chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous repot was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and second lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), second lasting for 8 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and third lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash.
Age: 69.0
Sex: M
Vaccine: HEPAB
Symptoms: Antibody test negative, Serology negative, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 69-year-old male patient who received TWINRIX adult. Co-suspect products included TWINRIX adult and TWINRIX adult (batch number AHABB253BC, expiry date 13th July 2014). On an unknown date, the patient received the 1st dose of TWINRIX adult and the 2nd dose of TWINRIX adult. On 23rd July 2013, the patient received the 3rd dose of TWINRIX adult (intramuscular) 1 ml. On an unknown date, several years after receiving TWINRIX adult and TWINRIX adult and 3 years after receiving TWINRIX adult, TWINRIX adult and TWINRIX adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additional details were provided as follows: The first two doses were administered at another facility. The reporter got the information from patient that he had a negative titer after receiving the TWINRIX series. It was not specified if it was for Hepatitis A, Hepatitis B or both. In 2016 (very recently), approximately several years after receiving, approximately several years after receiving first two doses and approximately 2 years after receiving 3rd TWINRIX series the negative titer was found, though the reporter did not know when specifically it was drawn.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Injection site vesicles
Clinical narrative: Blister at injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate increased, Pyrexia, Vision blurred
Clinical narrative: From 1/2-1 hour after injection patient experienced high fever, dizziness, fast heart rate and blurred vision for 10 hours.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # reported as M018635, expiration date 11-OCT-2017. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Pt's. sister noted injection site to be red and warm to touch from deltoid to elbow the morning after PNEUMOVAX 23 injection.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt's. sister noted injection site to be red and warm to touch from deltoid to elbow the morning after PNEUMOVAX 23 injection.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Pt noted injection site to be red and warm to touch with a fist size lump the morning after injection of PNEUMOVAX 23.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt noted injection site to be red and warm to touch with a fist size lump the morning after injection of PNEUMOVAX 23.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with PROQUAD, lot # M022400, expiration date: 01-JUL-2017 (strength, dose and route of administration were unknown), which were improperly stored at -12.7 C for 15 hours. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 47-year-old female patient who received BEXSERO. On 16th May 2016, the patient received the 1st dose of BEXSERO. On 20th May 2016, 4 days after receiving BEXSERO, the patient experienced injection site cellulitis, injection site lump, back pain, neck pain and injection site pain. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site cellulitis, injection site lump, back pain, neck pain and injection site pain were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site cellulitis, injection site lump, back pain, neck pain, injection site pain and injection site erythema to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The patient required outpatient visit for the events. The patient had a red hot lump. The patient had an ongoing pink mark at the injection site at the time of reporting.
Age: 47.0
Sex: F
Vaccine: MENB
Symptoms: Injection site warmth, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site cellulitis in a 47-year-old female patient who received BEXSERO. On 16th May 2016, the patient received the 1st dose of BEXSERO. On 20th May 2016, 4 days after receiving BEXSERO, the patient experienced injection site cellulitis, injection site lump, back pain, neck pain and injection site pain. On an unknown date, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site cellulitis, injection site lump, back pain, neck pain and injection site pain were recovered/resolved and the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site cellulitis, injection site lump, back pain, neck pain, injection site pain and injection site erythema to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The patient required outpatient visit for the events. The patient had a red hot lump. The patient had an ongoing pink mark at the injection site at the time of reporting.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a 14 year old female patient. The patient's concurrent conditions included celiac disease and asthma. The patient's medical history included adenopathy. There were no drug reactions and allergies. On 19-OCT-2016, the patient was vaccinated with an unspecified dose of GARDASIL 9 (lot number M028323 with an expiration date of 26-SEP-2018) (strength, dosage schedule, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. On the same date, after being administered GARDASIL 9, the patient experienced syncope. The patient sought medical attention and was seen by a physician, no treatment was given for the event and no laboratory studies were performed. The office manager stated that the patient recovered from the syncope in less than a minute on 19-OCT-2016. No product quality complaint was involved. The relatedness between the event and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Left upper arm. Warm to touch, bruising, redness that is spreading down arm, soreness, itching. Pt had PREVNAR vaccination on Thursday 9/29/16 and believes rash could be an allergic reaction. She has a large erythematous area over the medial side of her left bicep extending from the midline of the biceps muscle down to the back of her arm and extending from about mid way down the biceps muscle distal to the elbow. Surrounding this petechial rash she has a yellow discoloration of the skin that extends over the entirety of the seventh muscle in the lateral portion of the arm up to just below the deltoid muscle. The erythematous portion is warm to touch. No tenderness to palpation. Very minimal edema is present.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Oedema, Petechiae, Yellow skin
Clinical narrative: Left upper arm. Warm to touch, bruising, redness that is spreading down arm, soreness, itching. Pt had PREVNAR vaccination on Thursday 9/29/16 and believes rash could be an allergic reaction. She has a large erythematous area over the medial side of her left bicep extending from the midline of the biceps muscle down to the back of her arm and extending from about mid way down the biceps muscle distal to the elbow. Surrounding this petechial rash she has a yellow discoloration of the skin that extends over the entirety of the seventh muscle in the lateral portion of the arm up to just below the deltoid muscle. The erythematous portion is warm to touch. No tenderness to palpation. Very minimal edema is present.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 14-OCT-2016 from a field employee. He reported that per the physician, a patient (age and gender not reported) who was administered the ZOSTAVAX vaccine developed shingles. The patient's medical history, concurrent conditions and concomitant medications were not reported. The outcome of shingles was not reported. The physician did not rate the causal relationship between ZOSTAVAX and the shingles. No further information is expected as no contact information was provided.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 72 hours, with the lowest recorded temperature of 33 degree Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), third lasting for 88 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and fourth lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-OCT-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 48 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-FEB-2015, the patient was vaccinated with improperly stored dose of VAQTA pediatrician dose: 25U/0.5 ml (lot # J014584, expiration date: 16-JAN-2016; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 492 hours, with the lowest recorded temperature of -3 degrees Celsius, second lasting for 336 hours, with the highest recorded temperature of 59 degrees Fahrenheit (15 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 single dose: 0.5 ml (lot # L013428, expiration date: 03-FEB-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursion: first lasting for 72 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), third lasting for 88 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius) and fourth lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M014926, expiration date 17-FEB-2019; lot # M020102, expiration date 08-MAR-2019, dose and route not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Gait disturbance, Headache
Clinical narrative: Light headedness, dizziness, headache, developed walking issues.
Age: 82.0
Sex: U
Vaccine: PNC13
Symptoms: Intercepted drug administration error
Clinical narrative: PREVNAR 13 ordered, PNEUMOVAX 23 prepped for administration. Error caught during documentation, vaccine wasted before given to patient. Correct vaccine prepped and administered.
Age: 68.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: PNEUMOVAX ordered, PREVNAR given.
Age: 22.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Adult dose Hep A ordered, ped/adolescent Hep A dose given.
Age: 20.0
Sex: U
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Hep B ordered, HPV given.
Age: 52.0
Sex: U
Vaccine: FLUX, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was screened alongside family for recommended adult vaccines when receiving his seasonal influenza vaccine. Patient did not recall the last time he had a Tdap vaccine and the pharmacist recommended that he receive a dose of ADACEL along with his seasonal influenza vaccine. Pharmacist did not consult patient chart from all stores within the pharmacy chain or statewide registry before recommending immunization (Note: reporting to state registry is not mandatory in our state and often registry information is incomplete or non-existent). Pharmacist reviewed patient's full medication history for all stores within the pharmacy chain after administering ADACEL (to see if he had received Hepatitis B vaccine series) and discovered that he had received BOOSTRIX previously in 2015 at another store within the chain. Dose was administered at incorrect interval/2nd dose of pertussis-containing vaccine was not indicated. Age of patient at time of event: 52 years.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Nursing preparing a MENVEO inj for a patient noticed that the box of 5/5 and one extra vial of the liquid component (MenCYW-135) that should have been used for reconstitution for the lyophilized portion (MenA conj component). Suspect a plain diluent was used for reconstitution. 2 potential patients and one is missing the liquid component.
Age: 0.6
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Wrong drug administered
Clinical narrative: Order was given for PEDIARIX and HIB; PENTACEL and HIB were administered inadvertently.
Age: 13.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: On Monday 8/8/2016 I gave a 13 year old INFANRIX instead of ADACEL. No adverse reactions observed or reported. Age of patient at time of event: 13 years.
Age: 63.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: ZOSTAVAX ordered, VARIVAX given.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: PENTACEL ordered, only Dtap and IPV given. Staff did not mix with ActHib portion of combo vaccine. Type of Event: Vaccine/component omission - Only one component of multi-component vaccine administered.
Age: 4.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered
Clinical narrative: PENTACEL ordered, only ACTHIB given. Staff did not mix Dtap-IPV portion of combo vaccine with ACTHIB.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Medical Assistant gave a 4 month old child Hepatitis A vaccine by mistake instead of HIB. Noticed error after vaccine was administered. Quickly notified PCP and patient's mother. Age of patient at time of event: 3 months 23 days.
Age: 3.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: HIB component was mixed with sterile diluent instead of Dtap/IPV component. Therefore, patient received only HIB component mixed with sterile diluent.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: An 18 year old received the adult dose of Hep A vaccine versus the pediatric dose.
Age: 0.42
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine was given to pt. not of age. Age of patient at time of event: 5 months 16 days.
Age: 0.4
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine given to pt not of age. Age of patient at time of event: 4 months 25 days.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pediatric patient was given Adult dose of Hepatitis A. Age of patient at time of event: 18 months.
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: My son already had his two recommended doses on 10/23/2003 and 06/07/2007 and he was given a third dose on 08/28/2015 for an for an unexplained reason. I have brought this up to the Nurse in charge and she insisted that they did no wrong in this and that they did not over-vaccinated my child. I am reporting this error because it happened whether she wants to admit it or not. They are completely at fault for said error. They had all immunization records and still gave this vaccine.
Age: 20.0
Sex: U
Vaccine: HEP, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Pt was to receive MENVEO (HPV) and gave ENERGIX (Hep B) busy day and looked at order wrong.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect route of drug administration
Clinical narrative: Injection was administered Sub-q instead of IM. Age of patient at time of event: 18 years 5 months 28 days.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Medication error, No adverse event, Wrong drug administered
Clinical narrative: NP ordered Varicella, MMR and Hep A vaccines for patient. LVN removed vaccines from VFC freezer to give to the MA. LVN did not notice she removed PROQUAD, thus no single dose of Varicella was ever taken from freezer. Both employees overlooked the medication error. Patient was given wrong dosage (over dose) of Varicella vaccine-MA administered PROQUAD, Varicella, MMR and Hep A. This meant Varicella was given twice, as a single dose and as a combination vaccine in the PROQUAD. All staff involved were notified and patient's mother was informed of incident. Patient monitored at the clinic and instructions were given to mother on care of child at home. Patient was called the next day as follow up on status, mother stated no adverse reactions noted. Patient was stable.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: Drew up and gave PENTACEL, child should of been given KINRIX. Age of patient at time of event: 4 years.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Incorrect product storage
Clinical narrative: Our medical clinic refrigerators malfunctioned and created a too low temperature for vaccines to be viable. Patient received vaccination due to human error in not pulling the non-viable vaccines from refrigerator when it was reported that all non-viable vaccines were pulled correctly and transferred correctly. After speaking with all pharmaceutical companies regarding patient receiving non-viable vaccines, patient have been recalled and will received vaccine as soon as possible. Age of patient at time of event: 12 year 7 months.
Age: 5.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A 5 year old client with no prior vaccinations received a Tdap vaccine instead of a DTaP vaccine for the 1st dose. The Tdap was administered based on the date of birth provided and verified by the parent (year 2009). The parent noticed the wrong birthdate on the record after leaving the clinic. Parent was notified of the invalid dose. Age of patient at time of event: 5 years 10 days.
Age: 8.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Pt came in to receive vaccines that she was behind on, per her  schedule she needed DTaP/DT/TD/Tdap, Hep-B and IPV. Pt was given DTaP because she has only received 2 prior to doses however per schedule pt should have been given Tdap because of her age. Orders were given by provider to give DTaP.
Age: 9.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: An 8 and 9 yr. old received adult HEP A vaccine instead of Pediatric dose. Age of patient at time of event: 9 years 10 months.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 19 year old patient administered pediatric formulation of HAVRIX. Age of patient at time of event: 19 years.
Age: 1.2
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: 7 month old patient presented with mother to receive second dose of HIB vaccine. Medical Assistant that was administering the vaccine only administered the conjugate to the patient without reconstituting with the ACTHIB. Medical Assistant did not have another clinical staff member verify the vaccine that was being administered prior to administration. Error was recognized 1 business day later when auditing the vaccines that were administered the week prior.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Pruritus, Tenderness
Clinical narrative: Redness, itching, sensitive to the touch, a little pain when moving the arm, hurt.
Age: 10.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site rash, Skin reaction
Clinical narrative: Skin reaction/rash on patient's upper right thigh at site of TDaP, approx 4-5 days after vaccine. Made VAERS report per mom's request. Rash would seem most likely an allergic eruption, possibly related to alcohol wipe of the band aid applied and not infectious (cellulitis, and not a typical local vaccine reaction). The possibility that the rash might be shingles was discussed, but again not classic.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Nodule, Tenderness
Clinical narrative: Mom brought patient in today because his left arm where he received the BEXSERO vaccine is still hurting and sore two weeks after the vaccine. Provider examined him and there is no redness or warmth or rash. He does have a small "knot" of tissue in the deltoid muscle about two finger widths below the acromion that is tender to the touch. Provider thinks it is a little scar tissue that forms when vaccines are given as she has seen these before with MMR, IPV and PNEUMOVAX. It is not a contraindication to further vaccination but I may not wish to repeat BEXSERO right away for him.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Dyspnoea
Clinical narrative: Within 5 minutes of shot, pt complained of chest and back pain. There was also some shortness of breath. Symptoms subsided after patient was walked to a chair and comforted by family and staff.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria, Vaccination site induration, Vaccination site nodule, Vaccination site pain
Clinical narrative: Hives all over my back, arms and legs. Vaccine site became a hard knot and very sore.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Skin discolouration
Clinical narrative: Entire left arm black and blue.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Red circle around injection site the size of a tangerine. Soreness at injection site. Body aches and pains that continued to get worse over the next 2 days, and then proceeded to get better until she came it to report problems.
Age: 0.33
Sex: F
Vaccine: HIBV, PNC13, RV1
Symptoms: Barium enema, Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception treated with barium enema at Hospital.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient stated arm became very red and swollen near the injection site. Also became very stiff and sore.
Age: 60.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Immediate post-injection reaction, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Immediate burning sensation in arm which I know is to be expected but the pain since the shot has traveled to my neck, shoulder and down my arm almost to my finger tips.  Constant nagging pain, am taking Tylenol for pain every 6 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain, Skin warm, Urticaria
Clinical narrative: Received Zostavax on 10/19/2016 - Woke up Thursday morning with redness and heat in localized area with mild welting. Redness continued to spread down arm over the next two days. Still hot today (10/22/16). Burning/stinging sensation in localized area. No pain in shoulder/fingers/rest of arm. Stated seems better today (10/22/2016) than yesterday.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Hard knot, redness, swelling, warm to the touch, pain, itch (all at/around injection site).
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Impaired work ability, Injection site pain, Musculoskeletal stiffness, Pain, X-ray
Clinical narrative: Pain experienced at time of injection. Progressive increased pain after one hour. Localized pain with any light shoulder activity during ADL's, raising or leaning on arm, driving, etc. Significant pain with stiffness at night. Requires pain relief medication, experienced loss of work time. Symptoms persist currently.
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint stiffness, Mobility decreased, Pain in extremity
Clinical narrative: Pain experienced at time of injection. Progressive increased pain after one hour. Localized pain with any light shoulder activity during ADL's, raising or leaning on arm, driving, etc. Significant pain with stiffness at night. Requires pain relief medication, experienced loss of work time. Symptoms persist currently.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cough, Dyspnoea, Excessive eye blinking, Increased upper airway secretion, Tic
Clinical narrative: Developed various tics and shortness of breath. Facial contortions, gasping and sighing as if air hunger was present, excessive eye blinking, and odd sounds coming from her throat, nasal clearing, coughing. Followed up with doctor who rules out any lung and cardiology issue. Referred to an Allergist & Immunology specialist to rule out any allergy and strep infection that may be an agent for the tics. A referral to a neurologist has been made as well as of 10/22/2016. Symptoms are all present waxing and waning as of 10/22/2016.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Body temperature increased, Chills, Fatigue, Injection site pain
Clinical narrative: My younger brother had local muscle pain around the injection site, a slightly elevated body temperature (99.9 F according to an ear thermometer), fatigue, and chills.  No treatment was given except I had him remain in an air-conditioned room and wear loose clothing.  He recovered by this morning from the elevated temperature, chills, and fatigue.  There is still local muscle pain around the injection site.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Back pain, Chest pain, Erythema, Herpes zoster, Rash vesicular
Clinical narrative: Initially, soreness in upper right chest. On 10/17/16, observed first red patch on right chest. On 10/18/16, red patches increased on and were on upper right back. Soreness in chest and back increased. On 10/20/16, went to a dermatologist who diagnosed the then-blistering rashes as Shingles probably as a reaction to FLUZONE HIGH DOSE vaccination on 10/12/16; also had the PREVNAR 13 vaccination on 10/12/16. Dr. prescribed Valacyclovir 1 gram tablets.
Age: 65.0
Sex: M
Vaccine: FLUX, PNC
Symptoms: Arthralgia, Mobility decreased, Sleep disorder
Clinical narrative: Pain in entire left shoulder joint. Could not sleep. Cannot lift my arm. Next morning severe pain cannot lift arm .
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: Scratchy and itchy throat before leaving store, sore throat, runny nose, head ache, fever continuing on 10/21/2016. Fever broke 10/22/2016, other symptoms diminished.
Age: 48.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Severe pain and heat in deltoid where vaccine administered, which worsened over the course of 10/18/16. 3:00 AM 10/19/16 onset of chills and fever (100.7).  Fever persisted, averaging 101, throughout 10/19/16, and returned to normal on the morning of 10/20/16.  Severe arm pain persisted through 10/20/16.  Pain and heat have moderated, but pain continues upon deltoid contraction or local pressure; heat is constant.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Antinuclear antibody negative, Blood 25-hydroxycholecalciferol, Blood folate, Blood iron normal
Clinical narrative: Significant amount of hair started falling out.  Diagnosed 10/10/2016 by a Dermatologist as Telogen Effluvium following trauma to my body approx. 2 1/2 to 3 months prior.  I have been totally healthy and have had no trauma incidents except the vaccination. I believe that the PREVNAR 13 shot triggered this reaction that continues as of 10/22/2016 and I am told will continue for at least 6 months with 50% hair loss at a minimum.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Diffuse alopecia, Full blood count normal, Injury
Clinical narrative: Significant amount of hair started falling out.  Diagnosed 10/10/2016 by a Dermatologist as Telogen Effluvium following trauma to my body approx. 2 1/2 to 3 months prior.  I have been totally healthy and have had no trauma incidents except the vaccination. I believe that the PREVNAR 13 shot triggered this reaction that continues as of 10/22/2016 and I am told will continue for at least 6 months with 50% hair loss at a minimum.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Lipids normal, Metabolic function test normal, Thyroxine free normal, Thyroxine normal, Vitamin B12 normal
Clinical narrative: Significant amount of hair started falling out.  Diagnosed 10/10/2016 by a Dermatologist as Telogen Effluvium following trauma to my body approx. 2 1/2 to 3 months prior.  I have been totally healthy and have had no trauma incidents except the vaccination. I believe that the PREVNAR 13 shot triggered this reaction that continues as of 10/22/2016 and I am told will continue for at least 6 months with 50% hair loss at a minimum.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Respiratory tract oedema
Clinical narrative: Swelling of airway in throat and chest. Took Claritin and resolved.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm warm to touch and big as a 2x4, red and tender, hard and hurts.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Right arm warm to touch and big as a 2x4, red and tender, hard and hurts.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Dizziness, Fall, Feeling abnormal
Clinical narrative: At approximately at around 11:30 pm I went to get out of bed to use restroom. Bed is 3 feet off the floor, high. My feet hit the floor, next thing I am on the floor falling into my daughter's closet. I tried to get up, but too weak. I reached up to the bed rail and was too weak to pull myself up onto the mattress. I fell back to floor and tried two more times. The next thing I awoke and tried to pull myself up again to no avail. Third time I fell to the foot of the bed to the floor unable to get up. A while later I again awoke and crawled to the other side of the bed really weak all the time the room was spinning. It was light outside from my bedroom window. I somehow pulled myself up onto the mattress, still feeling weak and dizzy. The mattress was wet with urine and my clothing was soaked. I had lost urine I guess getting out of bed. Sometime later I managed to get out of bed to use the restroom, still weak, dizzy and loss of balance, running into the walls. My daughter came into my room and I explained what happened. I lay in bed for most of the morning like in a fog. Later getting up to eat but was too nauseated which lasted three more days. The second day I was still not waling correctly. I routinely get up at night every two hours to void,I estimated I laid on the floor about 4 to 6 hours. I was too embarrassed to call for help. The next day I called the FDA 1-800 number and they gave me your web page. I have had flu vaccines since 1980s and never had any reactions. I did not call 911.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Nausea, Urinary incontinence, Vertigo
Clinical narrative: At approximately at around 11:30 pm I went to get out of bed to use restroom. Bed is 3 feet off the floor, high. My feet hit the floor, next thing I am on the floor falling into my daughter's closet. I tried to get up, but too weak. I reached up to the bed rail and was too weak to pull myself up onto the mattress. I fell back to floor and tried two more times. The next thing I awoke and tried to pull myself up again to no avail. Third time I fell to the foot of the bed to the floor unable to get up. A while later I again awoke and crawled to the other side of the bed really weak all the time the room was spinning. It was light outside from my bedroom window. I somehow pulled myself up onto the mattress, still feeling weak and dizzy. The mattress was wet with urine and my clothing was soaked. I had lost urine I guess getting out of bed. Sometime later I managed to get out of bed to use the restroom, still weak, dizzy and loss of balance, running into the walls. My daughter came into my room and I explained what happened. I lay in bed for most of the morning like in a fog. Later getting up to eat but was too nauseated which lasted three more days. The second day I was still not waling correctly. I routinely get up at night every two hours to void,I estimated I laid on the floor about 4 to 6 hours. I was too embarrassed to call for help. The next day I called the FDA 1-800 number and they gave me your web page. I have had flu vaccines since 1980s and never had any reactions. I did not call 911.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Injection site (upper left arm) extremely painful. Pain in area has persisted in arm and shoulder, limiting range of motion and movement.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Lymphadenopathy, Myalgia, Pollakiuria
Clinical narrative: Fever up to 101.9, extreme muscle and joint pain in lower back, swollen glands, frequent urination.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever up to 101.9, extreme muscle and joint pain in lower back, swollen glands, frequent urination.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Urticaria
Clinical narrative: Hives all over body. Treating with Benadryl but the hives have not gone away yet.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Deafness, Dizziness, Dyskinesia, Fall
Clinical narrative: Dizziness, loss of sight/hearing for brief time.  She exhibited slight jerking movement, fell to concrete floor w/sm. scrape on her side. I gave her 25 mg. She felt better in 15 min.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Skin abrasion
Clinical narrative: Dizziness, loss of sight/hearing for brief time.  She exhibited slight jerking movement, fell to concrete floor w/sm. scrape on her side. I gave her 25 mg. She felt better in 15 min.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Chest pain, Computerised tomogram thorax, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Chest pain, difficult breathing, severe headache. Treated with Benadryl and Toradol.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Chest pain, difficult breathing, severe headache. Treated with Benadryl and Toradol.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Woke up with severe dizziness and vertigo. The dizziness caused mild nausea.The vertigo has continued and continues now four days later with no change in severity.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck with no fever.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Heart rate increased, Migraine, Nausea, Pain
Clinical narrative: Migraine, followed by has, high heart rate, nausea , body aches and severe diarrhea  and fever.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Migraine, followed by has, high heart rate, nausea , body aches and severe diarrhea  and fever.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain, Sensation of foreign body
Clinical narrative: When pt moves arm in backwards swinging motion, pt feels as though there is a needle in his arm. Not sore when he moves his arm in any other direction.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: A pink, itchy, non-raised to slightly raised rash approximately 4cm x 6cm around injection site on left thigh. It was not tender to palpation and blanched. Treated with topical steroid and oral antihistamine.
Age: 53.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: Rashes on right arm and on trunk of body. Joint pain and fever.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Headache, swollen at site, inflammation at site, heavy redness on entire upper arm.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mild erythema warmth st site. SC4 and 3 cm in circumference HPV (L) deltoid only.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased
Clinical narrative: Can't lift arm- even a month after. Shot too high in arm/shoulder.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Welt looking red rash, hot to touch, raised skin, 4" long/ 1" wide- has grown to 12" long/ 3" wide. Extremely sore to touch.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Fatigue, Headache, Pyrexia
Clinical narrative: Nonstop sneezing and post nasal drip; swelling around eyes; fever; headache; extreme fatigue; coughing.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Upper-airway cough syndrome
Clinical narrative: Nonstop sneezing and post nasal drip; swelling around eyes; fever; headache; extreme fatigue; coughing.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site vesicles, Vaccination site swelling
Clinical narrative: Swelling, redness, itching @ vac site. Within two days swelled to 4.5 inch circle w/2x4 inch blister in center and headache mid day. Post 3 days was swollen to 5x6 inches w/ larger blister.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Headache, Lethargy, Pain, Swelling face
Clinical narrative: Headache, body aches, lethargy started approx. 6 hours after admin. Facial swelling (mostly around eyes) and redness present 15 hours after admin. Progressed through 48 hours after admin.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose, Disturbance in attention, Dizziness, Fall, Syncope
Clinical narrative: Patient receiving influenza vaccine expressed a needle/injection phobia, elaborating that previous blood draws resulted in her feeling faint/fainting. Patient was counseled on rights not to receive vaccine if she did not want vaccine, but patient advised that she did wish to receive vaccine. Patient was told to wait after vaccination for observation and that pharmacist would be with her the whole time. Approximately 5 minutes post-vaccine the patient mentioned increasing dizziness and difficulty focusing. Pharmacist advised patient to remain seated and take her time, trying to relax and take deep breaths. About 2 minutes later the patient described a worsening of dizziness and pharmacist called in her husband to the immunization room. At this time the patient began to fall sideways from chair; pharmacist and patient's husband was able to allow a controlled fall to the ground. Patient did not appear to lose consciousness and did not suffer any trauma to body or head. Pharmacist advised patient that emergency services would be notified.  Emergency services engaged and took over care of patient. After approximately 20 minutes, patient was stable and of clear mental status. Patient did decline emergency room service and attending medic advised that patient was stable to decline this service, having patient sign off on the care received.   After discussing with patient and medic, this adverse event appeared to be resulting from a fear of needles and or needle sticks, which lead to vasovagal syncope.
Age: 14.0
Sex: M
Vaccine: HPVX
Symptoms: Headache, Neck pain
Clinical narrative: Woke up with neck pain on R side (vaccine administration side)  Pain got worse and patient went to urgent care - was prescribed steroid and NSAID and topical ice.
Age: 59.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Burning sensation, Chills, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Prior to my visit to the hospital this past October 18, 2016 to visit my primary care physician Dr. at Clinic, and after receiving the flu vaccine and the Tdap vaccine on that visit, I felt in perfect health. As the evening of Oct 18th approached I could feel the onset of body chills. By the morning of Oct 19th I had chills, headache and a fever that rose to 102 degrees. By Friday, Oct 21st, The headache, chills and fever had subsided but was replaced by a sore throat and, most troubling, by burning/pins-and-needles sensations in my left hand finger tips. By Saturday the sore throat continued and the burning/pins-and-needles sensation in the finger tips of my left hand was now also in my right hand and beginning in the toes of both feet. Yesterday, Oct 22, I still had the minor sore throat and I still had the sensation of painful/burning sensation in the finger tips of both hands and the toes and balls of both feet and visible were small red spots, some almost blister like in appearance. This morning, Sunday Oct 23, I still have the same symptoms as yesterday but they seem to be somewhat lessened. I feel that my symptoms are a direct result of the vaccines that I were administered at the clinic on Oct 18th.