chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 23-APR-2013, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 03-JAN-2017, the patient was treated by a physician's assistant at a family medicine office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of 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 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 not recovered. Causality assessment was related. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain, Pain in extremity, Tenderness
Clinical narrative: The day after receiving the vaccine patient says he began devoloping soreness and tenderness in most of the left arm as well as left thoracic side of body that has lasted about a week. No fever. Ibuprofen controls the pain. Recommended follow-up to be cautious or in case it is something else; patient is going to watch it for a day or two more to see if there is imrovement first.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Pink warm spot 6" below injection site for 2 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Developed flu-like symptoms, body aches, significant fatigue, fever of 100.6.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Blood test normal, Fall, Fatigue, Feeling hot
Clinical narrative: I received the 1st dose of the SHINGRIX vaccine. Before the vaccine I was active. A month after the injection, I started to notice that I was having difficulty walking, difficulty with my balance, I fell frequently and suffered from extreme fatigue, feeling hot in areas that moved around my body, ice cold hands and feet.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Peripheral coldness
Clinical narrative: I received the 1st dose of the SHINGRIX vaccine. Before the vaccine I was active. A month after the injection, I started to notice that I was having difficulty walking, difficulty with my balance, I fell frequently and suffered from extreme fatigue, feeling hot in areas that moved around my body, ice cold hands and feet.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Pt called with redness from elbow to armpit, but no fever and no other symptoms. I recommended her to see a physician. Physician determined it was probably an allergy and for patient to continue on benadryl. Pt reported that redness has gone down and is much better 2 days later on 12.17.2018
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient has had continued bilateral shoulder, arm, and neck pain since receiving vaccines on 10/9/18. Pain significantly increased since 10/11/2018. She has tried massage, OTC TYLENOL/Ibuprofen/topicals without relief. She will be seeing a chiropractor next.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue
Clinical narrative: Extreme fatigue upon waking up the morning after the shot (Saturday, Dec. 8) I had no energy.  All I wanted to do was sit on the sofa and close my eyes. I also experienced chills throughout that first day and had no appetite the first day. The second morning (Sunday, Dec. 9) I felt a little less fatigued, did not have any chills, and ate meals. The third day after the shot, Monday, Dec. 10 I felt back to normal. I have never had a reaction to any vaccination I have received in the past.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swelling and redness as per parents; Came into office to see M.D.; Swelling and redness resolved.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Confusional state, Immediate post-injection reaction, Injection site haemorrhage, Loss of consciousness, Tuberculin test
Clinical narrative: Very nervous about getting shots. Mother was in the room by her side. Patient sitting on end of exam table. Injection given. Bled moderately. I was holding a cotton ball on the site and she looked over. When I removed the cotton ball she saw the blood. She immediately passed out. I eased her to a laying position on the exam table. Was only seconds and she fought to sit back up. She was confused for about 5 seconds and then remembered she was getting shots. Placed a cool washcloth on her head. Encouraged deep breathing. After 10 minutes mom wanted the rest of her shots given. She received a Men B in right deltoid, HPV in left deltoid and LAIV 4 in left deltoid. Also completed a TB skin test. Patient had no difficulties with the rest of the injections. She remained laying down with the cool washcloth on her head for 15 minutes. Then I had her sit up for 5 minutes. Denied any side effects. Left clinic ambulatory with her mother. Encouraged good hydration and rest. Mom states during the incident that she has passed out when getting her blood drawn previously. States if she looks at her own blood she gets lighted.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling in the arm from elbow to just above the shoulder in the left arm.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Arthralgia, Fatigue, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Phone call received from patient's mom on Monday 12/17/18, stating that he had had a fever, joint and muscle aches, lethargy and fatigue on the two days following vaccination, 12/15-12/16/18. He also had significant redness, swelling, and pain in the R arm, in which he had received HPV and Meningococcal vaccines. Mom took him to a local Urgent Care. He was afebrile at visit. Chart notes state "The patient presents with a chief complaint of constant pain of the upper right arm since Friday, December 14, 2018. Pt with an erythematous growing painful rash that is expanding. R shoulder with a 4 cm x 6 cm area of erythema and bright red, with TTP (tenderness to palpation?) that is mild. No crepitus, fluctuance. No pain out of proportion. There is increased warmth. No streaking. Diagnoses: cellulitis of right upper limb".
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Lethargy, Myalgia
Clinical narrative: Phone call received from patient's mom on Monday 12/17/18, stating that he had had a fever, joint and muscle aches, lethargy and fatigue on the two days following vaccination, 12/15-12/16/18. He also had significant redness, swelling, and pain in the R arm, in which he had received HPV and Meningococcal vaccines. Mom took him to a local Urgent Care. He was afebrile at visit. Chart notes state "The patient presents with a chief complaint of constant pain of the upper right arm since Friday, December 14, 2018. Pt with an erythematous growing painful rash that is expanding. R shoulder with a 4 cm x 6 cm area of erythema and bright red, with TTP (tenderness to palpation?) that is mild. No crepitus, fluctuance. No pain out of proportion. There is increased warmth. No streaking. Diagnoses: cellulitis of right upper limb".
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Phone call received from patient's mom on Monday 12/17/18, stating that he had had a fever, joint and muscle aches, lethargy and fatigue on the two days following vaccination, 12/15-12/16/18. He also had significant redness, swelling, and pain in the R arm, in which he had received HPV and Meningococcal vaccines. Mom took him to a local Urgent Care. He was afebrile at visit. Chart notes state "The patient presents with a chief complaint of constant pain of the upper right arm since Friday, December 14, 2018. Pt with an erythematous growing painful rash that is expanding. R shoulder with a 4 cm x 6 cm area of erythema and bright red, with TTP (tenderness to palpation?) that is mild. No crepitus, fluctuance. No pain out of proportion. There is increased warmth. No streaking. Diagnoses: cellulitis of right upper limb".
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Influenza like illness, Malaise, Oral herpes
Clinical narrative: Immunization on Thursday, Friday -- arm was very sore, Sat/Sun -- pain was the worst, 4" circle of redness, cold sores in mouth, overall not feeling well, flu-like symptoms, NO fever.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Stress
Clinical narrative: Immunization on Thursday, Friday -- arm was very sore, Sat/Sun -- pain was the worst, 4" circle of redness, cold sores in mouth, overall not feeling well, flu-like symptoms, NO fever.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Rash developed yesterday to Right thigh, red area about 2-3 cm, warm. Has spread to the face, dots on tummy and back. Occasional diarrhea, slight runny nose. Erythematous macular papular rash on face, chest, abdomen, back, extremities, spares palms and soles. Focal indurated erythema right anterior thigh, with warmth, approx 2-3 cm in diameter, no fluctuance, no discharge.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash macular, Rhinorrhoea
Clinical narrative: Rash developed yesterday to Right thigh, red area about 2-3 cm, warm. Has spread to the face, dots on tummy and back. Occasional diarrhea, slight runny nose. Erythematous macular papular rash on face, chest, abdomen, back, extremities, spares palms and soles. Focal indurated erythema right anterior thigh, with warmth, approx 2-3 cm in diameter, no fluctuance, no discharge.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Flushing, Muscle spasms
Clinical narrative: Adverse event: flushing in the face and lower back spasm. Outcome: paramedic evaluated patient's blood pressure, eyes, lungs, orientation and more for a period of 20 minutes. Symptoms subsided before patient left pharmacy.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Soreness in shoulder since vaccination date.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bacterial test negative, Electrocardiogram normal, Gait disturbance
Clinical narrative: Patient reported that the morning of 12/15/18 he felt extremely weak and couldn't walk (was unable to make it to the bathroom in time as well). Patient felt so bad that he went to the hospital on 12/16/18 and the hospital did not find anything "wrong" with the patient (no urinary tract infection, nothing wrong with legs, no fever, no changes to EKG, etc). Patient stated on 12/17/18 that he was feeling better but still feels weak. He is due for surgery on 12/21/18 and feels he may have to reschedule due to his current state.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Feeling abnormal, Fluid retention, Mobility decreased, Pain in extremity
Clinical narrative: According to patient  "went in for a pneumonia shot and landed up here with fluid in my biceps" according to wife " her arm hurt for several days after getting the shot and she had a hard time lifting her arm. She then mentioned that pt was feeling so bad that he ended up going to the hospital for his arm".
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Injection site inflammation, Joint range of motion decreased, Myositis
Clinical narrative: According to patient  "went in for a pneumonia shot and landed up here with fluid in my biceps" according to wife " her arm hurt for several days after getting the shot and she had a hard time lifting her arm. She then mentioned that pt was feeling so bad that he ended up going to the hospital for his arm".
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema
Clinical narrative: According to patient  "went in for a pneumonia shot and landed up here with fluid in my biceps" according to wife " her arm hurt for several days after getting the shot and she had a hard time lifting her arm. She then mentioned that pt was feeling so bad that he ended up going to the hospital for his arm".
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema, Vaccination complication, Wrong technique in product usage process
Clinical narrative: According to patient  "went in for a pneumonia shot and landed up here with fluid in my biceps" according to wife " her arm hurt for several days after getting the shot and she had a hard time lifting her arm. She then mentioned that pt was feeling so bad that he ended up going to the hospital for his arm".
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity
Clinical narrative: According to Patient: her arm hurt for several days after getting the shot and she had a hard time lifting her arm. She then mentioned that spouse was feeling so bad that he ended up going to the hospital for his arm".
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Arm is swollen, red, itching and painful to the touch, headache.
Age: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient mentioned he was hospitalized with numbness and Guillain - Barre syndrome like symptoms.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Fibrin D dimer normal, Hypoaesthesia, Immediate post-injection reaction, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Immediately after the flu shot the patient noticed significant pain. Patient has had increasing pain in her arm since the vaccine. This morning (12/17/18) she woke up with severe, uncontrolled pain. Patient denies any swelling or redness. Reports numbness in her fingers once in a while.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: A month after the shot, patient states she still has sore arm.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness and swelling in a ring around injection site the evening after administration. These symptoms improved on 12/16/18 however they reappeared on 12/17/18 lower on the same arm closer to the elbow. Patient will ice the area and take acetaminophen is necessary. Will call PCP to see if they advise further action.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever, redness and pain, hard at injection site, hot to the touch for 2 days after shot.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Blood pressure decreased, Dizziness, Headache, Pain, Pallor
Clinical narrative: Pt pale - dizzy - faint - at 5 mins after vaccine received - started to vomit several mins after that - severe vomiting and HA x 10 mins - decreased BP also - recovered after 30 mins after vaccine given - H/A and soreness persisted into next day. HA = headache.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Vomiting
Clinical narrative: Pt pale - dizzy - faint - at 5 mins after vaccine received - started to vomit several mins after that - severe vomiting and HA x 10 mins - decreased BP also - recovered after 30 mins after vaccine given - H/A and soreness persisted into next day. HA = headache.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: I did not report my 1st dose of SHINGRIX, same pharmacy, 9 weeks ago - [10-5-18] side effect same: and CDC has reported this - severe body aches - chills and fever - 12 hours plus - MOTRIN helps. I agree with CDC current description of possible side effects for folks in age 51-59. I want you to know - it is a tough few hours - MOTRIN on a full stomach help - please advise Docs, and Pharmacies to tell patients in 51-59 group to eat and have MOTRIN handy.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Vaccination complication
Clinical narrative: Where vaccine was given it was red and tender to the touch about 2 in by 2.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dysarthria, Electrocardiogram normal, Hypoaesthesia, Metabolic function test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 710159). Information was received regarding a 12 year old male patient. The patient's current illnesses included upper respiratory symptoms and otitis externa. The patient's medical history included allergic conjunctivitis and weight increased. The patient's prior vaccinations and other medications were not reported. On 21-AUG-2017, the patient was vaccinated with second dose of GARDASIL 9 lot # M044717, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day within 5 minutes of giving the vaccine, the patient presented with feeling dizzy, wheezing, skin rash on chest, hypoaesthesia (also reported as numbness), slurred speech (also reported as dysarthria), the patient underwent metabolic function test (also reported as comprehensive metabolic panel (CMP)) and electrocardiogram (EKG) were normal. The patient was sent to emergency room (ER) by emergency medical service (EMS). In route the patient was given diphenhydramine hydrochloride (BENADRYL). Per patient's mother information within 40 minutes of being in the hospital was back to normal. In the hospital the patient was observed for about 6 hours. The patient was discharged on prednisolone (manufacturer unknown) for 5 days. The outcome of dizziness, wheezing, rash, metabolic function test normal, hypoaesthesia, electrocardiogram normal and dysarthria was reported as recovered/resolved. The causality assessment was not provided. Follow up information was received from a health care professional via regulatory authority regarding a male patient. Follow-up information was received from the physician. Physician stated that, without birth date or name he wont be able to give any information. And also reported that this incident did not happen in these past two months.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Wheezing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 710159). Information was received regarding a 12 year old male patient. The patient's current illnesses included upper respiratory symptoms and otitis externa. The patient's medical history included allergic conjunctivitis and weight increased. The patient's prior vaccinations and other medications were not reported. On 21-AUG-2017, the patient was vaccinated with second dose of GARDASIL 9 lot # M044717, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day within 5 minutes of giving the vaccine, the patient presented with feeling dizzy, wheezing, skin rash on chest, hypoaesthesia (also reported as numbness), slurred speech (also reported as dysarthria), the patient underwent metabolic function test (also reported as comprehensive metabolic panel (CMP)) and electrocardiogram (EKG) were normal. The patient was sent to emergency room (ER) by emergency medical service (EMS). In route the patient was given diphenhydramine hydrochloride (BENADRYL). Per patient's mother information within 40 minutes of being in the hospital was back to normal. In the hospital the patient was observed for about 6 hours. The patient was discharged on prednisolone (manufacturer unknown) for 5 days. The outcome of dizziness, wheezing, rash, metabolic function test normal, hypoaesthesia, electrocardiogram normal and dysarthria was reported as recovered/resolved. The causality assessment was not provided. Follow up information was received from a health care professional via regulatory authority regarding a male patient. Follow-up information was received from the physician. Physician stated that, without birth date or name he wont be able to give any information. And also reported that this incident did not happen in these past two months.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, IPV, DTAPIPVHIB, IPV
Symptoms: Extra dose administered
Clinical narrative: The medical assistant gave the patient a dose of PENTACEL and then gave a dose of Polio.
Age: 66.0
Sex: M
Vaccine: FLU4, FLUX, PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 66 year old male patient. The patient had no pertinent allergies and medical history. On an unknown date in 2016, the patient was concomitantly vaccinated with PREVNAR 13. On 18-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 (dosing details, frequency were unknown) intramuscular and influenza virus vaccine inactivated (unspecified) for an unknown indication. Concomitant therapies included ADVIL, CORGARD, FLOMAX, lisinopril and sulindac. On 25-DEC-2017, 8 days after onset of therapy the patient experienced hives (urticarial). Patient was performed with lab diagnostics which included immunoglobulin and basic north east allergy panel. The outcome of urticaria was reported as not recovered. Causality assessment was not provided. Lot # 25563 is not valid for PNEUMOVAX 23.
Age: 66.0
Sex: M
Vaccine: FLU4, FLUX, PPV
Symptoms: Allergy test, Immunoglobulins, Urticaria
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 66 year old male patient. The patient had no pertinent allergies and medical history. On an unknown date in 2016, the patient was concomitantly vaccinated with PREVNAR 13. On 18-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 (dosing details, frequency were unknown) intramuscular and influenza virus vaccine inactivated (unspecified) for an unknown indication. Concomitant therapies included ADVIL, CORGARD, FLOMAX, lisinopril and sulindac. On 25-DEC-2017, 8 days after onset of therapy the patient experienced hives (urticarial). Patient was performed with lab diagnostics which included immunoglobulin and basic north east allergy panel. The outcome of urticaria was reported as not recovered. Causality assessment was not provided. Lot # 25563 is not valid for PNEUMOVAX 23.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Urine analysis normal
Clinical narrative: Flu like symptoms next morning, followed by severe back pain. Unable to stand up straight. Pain radiating to the kidneys area of back. One week later still in pain went to the doctor he did urine test of kidneys and gave me a steroid shot. On day 9 was able to stand up straight. On day 19 pain was mostly gone. Still a bit of pain in the morning. Urine came back fine.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Dysstasia, Influenza like illness, Pain, Urine analysis normal
Clinical narrative: Flu like symptoms next morning, followed by severe back pain. Unable to stand up straight. Pain radiating to the kidneys area of back. One week later still in pain went to the doctor he did urine test of kidneys and gave me a steroid shot. On day 9 was able to stand up straight. On day 19 pain was mostly gone. Still a bit of pain in the morning. Urine came back fine.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia, Tremor, Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 65-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On 4th December 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, diarrhea, chills, tremor of hands and fever. The patient was treated with ADVIL. On an unknown date, the outcome of the nausea, vomiting, diarrhea, tremor of hands and fever were recovered/resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the nausea, vomiting, diarrhea, chills, tremor of hands and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported a patient who received their initial dose of SHINGRIX developed nausea, vomiting, diarrhea, severe chills, uncontrollable hand shaking and fever of 103 degree F within 24 hours of receiving injection. The patient took three ADVIL after which symptoms had completely resolved. No further details were reported.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 65-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On 4th December 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, diarrhea, chills, tremor of hands and fever. The patient was treated with ADVIL. On an unknown date, the outcome of the nausea, vomiting, diarrhea, tremor of hands and fever were recovered/resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the nausea, vomiting, diarrhea, chills, tremor of hands and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported a patient who received their initial dose of SHINGRIX developed nausea, vomiting, diarrhea, severe chills, uncontrollable hand shaking and fever of 103 degree F within 24 hours of receiving injection. The patient took three ADVIL after which symptoms had completely resolved. No further details were reported.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 65-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On 4th December 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting, diarrhea, chills, tremor of hands and fever. The patient was treated with ADVIL. On an unknown date, the outcome of the nausea, vomiting, diarrhea, tremor of hands and fever were recovered/resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the nausea, vomiting, diarrhea, chills, tremor of hands and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported a patient who received their initial dose of SHINGRIX developed nausea, vomiting, diarrhea, severe chills, uncontrollable hand shaking and fever of 103 degree F within 24 hours of receiving injection. The patient took three ADVIL after which symptoms had completely resolved. No further details were reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, fever and pain. On 7th December 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the headache, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient struggling with lingering side effects of SHINGRIX. After receiving the SHINGRIX the patient experienced severe headache high fever, aches and pain. On 7th December 2018, 48 hours later, the patient had no fever. The pharmacist who administered it, warned me about the severe side effects the patient was about to experience. Had I at least been able to more prepare for the consequent illness, I would had been both psychologically prepared, and not had scheduled the vaccine for a weekend day so it would not interfere with work.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, fever and pain. On 7th December 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the headache, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient struggling with lingering side effects of SHINGRIX. After receiving the SHINGRIX the patient experienced severe headache high fever, aches and pain. On 7th December 2018, 48 hours later, the patient had no fever. The pharmacist who administered it, warned me about the severe side effects the patient was about to experience. Had I at least been able to more prepare for the consequent illness, I would had been both psychologically prepared, and not had scheduled the vaccine for a weekend day so it would not interfere with work.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, fever and pain. On 7th December 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the headache, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient struggling with lingering side effects of SHINGRIX. After receiving the SHINGRIX the patient experienced severe headache high fever, aches and pain. On 7th December 2018, 48 hours later, the patient had no fever. The pharmacist who administered it, warned me about the severe side effects the patient was about to experience. Had I at least been able to more prepare for the consequent illness, I would had been both psychologically prepared, and not had scheduled the vaccine for a weekend day so it would not interfere with work.
Age: 25.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from an office manager referring to a 25 year old female patient. The patient's pertinent medical history was not provided. The patient had not drug reactions/allergies or concomitant medications. Her concurrent conditions included asthma. On 07-DEC-2018, the patient was inadvertently vaccinated with a dose of VARIVAX intramuscularly, lot # R013565 with expiration date 13-MAY-2020, for prophylaxis (reported as "receiving immunizations to complete the immigration protocol") (strength and anatomical location were not reported). No adverse effect was reported. On 11-DEC-2018, an immigration coordinator was reviewing the laboratory work for the immigration lawyer and noticed the vaccination. It was also reported that the patient disclosed that she was pregnant to a medical assistant on an unknown date. At the time of reporting, the patient's last menstrual period and the estimated date of delivery were unknown. The pregnancy outcome was pending and the fetal outcome was unknown.
Sex: U
Vaccine: PPV, PPV
Symptoms: Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-DEC-2018, the patient was inadvertently administered a dose of PNEUMOVAX 23 intramuscularly (dose, site of administration lot # and expiration date were not reported) for prophylaxis instead of GARDASIL 9 (lot# and expiration date were not reported). No adverse effects were reported.
Sex: U
Vaccine: PPV, PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-DEC-2018, the patient was inadvertently administered a dose of PNEUMOVAX 23 intramuscularly (dose, site of administration lot # and expiration date were not reported) for prophylaxis instead of GARDASIL 9 (lot# and expiration date were not reported). No adverse effects were reported.
Age: 29.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Rash, itching a site.
Age: 29.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pruritus, Rash
Clinical narrative: Rash, itching a site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, body aches, nausea, fatigue, loose stools. Injection site red, hot, swollen, pain when using arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Headache, body aches, nausea, fatigue, loose stools. Injection site red, hot, swollen, pain when using arm.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Aching, shivering, headache.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Malaise, Pyrexia
Clinical narrative: Got severe chills and a fever that lasted for about 6 hours. Was feeling sick and weak for the next 4 hours and then I was feeling back to normal.
Sex: M
Vaccine: HPV9
Symptoms: Acute disseminated encephalomyelitis, Biopsy brain abnormal, CSF oligoclonal band present, Enterovirus test positive, Hemiparesis
Clinical narrative: This spontaneous report was received from a physician concerning to a 14 years old male patient. It was reported that the patient was "a previously perfectly healthy 14 year old boy". Information regarding the patient's medical history and concomitant medication was not reported. On unknown date the patient was vaccinated with the second dose of GARDASIL for prophylaxis, (strength, dosage, route of administration, anatomical location, lot # and expiration date were not reported). On unknown date (reported as 5 days after vaccination), the patient was diagnosed with acute disseminated encephalomyelitis (confirmed by biopsy), additionally, the patient was hospitalized due to the event on an unknown date. The reporter described the acute disseminated encephalomyelitis as severe, with a left hemiparesis and progressive very impressive changes on magnetic resonance images (T2 MRI). His cerebrospinal fluid (CSF), contained two oligoclonal bands, but a massive serologic studies for autoimmune neurologic disease have otherwise been negative. The patient received some intensive steroids and plasmapheresis medication due to the acute disseminated encephalomyelitis. The following test was performed: Biopsy (unknown date): acute disseminated encephalomyelitis. Nasopharyngeal polymerase chain reaction (PCR) (unknown date): positive to rhinoenterovirus. The patient was reported to VAERS, and the reporter stated that some studies such as antibody index on his CFS and serum, which required determinate specific levels of human papillomavirus (HPV) quantitative immunoglobulin G (IgG) and serum, could help to determine the cause of acute disseminated encephalomyelitis. The reporter stated he was very aware that the association with GARDASIL, may just was an example of the "post hoc ergo propter hoc fallacy" (after this, therefore because of this). At the time of this report the outcome of acute disseminated encephalomyelitis was unknown. Upon internal review the acute disseminated encephalomyelitis was considered as serious event. The reported did not provided the causality assessment between GARDASIL, and acute disseminated encephalomyelitis. This is an amended report, the correct codification of the suspect therapy is GARDASIL 9.
Sex: M
Vaccine: HPV9
Symptoms: Human rhinovirus test positive, Immunology test normal, Nuclear magnetic resonance imaging abnormal, Plasmapheresis, Polymerase chain reaction positive
Clinical narrative: This spontaneous report was received from a physician concerning to a 14 years old male patient. It was reported that the patient was "a previously perfectly healthy 14 year old boy". Information regarding the patient's medical history and concomitant medication was not reported. On unknown date the patient was vaccinated with the second dose of GARDASIL for prophylaxis, (strength, dosage, route of administration, anatomical location, lot # and expiration date were not reported). On unknown date (reported as 5 days after vaccination), the patient was diagnosed with acute disseminated encephalomyelitis (confirmed by biopsy), additionally, the patient was hospitalized due to the event on an unknown date. The reporter described the acute disseminated encephalomyelitis as severe, with a left hemiparesis and progressive very impressive changes on magnetic resonance images (T2 MRI). His cerebrospinal fluid (CSF), contained two oligoclonal bands, but a massive serologic studies for autoimmune neurologic disease have otherwise been negative. The patient received some intensive steroids and plasmapheresis medication due to the acute disseminated encephalomyelitis. The following test was performed: Biopsy (unknown date): acute disseminated encephalomyelitis. Nasopharyngeal polymerase chain reaction (PCR) (unknown date): positive to rhinoenterovirus. The patient was reported to VAERS, and the reporter stated that some studies such as antibody index on his CFS and serum, which required determinate specific levels of human papillomavirus (HPV) quantitative immunoglobulin G (IgG) and serum, could help to determine the cause of acute disseminated encephalomyelitis. The reporter stated he was very aware that the association with GARDASIL, may just was an example of the "post hoc ergo propter hoc fallacy" (after this, therefore because of this). At the time of this report the outcome of acute disseminated encephalomyelitis was unknown. Upon internal review the acute disseminated encephalomyelitis was considered as serious event. The reported did not provided the causality assessment between GARDASIL, and acute disseminated encephalomyelitis. This is an amended report, the correct codification of the suspect therapy is GARDASIL 9.
Sex: M
Vaccine: HPV9
Symptoms: Serology negative
Clinical narrative: This spontaneous report was received from a physician concerning to a 14 years old male patient. It was reported that the patient was "a previously perfectly healthy 14 year old boy". Information regarding the patient's medical history and concomitant medication was not reported. On unknown date the patient was vaccinated with the second dose of GARDASIL for prophylaxis, (strength, dosage, route of administration, anatomical location, lot # and expiration date were not reported). On unknown date (reported as 5 days after vaccination), the patient was diagnosed with acute disseminated encephalomyelitis (confirmed by biopsy), additionally, the patient was hospitalized due to the event on an unknown date. The reporter described the acute disseminated encephalomyelitis as severe, with a left hemiparesis and progressive very impressive changes on magnetic resonance images (T2 MRI). His cerebrospinal fluid (CSF), contained two oligoclonal bands, but a massive serologic studies for autoimmune neurologic disease have otherwise been negative. The patient received some intensive steroids and plasmapheresis medication due to the acute disseminated encephalomyelitis. The following test was performed: Biopsy (unknown date): acute disseminated encephalomyelitis. Nasopharyngeal polymerase chain reaction (PCR) (unknown date): positive to rhinoenterovirus. The patient was reported to VAERS, and the reporter stated that some studies such as antibody index on his CFS and serum, which required determinate specific levels of human papillomavirus (HPV) quantitative immunoglobulin G (IgG) and serum, could help to determine the cause of acute disseminated encephalomyelitis. The reporter stated he was very aware that the association with GARDASIL, may just was an example of the "post hoc ergo propter hoc fallacy" (after this, therefore because of this). At the time of this report the outcome of acute disseminated encephalomyelitis was unknown. Upon internal review the acute disseminated encephalomyelitis was considered as serious event. The reported did not provided the causality assessment between GARDASIL, and acute disseminated encephalomyelitis. This is an amended report, the correct codification of the suspect therapy is GARDASIL 9.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, concerning 3 female patients of unknown age. The patients' concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis (strength, dose, anatomical location, lot/batch # and expiration date were not reported). On multiple unspecified dates, after the administration of PNEUMOVAX 23, the three patients experienced redness, swelling and warmth at the injection site. The patients sought for medical attention, but it was unknown if treatment, laboratory diagnostics, or studies were performed for the events. The outcome of the events was unknown. The reporter did not provide a causal relationship between therapy with PNEUMOVAX 23, and the events vaccination site erythema, vaccination site warmth and vaccination site swelling.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse on behalf of a physician and 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. On 03-DEC-2018, the patient was inadvertently vaccinated with improperly stored dose of GARDASIL 9 (lot # R017133, expiration date: 29-APR-2021, dose and route of administration were not provided) for prophylaxis. No adverse effects were reported. Administered dose of GARDASIL 9 experienced temperature excursion of 60 Fahrenheit degrees for 4 days and 8 hours. There was previous temperature excursion between 47 to 77 Fahrenheit degrees (reported also as 50 Fahrenheit degrees) for 24 hours on 29-NOV-2018. Digital data logger was involved.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to a 4 year old male patient. The patient's medical history, concomitant medications and drug allergies/reaction were not reported. On 04-DEC-2018,  the patient was vaccinated with VARIVAX injectable, 0.5 ml Vaccine National Drug Code (NDC) 0006-4827-01) administrated intramuscular instead of subcutaneous in the left thigh as routine immunization (lot # R017635 with expiration date on 20-JUN-2020) with sterile diluent (MERCK STERILE DILUENT). She also reported that the patient was there for an extra 30 minutes and she did not notice any events from the injection.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician, and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On unspecified dates, unspecified patients were inadvertently vaccinated subcutaneously with doses of VARIVAX (lot # and expiration date not provided), M-M-R II (lot # and expiration date not provided) and PROQUAD (lot # and expiration date not provided) for prophylaxis. All lots of VARIVAX, M-M-R II and PROQUAD were reconstituted with properly stored sterile diluent (MRK) (lot # and expiration date not provided). No adverse effect was reported. The temperature excursion was not provided. Digital data logger involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, pertinent medical histories, drug reactions or allergies provided. On 04-DEC-2018, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneously in the left arm, lot# R017629, expiration date 18-DEC-2019 (dose and dose number were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccines experienced the temperature excursion of -14 Celsius degrees to -10 Celsius degrees for 70 minutes and -9 Celsius degrees to +8 Celsius degrees (-8.49 Celsius degrees) for 35 minutes. Previous temperature was reported as -14 Celsius degrees to -10 Celsius degrees for 60 minutes and -9 Celsius degrees to 8 Celsius degrees for 40 minutes. Data logger was involved, detecting this storage error.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 04-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # N020951 and expiration date: 15-OCT-2018 (exact dose, frequency, route of administration were not provided). No adverse effects were reported. The causality assessment was not provided.