chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Influenza
Clinical narrative: This medically confirmed spontaneous report (initial receipt 30 Mar-2016) concerns a male patient of at least adult age (possibly elderly). The patient has a medical history of Guillain-Barre Syndrome (GBS). In Nov-2011, the patient received Afluria (influenza virus vaccine polyvalent; batch no: not reported; dose: 0.5 ml) via the intramuscular route for indication not reported. Five days after Afluria administration, the patient received a flu vaccine (influenza virus vaccine; brand and batch number unspecified). On an unknown date following the second flu vaccination, the patient's GBS symptoms worsened and were aggravated. The GBS became chronic inflammatory demyelinating polyneuropathy (CIDP) about two months later. The patient insists that the flu symptoms worsened and aggravated the pre-existing GBS.  The worsening of symptoms includes falling down, fogginess and loss of balance. The patient is being treated with intravenous immunoglobulin (IVIG) once daily every seven weeks. The outcome was not reported. Reporter's Comments: The reporter stated that worsening of symptoms include falling down, fogginess and loss of balance. Sender's Comments: Company comment: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, CIDP is unlisted.  All other events are also unlisted except GBS (symptoms worsened) and flu symptoms are listed. Causality: Unassessable. Time to onset was not specified. It is likely patient had CIDP at the outset diagnosed as GBS due to the similarity of presentation and as CIDP has recurrences with partial or complete recovery. Flu symptoms are likely due to influenza like illness that can follow vaccination but information such as (time to onset and laboratory diagnosis) is lacking to confirm potential lack of effect. Similarly it is not known if patient received a further dose of seasonal Influenza vaccine or pandemic (H1N1) vaccination within the same week and the effect of this on the reported events. Influenza vaccination is generally not advised in person with known history of GBS.  Overall there is insufficient information to attribute causality to Afluria.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a physician on 17-Jul-2015. A 49 years old male patient, whose medical history and concomitant medications were not reported had received first dose of DIPTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (batch number: U5235AA, expiry date not reported) in his left deltoid on 13-Jul-2015. Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were reported as NKA (No known allergies). Illness at the time of vaccination was reported as none. On 14-Jul-2015, a day after vaccination patient experienced pain in his left arm and elbow with decreased range of motion. The patient required Emergency Room visit. It was reported that there was some improvement on the next day as there was a limited range of motion in elbow. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of the event was recovering. Documents held by sender: none. Follow up information received from physician on 28 August 2015. The patient did not receive any vaccine four weeks prior to date of 13 July 2015. The patient did not have any known allergies and birth defect was unknown. Patient medical history reported as non-contributory with no prior chronic condition. On an unspecified date the patient was recovered from the events.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Prolonged pain at injection site and progressive loss of range of motion of left shoulder. Currently under care of Orthopedist; getting physical therapy.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Eye swelling, Laboratory test, Lip swelling, Mouth swelling, Pharyngeal oedema
Clinical narrative: ITCHING OF HANDS AND FEET, SWOLLEN-EYES, NOSE, LIPS, MOUTH, THROAT, AND HIVES ALL OVER LIMBS AND BUTTOCKS.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING OF HANDS AND FEET, SWOLLEN-EYES, NOSE, LIPS, MOUTH, THROAT, AND HIVES ALL OVER LIMBS AND BUTTOCKS.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: Patient called reporting that her left upper arm, where she received the Pneumonia vaccine, is very sore and has a knot. Pt also, reports that she had a low grade fever all on last evening after getting the vaccination. Pt reports that it is better today.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fluid retention, Swelling
Clinical narrative: Redness, swelling, and a pouch of fluids.
Age: 1.08
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Cough, Rash, Rhinorrhoea
Clinical narrative: Blanch-able pinpoint rash noticed on trunk and continued to spread over the next 2-3 days, cough with rhinorrhea since early morning on 4-10-16 and continuing today with rash noted more on extremities and face, cough, and rhinorrhea.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis, Injection site pain, Myalgia, Pain
Clinical narrative: Pain in left shoulder muscle started the day after receiving flu immunization.  Pain is in all of the shoulder muscle.  Moving her arm causes it to feel like shooting pain.  She rates her pain an 8 on scale of 1 - 10 with 10 being the worst.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, White blood cell count increased
Clinical narrative: Pain, erythema, induration at injection site. Extensive erythema and induration appx 10 x 15 cm.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Pt. states that her arm from the elbow down started to tingle. Her hand feels like it has "fallen asleep". When asked about redness, swelling, or tenderness at the site of the vaccination, patient states there is "a little" but not a lot. Pt. has spoken to MD about symptoms. Advised to seek MD attention with PCP or ER if symptoms persists.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Extreme pain in left shoulder and upper arm for approx. 4 weeks, followed by moderate pain continuing; treated with ice, heat, aspirin, ibuprofen, massage.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None known.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site reaction, Injection site vesicles, Skin lesion
Clinical narrative: Immediately after giving MMRV vaccine this RN noticed an area about half an inch away from injection site appearing to bubble in 2 - 3 places. The bubbles quickly coalesced into one larger bubble. The shape of the lesion was like a goldfish cracker with dimpled skin. It measured about 1 inch long and was half an inch wide at its widest point. Drs examined the lesion. Listened to her haert and lungs and advised that we watch child for possible allergic reaction. The area was drawn around with a black ballpoint and it did not increase in length or width. Pt was discharged at 11:15 AM after the providers had examined her again. The lesion was not as swollen but was still firm. (The height of the area had gone down). Patient remained conscious throughout and denied pain or itching or other symptoms.
Age: 63.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Middle insomnia, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Started by pain in left shoulder and progressed to inability to move shoulder and arm without severe pain. Could not lift are to put on a jacket. Pain was progressively worse and did not start to regress for about a month and I still have pain in left shoulder to where it wakes me up at night if I roll to that side. This shot was administered to the Bursa and rotator cuff in my left shoulder.
Age: 63.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site joint movement impairment, Injection site pain, Pain, Poor quality sleep
Clinical narrative: Started by pain in left shoulder and progressed to inability to move shoulder and arm without severe pain. Could not lift are to put on a jacket. Pain was progressively worse and did not start to regress for about a month and I still have pain in left shoulder to where it wakes me up at night if I roll to that side. This shot was administered to the Bursa and rotator cuff in my left shoulder.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Bedridden, Chills, Death, Decreased appetite, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her mother. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 27Oct2015 or 28Oct2015 and influenza vaccine, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The next day after vaccination (Oct2015), the patient was still very sick, dizziness/lightheadedness, loss of appetite, fatigue, listlessness, body aches, sweats, chills, fever, bedridden, lethargic, unable to stand. No treatment received. These symptoms started out the next day and increased plus multiplied within the time of her death. The patient died on 06Nov2015. It was not reported if an autopsy was performed. Follow-up (13Nov2015): New information reported from a contactable consumer includes: primary reporter's information. Follow-up (08Jan2016): Follow-up attempts completed. No further information expected. Follow-up (04Apr2016): New information obtained from the same contactable consumer includes: additional events, additional suspect drug, date of administration of PREVNAR 13.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Dysstasia, Fatigue, Hyperhidrosis, Lethargy, Listless
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her mother. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 27Oct2015 or 28Oct2015 and influenza vaccine, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The next day after vaccination (Oct2015), the patient was still very sick, dizziness/lightheadedness, loss of appetite, fatigue, listlessness, body aches, sweats, chills, fever, bedridden, lethargic, unable to stand. No treatment received. These symptoms started out the next day and increased plus multiplied within the time of her death. The patient died on 06Nov2015. It was not reported if an autopsy was performed. Follow-up (13Nov2015): New information reported from a contactable consumer includes: primary reporter's information. Follow-up (08Jan2016): Follow-up attempts completed. No further information expected. Follow-up (04Apr2016): New information obtained from the same contactable consumer includes: additional events, additional suspect drug, date of administration of PREVNAR 13.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her mother. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on 27Oct2015 or 28Oct2015 and influenza vaccine, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The next day after vaccination (Oct2015), the patient was still very sick, dizziness/lightheadedness, loss of appetite, fatigue, listlessness, body aches, sweats, chills, fever, bedridden, lethargic, unable to stand. No treatment received. These symptoms started out the next day and increased plus multiplied within the time of her death. The patient died on 06Nov2015. It was not reported if an autopsy was performed. Follow-up (13Nov2015): New information reported from a contactable consumer includes: primary reporter's information. Follow-up (08Jan2016): Follow-up attempts completed. No further information expected. Follow-up (04Apr2016): New information obtained from the same contactable consumer includes: additional events, additional suspect drug, date of administration of PREVNAR 13.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Culture negative, Headache, Ocular hyperaemia, Pain
Clinical narrative: Initial unsolicited report received from a nurse on 30 January 2015. A 54-year-old male patient had received a dose of TETANUS TOXOID (Tetanus Vaccine), (batch number unknown, dose and dose in series was not reported) intramuscularly in right deltoid on 29 January 2015. The patient had a medical history of migraine headaches, asthma and concomitant medications were not reported. On 30 January 2015; one day after vaccination, the patient experienced headache, red eyes and diffuse body aches. Oral flu swab was negative and patient was treated with Tamiflu. At the time of this report outcome of events were unknown. The parent required ER/doctor visit. Documents held by sender: none. Follow-up information received from a nurse on 16 March 2015: The patient had received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) corresponding to batch number U4939AA. On an unspecified date, the patient had recovered from the events.
Sex: F
Vaccine: TTOX
Symptoms: Malaise
Clinical narrative: Initial unsolicited report received from a consumer on 23 March 2016. This case involves a female patient (age unknown) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (batch number, expiry date, route and site of administration were not reported) on an unspecified date of 1980. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications was not reported. On an unspecified date in 1980, three days following the vaccination patient was extremely ill and was staying in bed. The patient's lab data and corrective treatment were not reported. The patient had not recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Transient ischaemic attack
Clinical narrative: Initial unsolicited report received from a Non-healthcare professional on 31 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a intramuscular dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number U5036AA, expiration date 30 June 2015, dose and site of administration was not reported) in 2014 (unspecified date). Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical condition was not reported. Concomitant medications were not reported. On an unspecified date in 2014, following the vaccination, the patient had a severe reaction and had to go the emergency department. It was reported that at the emergency department patient was diagnosed with transient ischemic attack. It was reported that patient did not have specific symptoms. Patient required emergency room or doctor visit. Lab data and corrective treatment was not reported. On an unspecified date, patient was recovered from event. Upon medical review, the case was considered as serious due to important medical event: transient ischemic attack. List of documents held by sender: none. Sender's Comments: This case is poorly documented and non-medically confirmed. No symptoms were reported. Time to onset is not reported. Further information on patient's medical history, details of symptoms, time to onset, lab data confirming the diagnosis, etc. will be required for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Edema, redness, warmth, pain; Patient given Keflex 500mg three times daily for 10 days.
Age: 15.0
Sex: M
Vaccine: FLU3, IPV, TDAP, VARCEL
Symptoms: Dizziness, Dyskinesia, Hyperhidrosis, Pallor, Posture abnormal
Clinical narrative: Patient was at the Trouble Shooting for Health Mobile Site for immunizations only. Patient moved here with an Immunization Record and verbalize not having access to a record. Mother wants to start over with immunizations after explanation of 7 shots. Consent for immunization was completed by mother. Vaccine information sheet(s) were provided to mother in different languages: Patient was screened for contraindications, and had no true contraindications. Hep B IM, Influenza A and B (Seasonal) IM, IPV IM, MCV-4 IM, MMR subcutaneous, Tdap (adol/adult formulation) IM and varicella subcutaneous given. 1325 After given Tdap, IPV, FLU and varicella pt started sinking in his chair, jerky body movements, pale, and sweaty. Patient was secured in the chair not to fall and feet elevated. Patient complained of dizziness. Patient denied nausea, SOB itching, difficulty swallowing, headache, chest pain and stomach ache. Assisted patient to lie down in Trendelenburg position. Vitals BP 159/89 HR 86, Resp 22 Temp 98.5 orally. 1326 Dr notified of patients conditioned and approves to give the other immunizations with the mothers consent. Patient skin pink, warm and dry to touch, denies pain, dizziness at this time. Mother consent to continue to vaccinating. 1330 Hep B, MCV-4 and MMR was given and tolerated well. 1335 patient sitting and denies complaints of pain, dizziness, nausea, headache, SOB, chest pain, itching difficulty swallowing, blurry vision and stomach ache. Patient alert O x 3, skin warm and dry to touch, skin color pink, respirations are even and unlabored, able to move all extremities. Lungs are clear in all 4 lobes, throat without swelling or redness noted. 1345 Dismissed home with mother ambulating in stable condition. ER precautions given and mother verbalize good understanding of instructions given. Explained to mother to follow-up with PCP for further episodes of syncope. Care instructions translated by PCS.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose decreased, Dizziness, Fall, Pain
Clinical narrative: Patient felt lightheaded, went down but did not lose consciousness. Vital signs were checked and within normal limits, glucose was low at 64 even though patient had eaten. Patient complained of left sided (same side as injection) achiness for two days after shot.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left upper dorsal arm is erythematous and warm. Vaccine entry site is visible, but no signs of infection. To apply cold compresses and take BENADRYL.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Body temperature increased, Dyspnoea, Erythema, Injection site erythema, Vaccination site swelling
Clinical narrative: (L) arm redness and swelling below vaccine site. Redness on chest and face, mild dyspnea. Elevated temp, no fever.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Muscular weakness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I've taken a flu shot every year for the past 5 years + or minus, but this is the first time that I've taken the FLUZONE QUAD. It was administered in my left arm and there was no issue with the injection site. About 2 hours after the injection my entire arm hurt; to the point that I couldn't sleep that night. It was over a week before I could even attempt to sleep on my left side. To date, my arm constantly aches and feels heavy; I have muscle weakness and severe pain with certain attempted movements. At times, there is a tingling all the way down my arm to my fingers and across my back to my shoulder blade and up my neck; which leads me to believe that there's a nerve issue. It's been over 3 months since the injection and I need to know if this is something that I need to consult a doctor about of if it's something that will remedy itself.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: I've taken a flu shot every year for the past 5 years + or minus, but this is the first time that I've taken the FLUZONE QUAD. It was administered in my left arm and there was no issue with the injection site. About 2 hours after the injection my entire arm hurt; to the point that I couldn't sleep that night. It was over a week before I could even attempt to sleep on my left side. To date, my arm constantly aches and feels heavy; I have muscle weakness and severe pain with certain attempted movements. At times, there is a tingling all the way down my arm to my fingers and across my back to my shoulder blade and up my neck; which leads me to believe that there's a nerve issue. It's been over 3 months since the injection and I need to know if this is something that I need to consult a doctor about of if it's something that will remedy itself.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein amniotic fluid normal, Delivery, Exposure during pregnancy, Injection site erythema, Injection site induration
Clinical narrative: Based on additional information received on 25 September 2015 this case was considered as medically confirmed. Initial unsolicited pregnancy report received from a Consumer (patient) on 02 Feb 2015. A 28 year old female patient (age not reported), had received an intramuscular first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) vaccine (lot number: unknown) in left deltoid on 30 Jan 2015. The patient illness at the time of vaccination was not reported. The last menstrual period was 27 Dec 2014 and estimated date of delivery was 03 Oct 2015. The patient was 5 weeks pregnant at the time of vaccination. On 31 Jan 2015 i.e. one day after vaccination patient had developed redness at injection site with a hard lump and soreness right below the injection site. Corrective treatments were not reported and no laboratory details. At the time of this report, outcome of the events was unknown. Documents held by sender: None. Follow up information received from a physician on 25 September 2015. Patient illness at the time of vaccination was reported as unknown. It was reported that patient had no maternal/paternal/relative history. Previous pregnancies was reported as none. Patient had received prenatal vitamins and Pitocin (during labour) as concomitant medications and other medications was reported as unknown. On 21 May 2015, Prenatal testing included alpha fetal protein test and sequential screen test were performed. Corrective treatment was not reported. Mode of delivery was reported as vaginal and it was reported that there was no complications during delivery. Pregnancy outcome was reported as live birth (normal baby) (male, Apgar score 9/9). it was reported that baby has no congenital anomaly. Additional information about the newborn conditions included breast feeding was reported as yes and baby has no neonate illness, no need for resuscitation, not received any corrective treatment and not transferred to intensive care unit or pediatric department.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Laboratory test normal, Prenatal screening test
Clinical narrative: Based on additional information received on 25 September 2015 this case was considered as medically confirmed. Initial unsolicited pregnancy report received from a Consumer (patient) on 02 Feb 2015. A 28 year old female patient (age not reported), had received an intramuscular first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) vaccine (lot number: unknown) in left deltoid on 30 Jan 2015. The patient illness at the time of vaccination was not reported. The last menstrual period was 27 Dec 2014 and estimated date of delivery was 03 Oct 2015. The patient was 5 weeks pregnant at the time of vaccination. On 31 Jan 2015 i.e. one day after vaccination patient had developed redness at injection site with a hard lump and soreness right below the injection site. Corrective treatments were not reported and no laboratory details. At the time of this report, outcome of the events was unknown. Documents held by sender: None. Follow up information received from a physician on 25 September 2015. Patient illness at the time of vaccination was reported as unknown. It was reported that patient had no maternal/paternal/relative history. Previous pregnancies was reported as none. Patient had received prenatal vitamins and Pitocin (during labour) as concomitant medications and other medications was reported as unknown. On 21 May 2015, Prenatal testing included alpha fetal protein test and sequential screen test were performed. Corrective treatment was not reported. Mode of delivery was reported as vaginal and it was reported that there was no complications during delivery. Pregnancy outcome was reported as live birth (normal baby) (male, Apgar score 9/9). it was reported that baby has no congenital anomaly. Additional information about the newborn conditions included breast feeding was reported as yes and baby has no neonate illness, no need for resuscitation, not received any corrective treatment and not transferred to intensive care unit or pediatric department.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 11 July 2015. A 26-years-old female patient, whose medical history was none and concomitant medication was not reported, had received a first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number, expiration date and dose were not reported) intramuscularly in left deltoid on 9 June 2015. On 11 June 2015, two days post-vaccination, the patient experienced painful to lift the left arm. The patient did not have pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Laboratory investigation and corrective treatment were not reported. At the time of this report, the patient was not recovered from event. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: 7.5 cm erythematous patch, warm to the touch.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TD, HEPA, IPV, TD, HEPA, IPV, TD
Symptoms: Local swelling
Clinical narrative: Patient awoke 4/9/16 (Saturday am) to find right neck swelling (soft and non tender) that resembled the "mumps." Denied any associated pain, redness, rash, itching, fever, difficulty breathing, difficulty with speech or any pain with movement. Swelling stable today - no worse. Patient did not seek medical evaluation for complaint. Went to schedule school classes this am without incident.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TD, HEPA, IPV, TD, HEPA, IPV, TD
Symptoms: Local swelling, Swelling face
Clinical narrative: Patient awoke 4/9/16 (Saturday am) to find right neck swelling (soft and non tender) that resembled the "mumps." Denied any associated pain, redness, rash, itching, fever, difficulty breathing, difficulty with speech or any pain with movement. Swelling stable today - no worse. Patient did not seek medical evaluation for complaint. Went to schedule school classes this am without incident.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Body aches, low grade fever, swollen lymph nodes (neck and behind ears), joint pain/stiffness, followed by a generalized rash 2 days later.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Body aches, low grade fever, swollen lymph nodes (neck and behind ears), joint pain/stiffness, followed by a generalized rash 2 days later.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on legs and arms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Red rash and swollen at site of injection (subcutaneously part of upper left arm) about 3 inches long and 1.5 inches width.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: First I had a big swelling, redness, fever in the site the first day, about the size of a golf ball or bigger, then I got weak, exhausted, achy all over, pain in site and exhaustion still going on 7 days later.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain
Clinical narrative: First I had a big swelling, redness, fever in the site the first day, about the size of a golf ball or bigger, then I got weak, exhausted, achy all over, pain in site and exhaustion still going on 7 days later.
Age: 10.0
Sex: F
Vaccine: FLUN4, HEP, IPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Low grade fever (99.5); redness at injection site in circular shape; tender to touch.
Age: 48.0
Sex: F
Vaccine: HEPA, TDAP, TYP
Symptoms: Malaise, Rash, Rash generalised, Rash pruritic
Clinical narrative: Patient called and states she received vaccines on 4/6/16 and the pm of 4/8/16 she began to develop a generalized red, raised, pruritic rash to extremities and trunk of body unrelieved by OTC Benadryl; denies any problems at injection sites or trouble breathing; states, "I just didn't feel well the next day. Someone told me I might need some steroids to help the itching."
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dizziness, Pain in extremity, Rash
Clinical narrative: Temp 102.6, dizziness, pain in arm and rash to face.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Hyperhidrosis, Pain, Thirst
Clinical narrative: Chills, body aches, increased thirst, diaphoresis.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Erythema, Local reaction, Lymphadenopathy, Oedema, Rash pustular
Clinical narrative: The patient is a 26 yo RN who received smallpox vaccine on 22 Mar 2016 (VV03-019 lot # ) and states had a normal reaction with development of pustule. She states she was in the field and sometime between day 8-10 she developed a significant local reaction of erythema, edema, warmth and streaking with +axillary lymphadenopathy. She was seen by medical provider and treated with SEPTRA. The site resolved over the next few days.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Skin warm
Clinical narrative: The patient is a 26 yo RN who received smallpox vaccine on 22 Mar 2016 (VV03-019 lot # ) and states had a normal reaction with development of pustule. She states she was in the field and sometime between day 8-10 she developed a significant local reaction of erythema, edema, warmth and streaking with +axillary lymphadenopathy. She was seen by medical provider and treated with SEPTRA. The site resolved over the next few days.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperaemia, Pyrexia, Rash papular
Clinical narrative: Diffuse hyperemic papulovesicular rash, worse on distal extremities - fever 103-104.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received PNEUMOVAX-23 vaccine (Lot #L017265) SC in the left arm on 10/6. Patient also received influenza high-dose vaccine on 10/6, however, this was injected IM in the right arm. Injection site on left arm is tender, red and warm to the touch.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Syncope, Urinary incontinence
Clinical narrative: Patient given 3rd dose of HPV9 (received #1 HPV4, #2 HPV9 prior) and sent to waiting room to do 15 minute wait period. Patient had syncope while seated on mom's lap had seizure and was incontinent of urine. Pt seen by CRNP VSS rested in office for 30 mins. Sent home.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Injection site pain
Clinical narrative: Weakness, Burning pain in left shoulder.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Started with local reaction at injection site (swollen/redness), then moved to underarms and down underside of arms bilaterally almost to elbow [looked like a friction burn (bright red)].  Patient said it burned- was getting better with Benadryl.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Blood test, Hallucination, Nausea, Pyrexia
Clinical narrative: CLIENT REPORTED NAUSEA, FEVER, HALLUCINATIONS, AND SEVERE JOINT PAIN. CLIENT ALSO STATED "I HAD EVERY REACTION YOU COULD HAVE LISTED ON THAT PIECE OF PAPER SHORT OF ANAPHYLAXIS."
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urine analysis
Clinical narrative: CLIENT REPORTED NAUSEA, FEVER, HALLUCINATIONS, AND SEVERE JOINT PAIN. CLIENT ALSO STATED "I HAD EVERY REACTION YOU COULD HAVE LISTED ON THAT PIECE OF PAPER SHORT OF ANAPHYLAXIS."
Age: 43.0
Sex: F
Vaccine: TDAP, FLUX
Symptoms: Chest discomfort, Impaired work ability, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: .D: 03/18/16 : 08:22pm .T: vaccine reaction Last Visit:  03/14/16 .ENC: JS: 1: 03/20/16: 08:22 PM: Office Visit: N: Y Assessment: .DX: Adverse reaction to Tdap - tetanus, diphtheria and acellular pertussis vaccine : ICD10 = T50.A15A / SNOMED = 429521000124101 Plan: VAERS Patient Education: prior to and follwing vaccines, you should take benadryl for about 48 hrs, preemptively, and tylenol. Follow-up: prn Subjective: Patient is a 43 year old female who got a Tdap on Monday, and developed fever of 102.5 on Tuesday and Wednesday, along with squeezing chest pressure off and on throughout the day for about 3 days, never lasting as long as a minute, as well as a huge local reaction with red swelling entire length of left lateral upper arm. She states she typically gets fever 102 with annual flu vaccines and takes Advil or Tylenol for this. She took a few days off work.  Did not call or tx with Benadryl, just an antipyretic. Objective: lateral left arm warm red swollen about 10 cm, now.
Age: 43.0
Sex: F
Vaccine: TDAP, FLUX
Symptoms: Local reaction, Pyrexia, Vaccination complication
Clinical narrative: .D: 03/18/16 : 08:22pm .T: vaccine reaction Last Visit:  03/14/16 .ENC: JS: 1: 03/20/16: 08:22 PM: Office Visit: N: Y Assessment: .DX: Adverse reaction to Tdap - tetanus, diphtheria and acellular pertussis vaccine : ICD10 = T50.A15A / SNOMED = 429521000124101 Plan: VAERS Patient Education: prior to and follwing vaccines, you should take benadryl for about 48 hrs, preemptively, and tylenol. Follow-up: prn Subjective: Patient is a 43 year old female who got a Tdap on Monday, and developed fever of 102.5 on Tuesday and Wednesday, along with squeezing chest pressure off and on throughout the day for about 3 days, never lasting as long as a minute, as well as a huge local reaction with red swelling entire length of left lateral upper arm. She states she typically gets fever 102 with annual flu vaccines and takes Advil or Tylenol for this. She took a few days off work.  Did not call or tx with Benadryl, just an antipyretic. Objective: lateral left arm warm red swollen about 10 cm, now.
Age: 43.0
Sex: F
Vaccine: TDAP, FLUX
Symptoms: Pyrexia
Clinical narrative: .D: 03/18/16 : 08:22pm .T: vaccine reaction Last Visit:  03/14/16 .ENC: JS: 1: 03/20/16: 08:22 PM: Office Visit: N: Y Assessment: .DX: Adverse reaction to Tdap - tetanus, diphtheria and acellular pertussis vaccine : ICD10 = T50.A15A / SNOMED = 429521000124101 Plan: VAERS Patient Education: prior to and follwing vaccines, you should take benadryl for about 48 hrs, preemptively, and tylenol. Follow-up: prn Subjective: Patient is a 43 year old female who got a Tdap on Monday, and developed fever of 102.5 on Tuesday and Wednesday, along with squeezing chest pressure off and on throughout the day for about 3 days, never lasting as long as a minute, as well as a huge local reaction with red swelling entire length of left lateral upper arm. She states she typically gets fever 102 with annual flu vaccines and takes Advil or Tylenol for this. She took a few days off work.  Did not call or tx with Benadryl, just an antipyretic. Objective: lateral left arm warm red swollen about 10 cm, now.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Musculoskeletal pain
Clinical narrative: Headache, shoulder pain worsening over several weeks, arm and hand weakness and numbness.  Prescription for prednisone after 3 weeks, relieved symptoms somewhat. Problems continued, recovery lasted another 8 weeks before getting back to normal.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site redness that radiated several inches past site, swelling, and painful area. Physician prescribed Keflex, and Medrol dosepack.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Fatigue, Influenza, Injection site movement impairment, Injection site pain
Clinical narrative: Patient experienced severe pain in left shoulder in which vaccination was administered. The pain caused immobility in left shoulder and difficulty sleeping due to pain. The pain was described as extremely sore when immobile and sharp pain when mobile. Any type of movement caused pain to the shoulder area during a two week period in which the pain was severe. The patient is still feeling soreness in the left shoulder although the pain is mild. Furthermore, the patient exhibited flu symptoms such as chills, high fever (103), severe body aches, and fatigue. These symptoms were severe for 4 days and lasted in some manner for 8 days.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Patient experienced severe pain in left shoulder in which vaccination was administered. The pain caused immobility in left shoulder and difficulty sleeping due to pain. The pain was described as extremely sore when immobile and sharp pain when mobile. Any type of movement caused pain to the shoulder area during a two week period in which the pain was severe. The patient is still feeling soreness in the left shoulder although the pain is mild. Furthermore, the patient exhibited flu symptoms such as chills, high fever (103), severe body aches, and fatigue. These symptoms were severe for 4 days and lasted in some manner for 8 days.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient's arm was red. She complained of soreness, swelling, and fever at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Rash
Clinical narrative: Rash 9 ml of  BENADRYL given assessed by provider.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: 10 x 10 cm of erythema with central induration.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Catch up vaccination of Hep B administered 4/11/16 that expired 4/1/16.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician via a company representative referring to a 12 year old male patient. On 07-APR-2016 the patient was vaccinated with a dose of MMR II (single dose) (reported as CDC guidelines). On the same day, the patient experienced a general rash. Localization of the rash was not specialized. The patient sought medical attention by speaking with physician. The event was treated with Steroids. The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding 1 patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX lot # L028286, expiration date 28-OCT-2016. No adverse event was reported. The outcome of the event was unknown. Yes there was a Previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. The pharmacist reported that a patient less than 50 years of age was vaccinated with ZOSTAVAX (dosing details were not reported) at another pharmacy location. No adverse effects were reported. No product quality complaint (PQC) was reported. The pharmacist also stated physician's are writing lots of prescription for less than 50 years of age clients to be vaccinated (captured in case# 1604USA006725). This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with a dose of MMR II (lot# L012480, expiration date 10-APR-2017, dose, dose# and route unknown) which were improperly stored. Temperature and time frame was 11 degree for 35.5 hours as well as 0 degree for 241 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with a dose of GARDASIL (lot # K008931, expiration date 04-MAR-2017, dose, dose # and route unknown) which were improperly stored. Temperature and time frame was 11 degree for 35.5 hours as well as 0 degree for 241 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant mediation was not provided. On unknown dates the patients were vaccinated with a dose of oral ROTATEQ (lot# L006184, expiration date 13-DEC-2016, oral, dose and dose# unknown) which were improperly stored. Temperature and time frame was 11 degree for 35.5 hours as well as 0 degree for 241 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified patient of unknown age and gender. On 25-MAR-2016 the patient was vaccinated with first dose of improperly stored (Oka/Merck) VARIVAX injection (dosing regimen unspecified) (lot # L000456, expiry 06-JAN-2017). Excursion details are as follows, which were exposed to the following conditions, were administered to the patient: temperature: 14.7 F, Time frame: 6 hours 42 minutes, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 62 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L027322, expiry date unspecified (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX was involved in temperature incident. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding 7 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L021216, expiration date- 10-JUN-2017, lot no. L034369, expiration date 08-SEP-2017. No adverse event was reported. The outcome of the event was unknown. Yes there was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 61 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L027322, expiry date unspecified (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX was involved in temperature incident. This is one of several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of currently 65 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified patient of unknown age and gender. On 18-MAR-2016 the patient was vaccinated with second dose of improperly stored PROQUAD (Merck) immunization series (dosing regimen unspecified) (lot # L040411, expiry 13-APR-2017). Excursion details are as follows, which were exposed to the following conditions, were administered to the patient: temperature: 14.7 F, Time frame: 6 hours 42 minutes, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.