chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2011, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about October 2015, the patient was treated by a physician for herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-MAR-2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 21-SEP-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MEN, MEN
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. This Nurse reported similar events for 3 patients on behalf of a physician. This is the third of 3 reports. A patient of unspecified age and gender received meningococcal group B Rlp2086 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported.  On 07Jun2018, the patient woke-up with pain, chills, tired and nausea. At the time of the report the outcome of the events was unknown. Pfizer is a Marketing Authorization Holder of Meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018288752 Same reporter/drugs/events different patients.;US-PFIZER INC-2018288886 Same reporter/drugs/events different patients.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Product preparation error
Clinical narrative: Initial information received on 10-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves two months old female patient who received 0.5 ml dose of ACT-HIB (batch number, expiry date) intramuscularly in the left leg on an unknown date. Concomitant medications included PREVENAR (lot number U1822AA and expiry date 02 June 2019). It was actual medication error due to Wrong solution used in drug reconstitution as nurse administered the ACTHIB vaccine, but used the diluent for the MMR vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 12 months old female patient who received ACT-HIB with expired 0.4 percent Nacl diluent/ no reportable adverse events. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired product administered. On 11-Jul-2018, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot U5859AB via intramuscular route in right leg. It was reported that patient received ActHIB with expired 0.4 percent NaCl diluent today/ no reportable adverse events. Expiration date on diluent read was 01 Jul 2018. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced caller states an expired MENACTRA vaccine was administered yesterday, while he/she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included BEXSERO for Immunization. On 10-Jul-2018, the patient received a 0.5 ml second booster dose of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine, lot U5567CA via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. (Other relevant tests included No lab data.) It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for caller states an expired MENACTRA vaccine was administered yesterday. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema of eyelid, Eyelid oedema, Injection site erythema, Injection site induration
Clinical narrative: Edematous upper and lower eyelids b/l, erythema of b/l upper and lower eyelids. On Left thigh there is a 5cm x 6cm erythematous and indurated area. Injection site of BEXSERO.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had SHINGRIX on 6/24/18,  and started to have stomach discomfort, injection site swelling/ redness, felt like having fever (did not take temperature), very fatigue since 6/25/18.  Patient took Ibuprofen yesterday, fever subsided.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: I had a strong adverse reaction which lasted for 48 hours or more. The reaction felt like I had the flu, headache, dizziness, body aches and extreme fatigue. I slept the rest of Tuesday and much of Wednesday.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Local reaction of left arm. Approx. 1.5in x 1.5in of erythema, swelling and warmth.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Potential Rotavirus associated Hematochezia. Had 2 MOS imms. on 7/13/18 and her Sxs developed on 7/16/18 with one time frank blood in stool. FOB positive. Parents aware. Child had loose stools.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Induration, Pain, Peripheral swelling
Clinical narrative: Arm swelled; hard spot in center - 7 days. Itched - 7 days, headache - 3 days. Still have red spot and sore - 12 days later. Returned to pharmacy 5 days later - told me this is normal.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Arm swelled; hard spot in center - 7 days. Itched - 7 days, headache - 3 days. Still have red spot and sore - 12 days later. Returned to pharmacy 5 days later - told me this is normal.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Patient had raised hives on abdomen and both arms. Patient stated that she had tongue, lip, eye swelling on 3 different occasions.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, nausea, upset stomach, terrible headache, for 3 days.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Chills, fatigue, sore injection site, redness and swelling at injection site, sweating, & muscle aches.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Chills, fatigue, sore injection site, redness and swelling at injection site, sweating, & muscle aches.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient came in for 5-yo WCC. It was determined that patient would need the Varicella and MMR vaccines. These were ordered and drawn up and administered. When attempting to enter the NDC and LOT numbers it was noticed that the wrong order was put in for the MMR. What had ultimately been determined was that the PROQUAD and Varicella was given instead of just single MMR and Varicella.  These were both recorded in patient's chart. State was called to make sure of any potential adverse reactions and any instructions needed from them. VIS was given to mom. Dr. was informed. Mother called to let her know what the mistake and what to look for. Reassured mom that we did not expect any reaction since he had had already received the first dose and was already exposed. Asked her to keep an eye out for any swelling, redness, fever, unusual behaviors. She understood. Business coordinator notified to have one the varicella vaccine charge be removed and only charge for the PROQUAD. Will call in a week to see how patient is doing to be sure no reactions occurred.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Ankylosing spondylitis, Arthralgia, Autoimmune disorder, Dysstasia, General physical health deterioration
Clinical narrative: I only received 2 shots out of the 3 as I am afraid the third would have killed me. My medical records indicate I received the GARDASIL vaccination with the FLU vaccine on the same date and ever since I have had multiple ailments that have yet to be alievated or resolved (all triggered by an autoimmune response). I live in chronic pain daily and as a former athlete I am astonished at how fast I have gone down hill with little to no help in managing my pain. I first developed back spasms and an arthritic like ache up and down my spine and in my hips which I saw an orthopedic immediatley for. I received multiple injections in my lower back and after a year and a half he told me to seek a second opinion because he did not know what was wrong with me. I tested HLA B 27 + and was then referred to a rheumatologist who confirmed ankylosing spondylitis and started me on humira. Humira helped initially but has helped less over the years. Since going on Humira in 2013 I have continued to decline physically and mentally from the amount of pain I am in. I can not sit or stand for more than a few minutes and constantly have to change positions to alleviate some of the agony.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: HLA-B*27 positive, Immune system disorder, Incomplete course of vaccination, Mental impairment, Muscle spasms
Clinical narrative: I only received 2 shots out of the 3 as I am afraid the third would have killed me. My medical records indicate I received the GARDASIL vaccination with the FLU vaccine on the same date and ever since I have had multiple ailments that have yet to be alievated or resolved (all triggered by an autoimmune response). I live in chronic pain daily and as a former athlete I am astonished at how fast I have gone down hill with little to no help in managing my pain. I first developed back spasms and an arthritic like ache up and down my spine and in my hips which I saw an orthopedic immediatley for. I received multiple injections in my lower back and after a year and a half he told me to seek a second opinion because he did not know what was wrong with me. I tested HLA B 27 + and was then referred to a rheumatologist who confirmed ankylosing spondylitis and started me on humira. Humira helped initially but has helped less over the years. Since going on Humira in 2013 I have continued to decline physically and mentally from the amount of pain I am in. I can not sit or stand for more than a few minutes and constantly have to change positions to alleviate some of the agony.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Spinal pain
Clinical narrative: I only received 2 shots out of the 3 as I am afraid the third would have killed me. My medical records indicate I received the GARDASIL vaccination with the FLU vaccine on the same date and ever since I have had multiple ailments that have yet to be alievated or resolved (all triggered by an autoimmune response). I live in chronic pain daily and as a former athlete I am astonished at how fast I have gone down hill with little to no help in managing my pain. I first developed back spasms and an arthritic like ache up and down my spine and in my hips which I saw an orthopedic immediatley for. I received multiple injections in my lower back and after a year and a half he told me to seek a second opinion because he did not know what was wrong with me. I tested HLA B 27 + and was then referred to a rheumatologist who confirmed ankylosing spondylitis and started me on humira. Humira helped initially but has helped less over the years. Since going on Humira in 2013 I have continued to decline physically and mentally from the amount of pain I am in. I can not sit or stand for more than a few minutes and constantly have to change positions to alleviate some of the agony.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient inadvertently received vaccine at age 49 instead of the recommended 50, no reported side effects at this time.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Patient was administered HPV vaccine without issues/complaints. Escorted to waiting room, ambulating without assistance. Patient later stood and walked to front desk with mother, at which point he felt dizzy/lightheaded and was guided to the floor with assistance of staff. Patient placed in semifowlers position, BP was checked, cool compresses applied to head/neck, and patient offered sips of juice until recovered to a sitting position. Patient monitored for 15 minutes and released with mother after symptoms resolved. During recovery mother informed staff that patient's father has had syncopal episodes following injections in the past, recommended to patient and mother that in the future staff being informed about possibility of syncopal events.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea the night of 7/17/18.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased appetite, Gait disturbance, Immediate post-injection reaction, Irritability, Lethargy
Clinical narrative: Patient had pain immediately after vaccination - worse on the right side than the left. Patient refused to walk for the remainder of the day. Patient did walk on the subsequent days but "guarding" her legs.  Developed fever that night and fever remains through this morning (7/19/2018)  fever ranging from 101 - 103 F and taken with a temporal artery thermometer. Baby has been fussy and more lethargic with a decreased appetite.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Patient had pain immediately after vaccination - worse on the right side than the left. Patient refused to walk for the remainder of the day. Patient did walk on the subsequent days but "guarding" her legs.  Developed fever that night and fever remains through this morning (7/19/2018)  fever ranging from 101 - 103 F and taken with a temporal artery thermometer. Baby has been fussy and more lethargic with a decreased appetite.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult Hep A was given to the patient who is 17 years of age.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Feeling abnormal, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: Began feeling like she "had the flu" with muscle aches and joints the evening after the vaccine (7/17) and continues to feel badly. On 7/19/18 the site of injection began is noted to be red, swollen, hard, hot and very tender to the touch. The area measures 9.8x9.3cm. Physician visited and wrote orders for ice to the area, PRN BENADRYL, TYLENOL and oral antibiotics.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Began feeling like she "had the flu" with muscle aches and joints the evening after the vaccine (7/17) and continues to feel badly. On 7/19/18 the site of injection began is noted to be red, swollen, hard, hot and very tender to the touch. The area measures 9.8x9.3cm. Physician visited and wrote orders for ice to the area, PRN BENADRYL, TYLENOL and oral antibiotics.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea
Clinical narrative: Multiple bouts of diarrhea over last 2 days - currently monitoring and oral hydration.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 26-JUN-2018, the patient was vaccinated with a properly stored but expired RECOMBIVAX HB injection, lot # M008551 and expiry date 02-JUN-2018 (strength, dose, route and frequency were not reported) (Expired product administered) for prophylaxis. No adverse effects were reported. This case was determined to be non-valid due to the lack of patient's identifier. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow-up information was received from physician on 06-JUL-2018 refers to a 21-year-old male patient. Patient had a nonreactive result for hepatitis B surface antibody despite 3 dose series given in first year of life. The patient needed to be given another 3 dose series from medical school. On 26-JUN-2018, the patient was administered two 0.5 ml vials of RECOMBIVAX HB (to administer vaccine as 1 injection) at left deltoid by intramuscular route from lot M008551 (expiration date 02-JUN-2018) and lot N002914 (expiration date 04-NOV-2019). Concomitant therapy included testosterone. Expiration date was checked on 1 vial prior to administration but not on second one. After administering vaccine, noticed that the second vial had a different lot # and expiration date. Internal studies indicated that vaccine still effective as on date given. Patient will be having repeat hepatitis B surface antibody titer drawn after 3 dose series. Office that supplied vaccine notified of expired stock. Patient also informed of event.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX and PROQUAD for prophylaxis (strength, dose, route of administration, frequency, lot number and expiration date were unknown). It was reported that the vaccines had a temperature excursion of 15°F to 46°F (17°F) for 20 minutes and 15°F to 46°F (30.6°F) for 40 minutes. There were no previous temperature excursions. Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-MAY-2014, the patient was inoculated with the ZOSTAVAX vaccine at a drug store as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2014, the patient was treated at a physician office for the onset of a vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-DEC-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or approximately 01-MAR-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately March 2014, the patient was inoculated with the ZOSTAVAX vaccine by a pharmacist or physician at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about October 2014, the patient was treated by at the emergency room for the onset herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving 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 will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Lung lobectomy, Lung neoplasm malignant
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored Program. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date in 2015 or 2016 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she got her regular pneumonia vaccine then had pneumococcal 13-val conj vac (dipht crm197 protein). In 2017, patient had her lower lobe of the lung was removed from lung cancer on an unspecified date. The outcome of event was unknown.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 05-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (Unknown demographics) who experienced extra dose administered, while he received vaccine MENACTRA. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL VACCINE lot C5385AA via unknown route at an unknown site. On an unknown date, (Unknown latency period), following the administration of MENINGOCOCCAL VACCINE the patient experienced mistakenly given a patient, 3 injections of MENACTRA, instead of the recommended 2. Final diagnosis was extra dose administered. It was not reported if the patient received a corrective treatment. The patient outcome reported as Not Applicable. Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood pressure decreased, Bradycardia, Hyperhidrosis, Hypotension, Immediate post-injection reaction
Clinical narrative: Vaccine administered intramuscularly to right deltoid. Patient became diaphoretic, ashen, and had  episode of syncope within 1 minute of injection. Patient placed in modified Trendelenburg position.  Continued to have bradycardia, hypotension, diaphoresis over the next 30 minutes. 3 mins following episode: HR 48, BP 100/58. 10 minutes following incident and in sitting position, BP drops to 80/48, HR 43. Returned to Trendelenburg position. Placed on 1 L oxygen via nasal cannula. EMS called 30 minutes after incident patient remains diaphoretic HR 58, BP 113/71. EMS transports to Medical Center for observation and IV fluids.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor, Syncope
Clinical narrative: Vaccine administered intramuscularly to right deltoid. Patient became diaphoretic, ashen, and had  episode of syncope within 1 minute of injection. Patient placed in modified Trendelenburg position.  Continued to have bradycardia, hypotension, diaphoresis over the next 30 minutes. 3 mins following episode: HR 48, BP 100/58. 10 minutes following incident and in sitting position, BP drops to 80/48, HR 43. Returned to Trendelenburg position. Placed on 1 L oxygen via nasal cannula. EMS called 30 minutes after incident patient remains diaphoretic HR 58, BP 113/71. EMS transports to Medical Center for observation and IV fluids.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Heart rate decreased, Loss of consciousness
Clinical narrative: Vaccine administered intramuscularly to right deltoid. Patient became diaphoretic, ashen, and had  episode of syncope within 1 minute of injection. Patient placed in modified Trendelenburg position.  Continued to have bradycardia, hypotension, diaphoresis over the next 30 minutes. 3 mins following episode: HR 48, BP 100/58. 10 minutes following incident and in sitting position, BP drops to 80/48, HR 43. Returned to Trendelenburg position. Placed on 1 L oxygen via nasal cannula. EMS called 30 minutes after incident patient remains diaphoretic HR 58, BP 113/71. EMS transports to Medical Center for observation and IV fluids.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Pt reported to fill lethargic with a fever and fell nauseated. Pt also reported to have rash on arms and body. Pt took Tylenol to help with the fever and pain. Pt is instructed to take Benadryl to help with the rash. Pt fell somewhat better the next day but was still tired and "out of it".
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: Pt reported to fill lethargic with a fever and fell nauseated. Pt also reported to have rash on arms and body. Pt took Tylenol to help with the fever and pain. Pt is instructed to take Benadryl to help with the rash. Pt fell somewhat better the next day but was still tired and "out of it".
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: PATIENT COMPLAINED OF PAIN IN ARM AND GENERAL MALAISE.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: That evening I started a fever. My arm was very sore, but I didn't care about that. I was weak and feverish. I laid on my daughter's couch and I couldn't get up for two days. Fever and weakness. Forced myself to stay awake long enough to take my reg. pills and eat crackers.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lymph node pain, Tenderness
Clinical narrative: Right arm tender at injection site. Tenderness spreading to arm pit. Right Axillary gland is tender along with the back of neck. Fatigue. Hasn't tried OTC meds.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Heart rate increased, Urticaria
Clinical narrative: Patient stated that she was feeling dizzy, and she broke out in hives, and high heart rate. Treatment that was given by Dr. was a Depo 80 injejection, and Benadryl 50 mg and stated to patient to take benadryly 25 mg q4hrs.
Age: 59.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Malaise, Mobility decreased, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Patient called pharmacy today stating that the arm that she received the Tdap vaccine in was very sore the day after receiving vaccine stating that she was even having trouble raising her arm. Patient also complained of an overall sense of not feeling well (shakes and mild fever) the day after receiving the vaccines.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site inflammation, Malaise, Pyrexia
Clinical narrative: Patient informed pharmacy that she has not been taking the increased dose of HIZENTRA as prescribed by prescriber because the prescriber did not let her know that she has to increase her dose. 6/28/2018 Symptoms of malaise, GI upset. Fever 101 degree F, and inflammation at injection site within 24hrs of SHINGRIX #2, injection approximately 3 month after 1st injection. Both injections (L) deltoid.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Back pain, Decreased activity
Clinical narrative: GARDASIL HPV vaccine reaction. 13 year old son received 1st shot. Day 1 nerve pain shooting down arm shoulder and back. Could not raise arm where shot was given without getting shooting pain through shoulder and back. That lasted for 1 day. Day 2 constant pain in shoulder, neck, and back. Day 3 constant pain in groin, spine, back, upper abs. High level of pain! Day 4 constant pain in back, arms, groin, abs, legs. Right leg was twitching uncommanded. Day 5 constant pain in back, groin, knees and arms. Severe pain. Day 6 pain was a little lighter; pain in back, groin, legs, arm, ankle pain still high. Day 7 severe pain groin, knees, ankle, arms, back, neck, elbows, knees, neck, shoulders, fingers, headache and lethargic. Day 8 had dizzy spell almost fell, pain in neck and legs. Day 9 neck, legs, ankle, back and all over the body. Hurts to move. Day 10 uncommanded muscle twitching increasing legs and arms pain in ankle, knees and lower back. Day 11 uncommanded twitching in arms and legs, pain in legs, arms, neck. Hurts all over, does not want to participate in baseball (tip tier player played baseball for 8 years and never asked to skip). Day 12 no change entire body hurt. Day 13 Muscle spasms, pain in back, elbow, calf and legs. Day 14 no change. Day 15 feeling better, pain mostly in Achilles. Day 16 severe pain in legs, back, knees, and trapezoids. Day 17 severe pain in knees, Achilles, legs, back, and trapezoids. Day 18 severe pain in groin, legs, and back. Day 19 pain in legs. Day 20 severe pain over entire body hard to stand or walk. Day 21 severe pain all over body, won't even get into the pool. Knees, hips, elbows, legs, and back. Day 22 no change. Day 23 a little better pain in back, hips, knees, and legs. Day 24 severe pain in back, legs, and knees. Day 25 severe pain in legs and back. Day 26 severe pain in legs, less pain in back. (Reminders that this boy had zero pains before HPV vaccine!) Day 27 severe pain all over, hands, elbows, forearms, legs, back. Didn't want to get out of bed. Day 28 severe pain in back of knees and back heavy pain all over his entire body. Day 29 severe pain in back of knees pain in back. Day 30 pain in Achilles back of knees, back of legs. Day 31 no change. Day 32 pain in back of knees. Day 33 pain in back of knees (no activity for two days just couch potato). Day 34 pain in Achilles and back of knees. MOTRIN does not help with pain, there was no pain with this child before the HPV vaccine!!!
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dysstasia, Gait disturbance, Groin pain, Headache
Clinical narrative: GARDASIL HPV vaccine reaction. 13 year old son received 1st shot. Day 1 nerve pain shooting down arm shoulder and back. Could not raise arm where shot was given without getting shooting pain through shoulder and back. That lasted for 1 day. Day 2 constant pain in shoulder, neck, and back. Day 3 constant pain in groin, spine, back, upper abs. High level of pain! Day 4 constant pain in back, arms, groin, abs, legs. Right leg was twitching uncommanded. Day 5 constant pain in back, groin, knees and arms. Severe pain. Day 6 pain was a little lighter; pain in back, groin, legs, arm, ankle pain still high. Day 7 severe pain groin, knees, ankle, arms, back, neck, elbows, knees, neck, shoulders, fingers, headache and lethargic. Day 8 had dizzy spell almost fell, pain in neck and legs. Day 9 neck, legs, ankle, back and all over the body. Hurts to move. Day 10 uncommanded muscle twitching increasing legs and arms pain in ankle, knees and lower back. Day 11 uncommanded twitching in arms and legs, pain in legs, arms, neck. Hurts all over, does not want to participate in baseball (tip tier player played baseball for 8 years and never asked to skip). Day 12 no change entire body hurt. Day 13 Muscle spasms, pain in back, elbow, calf and legs. Day 14 no change. Day 15 feeling better, pain mostly in Achilles. Day 16 severe pain in legs, back, knees, and trapezoids. Day 17 severe pain in knees, Achilles, legs, back, and trapezoids. Day 18 severe pain in groin, legs, and back. Day 19 pain in legs. Day 20 severe pain over entire body hard to stand or walk. Day 21 severe pain all over body, won't even get into the pool. Knees, hips, elbows, legs, and back. Day 22 no change. Day 23 a little better pain in back, hips, knees, and legs. Day 24 severe pain in back, legs, and knees. Day 25 severe pain in legs and back. Day 26 severe pain in legs, less pain in back. (Reminders that this boy had zero pains before HPV vaccine!) Day 27 severe pain all over, hands, elbows, forearms, legs, back. Didn't want to get out of bed. Day 28 severe pain in back of knees and back heavy pain all over his entire body. Day 29 severe pain in back of knees pain in back. Day 30 pain in Achilles back of knees, back of legs. Day 31 no change. Day 32 pain in back of knees. Day 33 pain in back of knees (no activity for two days just couch potato). Day 34 pain in Achilles and back of knees. MOTRIN does not help with pain, there was no pain with this child before the HPV vaccine!!!
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Lethargy, Loss of personal independence in daily activities, Muscle spasms, Muscle twitching
Clinical narrative: GARDASIL HPV vaccine reaction. 13 year old son received 1st shot. Day 1 nerve pain shooting down arm shoulder and back. Could not raise arm where shot was given without getting shooting pain through shoulder and back. That lasted for 1 day. Day 2 constant pain in shoulder, neck, and back. Day 3 constant pain in groin, spine, back, upper abs. High level of pain! Day 4 constant pain in back, arms, groin, abs, legs. Right leg was twitching uncommanded. Day 5 constant pain in back, groin, knees and arms. Severe pain. Day 6 pain was a little lighter; pain in back, groin, legs, arm, ankle pain still high. Day 7 severe pain groin, knees, ankle, arms, back, neck, elbows, knees, neck, shoulders, fingers, headache and lethargic. Day 8 had dizzy spell almost fell, pain in neck and legs. Day 9 neck, legs, ankle, back and all over the body. Hurts to move. Day 10 uncommanded muscle twitching increasing legs and arms pain in ankle, knees and lower back. Day 11 uncommanded twitching in arms and legs, pain in legs, arms, neck. Hurts all over, does not want to participate in baseball (tip tier player played baseball for 8 years and never asked to skip). Day 12 no change entire body hurt. Day 13 Muscle spasms, pain in back, elbow, calf and legs. Day 14 no change. Day 15 feeling better, pain mostly in Achilles. Day 16 severe pain in legs, back, knees, and trapezoids. Day 17 severe pain in knees, Achilles, legs, back, and trapezoids. Day 18 severe pain in groin, legs, and back. Day 19 pain in legs. Day 20 severe pain over entire body hard to stand or walk. Day 21 severe pain all over body, won't even get into the pool. Knees, hips, elbows, legs, and back. Day 22 no change. Day 23 a little better pain in back, hips, knees, and legs. Day 24 severe pain in back, legs, and knees. Day 25 severe pain in legs and back. Day 26 severe pain in legs, less pain in back. (Reminders that this boy had zero pains before HPV vaccine!) Day 27 severe pain all over, hands, elbows, forearms, legs, back. Didn't want to get out of bed. Day 28 severe pain in back of knees and back heavy pain all over his entire body. Day 29 severe pain in back of knees pain in back. Day 30 pain in Achilles back of knees, back of legs. Day 31 no change. Day 32 pain in back of knees. Day 33 pain in back of knees (no activity for two days just couch potato). Day 34 pain in Achilles and back of knees. MOTRIN does not help with pain, there was no pain with this child before the HPV vaccine!!!
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Neck pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: GARDASIL HPV vaccine reaction. 13 year old son received 1st shot. Day 1 nerve pain shooting down arm shoulder and back. Could not raise arm where shot was given without getting shooting pain through shoulder and back. That lasted for 1 day. Day 2 constant pain in shoulder, neck, and back. Day 3 constant pain in groin, spine, back, upper abs. High level of pain! Day 4 constant pain in back, arms, groin, abs, legs. Right leg was twitching uncommanded. Day 5 constant pain in back, groin, knees and arms. Severe pain. Day 6 pain was a little lighter; pain in back, groin, legs, arm, ankle pain still high. Day 7 severe pain groin, knees, ankle, arms, back, neck, elbows, knees, neck, shoulders, fingers, headache and lethargic. Day 8 had dizzy spell almost fell, pain in neck and legs. Day 9 neck, legs, ankle, back and all over the body. Hurts to move. Day 10 uncommanded muscle twitching increasing legs and arms pain in ankle, knees and lower back. Day 11 uncommanded twitching in arms and legs, pain in legs, arms, neck. Hurts all over, does not want to participate in baseball (tip tier player played baseball for 8 years and never asked to skip). Day 12 no change entire body hurt. Day 13 Muscle spasms, pain in back, elbow, calf and legs. Day 14 no change. Day 15 feeling better, pain mostly in Achilles. Day 16 severe pain in legs, back, knees, and trapezoids. Day 17 severe pain in knees, Achilles, legs, back, and trapezoids. Day 18 severe pain in groin, legs, and back. Day 19 pain in legs. Day 20 severe pain over entire body hard to stand or walk. Day 21 severe pain all over body, won't even get into the pool. Knees, hips, elbows, legs, and back. Day 22 no change. Day 23 a little better pain in back, hips, knees, and legs. Day 24 severe pain in back, legs, and knees. Day 25 severe pain in legs and back. Day 26 severe pain in legs, less pain in back. (Reminders that this boy had zero pains before HPV vaccine!) Day 27 severe pain all over, hands, elbows, forearms, legs, back. Didn't want to get out of bed. Day 28 severe pain in back of knees and back heavy pain all over his entire body. Day 29 severe pain in back of knees pain in back. Day 30 pain in Achilles back of knees, back of legs. Day 31 no change. Day 32 pain in back of knees. Day 33 pain in back of knees (no activity for two days just couch potato). Day 34 pain in Achilles and back of knees. MOTRIN does not help with pain, there was no pain with this child before the HPV vaccine!!!
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Spinal pain, Tendon pain
Clinical narrative: GARDASIL HPV vaccine reaction. 13 year old son received 1st shot. Day 1 nerve pain shooting down arm shoulder and back. Could not raise arm where shot was given without getting shooting pain through shoulder and back. That lasted for 1 day. Day 2 constant pain in shoulder, neck, and back. Day 3 constant pain in groin, spine, back, upper abs. High level of pain! Day 4 constant pain in back, arms, groin, abs, legs. Right leg was twitching uncommanded. Day 5 constant pain in back, groin, knees and arms. Severe pain. Day 6 pain was a little lighter; pain in back, groin, legs, arm, ankle pain still high. Day 7 severe pain groin, knees, ankle, arms, back, neck, elbows, knees, neck, shoulders, fingers, headache and lethargic. Day 8 had dizzy spell almost fell, pain in neck and legs. Day 9 neck, legs, ankle, back and all over the body. Hurts to move. Day 10 uncommanded muscle twitching increasing legs and arms pain in ankle, knees and lower back. Day 11 uncommanded twitching in arms and legs, pain in legs, arms, neck. Hurts all over, does not want to participate in baseball (tip tier player played baseball for 8 years and never asked to skip). Day 12 no change entire body hurt. Day 13 Muscle spasms, pain in back, elbow, calf and legs. Day 14 no change. Day 15 feeling better, pain mostly in Achilles. Day 16 severe pain in legs, back, knees, and trapezoids. Day 17 severe pain in knees, Achilles, legs, back, and trapezoids. Day 18 severe pain in groin, legs, and back. Day 19 pain in legs. Day 20 severe pain over entire body hard to stand or walk. Day 21 severe pain all over body, won't even get into the pool. Knees, hips, elbows, legs, and back. Day 22 no change. Day 23 a little better pain in back, hips, knees, and legs. Day 24 severe pain in back, legs, and knees. Day 25 severe pain in legs and back. Day 26 severe pain in legs, less pain in back. (Reminders that this boy had zero pains before HPV vaccine!) Day 27 severe pain all over, hands, elbows, forearms, legs, back. Didn't want to get out of bed. Day 28 severe pain in back of knees and back heavy pain all over his entire body. Day 29 severe pain in back of knees pain in back. Day 30 pain in Achilles back of knees, back of legs. Day 31 no change. Day 32 pain in back of knees. Day 33 pain in back of knees (no activity for two days just couch potato). Day 34 pain in Achilles and back of knees. MOTRIN does not help with pain, there was no pain with this child before the HPV vaccine!!!
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pain, Photosensitivity reaction, Polymorphic light eruption
Clinical narrative: I received the Zoster Vaccine (Recombinant) on 6/15/18. This was my first injection of the vaccine. On 6/16 I was outdoors in the sun for about 1/12 hours. On 6/17 I started developing a severe red rash and burning sensation with some blisters where my skin was exposed to sun on 6/16. Over the next several days the rash and burning intensified. The pharmacist who gave the injection saw it and said it was a photosensitivity. On 6/20 I saw a PA who diagnosed polymorphus light eruption, plaque type. I was given a 5 day Rx for prednisone. Neither the printed vaccine information from the pharmacy nor the CDC website listed photosensitivity as a possible side effect of the vaccine. (After 3 doses of prednisone, I developed an additional rash on the remainder of my body and stopped taking prednisone). The rash, blisters, pain and burning on the exposed areas of my skin took two weeks to go away. Because of this photosensitivity, I will not be getting the second dose of the vaccine. Why was this possible side effect and an appropriate caution statement not listed on the information from the pharmacy that administered the vaccine or on the CDC website? This reaction was very painful.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: I received the Zoster Vaccine (Recombinant) on 6/15/18. This was my first injection of the vaccine. On 6/16 I was outdoors in the sun for about 1/12 hours. On 6/17 I started developing a severe red rash and burning sensation with some blisters where my skin was exposed to sun on 6/16. Over the next several days the rash and burning intensified. The pharmacist who gave the injection saw it and said it was a photosensitivity. On 6/20 I saw a PA who diagnosed polymorphus light eruption, plaque type. I was given a 5 day Rx for prednisone. Neither the printed vaccine information from the pharmacy nor the CDC website listed photosensitivity as a possible side effect of the vaccine. (After 3 doses of prednisone, I developed an additional rash on the remainder of my body and stopped taking prednisone). The rash, blisters, pain and burning on the exposed areas of my skin took two weeks to go away. Because of this photosensitivity, I will not be getting the second dose of the vaccine. Why was this possible side effect and an appropriate caution statement not listed on the information from the pharmacy that administered the vaccine or on the CDC website? This reaction was very painful.