chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Lymphadenopathy, Malaise, Rash, Rash erythematous
Clinical narrative: Malaise, redness L arm near injection site, swollen neck glands, few small red itchy bumps on back.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Malaise, redness L arm near injection site, swollen neck glands, few small red itchy bumps on back.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Patient experienced a rash and bump at the injection site, that spread to entire upper arm. Also experienced nausea and fever of unknown severity. The nausea and fever resolved by reporting date, lasting for about 2 days. The rash and bump had improved but not resolved as of reporting, 3 days later. She has been icing the area, and plans to continue to do so. She declined to use BENADRYL due to possible side effects. She had not contacted her physician, but was counseled that was a valid course of action should she wish to.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient presented to the pharmacy with complaints of arm pain, progressively worsening over the past week after vaccination. He states the pain stated 1-2 days after receiving the vaccine, and has gotten worse over time. He described the pain as sharp, seering, shooting pain in his right shoulder (site of vaccination).
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient got flu shot on 9-21-17. Patient called 10-11-17 with symptoms of painful arm that started the previous evening. Patient said it hurt to lift her arm above her head but was not red or warm to touch. Patient wanted to know if that was normal after receiving flu shot.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Slight bruise at injection site. Warmth to touch and red-blotchy skin in 3-4 inch radius from the injection site. Patient reports no ill feeling, no itching, just redness and warmth. Patient presented to pharmacy and I have documented based on signs that are visible to me as well.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness of injection site, warm to touch. Patient noticed the morning after injection after removing band-aid. Patient will keep a close eye and report any worsening. Will also try triple antibiotic ointment.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Generalised erythema, Pyrexia, Urticaria
Clinical narrative: PATIENT RECEIVED FLU SHOT AROUND 9:30AM. UPON GOING HOME FOR THE DAY, HE SPIKED A FEVER OF 104 AND HIS ENTIRE BODY TURNED BRIGHT RED. HE BECAME DISORIENTED. BY THE NEXT MORNING, HE HAD HIVES ON HIS CHEST AND ABDOMEN. HE TOOK BENADRYL WHICH RESOLVED THE HIVES FOR A COUPLE HOURS, BUT THEN THEY RETURNED AND COVERED HIS ENTIRE BODY. HE IS CONTINUALLY TAKING BENADRYL, WHICH RESOLVES THE HIVES UNTIL THE DOSE WEARS OFF AND HE HAS TO TAKE MORE. I HAVE INSTRUCTED HIM TO CALL HIS PHYSICIAN ASAP.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Edema to Lt upper arm at site of injection warm and tender.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Fall, Malaise, Peripheral swelling
Clinical narrative: She says the night of the vaccination her eyes swelled up and her (both) arms were swollen. There was a language barrier.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Eye swelling, Peripheral swelling
Clinical narrative: She says the night of the vaccination her eyes swelled up and her (both) arms were swollen. There was a language barrier.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot# M027884 (also reported as: M0027884), expiration date: 19-APR-2019, (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccine underwent a temperature excursion from 22 degrees Fahrenheit to 37 degrees Fahrenheit for 1381 hours in total. There was no previous temperature excursion. Data logger was not involved. There were no adverse effects reported.; Sender's Comments: US-009507513-1709USA006071: US-009507513-1709USA009874: US-009507513-1709USA009815: US-009507513-1709USA009750:
Age: 0.5
Sex: F
Vaccine: FLUX, HEPA, HIBV, MMRV, PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 6 month old female patient. The patient did not have any pre-existing allergies, birth defects or medical conditions and did not suffer form any illness at the time of vaccination. On 20-SEP-2017, the patient was vaccinated with PROQUAD lot # N016993, expiration date 29-NOV-2017, rHa, 0.5 ml, subcutaneously in the right arm for prophylaxis reconstituted with sterile diluent (STERILE DILUENT). On the same day, the patient also received PEDVAXHIB, hepatitis A virus vaccine (unspecified). Concomitant therapies included M-M-R II, HEPATITIS A VACCINE, INACTIVATED, PEDIARIX, PREVNAR 13 and and influenza virus vaccine (unspecified) (concomitant medications also reported as "none"). The patient was observed for 20 minutes after vaccination and no reactions were noted. The patient's mother called the day after vaccine was administered and provided that the child was feeling well.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus, Skin infection
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with ZOSTAVAX, lot # M042850, expiration date 18-JAN-2018 for prevention of shingles (dosage and route of administration were not reported). ZOSTAVAX was reconstituted with sterile diluent (STERILE DILUENT), lot# reported as "M032268" (verified as not valid for ZOSTAVAX, expiration date 19-APR-2019 (dosage, route of administration were not reported). In approximately September 2017, the patient experienced itching, redness and inflammation above the elbow. On 18-SEP-2017, the patient returned to the pharmacy with the events. The patient's primary physician diagnosed mild skin infection and prescribed unspecified treatment for the event. The outcome of the events and the relatedness between the events and ZOSTAVAX and sterile diluent (STERILE DILUENT) were not reported.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2-month-old patient of unknown gender. No information on the patient's concomitant medications, pertinent medical history, drug reactions or allergies was reported. On 22-SEP-2017, the patient was vaccinated with a dose of VAQTA injection (lot # N005274 with expiration date on 03-APR-2018; exact dose and route of administration were not reported) for prophylaxis. This administration of the vaccine was outside the recommendations per the VAQTA prescribing information. No adverse effects were reported. No product quality complaint was involved.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 12 month old (also reported as "15 months") female patient. It was reported none medical history, none illness at time of vaccination and none drug reactions or allergies. On 20-JUL-2017, the patient was vaccinated with the third dose of PREVNAR 13 and the third dose of an unspecified Hepatitis B virus vaccine (manufacturer unknown). On 26-SEP-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously in the left thigh, lot number N017399, expiration date 07-JUN-2019 (strength and dose were not reported), for prophylaxis. It was reported that the vaccine had been inadvertently administered intramuscularly (IM); however the registered nurse confirmed that it was subcutaneously rather than IM. Other suspect therapies included an unspecified Hepatitis A virus vaccine (manufacturer unknown) (first dose, in the left thigh, lot number N017094) which was administered on 26-SEP-2017. Concomitant therapies included a PREVNAR 13 (fourth dose, in the right thigh, lot number 535324) administered on the same date and an sterile diluent. On 26-SEP-2017, the patient experienced a red hardened area of about 1.5 inches, at the site of the VARIVAX injection (vaccination site erythema and vaccination site induration). On 27-SEP-2017, the patient went to office. No treatment was provided and lab diagnostics or studies were not performed. The nurse practitioner (also reported as the responsible physician) determined that it was an injection site reaction and told the patient's mom to continue monitoring. The outcome of vaccination site erythema and vaccination site induration was reported as resolved. The causality assessment between VARIVAX and the aforementioned events were not provided.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report has been received from a male pharmacist of unknown age reporting on himself via company representative. The patient did not have pertinent medical history, drug reactions or allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that after receiving PNEUMOVAX 23, the patient experienced injection site pain. None laboratory test were performed. It was unknown if a treatment was given to the patient. The outcome of vaccination site pain was reported as resolved. The causality assessment between PNEUMOVAX 23 and the event was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 18-JUL-2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUL-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. On or about 12-OCT-2016, the patient was treated again by her physician for ongoing and worsening symptoms of shingles infection. The patient has been prescribed VALTREX and nystatin cream (manufacturer unknown) for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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 expense, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation for a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 17-MAY-2011 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-AUG-2014 the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster or shingles. On or about 16-JAN-2014 the patient sought subsequent treatment from the physician for ongoing and worsening symptoms of shingles accompanied by post-herpetic neuralgia, a condition of chronic nerve pain and damage secondary to shingles infections. (Conflicting information: the even onset for post-herpetic neuralgia is prior to the reported onset of severe herpes zoster or shingles). The patient has been prescribed TMC 0.5% cream for management of his painful condition. As a direct and proximate result of these malfunctions. 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.      Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation for a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On 05-NOV-2014 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-OCT-2015 the patient was treated by a physician for the onset of a severe vesicular rash that had been present for four months accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed Gabapentin and valacyclovir (VALTREX) for management of his painful condition. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Cardiac disorder, Erythema, Inflammation, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse received via Pfizer company representative. A 62-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 31May2017 at single dose for immunization. Medical history included asplenia. The patient's concomitant medications were not reported. After vaccination patient experienced local inflammation and redness from his shoulder to his elbow as well as arm pain. Patient was still experiencing arm pain. Patient also experienced a cardiac event after vaccination. The outcome of event arm pain was not recovered, the outcome of the other events was unknown.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Delayed puberty, Fatigue, Menstruation delayed
Clinical narrative: Child became tired and lacked energy shortly following  the  vaccine. Child remained tired and lacking energy continuously following the vaccine. The child was expected to start menstruation and it appears that puberty has stopped for her. The child has not started menstruation to date.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: The pain at the injection sight became more intense over the following 24 hours and spread to my entire arm and upper left side of my chest. I finally took a muscle relaxant and the pain began to subside in my chest. To date, I still experience intense pain in my upper left arm, upper part of left shoulder, down left arm sometimes and left hand. I finally saw an on-call doctor at my internist's practice October 5, 2015 this persistent pain has lasted so long.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness postural, Dyspnoea, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: Pt emailed writer, RN that administered the TdaP vaccine, at 0713 on 10/12/2017 regarding suspected s/sx adverse reaction to the TdaP vaccine. Pt stated, "I am quite sick since getting that shot yesterday. Started about 10pm severe headache, stiff neck, nausea with emesis, slight dyspnea and a bounding heartbeat at times. Any suggestions?  I am not working today because if this please contact me on my personal phone." Writer sent CDC information regarding the TdaP vaccine (gave VIS as well on 10/11/2017) and assured pt that writer would follow-up with manager at 1022. Manager responded to writer's email at 1044 that pt should call her healthcare provider and ask if she needs to be seen or if there is necessary treatment and/or follow-up and the manager also directed writer to fill out a VAERS form. Writer call pt at 1101 and advised her to call her provider and to call 911 if necessary. Writer requested that pt call back with any information or updates. Pt verbally told writer that she felt dizzy and nauseous when she stood up. No report of emesis. Right-sided headache.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pulse abnormal, Vomiting
Clinical narrative: Pt emailed writer, RN that administered the TdaP vaccine, at 0713 on 10/12/2017 regarding suspected s/sx adverse reaction to the TdaP vaccine. Pt stated, "I am quite sick since getting that shot yesterday. Started about 10pm severe headache, stiff neck, nausea with emesis, slight dyspnea and a bounding heartbeat at times. Any suggestions?  I am not working today because if this please contact me on my personal phone." Writer sent CDC information regarding the TdaP vaccine (gave VIS as well on 10/11/2017) and assured pt that writer would follow-up with manager at 1022. Manager responded to writer's email at 1044 that pt should call her healthcare provider and ask if she needs to be seen or if there is necessary treatment and/or follow-up and the manager also directed writer to fill out a VAERS form. Writer call pt at 1101 and advised her to call her provider and to call 911 if necessary. Writer requested that pt call back with any information or updates. Pt verbally told writer that she felt dizzy and nauseous when she stood up. No report of emesis. Right-sided headache.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Mother reported rash on injection site, see by Dr. who reports she does have localized swelling, warmth and erythema on injection site, no further complications noted.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dizziness, Dyspnoea, Injection site erythema, Injection site hypoaesthesia
Clinical narrative: Injection site reaction--numbness, swelling, redness, heat. Chest pain (which was somewhat relieved by asthma inhaler). Dizziness (which patient has from time to time). Shortness of Breath.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction--numbness, swelling, redness, heat. Chest pain (which was somewhat relieved by asthma inhaler). Dizziness (which patient has from time to time). Shortness of Breath.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Patient experienced redness, swelling, itching, warm to touch. Patient was a lot sore whether or not it was the vaccine or the bandaid that cause reaction. Bandaid was non latex.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle swelling
Clinical narrative: Patient received Pneumovax 23 inj 0.5ml on her left deltoid IM. She came back this morning 10/12/17 and reported her deltoid muscle swollen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Deltoid red swollen, painful mom gives MOTRIN and puts ice compress.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Skin discolouration, Swelling
Clinical narrative: Swelling, dark spot, clot like appearance. Not painful but unsightly. Possibly hematoma.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Patient came in and said the area got larger each day (the red). It also got warm when I see her and about 4 inches long.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Employee describes intense pain in (L) deltoid immediately at the time of the injection - by clinician (LPN) at the flu clinic.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site bruising
Clinical narrative: Right arm had bruise where vaccine administered but concern was underneath had large red box that appeared to possibly be allergic reaction (PREVNAR).
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Left arm - red, non raised rash approx 20mm x 30 mm, itchy, hydrocortisone applied.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema
Clinical narrative: Patient reports a large red area on left arm, no itching or swelling, but area is large, approximately 5 inches by 3 inches.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Constipation, Diarrhoea, Muscle disorder, Screaming, Seizure
Clinical narrative: My grandson was force vaccinated against my daughter's consent. My daughter has a severe learning disability and has authorized me to advocate on her behalf, so I'm helping her submit this report.  We've observed seizures, muscle freezing, problems with constipation and diarrhea, and high pitched screaming starting spring of 2016. He was taken from her at birth and her now ex-husband, a convicted pedophile only allowed her to hold him twice. They were rescued from their predator, but father was able to manipulate 50/50 custody. Patient was force vaccinated without her consent on two additional dates in 2016. We will fill out separate forms for the other two dates.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash around the injection site.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Culture stool, Culture urine negative, Diarrhoea, Ear infection
Clinical narrative: Patient was brought to office on 10/11/2017 with abdominal pain, fever, diarrhea, and vomiting. Was diagnosed with a left ear infection and started on 10/11/17. Patients mother called office to be seen  again on 10/12/17 and we had her go to lab to get a stool culture and then to come to the office.  Patient was brought in with complaint from mother that infant still is not feeling better. Patient did have an ear infection, but when leaving the office patient changed diaper and it appeared to have blood in diaper. Patient was sent to Medical Center to be evaluated and treated.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Malaise, Pyrexia, Vomiting
Clinical narrative: Patient was brought to office on 10/11/2017 with abdominal pain, fever, diarrhea, and vomiting. Was diagnosed with a left ear infection and started on 10/11/17. Patients mother called office to be seen  again on 10/12/17 and we had her go to lab to get a stool culture and then to come to the office.  Patient was brought in with complaint from mother that infant still is not feeling better. Patient did have an ear infection, but when leaving the office patient changed diaper and it appeared to have blood in diaper. Patient was sent to Medical Center to be evaluated and treated.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Constipation, Diarrhoea, Ear discomfort, Muscle disorder, Screaming
Clinical narrative: My grandson was force vaccinated against my daughter's consent. My daughter has a severe learning disability and has authorized me to advocate on her behalf, so I'm helping her submit this report.  We've observed seizures, muscle freezing, problems with constipation and diarrhea, slapping his ears really hard, and high pitched screaming starting spring of 2016. He was taken from her at birth and her now ex-husband, a convicted pedophile only allowed her to hold him twice. They were rescued from their predator, but father was able to manipulate 50/50 custody. Pt was vaccinated without her consent.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13
Symptoms: Seizure
Clinical narrative: My grandson was force vaccinated against my daughter's consent. My daughter has a severe learning disability and has authorized me to advocate on her behalf, so I'm helping her submit this report.  We've observed seizures, muscle freezing, problems with constipation and diarrhea, slapping his ears really hard, and high pitched screaming starting spring of 2016. He was taken from her at birth and her now ex-husband, a convicted pedophile only allowed her to hold him twice. They were rescued from their predator, but father was able to manipulate 50/50 custody. Pt was vaccinated without her consent.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Dyspnoea
Clinical narrative: Patient had intense joint pain in back and hips. At the beginning he thought he had trouble breathing but it quickly went away. No treatment given. Medical care was offered and patient left with his wife feeling better.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: PT REPORTED CHILLS/FEVER BEGINNING ABOUT 1 AND 1/2 HOURS POST-INJECTION. BY NIGHT PT EXPERIENCED SWEATS, NAUSEA, JOINT PAIN (HANDS, ELBOWS, WRISTS, KNEES). PT TOOK TYLENOL FOR SYMPTOMS. REPORTED RXN APPROXIMATELY NOON TODAY. STILL HAD JOINT PAINS. PT QUESTIONED WHETHER RADIATION THERAPY ONE YEAR EARLIER MAY HAVE CONTRIBUTED, AS HE HAD NEVER EXPERIENCED AN ADVERSE REACTION PREVIOUSLY.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 29-JUL-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  24-SEP-2015, the patient was treated in the office by his physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 07-OCT-2015, the patient sought subsequent treatment from the same physician for ongoing and worsening outbreaks of shingles. The patient has been prescribed ZORIVAX and NORCO for management of his painful condition. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications.  It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 05-FEB-2008 at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-APR-2017, the patient was treated by two physicians for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 03-MAY-2017, 12-MAY-2017, and 30-MAY-2017, the patient received subsequent treatment at her physician's office for ongoing and worsening symptoms of shingles, as well as the new diagnosis of post-herpetic neuralgia, a chronic condition of nerve pain and damage secondary to severe shingles infection. On or about the dates of 05-JUN-2017, 14-JUN-2017, 10-JUL-2017, and 08-AUG-2017, the patient received additional treatment for new outbreaks of shingles with complication, and continued neuralgia pain. The patient has been prescribed VALTREX, gabapentin, hydrocodone and tramadol for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 25-NOV-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-MAY-2015, the patient was treated in the office by her physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 11-MAY-2015, the patient sought subsequent treatment in the office by her physician for ongoing and worsening outbreaks of shingles. The patient has been prescribed acyclovir and NORCO for management of her painful condition. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 59-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot S89564, expiry date Sep2018) via an unspecified route of administration in the left deltoid on 25Sep2017 at 12:19 pm at 0.5 ml single for routine immunization.  The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and pain at left upper arm since 26Sep2017 and she was diagnosed with cellulitis at left upper arm (vaccination site). The patient had previously received diphtheria, tetanus and acellular pertussis (TDAP) for routine immunization a few years before this report and she had experienced redness and swelling in the same arm. Reaction after pneumococcal 13-val conj vac (dipht crm197 protein) was more severe. The reporter was wondering if there was a relationship between the two shots (if it was an ingredient in the 2 vaccines or if it was just a lot number problem). Past vaccines given for immunization also included influenza vaccine in 2016 at work and hepatitis B vaccine series on unspecified dates. The reporter stated that the patient's symptoms had a gradual onset. The patient's left upper arm started to become red and swollen. The redness spread with pain. The area was outlined. The patient presented on 28Sep2017 with pain, swelling and redness for 3 days. Cellulitis was diagnosed and ibuprofen and warm compresses were recommended. The patient went to the see the on call doctor on 03Oct2017 and she was sent to the emergency room (ER). The patient was admitted to hospital on 03Oct2017 and treated with two doses of vancomycin and ROCEPHIN. The patient was sent home on FLAGYL after an unspecified number of days on an unspecified date in Oct2017. The symptoms were initially worsened, but the reporter was not able to talk to the patient since the ER visit, so the final outcome of event was unknown. The event was considered serious as medically significant event and per initial hospitalization. The reporter stated that the doctor and the patient felt that redness, swelling, pain, and cellulitis were related to pneumococcal 13-val conj vac (dipht crm197 protein), while the reporter did not have a personal opinion on it. Sender's Comments: Based on the information currently provided, the vaccination with PREVNAR 13 may play a contributory role in triggering the occurrence of cellulitis at left upper arm (vaccination site) considering the close time association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Severe pain in arm radiating into her neck and unable to move her arm, have started on MEDROL DOSEPAK today and outcome unknown at this time.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY THE MORNING AFTER SHE WAS GIVEN HER FLU SHOT WITH HIVES OVER HER ARMS AND TORSO. SHE HAD BEEN RECOMMENDED BY HER PHYSICIAN TO PICK UP CLARITIN TO HELP RESOLVE HER REACTION.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pruritus, Throat irritation
Clinical narrative: The vaccinations were administered around 12:50 pm. She started complaining of itchiness around 1:10pm. 50 mg of diphenhydramine was given at 1:21 pm. Her blood pressure was 118/90 at 1:26 pm and 110/78 at 1:36 pm. Shortly after taking the diphenhydramine she complained of a "funny sensation" in her throat. Paramedics arrived at 1:46 pm and took over her care.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site rash, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Rash, swelling, warmth at injection site. Chills. Muscle pain throughout body.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest discomfort, Feeling abnormal, Nausea, Paraesthesia oral, Tongue disorder
Clinical narrative: 20 minutes after vaccine. She reported blurred vision, a feeling of "not feeling right", nausea, chest tightness, tingling of lips and tongue feeling "thick". Patient was nurse working at a Long Term Care center. After symptoms started pt. was transferred to the Emergency Dept. were she received oxygen, aerosol treatments, medication for symptoms.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Vision blurred
Clinical narrative: 20 minutes after vaccine. She reported blurred vision, a feeling of "not feeling right", nausea, chest tightness, tingling of lips and tongue feeling "thick". Patient was nurse working at a Long Term Care center. After symptoms started pt. was transferred to the Emergency Dept. were she received oxygen, aerosol treatments, medication for symptoms.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Localized injection site reaction....area of about 3inch diameter red, swollen, hard, and hot to touch.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Localized injection site reaction....area of about 3inch diameter red, swollen, hard, and hot to touch.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling from shoulder to elbow. Visited Dr office and was told to use Benadryl, cold compress, and Tylenol.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Electroencephalogram abnormal, Epilepsy, Partial seizures, Seizure
Clinical narrative: The pediatrician suggested a flu shot and dtap be given at the same time/same day one after the other. Days after, my baby started having seizures for the first time and has been diagnosed with epilepsy since and is still having seizures bith partial and IS. I believe both shots given on the same day cause my baby's seizures. I'm upset that the pediatrician even suggested it. My baby was a preemie born at 25 weeks which may have put him at risk of complications with the two given at the same time.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Limb mass
Clinical narrative: Patient noticed redness and lump under arm after getting vaccine. Iced and watched and 4 days later bruise appeared.
Age: 74.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Mild Fever, Rash/redness at site, bruising. Took some TYLENOL for the fever which helped. The redness/rash greatly reduced the next day when she came in and reported the event. She had never had a reaction to the flu shot before. Her other shot felt fine.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Pain in left arm with movement, decrease range of motion.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Discovered on 10.12.17 that vaccine was expired. Called pt to schedule re-vaccination time.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Crying
Clinical narrative: Pt. anxious and weepy. After receiving vaccination @ 3:35PM walked to chair, sat down and started talking to his mother. He then became still for several seconds with head down as he was sitting up. Mother and LPN talked with patient. He responded took orange juice and was then alert and communicating. Entire event lasted approximately 15-20 seconds.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Urticaria
Clinical narrative: Patient states that she has hives on her arms and torso. She denies any SOB, wheezing, angioedema. Patient states that any time she gets a sinus infection she breaks out in similar hives. Counseled patient to take Benadryl po x1 and to monitor for worsening of signs and symptoms. told pt to go to ER if condition worsens.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cough, Dyspnoea, Fatigue, Injection site erythema
Clinical narrative: Within hours, I had the following: low fever, sore throat, cough, runny nose, frequent sneezing, labored breathing, weakness and fatigue. Redness, swelling and soreness in area of arm where I received vaccine. These symptoms lasted a full week. Only today on day 9, do I feel close to normal again.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Within hours, I had the following: low fever, sore throat, cough, runny nose, frequent sneezing, labored breathing, weakness and fatigue. Redness, swelling and soreness in area of arm where I received vaccine. These symptoms lasted a full week. Only today on day 9, do I feel close to normal again.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Sneezing
Clinical narrative: Within hours, I had the following: low fever, sore throat, cough, runny nose, frequent sneezing, labored breathing, weakness and fatigue. Redness, swelling and soreness in area of arm where I received vaccine. These symptoms lasted a full week. Only today on day 9, do I feel close to normal again.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: DISCOVERED ON 10.12.17 THAT VACCINE WAS EXPIRED. CALLED PT TO SCHEDULE RE-VACCINATION TIME.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on the inside of upper left arm.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Rash erythematous, Urticaria
Clinical narrative: Immediately following vaccine administration, a welt-like rash approx. 2 inches x 2 inches developed on elbow area and upper arm. Rash progressed to his head, neck, and lower extremities. Rash was extremely red and raised. .4ml IM of diphenhydramine 50mg/1 ml was administered IM in left deltoid. Child remained in clinic for observation an additional 30 minutes following administration of diphenhydramine. Rash became less red and had begun to improve when the child left. No other problems noted.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Myalgia
Clinical narrative: The student received the FLUZONE QUADRIVALENT vaccination on 10/4/17. C/O pain and numbness in left arm at the injection site - onset 10/9/17 at 6 PM. Has limited mobility in left arm due to muscle pain.
Age: 60.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red swollen arm and feels warm.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient came in the pharmacy on 10/12/17 around 1 PM to show the pharmacist her arm. Patient's arm appeared red and inflamed at the injection site about 2 inches in diameter. Patient stated that it was warm to touch.
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Patient experienced chest pressure, shortness of breath, increase in blood pressure, light-headedness.
Age: 67.0
Sex: M
Vaccine: PNC10
Symptoms: Erythema
Clinical narrative: Arm of injection has turned red one day after injection.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Fluzone for ages 6-35months was given instead of 36 months and up.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Computerised tomogram abnormal, Condition aggravated, Injection site abscess
Clinical narrative: Patient admitted to hospital with cellulitis on 10/2/17, condition worsened, abscess to Right deltoid found via CT scan; patient is currently hospitalized.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: The day after receiving the immunization she began experiencing pain in her shoulder, that quickly spread throughout her arm. She also experienced numbness in that arm to the fingertips. Both persist to some degree to this day, one month later. She has tried to put some heat on it, with minimal to no relief. She has not sought medical attention, but plans to soon.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, warm to touch day of. Next day redness and swelling had increased in diameter to 14x17 cm's in an oval area.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On 21-MAR-2006, the patient received the first dose of VAQTA (dose, route, lot number and expiration date were not reported), and on 19-SEP-2006, the patient received the second dose of VAQTA (dose, route, lot number and expiration date were not reported) both for prophylaxis (extra dose administered). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 06-OCT-2017 from  a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 10-SEP-2014 at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  22-JUN-2016, the patient was treated at an Urgent Care Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-DEC-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-NOV-2012, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles.  The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Patient states her arm was sore and started to get red a few hours after injection. Then she said it wasn't sore the next morning, but the rash was worse. She went to see the doctor on 10/12 and they gave her KEFLEX, but she states the rash is better 10/12 than 10/11.