chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient reported severe redness 4 days after the vaccine was given - the redness was lower than where the vaccine was injected. Patient reports it has gotten better. It is not bothering her, but if it was she could take some Benadryl. I advised the patient that if it does not get better in the next day or two, to contact MD.
Age: 2.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Capillary nail refill test, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: The area of induration started last night. The area is a 4.5 x 6 inch erythematous lesion on the right upper anterior thigh, slightly swollen, no significant warmth, good capillary refill of Right toes, +2 dorsalis pedis pulse. To use cool & warm compresses, Benadryl prn
Age: 2.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Skin lesion
Clinical narrative: The area of induration started last night. The area is a 4.5 x 6 inch erythematous lesion on the right upper anterior thigh, slightly swollen, no significant warmth, good capillary refill of Right toes, +2 dorsalis pedis pulse. To use cool & warm compresses, Benadryl prn
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reported on 3/20/2020 that a few weeks after his immunization on 2/3/2020 that he had a rash on the injection site and on the opposite shoulder.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or 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. On or about 20-JAN-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-FEB-2012, patient was treated by a healthcare provider for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. She was prescribed ibuprofen and valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-APR-2016, patient was treated by a healthcare provider for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse symptoms reported; patient was inadvertently administered one dose of VARIVAX four days past its labeled expiry; This spontaneous report was received from a nurse and refers to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-MAR-2020, the patient was inadvertently vaccinated with one dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R007695, expiration date 14-MAR-2020, subcutaneous (dose was not reported) for prophylaxis. Concomitant therapies included sterile diluent. The suspect vaccine was four days past its labeled expiry. No additional adverse symptoms reported. The outcome of expired product administered and was unknown.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Incorrect route of product administration, Paraesthesia, Swelling
Clinical narrative: Burning and tingling immediately after injection; burning and tingling immediately after injection/ tingling throughout the right arm and fingers; developed redness and swelling; developed redness and swelling; Patient received Shingrix back of right arm, maybe subcutaneous; This case was reported by a other health professional via sales rep and described the occurrence of burning sensation in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2020, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, immediately after receiving Shingrix, the patient experienced burning sensation, tingling of extremity, erythema, swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the burning sensation, erythema, swelling and intramuscular formulation administered by other route were unknown and the outcome of the tingling of extremity was not recovered/not resolved.   The reporter considered the burning sensation, tingling of extremity, erythema and swelling to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix back of right arm, maybe subcutaneous, which led to intramuscular formulation administered by other route. The patient complained of burning and tingling immediately after injection, also developed redness and swelling. After 2 week follow up patient was still experiencing tingling throughout the right arm and fingers. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: The next day Jan 6, I had a low-grade fever and chills with fatigue, requiring a mid-day nap.  This resolved on its own after taking ibuprofen.  The next week on Jan 12, I woke to an outbreak of pox like vesicles on my right side.  It took about a couple of weeks to resolve and they did so on there own.  They were sore but not painful.  Periodically, since  I continue to have pox like vesicles appear on my arms, breast, legs, and torso.    Additionally, my axillary lymph nodes swell and are painful with red spots that are visible to see but no vesicles periodically.  Today on March 20, I have a vesicle on my lower abdomen and back of my leg.  My lymph nodes in other parts of my body do not swell nor are they painful.  I am a clinician with over 30 years in healthcare and now a professor, I have pulled as much data as I can, from my health science library and have not seen any documentation on this type of reaction from the shingrix vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash macular
Clinical narrative: The next day Jan 6, I had a low-grade fever and chills with fatigue, requiring a mid-day nap.  This resolved on its own after taking ibuprofen.  The next week on Jan 12, I woke to an outbreak of pox like vesicles on my right side.  It took about a couple of weeks to resolve and they did so on there own.  They were sore but not painful.  Periodically, since  I continue to have pox like vesicles appear on my arms, breast, legs, and torso.    Additionally, my axillary lymph nodes swell and are painful with red spots that are visible to see but no vesicles periodically.  Today on March 20, I have a vesicle on my lower abdomen and back of my leg.  My lymph nodes in other parts of my body do not swell nor are they painful.  I am a clinician with over 30 years in healthcare and now a professor, I have pulled as much data as I can, from my health science library and have not seen any documentation on this type of reaction from the shingrix vaccine.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash
Clinical narrative: rash over left arm, neck, shoulder
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Swelling
Clinical narrative: general swelling, induration of approx. 50mm, pain with movement and painful to touch. Informed by MD as well as Medical Assistant who administered the vaccine that it would be painful .   With that said, yes it was that and a WHOLE lot more.  There should be some other additive  or solution that should be used to prevent such a reaction and pain.  This vaccine is set out for the elderly and with reduced muscle mass and increased tenderness , it will be no wonder if people do not get the second one.  Some may not even get it at all if they take the advice of someone who did get it.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: PATIENT EXPERIENCED REDNESS AND SWELLING EVENING AFTER  RECEIVING. SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH CELLULITIS, WAS PRESCRIBED ANTIBIOTIC.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: On 3/9/2020  developed severe itching, redness and swelling of his entire left upper arm. He was treated with benedryl for symptoms and the reaction resolved after 6 days.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Nurse reported the patient had a urine pregnancy test done on 3/10/2020 after the third GARDASIL 9 dose was administered which was positive; the patient was administered the fist dose ofGARDASIL 9 on 1/14/2016 and was administered the second dose ofGARDASIL 9 on 3/14/2016 and was administered the third dose ofGARDASIL 9 on 3/10/2020/had a urine pregnancy test done on 3/10/2020 which was p; the patient was administered the first dose of GARDASIL 9 on 1/14/2016 and was administered the second dose of GARDASIL 9 on 3/14/2016 and was administered the third dose of GARDASIL 9 on 3/10/2020; This initial spontaneous prospective pregnancy report as received from a registered nurse refers to a currently 15-year-old female patient. She did not have a pertinent medical history. She had an allergy to pollen. Concomitant therapies included polyethylene glycol 3350 (MIRALAX) and loratadine (CLARITIN). This report concerned 1 patient and 1 combination product.  On 14-JAN-2016, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot number K011325, expiration date 08-APR-2017. On 14-MAR-2016, she was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot number K011325, expiration date 08-APR-2017, and on 10-MAR-2020, she was vaccinated with a third dose of  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, intramuscularly, lot number 1637641, expiration date 16-FEB-2022 (exact doses and anatomical location of administration were not reported) as prophylaxis (reported as finish the series). On 10-MAR-2020, after the third dose of vaccine, the patient had an urine pregnancy test done, which was positive. Her last menstrual period (LMP) was on 17-FEB-2020 and the estimated date of delivery (EDD) was on 23-NOV-2020. The patient was provided counseling and a referral to obstetrics (OB) (also reported that the patient did not sought a medical attention). The pregnancy outcome was pending. The fetal outcome was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp., devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; a shipment of PNEUMOVAX 23 was due to be delivered on 26-FEB-2020 but was not delivered until 27-FEB-2020; This initial spontaneous report was received from a nurse, referring to a patient of unknown age and gender. This case concerns 1 patient and 1 combination product. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 05-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route of administration and vaccination scheme were not reported; lot number S029542, expiration date 10-JUN-2021) as prophylaxis. The vaccine was supposed to be delivered on 26-FEB-2020, but was not delivered until 27-FEB-2020 (product distribution issue). The patient experienced no symptoms.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA004890:
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Hemiparesis, Hypoaesthesia, Transient ischaemic attack
Clinical narrative: left cerebral hemispheric stoke; transient ischemic attack; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. On or about 09-FEB-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient suffered left sided numbness and weakness. The patient was hospitalized and diagnosed with left cerebral hemispheric stroke and transient ischemic attack. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered/not resolved. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, left cerebral hemispheric stroke and transient ischemic attack were considered to be medically significant. Left cerebral hemispheric stroke and transient ischemic attack were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 03-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-JAN-2015, patient was treated by a healthcare provider for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or 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 12-NOV-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) at a pharmacy, for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 11-MAR-2016, patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. Patient was prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel really bad today; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2020, the patient received Shingrix. On 4th March 2020, 1 days after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received vaccine and felt really bad on the day of reporting.  The patient wanted to knowhow long did the side effects usually last. This was 1 of the 5 cases, reported by same reporter.
Sex: F
Vaccine: PNC13
Symptoms: Renal failure, Wrong product administered
Clinical narrative: renal failure; The patient was given another Prevnar 13/ instead of receiving pneumovax 23; This is a spontaneous report from a contactable physician.   An adult female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose in Aug2018 for immunisation.   The patient medical history included renal transplant. The concomitant medications were not reported.  The patient received the 1st dose of PREVNAR 13 at single dose on 26Jul2018 for immunisation.   The patient experienced renal failure on an unspecified date.  The patient received 2 PREVNAR 13 injections by accident 2 yrs before this report. Since she was a renal transplant patient, the schedule for the pneumovax is different. The patient was to receive a Prevnar 13 and then Pneumovax 23. The patient was seen two years ago. The patient was seen 26Jul2018. The immunization with Prevnar 13 was administered with instructions to come back after 4 weeks for the Pneumovax 23. She was scheduled the following month in Aug2018. The patient was given instead another Prevnar 13. The physician wanted to know if the Pneumovax 23 can be given on next Monday (23Mar2020) when the patient will be seen. The outcome of events was unknown.    Information on the lot/ batch number has been requested.; Sender's Comments: There is no reasonable possibility that the event renal failure was related to pneumococcal 13-valent conjugate vaccine. This is more likely associated with the underlying history of renal transplant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a clinic.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated in a health center, for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site rash, Rash pruritic
Clinical narrative: Patient called the pharmacy and reported an itchy rash at injection site and blister on back.  The patient said that he contacted the primary MD  but she did not recommend any treatment to patient other than to not receive the second vaccine.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash on left upper arm where injection was given; developed 3/18/2020.  Red, itchy, painful.  Slightly raised.  Looks like hives.  Had fever the other day but feels fine today. Advised to contact PCP should rash worsen and ER if trouble breathing.  Advised to try Benadryl cream for itchiness & Ibuprofen or Tylenol for discomfort.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Rash on left upper arm where injection was given; developed 3/18/2020.  Red, itchy, painful.  Slightly raised.  Looks like hives.  Had fever the other day but feels fine today. Advised to contact PCP should rash worsen and ER if trouble breathing.  Advised to try Benadryl cream for itchiness & Ibuprofen or Tylenol for discomfort.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Per patient, he has had shoulder pain since the first injection.  He got a second injection of Shingrix 10/8/19.  He says he has needed physical therapy for that arm.  His son suggested he get the name of the manufacturer to report this to them.  We have reported it internally at pharmacy.  Our pharmacists are thoroughly trained to ALWAYS have both patient and pharmacist seated to ensure proper placement into to deltoid muscle.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Per patient, he has had shoulder pain since the first injection.  He got a second injection of Shingrix 10/8/19.  He says he has needed physical therapy for that arm.  His son suggested he get the name of the manufacturer to report this to them.  We have reported it internally at pharmacy.  Our pharmacists are thoroughly trained to ALWAYS have both patient and pharmacist seated to ensure proper placement into to deltoid muscle.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Tenderness
Clinical narrative: On date indicated after shot, I developed a shingles-like rash on my upper left abdomen.  It was tender to the touch but not painful.  Lasted 24 hours.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Per patients husband, patient's arm started to hurt after the Shingrix shot given 10/8/19.  This was the 2nd dose in the series.  The first shot did not cause pain.  However, the 2nd dose has given her a sore arm.  The pharmacists are thoroughly trained to make sure both patient and pharmacist are seated for ALL vaccinations to be sure to administer vaccine into the deltoid muscle.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Neck pain
Clinical narrative: Per patients husband, patient's arm started to hurt after the Shingrix shot given 10/8/19.  This was the 2nd dose in the series.  The first shot did not cause pain.  However, the 2nd dose has given her a sore arm.  The pharmacists are thoroughly trained to make sure both patient and pharmacist are seated for ALL vaccinations to be sure to administer vaccine into the deltoid muscle.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Electromyogram, Hypoaesthesia, Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Malaise
Clinical narrative: Pain and tingling in legs mostly. Sometimes pain in my arms and hands as  well.  Started as pain in both legs followed by numbness and then twitching started in both legs.  Visible twitching.  Malaise, general feeling of being sick.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Muscle twitching, Pain in extremity, Ultrasound scan
Clinical narrative: Pain and tingling in legs mostly. Sometimes pain in my arms and hands as  well.  Started as pain in both legs followed by numbness and then twitching started in both legs.  Visible twitching.  Malaise, general feeling of being sick.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles after receiving the first dose of the Shingrix vaccine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Acute respiratory failure, Anaphylactic reaction, Atrial fibrillation, Cardioversion, Condition aggravated
Clinical narrative: At 2pm, while driving on freeway, patient could not breathe.  Patient got off the freeway and called 911; they intubated her on the spot.  Patient taken to Medical Center; and was hospitalized for 9 days--discharged on 10/26.  Patient diagnosis was anaphylaxis, acute respiratory failure, and Takotsubo cardiomyopathy (broken heart syndrome).  After discharge patient followed up with PCP (Dr.) and cardiologist (Dr.). Went into AFib, so had 2 visits to hospital (Hospital) both ER and hospital3 days. Patient had a cardio eco also. Patient was cardioverted twice in this facility. Patient had had several hospital visits to hospital. On 12/20 had a visit because of slight Pneumonia; patient was given prescription for antibiotics.  On 2/18 patient was cardioverted in same facility before going back. Before vaccine, patient had not had AFib for 2.5 years. AFib-wise, patient has been doing well since last procedure.  Patient has been in contact with PCP over the phone and has not been able to go to the cardiologist because of Coronavirus. Patient shakes all the time; never did that before vaccine. Patient has also lost a lot of weight since then.  Three years ago, patient had breathing problems when received the Flu vaccine; the adverse events were just slight so vaccine was not contraindicated.  Patient received Flu vaccine in 10/17 because deceased son had cancer and did not want to compromise him.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Echocardiogram, Endotracheal intubation, Pneumonia, Stress cardiomyopathy
Clinical narrative: At 2pm, while driving on freeway, patient could not breathe.  Patient got off the freeway and called 911; they intubated her on the spot.  Patient taken to Medical Center; and was hospitalized for 9 days--discharged on 10/26.  Patient diagnosis was anaphylaxis, acute respiratory failure, and Takotsubo cardiomyopathy (broken heart syndrome).  After discharge patient followed up with PCP (Dr.) and cardiologist (Dr.). Went into AFib, so had 2 visits to hospital (Hospital) both ER and hospital3 days. Patient had a cardio eco also. Patient was cardioverted twice in this facility. Patient had had several hospital visits to hospital. On 12/20 had a visit because of slight Pneumonia; patient was given prescription for antibiotics.  On 2/18 patient was cardioverted in same facility before going back. Before vaccine, patient had not had AFib for 2.5 years. AFib-wise, patient has been doing well since last procedure.  Patient has been in contact with PCP over the phone and has not been able to go to the cardiologist because of Coronavirus. Patient shakes all the time; never did that before vaccine. Patient has also lost a lot of weight since then.  Three years ago, patient had breathing problems when received the Flu vaccine; the adverse events were just slight so vaccine was not contraindicated.  Patient received Flu vaccine in 10/17 because deceased son had cancer and did not want to compromise him.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Weight decreased
Clinical narrative: At 2pm, while driving on freeway, patient could not breathe.  Patient got off the freeway and called 911; they intubated her on the spot.  Patient taken to Medical Center; and was hospitalized for 9 days--discharged on 10/26.  Patient diagnosis was anaphylaxis, acute respiratory failure, and Takotsubo cardiomyopathy (broken heart syndrome).  After discharge patient followed up with PCP (Dr.) and cardiologist (Dr.). Went into AFib, so had 2 visits to hospital (Hospital) both ER and hospital3 days. Patient had a cardio eco also. Patient was cardioverted twice in this facility. Patient had had several hospital visits to hospital. On 12/20 had a visit because of slight Pneumonia; patient was given prescription for antibiotics.  On 2/18 patient was cardioverted in same facility before going back. Before vaccine, patient had not had AFib for 2.5 years. AFib-wise, patient has been doing well since last procedure.  Patient has been in contact with PCP over the phone and has not been able to go to the cardiologist because of Coronavirus. Patient shakes all the time; never did that before vaccine. Patient has also lost a lot of weight since then.  Three years ago, patient had breathing problems when received the Flu vaccine; the adverse events were just slight so vaccine was not contraindicated.  Patient received Flu vaccine in 10/17 because deceased son had cancer and did not want to compromise him.
Age: 58.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Musculoskeletal disorder, Pain, Skin warm
Clinical narrative: Patient stated that experienced significant pain near the injection site (about 5 inches below the shoulder the very morning after receiving the vaccine. She described it as a dull ache and the pain was very constant (pain intensified when using that arm directly, could hardly lift anything or use it). The patient reported to the pharmacy 2 days after the vaccination (48 hours had elapsed) to report this. The area was still visibly very red and hot to the touch, a mostly circular pattern roughly 4 inches in diameter with the addition of a line extending outward.  Patient had not taken any medication, Benadryl was recommended to her to start, if no improvement she should visit an urgent care for follow-up.
Age: 32.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: PATIENT CAME UP TO THE PHARMACTY ON 03/19/20 AND REPORTED ARM HURTING AT SITE OF INJECTION AND RED. SHE ALSO STATED THAT THE ARM HURTS A LITTLE WHEN MOVING AND IS SLIGHTLY SWOLLEN AT INJECTION SITE AND IT STARTED THAT MORNING AT 10AM .  tHE VAERS SITE CRASHED LAST NIGHT SO i COULDN'T COMPLETE THE REPORT.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever after 1 week. Rash after 10 days.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: At 4:00am I developed a nasty headache and generally felt awful.  Felt very low on energy that day and spent half the day in bed.  The next day, today, I still feel below normal and am unable to do work requiring much physical effort.  I suspect tomorrow I will be back to normal.  No medical professional was contacted.  I did not feel like I had a fever, and did not take my temperature.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood pressure increased, Chest discomfort, Dysstasia
Clinical narrative: Gave shot, she sat timer for 20 minutes to watch for adverse reactions but then went to sit in car. she said her chest got tight and her hips hurt and she noticed she could not stand up. Her friend came to pharmacy and got me and I took the emergency kit outside to her car. When I got out there she stated she was much better and wanted no treatment from me. I called the ambulance on the way out to her car and when they arrived she refused to go. The EMT's took her in the ambulance and took her blood pressure. They said it was slightly elevated and she was up and walking and told me she was fine, probably just got nervous. She then drove herself home.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea,  fever
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Localised oedema
Clinical narrative: & LOCALIZED EDEMA
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Asthenia, Headache, Presyncope
Clinical narrative: Pt had a pre-syncopal episode after the vaccinations. Pt was put in a supine position with his legs up. Pt given sips of water. Pt reported a headache. BP at 10:04 was 89/52 HR 65. At 10:15 His BP was 99/63 HR: 65. 10:25 BP 105/63 HR 66. Pt was feeling better and was instructed to sit up. 10:35 BP was 97/69 HR: 70. PT was given more water to drink and pretzels to eat. 10:49 BP was 101/66 HR: 58. By 11:10 PT was feeling much better. His energy picked up and he walked to the bathroom. BP 95/57 HR:67. Pt walked out of the office unassisted and without incident.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: & INJECTION SITE PAIN
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Angioedema
Clinical narrative: Angioedema
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Pain, Pain in extremity
Clinical narrative: very Low energy later in day after shot. Very slight headache. No energy all Next day (unlike Me) "zapped" of course arm very sore. Hurt to lift it outward. Better in couple of days
Age: 1.08
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness, swelling, hard lump, bruising  started ~ 12 hrs after injection, worsened  by day 2 at Prevnar site  Treatment - marked redness with skin marker  Ice & Ibu/Tylenol if bothering pt.
Age: 31.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Back pain, Chills, Decreased appetite, Fatigue, Immediate post-injection reaction
Clinical narrative: Immediate pain and tenderness right after injections. The next morning after the injections and continuing for each day ever since then I am unable to lift arm, even leaving my arm by my side causes more pain, it is very hot to the touch not just where the injections were placed but also a big area surrounding, redness not just where the vaccine was injected also a big area surrounding the injection site, I am in much more pain now than I was right after the injections, my entire upper arm area is really hard to the touch like a rock, the area of arm that it still so tender that a t-shirt rubbing against my skin hurt makes it hurt even worse that I want to cry and that has continued since the morning after the injections, migraines, neck and back hurting much more than usual, fever, chills, loss of appetite, tiredness, a knot that feels like a round ball in my clavicle on the left side. The pain isn't just on my arm  in the big area surrounding the injections site it also extends up through my shoulder and neck.
Age: 31.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Neck pain
Clinical narrative: Immediate pain and tenderness right after injections. The next morning after the injections and continuing for each day ever since then I am unable to lift arm, even leaving my arm by my side causes more pain, it is very hot to the touch not just where the injections were placed but also a big area surrounding, redness not just where the vaccine was injected also a big area surrounding the injection site, I am in much more pain now than I was right after the injections, my entire upper arm area is really hard to the touch like a rock, the area of arm that it still so tender that a t-shirt rubbing against my skin hurt makes it hurt even worse that I want to cry and that has continued since the morning after the injections, migraines, neck and back hurting much more than usual, fever, chills, loss of appetite, tiredness, a knot that feels like a round ball in my clavicle on the left side. The pain isn't just on my arm  in the big area surrounding the injections site it also extends up through my shoulder and neck.
Age: 31.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Nodule, Pyrexia
Clinical narrative: Immediate pain and tenderness right after injections. The next morning after the injections and continuing for each day ever since then I am unable to lift arm, even leaving my arm by my side causes more pain, it is very hot to the touch not just where the injections were placed but also a big area surrounding, redness not just where the vaccine was injected also a big area surrounding the injection site, I am in much more pain now than I was right after the injections, my entire upper arm area is really hard to the touch like a rock, the area of arm that it still so tender that a t-shirt rubbing against my skin hurt makes it hurt even worse that I want to cry and that has continued since the morning after the injections, migraines, neck and back hurting much more than usual, fever, chills, loss of appetite, tiredness, a knot that feels like a round ball in my clavicle on the left side. The pain isn't just on my arm  in the big area surrounding the injections site it also extends up through my shoulder and neck.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph nodes in armpit and on side of breast occurring on side of injection which was right deltoid. Started Thursday morning.  Noticed when woke up.  Vaccine received on Monday, 16MAR2020.  Saturday morning still swollen and painful.  Symptomatic treatment.  Ibuprofen and heat packs applies to affected area.  Not resolved.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Pt developed persistant left arm pain after vaccination
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt states he experienced a rash starting "(about) two weeks after" he received the first Shingrix vaccine. The rash was present on his arms and upper torso. Per patient, Dr determined that it was clearly a reaction to the vaccine. The patient was told that he could use OTC Benadryl to treat the symptoms but states he declined to do so. He states that the rash has improved greatly since that time but has not entirely cleared as of today.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Abdominal X-ray, Enema administration, Full blood count, Intussusception, Metabolic function test
Clinical narrative: Intussusception
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Occult blood, Ultrasound abdomen
Clinical narrative: Intussusception
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Hypoaesthesia
Clinical narrative: Approximately 2 hours after receiving the shot she reported feeling weak, dizzy, numb legs. She rested and felt better later in the day
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Local reaction, Pain in extremity, Paraesthesia
Clinical narrative: Patient received vaccine on 1/2 and had no immediate side effects. Approximately one week later  she developed a giant, red local reaction that lasted approximately 5-6 days. Once that cleared up she developed pain, tingling and numbness to radiating to fingertips in that arm, lasting approximately 1-2 weeks.  She had xrays to check for arthritis or anything else and they ruled out any injury or arthritis following xray. She did receive a course of tizanidine and naproxen as a result.  She has declined the second immunization of the series.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: Patient received vaccine on 1/2 and had no immediate side effects. Approximately one week later  she developed a giant, red local reaction that lasted approximately 5-6 days. Once that cleared up she developed pain, tingling and numbness to radiating to fingertips in that arm, lasting approximately 1-2 weeks.  She had xrays to check for arthritis or anything else and they ruled out any injury or arthritis following xray. She did receive a course of tizanidine and naproxen as a result.  She has declined the second immunization of the series.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Nausea, headache, Violent chills and fever which spiked over a 2 hour period. The fever slowly came down through the night. Temperature normal at 8am. Flu like symptoms remain - body aches, nausea, headache - for 2 days after. Rash, redness and soreness at injection site.  Normal activity possible on 3/20/2020.   With the first shot, I had some muscle soreness, but nothing like this second injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, headache, Violent chills and fever which spiked over a 2 hour period. The fever slowly came down through the night. Temperature normal at 8am. Flu like symptoms remain - body aches, nausea, headache - for 2 days after. Rash, redness and soreness at injection site.  Normal activity possible on 3/20/2020.   With the first shot, I had some muscle soreness, but nothing like this second injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Immediate post-injection reaction, Pain, Tenderness
Clinical narrative: Soreness right away.  Tender when pressure place on it or laying on side.  Range of motion reaching upward or trying to reach behind (such as clasping a bra).  Has not improved over time.  Patient has seen her doctor (MD) about the continuing discomfort.  MD suggested exercise/PT and to report adverse reaction.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Severe fatigue and muscle/joint aches and nausea for 36 hours; unable to do any regular daily activities. This was Shingrix dose #2; had a similar adverse reaction to dose #1.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient reported the area where the injection went in swelled up and became very red and itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Aphasia, Blindness cortical, Blood test, Brain injury, Communication disorder
Clinical narrative: He had status epilepticus, arrested and was intubated on a ventilator. He was then put in an induced coma to control the seizures. But it was too late, the MRI showed encephalitis and brain injury. He never really woke up. He is left with dystonia and corticol blindness. Is wheelchair bound and unable to speak or communicate. My son was a healthy, walking, talking 4 year old before all of this!
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Culture, Depressed level of consciousness, Dystonia, Echocardiogram, Electroencephalogram
Clinical narrative: He had status epilepticus, arrested and was intubated on a ventilator. He was then put in an induced coma to control the seizures. But it was too late, the MRI showed encephalitis and brain injury. He never really woke up. He is left with dystonia and corticol blindness. Is wheelchair bound and unable to speak or communicate. My son was a healthy, walking, talking 4 year old before all of this!
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Encephalitis, Endotracheal intubation, Epilepsy, Gait inability, Lumbar puncture
Clinical narrative: He had status epilepticus, arrested and was intubated on a ventilator. He was then put in an induced coma to control the seizures. But it was too late, the MRI showed encephalitis and brain injury. He never really woke up. He is left with dystonia and corticol blindness. Is wheelchair bound and unable to speak or communicate. My son was a healthy, walking, talking 4 year old before all of this!
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Magnetic resonance imaging brain abnormal, Mechanical ventilation, Medical induction of coma, Respiratory arrest, Seizure
Clinical narrative: He had status epilepticus, arrested and was intubated on a ventilator. He was then put in an induced coma to control the seizures. But it was too late, the MRI showed encephalitis and brain injury. He never really woke up. He is left with dystonia and corticol blindness. Is wheelchair bound and unable to speak or communicate. My son was a healthy, walking, talking 4 year old before all of this!