chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Flushing, Myalgia
Clinical narrative: Severe muscle aches; Chills; Face flushing; This case was reported by a consumer and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, chills and facial flushing. On an unknown date, the outcome of the myalgia, chills and facial flushing were unknown.   It was unknown if the reporter considered the myalgia, chills and facial flushing to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix  and had severe muscle aches, chills and face flushing.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Vomiting
Clinical narrative: headache; vomiting for 12 hours on the day of administration; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache and vomiting. On an unknown date, the outcome of the headache and vomiting were recovered/resolved.   It was unknown if the reporter considered the headache and vomiting to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had headache and vomiting for 12 hours on the day after administration.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bronchospasm, Dyspnoea, Feeling abnormal, Middle insomnia
Clinical narrative: Every joint aching; Could hardly move; Arm pain; felt crapy; Spasms in her left lung; Gasp for breath; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (received vaccine on an unknown date and experienced pain in arm).   On 25th July 2019, the patient received the 1st dose of Shingrix .5 ml. On 26th July 2019, 1 days after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the patient experienced joint pain, mobility decreased, bronchospasm, gasping and pain in arm. On an unknown date, the outcome of the joint pain, mobility decreased, bronchospasm and gasping were recovered/resolved and the outcome of the feeling abnormal and pain in arm were unknown.   It was unknown if the reporter considered the joint pain, mobility decreased, feeling abnormal, bronchospasm, gasping and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination awoke in the middle of night with every joint aching. The patient could hardly move. The patient couple of weeks after the first dose had spasms in her left lung, that caused her to gasp for breath. This is 1 of the 3 cases reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Every joint aching; Could hardly move; Arm pain; felt crapy; Spasms in her left lung; Gasp for breath; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (received vaccine on an unknown date and experienced pain in arm).   On 25th July 2019, the patient received the 1st dose of Shingrix .5 ml. On 26th July 2019, 1 days after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the patient experienced joint pain, mobility decreased, bronchospasm, gasping and pain in arm. On an unknown date, the outcome of the joint pain, mobility decreased, bronchospasm and gasping were recovered/resolved and the outcome of the feeling abnormal and pain in arm were unknown.   It was unknown if the reporter considered the joint pain, mobility decreased, feeling abnormal, bronchospasm, gasping and pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination awoke in the middle of night with every joint aching. The patient could hardly move. The patient couple of weeks after the first dose had spasms in her left lung, that caused her to gasp for breath. This is 1 of the 3 cases reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Prostatic specific antigen increased
Clinical narrative: PSA increased from 1 to 5 after first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of psa increased in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced psa increased. On an unknown date, the outcome of the psa increased was unknown.   It was unknown if the reporter considered the psa increased to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Post vaccination the patient had increase in prostate specific antigen from 1 to 5. The reporter consented to follow up.      Lab Comments: Laboratory test was done on an unspecified day
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site necrosis
Clinical narrative: Necrosis of the skin that is approximately 3 inches around injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site necrosis in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site necrosis (serious criteria GSK medically significant). On an unknown date, the outcome of the injection site necrosis was not recovered/not resolved.   It was unknown if the reporter considered the injection site necrosis to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination the patient had necrosis of the skin that was approximately 3 inches around injection site. On 11th November 2019, the patient was seen by doctor's office. On 2nd December 2019, the patient saw a dermatologist. Till the 27th December 2019, the skin necrosis was not recovered. The reporter stated that, the vaccine was administered at the pharmacy that was adjacent to the clinic. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. Post vaccination the patient had sore arm. This case was linked to another case US2020AMR003672 reported for the same patient (2nd dose).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: pain/ pain in the left arm; pain in the left arm started to get worse and now the pain involves the whole left arm, radiating to the left shoulder; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th November 2019, immediately after receiving Shingrix, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were unknown.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine intramuscularly into the deltoid muscle of the left arm. Post vaccination the patient started to experience pain almost  immediately. The patient stated that gradually the pain in the left arm started to get worse and at the time of reporting the pain involved the whole left arm, radiating to the left shoulder.   No additional information was provided. The reporter consented to follow up.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Tendonitis
Clinical narrative: PROLONGED INJECTION SITE PAIN. PATIENT REPORTS DOCTOR DIAGNOSED TENDONITIS.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Headache
Clinical narrative: Headache and warmth in the upper body. No treatment perform, employee already left center and did not perform any treatment at home. Headache and warmth lasted a couple hours.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Employee started feeling nauseous and light headed. States she drank water and symptoms resolved within 20 minutes,
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient experienced joint and muscle pain in the middle of the night that continued to the next day
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Sever chills (teeth chattering), fever, major aching, nausea and fatigue through much of the night 1/3-4.  Next day severe fatigue.  ilder fatigue for the next three days.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Cardiac murmur, Cough, Diarrhoea, Gastrointestinal disorder, Headache
Clinical narrative: 11/9/19 Patient woke up with a very swollen and red right thigh. He had a hard nodule under his skin at the injection site. He proceeded to develop a rash on his leg as well as on his face on the right side. THe rash began to worsen and progress. Over the course of the weeken the rash spread to his abdomen, chest, neck, both sides of his face, head and feet and legs. He began having sever gi symptoms, repeated vomiting, diarhea which caused him to fail to gain weight appropriately as this progressed for several weeks. We brought patient to Dr. several times for the rash, gastrointstinal issues. He also had extreme head pain. We thought he had an ear infection as he woke up out of a sleep several times screaming uncontrollablu holding his head. The doctor ruled out ear infection. We were referred to a dermatologis which we saw. This was scheduled by the pediatricians office. The dermatologist confirmed the the rash was due to a vaccine reaction and said to hold off on further vaccinating at this time until he is older and can verbalize symptoms as well as has a stronger immune system. He said the next reaction could result in the need for prednisone and could be anaphalactic or worse. That some children are not able to handle the vaccines and that we should consider the benefits/reactions and decide if it is worth continuing especially considering a family history of vaccine reactions on both sides of our family. In addition to this patient developed a terrible cough, respiratory distress and congestion. THis began within a week of the vaccines. He was tested for RSV twice which was negative. He has continuously treated with saline, beudesonide and albuterol nebulizer treatments. The cough persists as well as the congestion. He has not fully recovered at this point but the pediatrician does not accept patients who do not vaccinate. We are reluctant to move forward as he is not recovered and shows signs of genetic inability to process vaccinations safely. Has developed heart murmur from increased respiratory distress according to cardiologist - 12/31/19
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site rash, Injection site swelling
Clinical narrative: 11/9/19 Patient woke up with a very swollen and red right thigh. He had a hard nodule under his skin at the injection site. He proceeded to develop a rash on his leg as well as on his face on the right side. THe rash began to worsen and progress. Over the course of the weeken the rash spread to his abdomen, chest, neck, both sides of his face, head and feet and legs. He began having sever gi symptoms, repeated vomiting, diarhea which caused him to fail to gain weight appropriately as this progressed for several weeks. We brought patient to Dr. several times for the rash, gastrointstinal issues. He also had extreme head pain. We thought he had an ear infection as he woke up out of a sleep several times screaming uncontrollablu holding his head. The doctor ruled out ear infection. We were referred to a dermatologis which we saw. This was scheduled by the pediatricians office. The dermatologist confirmed the the rash was due to a vaccine reaction and said to hold off on further vaccinating at this time until he is older and can verbalize symptoms as well as has a stronger immune system. He said the next reaction could result in the need for prednisone and could be anaphalactic or worse. That some children are not able to handle the vaccines and that we should consider the benefits/reactions and decide if it is worth continuing especially considering a family history of vaccine reactions on both sides of our family. In addition to this patient developed a terrible cough, respiratory distress and congestion. THis began within a week of the vaccines. He was tested for RSV twice which was negative. He has continuously treated with saline, beudesonide and albuterol nebulizer treatments. The cough persists as well as the congestion. He has not fully recovered at this point but the pediatrician does not accept patients who do not vaccinate. We are reluctant to move forward as he is not recovered and shows signs of genetic inability to process vaccinations safely. Has developed heart murmur from increased respiratory distress according to cardiologist - 12/31/19
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Middle insomnia, Rash, Respiratory distress, Respiratory syncytial virus test negative, Respiratory tract congestion
Clinical narrative: 11/9/19 Patient woke up with a very swollen and red right thigh. He had a hard nodule under his skin at the injection site. He proceeded to develop a rash on his leg as well as on his face on the right side. THe rash began to worsen and progress. Over the course of the weeken the rash spread to his abdomen, chest, neck, both sides of his face, head and feet and legs. He began having sever gi symptoms, repeated vomiting, diarhea which caused him to fail to gain weight appropriately as this progressed for several weeks. We brought patient to Dr. several times for the rash, gastrointstinal issues. He also had extreme head pain. We thought he had an ear infection as he woke up out of a sleep several times screaming uncontrollablu holding his head. The doctor ruled out ear infection. We were referred to a dermatologis which we saw. This was scheduled by the pediatricians office. The dermatologist confirmed the the rash was due to a vaccine reaction and said to hold off on further vaccinating at this time until he is older and can verbalize symptoms as well as has a stronger immune system. He said the next reaction could result in the need for prednisone and could be anaphalactic or worse. That some children are not able to handle the vaccines and that we should consider the benefits/reactions and decide if it is worth continuing especially considering a family history of vaccine reactions on both sides of our family. In addition to this patient developed a terrible cough, respiratory distress and congestion. THis began within a week of the vaccines. He was tested for RSV twice which was negative. He has continuously treated with saline, beudesonide and albuterol nebulizer treatments. The cough persists as well as the congestion. He has not fully recovered at this point but the pediatrician does not accept patients who do not vaccinate. We are reluctant to move forward as he is not recovered and shows signs of genetic inability to process vaccinations safely. Has developed heart murmur from increased respiratory distress according to cardiologist - 12/31/19
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Screaming, Skin reaction, Vaccination complication, Vomiting, Weight gain poor
Clinical narrative: 11/9/19 Patient woke up with a very swollen and red right thigh. He had a hard nodule under his skin at the injection site. He proceeded to develop a rash on his leg as well as on his face on the right side. THe rash began to worsen and progress. Over the course of the weeken the rash spread to his abdomen, chest, neck, both sides of his face, head and feet and legs. He began having sever gi symptoms, repeated vomiting, diarhea which caused him to fail to gain weight appropriately as this progressed for several weeks. We brought patient to Dr. several times for the rash, gastrointstinal issues. He also had extreme head pain. We thought he had an ear infection as he woke up out of a sleep several times screaming uncontrollablu holding his head. The doctor ruled out ear infection. We were referred to a dermatologis which we saw. This was scheduled by the pediatricians office. The dermatologist confirmed the the rash was due to a vaccine reaction and said to hold off on further vaccinating at this time until he is older and can verbalize symptoms as well as has a stronger immune system. He said the next reaction could result in the need for prednisone and could be anaphalactic or worse. That some children are not able to handle the vaccines and that we should consider the benefits/reactions and decide if it is worth continuing especially considering a family history of vaccine reactions on both sides of our family. In addition to this patient developed a terrible cough, respiratory distress and congestion. THis began within a week of the vaccines. He was tested for RSV twice which was negative. He has continuously treated with saline, beudesonide and albuterol nebulizer treatments. The cough persists as well as the congestion. He has not fully recovered at this point but the pediatrician does not accept patients who do not vaccinate. We are reluctant to move forward as he is not recovered and shows signs of genetic inability to process vaccinations safely. Has developed heart murmur from increased respiratory distress according to cardiologist - 12/31/19
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chills, Ear pain, Facial pain, Fatigue
Clinical narrative: Days 1-3: fatigue, aches, night sweats, chills, mild headache, nausea. Continuing for another week, started to have left ear and face pain, left nostril burning, insomnia, anxiety, 12/28 developed shingle or herpes leisons in l nostril! Saw primary care physician on 12/28, prescribed Valacyclclonir 1 gram every 8 hours. Only 2 doses, bad side effects. 12/30 lesions  healing but other effects still present! Developed vertigo on 1/5/2020, lasted 24 hours, headache, night sweats, fatigue, insomnia. Have not had elevated temp or cold symptoms. Just these others, very concerned about this! I have never had shingles before this vaccine!
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Insomnia, Nasal discomfort, Nausea
Clinical narrative: Days 1-3: fatigue, aches, night sweats, chills, mild headache, nausea. Continuing for another week, started to have left ear and face pain, left nostril burning, insomnia, anxiety, 12/28 developed shingle or herpes leisons in l nostril! Saw primary care physician on 12/28, prescribed Valacyclclonir 1 gram every 8 hours. Only 2 doses, bad side effects. 12/30 lesions  healing but other effects still present! Developed vertigo on 1/5/2020, lasted 24 hours, headache, night sweats, fatigue, insomnia. Have not had elevated temp or cold symptoms. Just these others, very concerned about this! I have never had shingles before this vaccine!
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pain, Skin lesion, Vertigo
Clinical narrative: Days 1-3: fatigue, aches, night sweats, chills, mild headache, nausea. Continuing for another week, started to have left ear and face pain, left nostril burning, insomnia, anxiety, 12/28 developed shingle or herpes leisons in l nostril! Saw primary care physician on 12/28, prescribed Valacyclclonir 1 gram every 8 hours. Only 2 doses, bad side effects. 12/30 lesions  healing but other effects still present! Developed vertigo on 1/5/2020, lasted 24 hours, headache, night sweats, fatigue, insomnia. Have not had elevated temp or cold symptoms. Just these others, very concerned about this! I have never had shingles before this vaccine!
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Injection site pain, Pregnancy test positive
Clinical narrative: took "two home pregnancy tests, and they both were positive"; her arm was sore at the injection site; her arm was sore at the injection site; This spontaneous prospective pregnancy report was received from a 27- year- old female patient, who was reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies. There were no concomitant medications.   On an unspecified date in July 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 18-DEC-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.   The patient's arm was sore at the injection site after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) administration in July 2019. On 18-DEC-2019, the patient's arm was sore at the injection site, after the second vaccination. The patient did not receive any treatment.  The patient became pregnant with last menstrual period (LMP ) of 20-NOV-2019 and estimated delivery date (EDD) of 26-AUG-2020 (dates calculated based on information, that at the moment of report gestation age was 4 weeks). The patient told the medical assistant, that she was one and a half weeks late on period, however the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered.  The pregnancy was confirmed by two home pregnancy tests performed on 18-DEC-2019, after the vaccination. Both showed positive result. No additional lab diagnostics were performed. The patient did not seek medical attention and was not hospitalized. The pregnancy outcome was pending. The fetal outcome was unknown. The outcome of injection site pain (onset date: July 2019) was not reported, the outcome of injection site pain (onset date: 18-DEC-2019) was recovering. The causality assessment between the events of injection site pain and the therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.   In 2016, the patient was inoculated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a physician for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 18-FEB-2015, the patient was inoculated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: 2 hours after receiving the Pneumococcal vaccine I had (extreme) pain 10 of 10 and could not use my Left arm. 4 days before I could take off shirt over my head and another 10 days before mostly full use
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: 11/30/19 @ 2am felt feverish and pain to left arm, red from shoulder to elbow and very swollen. 12/1/19 - left hand was swollen, arm more swollen and red 12/2 - 12/3/19 - Puffy, pink in color and itchy @ the site
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Pyrexia
Clinical narrative: 11/30/19 @ 2am felt feverish and pain to left arm, red from shoulder to elbow and very swollen. 12/1/19 - left hand was swollen, arm more swollen and red 12/2 - 12/3/19 - Puffy, pink in color and itchy @ the site
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported that his left leg was swollen and he was favoring it the night of the injection but she thought it was just sore from injection.  The next morning the child's left leg was more swollen, warmer that the right leg but there was no redness.   The child was seen and evaluated in the clinic and was prescribed Cleocin 195mg 3 times per day for 10 days but mother didn't pick it up due to the cost.  Mother reports that 2 days after the injection the swelling reduced.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Bruxism, Hyperhidrosis, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient stated that he was not fond of needles prior to injection.  After Td injection IM in L deltoid, patient stood up to walk out of door and stated " I better sit down for a minute".  Patient sat and immediately  lost consciousness for about 15-20 seconds total.  His body stiffened; jaw clenched and hands clenched to chest.  This nurse held him upright in the chair until he started sliding to the floor.  Allowed with assistance.  No injuries resulted.  Upon "coming to" patient was sweaty and pale.  Applied cool compress to forehead.  Patient arose and walked across room to a couch and lied down.  Gave water and a protein bar.  Patient stated his teeth hurt, top and bottom, from clenching.  BP 130/78.  Laid there resting for several minutes.  Discussed his fear of needles and the fact that he is not surprised  at his reaction to getting the injection.  Stated he felt better and was ready to return to work.  Advised to report any further changes and to lower to ground if he feels lightheaded again.  Verbalized understanding.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Toothache
Clinical narrative: Patient stated that he was not fond of needles prior to injection.  After Td injection IM in L deltoid, patient stood up to walk out of door and stated " I better sit down for a minute".  Patient sat and immediately  lost consciousness for about 15-20 seconds total.  His body stiffened; jaw clenched and hands clenched to chest.  This nurse held him upright in the chair until he started sliding to the floor.  Allowed with assistance.  No injuries resulted.  Upon "coming to" patient was sweaty and pale.  Applied cool compress to forehead.  Patient arose and walked across room to a couch and lied down.  Gave water and a protein bar.  Patient stated his teeth hurt, top and bottom, from clenching.  BP 130/78.  Laid there resting for several minutes.  Discussed his fear of needles and the fact that he is not surprised  at his reaction to getting the injection.  Stated he felt better and was ready to return to work.  Advised to report any further changes and to lower to ground if he feels lightheaded again.  Verbalized understanding.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: swelling, pain and reduced ROM of the R shoulder, redness, warmth and axillary Lymphadenopathy
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound Doppler normal
Clinical narrative: swelling, pain and reduced ROM of the R shoulder, redness, warmth and axillary Lymphadenopathy
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Musculoskeletal pain, Neck pain, Paraesthesia
Clinical narrative: tingle - nerve sensation;  in left arm from shoulder to fingers- stronger in fore arm and arm, over all surface of the arm. Also a little sore up left side on neck and left shoulder blade but No tingling in these two locations.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: Patient was given the oral rotavirus and in less than 30 seconds child developed hives. Doctor cancelled the rest of the vaccines and had patient come back on another day to get vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Metabolic function test, Nausea, Urine analysis, Vomiting
Clinical narrative: Nausea and vomiting. 24hrs later.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Mobility decreased, Swelling
Clinical narrative: Donor reported numbness, swelling and difficulty moving.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint stabilisation, Musculoskeletal pain
Clinical narrative: severe shoulder pain and immobilization
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Child developed redness around the site of injection on (R) thigh. Seen 1/9/2020 for cellulitis -> Keflex started.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Redness, swelling, itching Left upperarm. fever (low grade) Benadryl given Tx in office - cephalexin, Zyrtec
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Chills, Dysuria, Headache, Injection site pain
Clinical narrative: Pt statEs hE developed a headache, chEst pAIN, chills + pAIN @ immunization sitE. 2 days latER hE statEs hE had pain + burning with uRination X 1. 1200 - chEst pAIN, headache. 1800 - pAIN + swElling @ injEction sitE + developed chills. Chills off + on x 2 days Chest pAIN off + on x 1 day pAIN + SWElling to (R) dEltoid (inj. sitE) - 8 days Headache x 4 days. Pt did not REport to mEdical at time of incidEnt. Seen by PA on 1/8/20
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Pt statEs hE developed a headache, chEst pAIN, chills + pAIN @ immunization sitE. 2 days latER hE statEs hE had pain + burning with uRination X 1. 1200 - chEst pAIN, headache. 1800 - pAIN + swElling @ injEction sitE + developed chills. Chills off + on x 2 days Chest pAIN off + on x 1 day pAIN + SWElling to (R) dEltoid (inj. sitE) - 8 days Headache x 4 days. Pt did not REport to mEdical at time of incidEnt. Seen by PA on 1/8/20
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 67 years old female patient received a 0.5 ml dose of an expired Adacel vaccine, no AE; Based on additional information received on 29-Dec-2019, this case becomes medically confirmed.   Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 67 years old female patient who was vaccinated with an expired dose 0.5 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U5829AB and expiry date: 24-Nov-2019) via intramuscular route in the left arm on 03-Dec-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information received on 29-Dec-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.  Case became medically confirmed. No new information was received.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: patient received two 0.25mL Fluzone Quadrivalent doses on 13Nov2019 due to inadequate supply of Fluzone Quad 0.5 ml, no AE; Initial information received on 23-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 12 years old male patient who received 0.5 ml vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U6653BD and expiry date: 30-Jun-2020) via intramuscular route in the left arm, on 13-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong technique in drug usage process. It was reported that 12 year old patient received two 0.25mL Fluzone Quadrivalent doses on 13Nov2019 due to inadequate supply of Fluzone Quad 0.5mL.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: vaccination done accidentally to 14 years old patient-no ae; Initial information received on 26-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 14 years old female patient who accidentally received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Product administered to patient of inappropriate age).  Medical history, medical treatments, vaccinations and family history were not provided.   On an unknown date (today), the patient received a dose of suspect received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to product administered to patient of inappropriate age.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Caller stated that she received an AE for a patient who was 17 years old and received Flublok; Initial information received on 06-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female who received flublok (Product administered to patient of inappropriate age) of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Nov-2019, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to product administered to patient of inappropriate age.  It was reported that patient experienced adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The information on the batch number was requested.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Pityriasis rosea, Rash
Clinical narrative: within a day or few days after flu vaccine administration patient gradually developed rash to chest, abdomen, back, which reached peak 7 days after vaccination and has persisted to this day Jan 9, 2020: diagnosed as pityriasis rosea
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Bladder catheterisation, Blood test, Computerised tomogram, Constipation
Clinical narrative: My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dysstasia, Gait inability, Immunoglobulin therapy, Injury, Magnetic resonance imaging
Clinical narrative: My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Magnetic resonance imaging spinal abnormal, Mobility decreased, Muscular weakness, Myelitis, Pain
Clinical narrative: My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity, Plasmapheresis, Sensory loss, Urinary retention, Urinary tract infection
Clinical narrative: My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: X-ray
Clinical narrative: My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.
Age: 62.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bedridden, Constipation, Dysstasia, Magnetic resonance imaging spinal abnormal, Myelitis
Clinical narrative: My mother got her FLU vaccine on 10/29/19 and on 11/01/19, she started having severe pain to her hip radiating to her legs, right greater than the left around at noon time. Around at 08:00 pm she lost sensation and the ability to move to her hip and right leg. She also lost control of her bladder and bowel ending up with urinary retention and constipation. She also became weak to her left leg and also has diminished her sensation. On her MRI it shows she has myelitis in T2 section. She was given high dose IV steroids, IVIG and plasmapheresis. After these treatments she was transferred to Rehab for physical and occupational therapy. For urinary retention she was placed with urinary catheter ended up with UTI and was treated with antibiotics.  After these aggressive treatments she is still weak to her right leg resulting in in-ability to stand or walk by herself. She has to cath herself every 4-6 hrs to drain her urine out from the bladder and also, she is taking stool softener to soften her stool and to manually evacuate her stool. Till date she is still in Rehab and hasn't return back home after the injury.