chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given a flucelvax 0.25mg instead of the fluzone .5mg. We didn not have any state fluzone in stock at the time and that is why Dr. decided to have the child receive .25 of the flucelvax. I called the CDC and spoke to staff on 10/31/2019 he stated it was not harmful and often times can be ignored. Not a live vaccine. Patient does need to return for the fluzone .5mg because last year was her first dose but she only received one dose instead of two. Mom was notified baby was fine, no side effects and will bring her in for the fluzone.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Child developed a rash at the injection site. Reported it to me, the school nurse, the day after receiving her vaccine. Says that she did notice it yesterday evening as well. Area is red, warm, and slightly raised. Area affected is approx. 4 in by 3 in. No itching or systemic reaction. Area is sore. No other symptoms.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: 2 inch diameter red rash, hot to the touch and sore.  Patient is currently treating it with Ibuprofen and Allertec otc.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Flushing, Urticaria
Clinical narrative: Non severe hives on face with flushing. Continued until next day. Currently taking benadryl for symptoms
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Feeling cold, Pain, Sinus headache
Clinical narrative: chills, dizzy, weakness, body aches, sinus symptoms-Headache. Lasted for 3 days.   Consulted his family practice clinic on the 2nd day  and was prescribed Doxycycline.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Flu vaccine. Arm sore for days. Shoulder sore when moved a certain way.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash, Rash pruritic
Clinical narrative: Rash that itches burns; Rash that burns; Rash tender; tender when clothes touches it; This case was reported by a consumer and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2019, the patient received Shingrix. On 26th October 2019, 1 days after receiving Shingrix, the patient experienced itchy rash, burning sensation, painful rash and tenderness. On an unknown date, the outcome of the itchy rash, burning sensation, painful rash and tenderness were unknown.   It was unknown if the reporter considered the itchy rash, burning sensation, painful rash and tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On friday in the morning, the patient received Shingrix. On saturday in the afternoon, the patient experienced had a rash that itches burns and tender when clothes touches it. It was about an inch under the injection site. The patient asked whether she need to worry about the rash or could it be a small case of the shingles.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Tenderness
Clinical narrative: Area itches; Area sore to touch; This case was reported by a consumer and described the occurrence of localized itching in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On 24th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced localized itching and tenderness. On an unknown date, the outcome of the localized itching and tenderness were unknown.   It was unknown if the reporter considered the localized itching and tenderness to be related to Shingrix.  Additional details were provided as follows: On thursday before the reporting date, the patient received second shingle shot. The patient experienced area itched and sore to touch. The patient did not had his with first one.
Sex: F
Vaccine: VARZOS
Symptoms: Auditory nerve disorder, Hypersensitivity, Lumbar puncture, Magnetic resonance imaging, Malaise
Clinical narrative: Inflammation of the lining of the brain; Been sick; Inflamed auditory nerves; Extreme vertigo; hypersensitivity to her muscles; Muscle jerk; Quality of life has severely diminished; migraines; This case was reported by a consumer and described the occurrence of brain inflammation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced brain inflammation (serious criteria GSK medically significant), malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine were not recovered/not resolved.   It was unknown if the reporter considered the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, for the past 11 months from the date of reporting, the patient was sick. The patient also experienced inflammation of the lining of the brain and inflamed auditory nerves.  The patient also experienced extreme vertigo and hypersensitivity to her muscles to the point where her leg muscles jerk. The patient had to have trips to the hospital, underwent MRI's, spinal taps, concussion therapy and migraines, along with high doses of steroids before having any relief. At the time of reporting, it was 11 months and she is still having problems.  It was reported that, people should be warned  before giving them Shingrix that these were the possible side effects.  This has been life changing for her and her family. Her quality of life has severely diminished.      Lab Comments: on an unknown date, the patient underwent MRI's, spinal taps.
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Muscle spasms, Myoclonus, Noninfective encephalitis, Quality of life decreased
Clinical narrative: Inflammation of the lining of the brain; Been sick; Inflamed auditory nerves; Extreme vertigo; hypersensitivity to her muscles; Muscle jerk; Quality of life has severely diminished; migraines; This case was reported by a consumer and described the occurrence of brain inflammation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced brain inflammation (serious criteria GSK medically significant), malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine were not recovered/not resolved.   It was unknown if the reporter considered the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, for the past 11 months from the date of reporting, the patient was sick. The patient also experienced inflammation of the lining of the brain and inflamed auditory nerves.  The patient also experienced extreme vertigo and hypersensitivity to her muscles to the point where her leg muscles jerk. The patient had to have trips to the hospital, underwent MRI's, spinal taps, concussion therapy and migraines, along with high doses of steroids before having any relief. At the time of reporting, it was 11 months and she is still having problems.  It was reported that, people should be warned  before giving them Shingrix that these were the possible side effects.  This has been life changing for her and her family. Her quality of life has severely diminished.      Lab Comments: on an unknown date, the patient underwent MRI's, spinal taps.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Inflammation of the lining of the brain; Been sick; Inflamed auditory nerves; Extreme vertigo; hypersensitivity to her muscles; Muscle jerk; Quality of life has severely diminished; migraines; This case was reported by a consumer and described the occurrence of brain inflammation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced brain inflammation (serious criteria GSK medically significant), malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine were not recovered/not resolved.   It was unknown if the reporter considered the brain inflammation, malaise, auditory nerve disorder, vertigo, muscle spasm, myoclonus, quality of life decreased and migraine to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, for the past 11 months from the date of reporting, the patient was sick. The patient also experienced inflammation of the lining of the brain and inflamed auditory nerves.  The patient also experienced extreme vertigo and hypersensitivity to her muscles to the point where her leg muscles jerk. The patient had to have trips to the hospital, underwent MRI's, spinal taps, concussion therapy and migraines, along with high doses of steroids before having any relief. At the time of reporting, it was 11 months and she is still having problems.  It was reported that, people should be warned  before giving them Shingrix that these were the possible side effects.  This has been life changing for her and her family. Her quality of life has severely diminished.      Lab Comments: on an unknown date, the patient underwent MRI's, spinal taps.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin positive
Clinical narrative: Miscarriage. Bleeding started on 10/19/19 and tissue was passed 10/20/19.  EDD: 5/17/19, no previous pregnancy complications.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Arm very swollen, red, sore, and warm to touch
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Influenza like illness, Lip blister, Oral herpes
Clinical narrative: pt describes flu like symptoms for 2 days, excessive redness/swelling, as well as a cold sore/blister outbreak on lips and face.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: pt describes flu like symptoms for 2 days, excessive redness/swelling, as well as a cold sore/blister outbreak on lips and face.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain, Syringe issue
Clinical narrative: Patient stated that the individual administering the vaccine had difficulty pushing the plunger.  She developed 8/10 pain within 24 hours of the vaccination which persisted for several days.  Moderate level of pain then persisted for 2 weeks before she was seen.  On revaluation on 24 October she continued to have moderate pain, decreased ROM and pain with ROM, especially with flexion of the shoulder.   She has been treated with ibuprofen, home physical therapy exercise, ice and Medrol dose pack.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Feeling cold, Lethargy, Pyrexia
Clinical narrative: Patient experienced fever, chills, and lethargy for two days following the injection.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: patient presenting with left arm redness, swelling, warmth, tenderness at the reported site of the prevnar 13. symptoms reported by patient to have started right after the injection and have worsened. no drainage. no red streaks. area is firm to touch. was seen in office on 11/4/19, vaccines given in pharmacy on 10/29/19, records obtained from pharmacy, scanned into patient chart.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site warmth
Clinical narrative: patient presenting with left arm redness, swelling, warmth, tenderness at the reported site of the prevnar 13. symptoms reported by patient to have started right after the injection and have worsened. no drainage. no red streaks. area is firm to touch. was seen in office on 11/4/19, vaccines given in pharmacy on 10/29/19, records obtained from pharmacy, scanned into patient chart.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abnormal behaviour, Crying, Gastrointestinal disorder, Lethargy
Clinical narrative: Extreme lethargy, inconsolable crying, gastrointestinal issues for weeks, and behavioral changes.
Age: 46.0
Sex: F
Vaccine: HEP, TD
Symptoms: Blood urine present, C-reactive protein, Chills, Diarrhoea, Erythema
Clinical narrative: 9-29:  Reported to ER with red welt on arm that increased since administration, red area w/lump under it, red raised area upper left arm where shots given.  Per pt report, has felt flulike symptoms since 1st Hep B vaccine about 1 month prior.  She is getting series in order to qualify for job.  Some pain and redness at injection site and spread over past 2 days.  Only tried Benadryl cream on area.  ER gave pt hydrocortisone cream and advised ice to area and f/u with employee health.   Employee health referred pt to Allergy clinic.  10-3:  Allergy clinic noted at 1 week that pt still had local redness and tenderness at injection site, fever, chills, fatigue, diarrhea.  Assessed as type 3 hypersensitivity reaction.  Lab work ordered.  Possible serum sickness / local arthus reaction.  Steriods declined by pt.  Hep B likely culprit, but cannot rule out tetanus.  10-22:  Noted hematuria on UA and pt referred to urology for assessment.
Age: 46.0
Sex: F
Vaccine: HEP, TD
Symptoms: Fatigue, Haematuria, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 9-29:  Reported to ER with red welt on arm that increased since administration, red area w/lump under it, red raised area upper left arm where shots given.  Per pt report, has felt flulike symptoms since 1st Hep B vaccine about 1 month prior.  She is getting series in order to qualify for job.  Some pain and redness at injection site and spread over past 2 days.  Only tried Benadryl cream on area.  ER gave pt hydrocortisone cream and advised ice to area and f/u with employee health.   Employee health referred pt to Allergy clinic.  10-3:  Allergy clinic noted at 1 week that pt still had local redness and tenderness at injection site, fever, chills, fatigue, diarrhea.  Assessed as type 3 hypersensitivity reaction.  Lab work ordered.  Possible serum sickness / local arthus reaction.  Steriods declined by pt.  Hep B likely culprit, but cannot rule out tetanus.  10-22:  Noted hematuria on UA and pt referred to urology for assessment.
Age: 46.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site swelling, Mass, Pyrexia, Type III immune complex mediated reaction, Urticaria
Clinical narrative: 9-29:  Reported to ER with red welt on arm that increased since administration, red area w/lump under it, red raised area upper left arm where shots given.  Per pt report, has felt flulike symptoms since 1st Hep B vaccine about 1 month prior.  She is getting series in order to qualify for job.  Some pain and redness at injection site and spread over past 2 days.  Only tried Benadryl cream on area.  ER gave pt hydrocortisone cream and advised ice to area and f/u with employee health.   Employee health referred pt to Allergy clinic.  10-3:  Allergy clinic noted at 1 week that pt still had local redness and tenderness at injection site, fever, chills, fatigue, diarrhea.  Assessed as type 3 hypersensitivity reaction.  Lab work ordered.  Possible serum sickness / local arthus reaction.  Steriods declined by pt.  Hep B likely culprit, but cannot rule out tetanus.  10-22:  Noted hematuria on UA and pt referred to urology for assessment.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Fatigue, Injection site swelling, Nausea
Clinical narrative: swelling at injection site and pain with motion, then nausea,dizziness, fatigue on friday and saturday, arm began to itch and burn on sunday and on Monday patient applied triamcinolone ointment to the site. Tuesday a 1 inch by 5.5 inch welp appeared on the upper arm that is stinging and burning. patient has continued to take tylenol for the pain
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: swelling at injection site and pain with motion, then nausea,dizziness, fatigue on friday and saturday, arm began to itch and burn on sunday and on Monday patient applied triamcinolone ointment to the site. Tuesday a 1 inch by 5.5 inch welp appeared on the upper arm that is stinging and burning. patient has continued to take tylenol for the pain
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine; This spontaneous report was received from a physician and refers to an identifiable patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003865, expiration date 08-AUG-2020) (strength, route of administration and dose were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 32.5 Fahrenheit degrees (F) for 8 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Diagnosed as being "HPV positive"; This spontaneous report was received from a licensed practical nurse and refers to a 22-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 22-SEP-2019, the patient was diagnosed as being Human Papilloma Virus (HPV) positive.  The outcome of the event and the relatedness between the event and the suspect therapy were not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered expired VAQTA; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.      On 08-OCT-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # R021233, expiration date 05-SEP-2019 (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: received improperly stored VARlVAX; No adverse effect reported; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 24-SEP-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number: S005078, expiration date: 19-FEB-2021 or lot number: R019237, expiration date: 04-JUL-2020) for prophylaxis (exact dose and route of administration were not provided). varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.  The vaccine experienced temperature excursion from -14 degree Celsius to -10 degree Celsius (-9.74 degree Celsius). The previous temperature excursion was not reported. The digital data logger was involved.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: the patient was pregnant during the time of second dose of garadsilk 9; This spontaneous retrospective pregnancy report was received from a pharmacist regarding an approximately 19 year old female patient. The patient had no medical history, concurrent conditions and concomitant medications. On 11-MAY-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiry date were unspecified) (route of administration: intramuscular) to prevent HPV (human papilloma virus). On 11-JUN-2018, the patient received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiry date were unspecified). It was reported that the patient was pregnant when she received 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccine exposure during pregnancy). Estimated date of last menstrual period (LMP) was approximately to be 2018. No laboratory/diagnostic tests were performed. The patient gave birth to a healthy baby. The outcome of the event was reported as recovered.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Fatigue, Pain
Clinical narrative: Redness; Pain; Tiredness; Upset stomach; This case was reported by a consumer via sales rep and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. On 28th October 2019, 3 days after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the patient experienced erythema, pain and fatigue. On an unknown date, the outcome of the erythema, pain, fatigue and upset stomach were unknown.   It was unknown if the reporter considered the erythema, pain, fatigue and upset stomach to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced the redness, pain, tiredness and upset stomach. The patient asked if it is common to experience the upset stomach, three days after receiving the first shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red; Injection site swollen/ injection side be huge; Injection site painful; Injection site hot/warm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site warmth to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient inquired, how long should the injection side be huge, red, swollen, painful and hot or warm. The patient asked how long the side effects remains. The patient stated that will contact the physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: This case was reported by the physician on behalf of his wife. The age at vaccination was not reported. The reporter stated that the patient experienced pain at the injection site, lasting almost 2 months.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: Feverish; Achy; Headache; Stomach pains; Diarrhea; This case was reported by a consumer and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received Shingrix. On 30th October 2019, 1 days after receiving Shingrix, the patient experienced fever, pain, headache, stomach pain and diarrhea. On an unknown date, the outcome of the fever, pain, headache, stomach pain and diarrhea were unknown.   It was unknown if the reporter considered the fever, pain, headache, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was achy, feverish,  had a headache, stomach pain and diarrhea after reciving shingrix vaccine.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: golf ball - sized lymph node swelling in his right arm pit; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2019, the patient received the 2nd dose of Shingrix. On 26th October 2019, 1 days after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The reported stated that the patient experienced golf ball sized lymph node swelling in his right arm pit. No other symptoms reported. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache
Clinical narrative: severe headache; fatigue; This is a spontaneous report from a contactable healthcare professional via Pfizer sales professional. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization and meningococcal vaccine conj (MENINGOCOCCAL VACCINE) via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe headache and fatigue within an hour of vaccination with meningococcal group b rlp2086 and a MCV4 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained
Sex: U
Vaccine: PNC13
Symptoms: Abscess, Product administered at inappropriate site
Clinical narrative: abscess; administered pneumococcal 13 at patient buttocks; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for an immunisation. The patient medical history and concomitant medications were not reported. It was reported that the Doctor administered pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) at patients buttocks. Patient developed an abscess and ended up to the hospital. Patient was doing okay. The outcome of the event was recovering.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVNAR 13 may have played a contributory role in triggering the onset of abscess in the patient.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Laboratory test, Oxygen saturation decreased, Pneumonia bacterial, Pyrexia
Clinical narrative: got bacteria pneumonia last month and was in hospital for 5 days; got bacteria pneumonia last month and was in hospital for 5 days; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer Sponsored Program. An 81-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at the age of 74 (unit not provided), via an unspecified route of administration on an unspecified date in 2015 at single dose for preventing pneumonia, pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), via an unspecified route of administration on an unspecified date in 2016 at unspecified dose for preventing pneumonia. Medical history included A fib (atrial fibrillation) (diagnosed a year and a half ago, not on any medication), had heart issues in the past, and went to a heart doctor every year to have tests to make sure nothing else was going on, diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities (including diabetes). There were no concomitant medications. The patient got bacteria pneumonia last month and was in hospital for 5 days (as reported) on Sep2019 with outcome of recovering.  The patient got sick in Sep2019 and went on 07Sep2019 to the hospital where he stayed until 11Sep2019 (also reported as 07Sep2019 to 11Oct2019). The patient took flu shots and got other shots and went to doctors for all tests and got 6 months checkups. The patient started having a high fever and oxygen levels was going down. The patient went to the doctor and when the doctor saw the chest x-ray results for pneumonia he sent them and they went on to the hospital to have him treated. It had taken a toll on her husband and had taken a while for him to recover. He had a few issues with it and had been gradually getting better. He was given several antibiotics that he took for treatment, and breathing treatments as well. Several tests were made by a lung doctor to rule out and make sure that it was just pneumonia. Those tests came back fine. All of a sudden the patient's weight was going up again, though he lost about 12 pounds in the hospital. The patient's weight was gradually gaining it back. The patient spent 5 days at hospital. The times they received each vaccine was the only time they had received them since they thought they only had to do them one time each. The patient underwent lab tests and procedures which included chest X-ray: pneumonia on Sep2019.
Sex: M
Vaccine: PNC13
Symptoms: Weight increased
Clinical narrative: got bacteria pneumonia last month and was in hospital for 5 days; got bacteria pneumonia last month and was in hospital for 5 days; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer Sponsored Program. An 81-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at the age of 74 (unit not provided), via an unspecified route of administration on an unspecified date in 2015 at single dose for preventing pneumonia, pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), via an unspecified route of administration on an unspecified date in 2016 at unspecified dose for preventing pneumonia. Medical history included A fib (atrial fibrillation) (diagnosed a year and a half ago, not on any medication), had heart issues in the past, and went to a heart doctor every year to have tests to make sure nothing else was going on, diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities (including diabetes). There were no concomitant medications. The patient got bacteria pneumonia last month and was in hospital for 5 days (as reported) on Sep2019 with outcome of recovering.  The patient got sick in Sep2019 and went on 07Sep2019 to the hospital where he stayed until 11Sep2019 (also reported as 07Sep2019 to 11Oct2019). The patient took flu shots and got other shots and went to doctors for all tests and got 6 months checkups. The patient started having a high fever and oxygen levels was going down. The patient went to the doctor and when the doctor saw the chest x-ray results for pneumonia he sent them and they went on to the hospital to have him treated. It had taken a toll on her husband and had taken a while for him to recover. He had a few issues with it and had been gradually getting better. He was given several antibiotics that he took for treatment, and breathing treatments as well. Several tests were made by a lung doctor to rule out and make sure that it was just pneumonia. Those tests came back fine. All of a sudden the patient's weight was going up again, though he lost about 12 pounds in the hospital. The patient's weight was gradually gaining it back. The patient spent 5 days at hospital. The times they received each vaccine was the only time they had received them since they thought they only had to do them one time each. The patient underwent lab tests and procedures which included chest X-ray: pneumonia on Sep2019.
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Feeling abnormal
Clinical narrative: Felt like he was in outer space; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization, influenza vaccine inact split virion 4v (FLUARIX QUADRIVALENT), via an unspecified route of administration on an unspecified date at unknown dose for immunization. The patient's medical history was not reported. Concomitant medication included patient also stated that he was on several pharmaceuticals. It was reported that the patient felt like he was in outer space on an unspecified date after receiving pneumococcal 13-val conj vac (dipht crm197 protein) and influenza vaccine inact split virion 4v. The outcome of event was unknown.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Lip swelling, Urticaria
Clinical narrative: pt went to the ER stating having hives, difficulty breathing, and swollen lips. ER gave pt benadryl. pt will be taking benadryl for couple of days and as of 11.5 pt is feeling much better. ER md and pt are not sure if this was due to the flu shot
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nerve injury, Neuralgia, Paraesthesia
Clinical narrative: Patient experienced pain at time of injection and pain at injection site. He described feeling like it hit a nerve. Over time the tingling has subsided but he still experiences pain with the nerve a year later.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Clients states at 4:00 pm on 11/4/19 headache that was not resolved with Tylenol.  At 11:00 pm through the next morning  client vomited x3.  Headache continues and now nausea. Call received from client at aprox.. 9:30 on  11/5/19.  Nurse spoke with provider and information relayed to client to seek attention with urgent care or her provider for the nausea.  Client advised headache may be a side affect from the vaccine.  Site of immunization injection has no redness/swelling or irritation.  Client verbalized to nurse no other symptoms exist at this time.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: RASH ON CHEST
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Muscle spasms, Pain
Clinical narrative: Chills, Spasm, Aches  Do not know connection but with prescription chough medicine resulted in a over night hospital stay
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Bursitis, Pain in extremity, Ultrasound scan
Clinical narrative: Left arm pain, bursitis treated with cortisone shot.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pityriasis rosea, Pruritus, Pyrexia
Clinical narrative: Low grade fever, Pityriasis rosea rash on back neck, torso. Patient reporting itching, no pain.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Skin surrounding injection site noted to become dark pink, warm and firm to touch. Patient denied any pain to the area
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Subjective: Patient is here for rash for 2-3 weeks. It initially started the same night as she received her flu shot. Started on neck, then back, arms. It has mostly resolved but she now has some on her upper forehead.  Previously tolerated influenza vaccine without any issues. No signs of anaphylaxis, no throat/oral swelling, wheezing, SOB, or hive-like rash. Rash described as tiny small bumps, fairly itchy. Not painful. Exposure to new foods, soaps, detergents, or skin care products: No Recent viral symptoms: No MRSA history: No prior history of MRSA or other serious infections. ROS: Has not had fever, rash, cough, difficulty breathing, vomiting, diarrhea or dehydration concerns.  PMHx: Generally healthy since birth, no chronic health problems.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Reaction started the night patient received the Shingrix shot, 10/03/19 and lasted until Monday, Oct 7th.  She had a real high fever, arm swollen to the size of grapefruit where she received shot and was red and painful.  Swelling and pain have gone down.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperaesthesia, Lymphadenopathy, Pain, Pain in extremity, Swelling
Clinical narrative: Swollen lymph node under left armpit. Painful when moving arm and sensitive to the touch. Swelling lasted 4 days. No over the counter or prescription medications were taken for the symptoms.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rash erythematous
Clinical narrative: RED RASH ON BOTH ARMS
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Pt came in 7 days after injection with redness below site of injection that wrapped almost completely around arm.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray, Chills, Cough, Fatigue, Headache
Clinical narrative: Symptoms include fever, chills, muscle aches, cough, congestion, runny nose, headaches, and fatigue and sore throat.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Myalgia, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Symptoms include fever, chills, muscle aches, cough, congestion, runny nose, headaches, and fatigue and sore throat.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Rhinorrhoea
Clinical narrative: Symptoms include fever, chills, muscle aches, cough, congestion, runny nose, headaches, and fatigue and sore throat.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient insisted in getting both injections in the same arm, despite my recommendation against it, and experienced redness and pain at injection site
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Injection site red erruption, arm soreness, itchiness, warm to touch,
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm very red, swollen, hot to the touch, clear line of demarcation between swollen and non-swollen areas
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Soreness and swelling at injection site,fever 100.2, chills, dry heaves, headache, body aches, fatigue, thirst. All occurred the same days as vaccination - lasted the rest of the day and the next day.  All gone by the third day.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Retching, Thirst
Clinical narrative: Soreness and swelling at injection site,fever 100.2, chills, dry heaves, headache, body aches, fatigue, thirst. All occurred the same days as vaccination - lasted the rest of the day and the next day.  All gone by the third day.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Patient reported small Macopapular rash that extended from elbow down to wrist of left arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient experienced a mild case of shingles even though she was administered 2 shots of Shingrix
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Pain
Clinical narrative: PAIN AFTER INJECTION THAT RAIDATES DOWN TO WRIST AND UNDER ARMPIT,  PAIN WITH MOVEMENT
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: The patient's arm swelled up and became very red.  It was warm to the touch and the spot was from the shoulder down to the forearm region of her right arm.  The patient went to her doctor's office on Saturday (11/02/19) and was give scripts of prednisone and keflex because to them it looked more like a case of cellulitis instead of an adverse reaction to the vaccine.  The patient wasn't convinced of their diagnosis and didn't take the antibiotic.  She did take the prednisone and when counseled asked for me to report the event.   Upon speaking with the patient today at 1pm, she stated that her arm was back to normal..
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Electroencephalogram normal, Feeling abnormal, Headache, Immediate post-injection reaction, Magnetic resonance imaging normal
Clinical narrative: Immediately after receiving the shot, my son complained about a headache and "not feeling right." He went back to school, but as he came home the same afternoon he said he still did not feel well. We decided to go to hockey practice that evening and "sweat it out." Looking off and sluggish the entire practice, his head slumped forward in the car on the way home. This was his first seizure. It is now around 7,20 p.m. the same day he received Gardasil 9. He is still suffering from these seizures to this day.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Malaise, Posture abnormal, Seizure, Sluggishness
Clinical narrative: Immediately after receiving the shot, my son complained about a headache and "not feeling right." He went back to school, but as he came home the same afternoon he said he still did not feel well. We decided to go to hockey practice that evening and "sweat it out." Looking off and sluggish the entire practice, his head slumped forward in the car on the way home. This was his first seizure. It is now around 7,20 p.m. the same day he received Gardasil 9. He is still suffering from these seizures to this day.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Myalgia
Clinical narrative: MUSCLE SORENESS ON RIGHT ARM
Age: 60.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Bone pain, Lymphadenopathy, Pain in extremity
Clinical narrative: PATIENT stated very sore arm that extended down to her wrist over a number of days. she stated that "her bones hurt" and that she had swelling under her arm (in lymph node area). She said that the reaction subsided over a number of weeks.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Product administered at inappropriate site, Sleep disorder
Clinical narrative: the patient states that she felt a "pop" when the shot was given high in the upper arm.  Her arm hurts when she lifts her arm or rotates her arm. She wakes up at night with arm pain.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Loss of personal independence in daily activities, Pain, Rash pruritic
Clinical narrative: Had fatigue and generalized body aches.  Developed an itchy rash that started on her face and spread to her scalp chest, trunk and bilateral arms. She was off of work for one week and was treated with Cephalexin to prevent any secondary infection.  Was given a mask to wear during contagious period.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Erythema, Pain, Rash
Clinical narrative: Rash, red, swollen, weak, pain, sleepy Loss of appetite
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Swelling
Clinical narrative: Rash, red, swollen, weak, pain, sleepy Loss of appetite
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; one dose of improperly stored MMR II as inadvertenlty administered to the one patient; This spontaneous report as received from a medical assistant refers to a 12-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # R028003, expiration date 01-OCT-2020, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided), which was reconstituted with properly stored sterile diluent. The vaccine was exposed to temperature of 52 degrees Fahrenheit for 10 hours. The call was made because of digital data logger. There were no previous temperature excursion. There were no adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Peripheral swelling, Pruritus
Clinical narrative: Arm is swollen; Arm feels heavy; Arm is itching bad; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced swelling arm, heaviness in arm and itchy upper limbs. On an unknown date, the outcome of the swelling arm, heaviness in arm and itchy upper limbs were unknown.   It was unknown if the reporter considered the swelling arm, heaviness in arm and itchy upper limbs to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination had arm swelling, felt heavy and itching bad. The patient asked whether to consult a physician.