was found. There were no adverse reactions or complaints reported. This adverse event was immediately reported to Sanofi Pasteur upon discovery.
Age: 0.33
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Incorrect product formulation administered, Product preparation error, Product preparation issue
Clinical narrative: Vaccine was mixed with sterile diluent instead of the provided Saline Diluent. This was discovered the next business day when an extra bottle of Saline Diluent was found. There were no adverse reactions or complaints reported. This adverse event was immediately reported to Sanofi Pasteur upon discovery.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Nodule
Clinical narrative: Nodule on left deltoid since injection.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Patient did not have health concerns however the vaccines were deemed unviable due to no temperature logs being done in the Month of October 2018.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient did not have health concerns however the vaccines were deemed unviable due to no temperature logs being done in the Month of October 2018.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Emotional distress, Irritability, Regressive behaviour
Clinical narrative: Mother reported today 1/9/19, that patient was extremely fussy, inconsolable and had regressions in all aspects for weeks following his 2 month vaccines that were given on 11/12/18. Mother could not provide distinctive information or exact dates of symptoms. Patient was not evaluated at any office or clinic for these symptoms.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Pt was given BEXSERO then realized pt needed MENACTRA per mother. Upon re-entry to exam room had hives on chest and starting at injection site. Pt was not given MENACTRA for this reason. Vitals were stable, on-call provider Dr. called to assess pt. Pt was then sent to urgent care for allergic reaction. Per urgent care note: "Patient is a 18 year old female who presents for hives. She was in the clinic today for a meningococcal vaccine and subsequently developed a rash on the arms, chest, face (red). BENADRYL every 4-6 hours PRN and prednisone 20 mg QDx5 days." Spoke to pt's mother today (1/9/19) pt took 2 doses of BENADRYL yesterday but decided to not take the prednisone.
Age: 50.0
Sex: F
Vaccine: FLUR3, UNK
Symptoms: Dizziness
Clinical narrative: Dizziness daily began 13 days after injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site rash, Injection site urticaria, Oropharyngeal pain
Clinical narrative: Day 1 after immunization, patient reported flu-like symptoms. Day 3 after immunization, patient reported wheel type rash at injection area and could not lift arm very high. Day 5 after immunization, patient developed tight feeling in throat and felt pain when lifting chin upward. Day 8 after immunization, patient had developed a rash and was seen at urgent care and given a shot of dexamethasone. She reports feeling better after the steroid, but now presents on 01/09/19 which small rash reappearing at site of injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Throat tightness
Clinical narrative: Day 1 after immunization, patient reported flu-like symptoms. Day 3 after immunization, patient reported wheel type rash at injection area and could not lift arm very high. Day 5 after immunization, patient developed tight feeling in throat and felt pain when lifting chin upward. Day 8 after immunization, patient had developed a rash and was seen at urgent care and given a shot of dexamethasone. She reports feeling better after the steroid, but now presents on 01/09/19 which small rash reappearing at site of injection.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: After injection, patient passed out after walking away from pharmacy, associate alerted pharmacy, pharmacist attended to patient, patient was given water and was seated for 10+minutes.
Age: 67.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Client reported after taking first oral dose as ordered she developed rash to right side of face. Took the 2nd pill after skipping a day and the rash traveled to the left side of face and to neck. No itching or other symptoms.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Injection site erythema, Injection site swelling, Pruritus, Vaccination complication
Clinical narrative: Pt called and stated she had a reaction to the vaccine that was given on 1/7. Pt states it began after hours at 6:30 she felt very itchy and then noticed her arm around the area was swollen like a balloon and red around the edges. Pt states she contacted after hours. Pt took BENADRYL and Cortisone cream and is feeling better but her arm is still swollen. PCP contacted patient today and she  said that itching and swelling has improved since yesterday. Felt a little disoriented yesterday.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypersomnia, Myalgia, Pain
Clinical narrative: 13 hrs after injection, I awoke to severe shivering, headache, body and muscle aches. Took a TYLENOL and approximately 1 1/2 hours later the shivering stopped and I fell asleep. I woke up approximately every 2 hours after that and took another TYLENOL for the headache and body pains. I slept the day of 1/8/2019 and the following day I awoke feeling normal.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt has started with itching, urticarial rash on upper left half of her body. She is unsure if vaccine was given on right or left arm. Also has new rash on right lower ant leg that started later than the upper rash.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Muscle soreness, beginning in lower back and extending throughout the back, shivering, tiredness, fever. After the vaccination, I worked out at the gym (weightlifting and running, followed by steam room), and noticed some soreness in lower back (about 1-2 hours after vaccination). Tiredness began later in the afternoon. By 7pm, I had muscle soreness throughout the back, a low-grade headache, and by 9 pm extreme shivering. Later that evening, I also had a low-grade fever. Took  hot shower for the shivering, stretched for the muscle soreness, and took acetaminophen for fever and then went to bed about 10:30pm. Slept for about 11 hours, waking up about every 3 hours.  The following day (today) I have felt like I'm recovering from a cold, with continuing headache, but receding soreness and no recurrence of shivering.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle soreness, beginning in lower back and extending throughout the back, shivering, tiredness, fever. After the vaccination, I worked out at the gym (weightlifting and running, followed by steam room), and noticed some soreness in lower back (about 1-2 hours after vaccination). Tiredness began later in the afternoon. By 7pm, I had muscle soreness throughout the back, a low-grade headache, and by 9 pm extreme shivering. Later that evening, I also had a low-grade fever. Took  hot shower for the shivering, stretched for the muscle soreness, and took acetaminophen for fever and then went to bed about 10:30pm. Slept for about 11 hours, waking up about every 3 hours.  The following day (today) I have felt like I'm recovering from a cold, with continuing headache, but receding soreness and no recurrence of shivering.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Persistent muscle pain in area of injection x 4 months.
Age: 0.33
Sex: M
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Pt was given ROTARIX by oral route. A couple minutes after administration the pt broke out in hives on his face and head. I asked a provider to come verify that the pt had an allergic reaction and call in some medication for the pt. Medication was called in and mom went, picked it up and administered 1 dose.
Age: 0.33
Sex: M
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Pt was given ROTARIX by oral route. A couple minutes after administration the pt broke out in hives on his face and head. I asked a provider to come verify that the pt had an allergic reaction and call in some medication for the pt. Medication was called in and mom went, picked it up and administered 1 dose.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling jittery, Headache, Pain, Petechiae, Screaming
Clinical narrative: Spoke with mom states that pt was seen Monday and given immunizations, that night pt was jittery and vomited x2 in evening, since then has had what looks like petechiae on face and face has appeared a little swollen. Also complained of severe HA where he was screaming in pain. Dad stated that he has never done this in his life. Petechaie noted under eyes and started resolving within 4 days. No other symptoms after that initial episode.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swelling face, Vomiting
Clinical narrative: Spoke with mom states that pt was seen Monday and given immunizations, that night pt was jittery and vomited x2 in evening, since then has had what looks like petechiae on face and face has appeared a little swollen. Also complained of severe HA where he was screaming in pain. Dad stated that he has never done this in his life. Petechaie noted under eyes and started resolving within 4 days. No other symptoms after that initial episode.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Syncopal episode and vomiting.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe shoulder pain causing limited range of motion and strength in deltoid. Pain radiated down arm and into hand. After 5 weeks of no relief, went to Dr office and determined bursitis in shoulder (I do have a history of bursitis in that shoulder but was not experiencing pain in shoulder prior to flu shot). Given a steroid injection into shoulder.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Amnesia, Confusional state, Transient global amnesia
Clinical narrative: Approximately 4 hours after receiving his first dose of the SHINGRIX vaccination, the patient began experiencing confusion and memory loss. He did not recall events that had happened approximately 30 minutes prior, and appeared confused to those he was with. The patient was seen in the Emergency Room shortly after the symptoms were identified, and was diagnosed with Transient Global Amnesia. His health care provider at the facility stated they did not feel it was due to the recent vaccination, however the patient and his wife would like this event recorded and requested the author's assistance in reporting the incident.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Patient was given an oral vaccine by intramuscular route. (Rotavirus) Mom was educated on signs and symptoms to be aware of as well as what actions need to be taken in the event that the baby was to have a reaction. Patient was monitored in clinic for 20 minutes without any reaction.  Patient was also contacted the same afternoon to check on status.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: As of 01/09/2019 at 05:31pm there have not been any adverse events.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Patient describes initial reaction within 4 hrs of receiving vaccine as "palm-sized" area that was red, warm to touch, and firm. On Urgent care date of service, patient presented with spot nearer to elbow which was red, warm to touch, and firm. She denied pain at that time. Today patient describes size of reaction site as "less than 2 fingers" width. She states that there is still warmth, but it is "less than before." Patient states that there is a reduction in firmness. Denies Pain today.  Denies SOB, wheezing; difficulty swallowing; Fever, chills, or other S/Sx of anaphylaxis. Patient is currently taking CLARITIN per PA at Urgent Care. Was icing 20 min on 1-2 hrs off, denies need to ice today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Discomfort, Injection site pain, Pain, Pain in extremity
Clinical narrative: At first it was normal discomfort but as the days went on, the pain got worse. It started as a sharp repetitive stabbing pain at the injection site and it had a burning sensation in my arm. That lasted for a while off and on and this morning I woke up and it was aching pain in my arm and it hurts to move and touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza, Skin warm, Tenderness
Clinical narrative: Red area of approximately 3" X 3" for 7-10 days; fluish symptoms for 3-days; painful to touch for 4-5 days; warm to the touch for 4-5 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Immobile, Pain
Clinical narrative: Shivers, headache, body ache, felt immobile.