chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with dose 2 of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date (reported as longer than 6 months ago), the patient fainted and upon hitting the floor, the patient may have had a seizure after receiving her dose 2 of GARDASIL. The patient did not seek any medical attention. It was unspecified if the patient was treated or if any lab tests were performed. The outcome of the events were unknown. The relatedness for the events was unknown for GARDASIL. Upon internal review, the event seizure was considered as medically significant. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 12 cm x 7 cm area of induration/erythema surrounding injection site Rt thigh.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Influenza like illness, Mobility decreased, Pain
Clinical narrative: Flu-like symptoms, aches, numbness/weakness and pain doctor appointments on 10/10/12. Collapsed while walking on evening of 10/11/12 and could only crawl, doctor appointment 10/12/12 and 10/16/12. Went to ER on 10/18/12 admitted on 10/19/12.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Flu-like symptoms, aches, numbness/weakness and pain doctor appointments on 10/10/12. Collapsed while walking on evening of 10/11/12 and could only crawl, doctor appointment 10/12/12 and 10/16/12. Went to ER on 10/18/12 admitted on 10/19/12.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Patient complained of mild tenderness, small area of redness at vaccination site.
Age: 12.0
Sex: F
Vaccine: FLU3, HEP, TDAP, TYP
Symptoms: Injection site pain
Clinical narrative: Left deltoid muscle pain, this pain has continued over two weeks and patient c/o increasing pain. No redness, swelling, or lump felt in muscle.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity
Clinical narrative: Received VARIVAX 3-26; complained 3-27 arm being sore. Mother circled reaction area and by 3-28 red indurated 2x in size from 3-27. On exam 4"x4" - red indurated area. No lymphadenopathy. Given OMNICEF for cellulitis.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal pain, Nausea, Oedema peripheral
Clinical narrative: I started experiencing a chaffing feeling and pain in the right side of my vagina and buttocks. That continued through the next week and became worse with extended time spent on my feet. I felt run down and sick to my stomach at times throughout the next week, also experiencing headaches. The following Monday, 3/18/13, I felt extreme amounts of pain and now had severe swelling on the right side of my vagina. I also had pain in the right side of my buttocks and right leg. The following day I went to ER thinking I had a bartholin cyst in the vagina. I did not but it was noted I had swelling on right side of vagina, buttocks, and leg. That night I developed a very painful headache. I woke up the next morning with a mild, very painful, and itchy rash on the right butt cheek and inside near the rectum. I was and still am experiencing extreme pain and spreading of rash as of today 3/27/13.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Varicella virus test positive, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: I started experiencing a chaffing feeling and pain in the right side of my vagina and buttocks. That continued through the next week and became worse with extended time spent on my feet. I felt run down and sick to my stomach at times throughout the next week, also experiencing headaches. The following Monday, 3/18/13, I felt extreme amounts of pain and now had severe swelling on the right side of my vagina. I also had pain in the right side of my buttocks and right leg. The following day I went to ER thinking I had a bartholin cyst in the vagina. I did not but it was noted I had swelling on right side of vagina, buttocks, and leg. That night I developed a very painful headache. I woke up the next morning with a mild, very painful, and itchy rash on the right butt cheek and inside near the rectum. I was and still am experiencing extreme pain and spreading of rash as of today 3/27/13.
Age: 37.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Burning sensation, Herpes zoster, Pain, Paraesthesia
Clinical narrative: I started experiencing a chaffing feeling and pain in the right side of my vagina and buttocks. That continued through the next week and became worse with extended time spent on my feet. I felt run down and sick to my stomach at times throughout the next week, also experiencing headaches. The following Monday, 3/18/13, I felt extreme amounts of pain and now had severe swelling on the right side of my vagina. I also had pain in the right side of my buttocks and right leg. The following day I went to ER thinking I had a bartholin cyst in the vagina. I did not but it was noted I had swelling on right side of vagina, buttocks, and leg. That night I developed a very painful headache. I woke up the next morning with a mild, very painful, and itchy rash on the right butt cheek and inside near the rectum. I was and still am experiencing extreme pain and spreading of rash as of today 3/27/13.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Lumbar puncture normal, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Severe stiffness of neck and spine. Patient could not move soon after the vaccine was given and it lasted for 4 weeks.
Age: 7.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Lg reddened welt to (L) arm; Sm reddened welt to (R) arm.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, burning at site, followed by swelling, increased pulse, difficulty breathing. Seen in ER, given Epi x2 and BENADRYL.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Child had swelling in the injection area (right arm). Parent was advise to apply warm/cold compresses and move arm as much as possible.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Dyskinesia, Injection site reaction
Clinical narrative: Involuntary movement of left arm (in same arm) as immunization given for less than 5 mins.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, soreness at injection site 3 cm deep erythematous area w/ a 6 cm lighter erythematous area left upper arm, warmth & tenderness, no weeping or palsations. Rx with: Azithromax Loratadine Hydroxyzine.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood electrolytes normal, Blood glucose normal, Febrile convulsion, Full blood count normal, Pyrexia
Clinical narrative: Within seven hours of the vaccines, he developed fever to 101.7 and had two febrile seizures within 15 minutes of each other. Child evaluated at Emergency Room. Antipyretics given.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urine analysis normal
Clinical narrative: Within seven hours of the vaccines, he developed fever to 101.7 and had two febrile seizures within 15 minutes of each other. Child evaluated at Emergency Room. Antipyretics given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain. Advised ice pack on left deltoid.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Acne, Erythema, Injection site cellulitis, Injection site pruritus, Injection site reaction
Clinical narrative: Varicella vaccine administered in (R) upper arm subcutaneously on Monday, 03/25/13. On 03/26/13, Pt said she woke up and noted a small pimple at site of injection. Patient said reaction continued to grow. Patient came into clinic on 03/28/13 area with erythema, edema 11cm x 13cm. Patient c/o itching at site and pain with movement. Patient treated for cellulitis at injection site. Doctor prescribed BACTRIM x 10 days.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Localised oedema, Pain
Clinical narrative: Varicella vaccine administered in (R) upper arm subcutaneously on Monday, 03/25/13. On 03/26/13, Pt said she woke up and noted a small pimple at site of injection. Patient said reaction continued to grow. Patient came into clinic on 03/28/13 area with erythema, edema 11cm x 13cm. Patient c/o itching at site and pain with movement. Patient treated for cellulitis at injection site. Doctor prescribed BACTRIM x 10 days.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report by a contactable nurse from a physician's office via a Pfizer Sales Representative. This 92-year-old female patient received PREVNAR 13 single dose on unknown anatomical site in Feb2013. Relevant medical history included cochlear implant. Relevant concomitant medications included unspecified medication and it was unknown if and she was taking the concomitant medication during the event. Vaccines given in the same day and within the last four weeks were unknown. In 2013, she experienced cellulitis. Relevant lab data was unknown. Outcome was unknown. Company Causality evaluation comment: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. In particular the location and lab findings regarding the reported event are needed for the causality assessment. Currently, considering the nature of the event, the company considers unlikely a causal relationship between the vaccination with PREVENAR 13 and the occurrence of cellulitis in the advanced age old patient.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Had Tdap #1 & MCO #1 left arm 3/20/13, developed some swelling & redness at site that AM & increased in size so seen at ER 3/22/13 and dx allergic reaction to immunizations - was already on AMOX --> changed to Clindamycin, ORAPRED & BENADRYL.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Abnormal behaviour
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 5 year old male patient. No medical history was reported. On 25-MAR-2013, the patient was vaccinated with a dose of M-M-R II (lot #, dose, route not reported) and (merck) VARIVAX (lot #, dose, route not reported). No concomitant medications were reported. On 26-MAR-2013, the patient began acting, possessed and crazy. No treatment was given. Patient sought medical attention (spoke to HCP on 26-MAR-2013). The outcome of the patient began acting, possessed and crazy was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blister, Fatigue, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with allergy to LORTAB, codeine, lisinopril (manufacturer unknown) (MARRS # 1303USA013877) and an anaphylactic reaction to something during surgery. The reporting pharmacist stated he was not aware of any pertinent medical history. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # H020845, expiration date 20-FEB-2014) (dose, frequency not reported, subcutaneous route). Concomitant therapies included NEURONTIN, KLOR-CON, pravastatin sodium, verapamil, alprazolam, famotidine (manufacturer unknown), acetaminophen, LORTAB, fluoxetine, B-12 shots, levothyroxine sodium (manufacturer unknown) and clobetasol propionate and a topical compound medication. The same day the patient was vaccinated, felt anxious and developed a warm rash at the injection site. On 16-MAR-2013, the patient developed small water blisters around injection site, felt fatigues, and her arm hurt. All that occurred on 16-MAR-2013 after the patient was in the sum with arm covered. On 18-MAR-2013 there was now a long water blister a little over an inch long. The patient sought medical attention by presenting at the pharmacy and no treatment was given for the adverse event. None laboratory diagnostic studies were performed. At the time of the report the patient's outcome for all adverse event was not recovered. This is one of two reports of the same patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with allergy to LORTAB, codeine, lisinopril (manufacturer unknown) (MARRS # 1303USA013877) and an anaphylactic reaction to something during surgery. The reporting pharmacist stated he was not aware of any pertinent medical history. On 15-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # H020845, expiration date 20-FEB-2014) (dose, frequency not reported, subcutaneous route). Concomitant therapies included NEURONTIN, KLOR-CON, pravastatin sodium, verapamil, alprazolam, famotidine (manufacturer unknown), acetaminophen, LORTAB, fluoxetine, B-12 shots, levothyroxine sodium (manufacturer unknown) and clobetasol propionate and a topical compound medication. The same day the patient was vaccinated, felt anxious and developed a warm rash at the injection site. On 16-MAR-2013, the patient developed small water blisters around injection site, felt fatigues, and her arm hurt. All that occurred on 16-MAR-2013 after the patient was in the sum with arm covered. On 18-MAR-2013 there was now a long water blister a little over an inch long. The patient sought medical attention by presenting at the pharmacy and no treatment was given for the adverse event. None laboratory diagnostic studies were performed. At the time of the report the patient's outcome for all adverse event was not recovered. This is one of two reports of the same patient.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of 6 years with no reported medical history. On June 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 1 (exact date, route, dose and lot number unknown). On July 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 2 (exact date, route, dose and lot number unknown). On August 2009 the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) dose 3 (exact date, route, dose and lot number unknown). On August 2009 the patient experienced received first dose on 06/2009, 2nd dose on 07/2009 and third on 08/2009 (Inappropriate schedule of vaccine administered). The nurse reported that 2 unspecified patients, one female and one male, had received vaccines that were given outside of the vaccine schedule. The female patient also received an unspecified HPV vaccine, GARDASIL could not be ruled out, on June 2009, the 2nd dose on July 2009 and the third on August 2009. This female patient also received an unspecified HPV vaccine, GARDASIL could be ruled out, on June 2009, the 2md dose on July 2009 and the third on Octobre 2009. This case was linked to 1303USA012014 (same reporter link). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 14-MAR-2013, the patient was vaccinated with a first dose of (merck) VARIVAX (Lot number, expiry date were not reported) 0.5 milliliter (ml) subcutaneously. The patient who was an adult employee was given a second dose of (merck) VARIVAX early on 22-MAR-2013. Patient was not experiencing any adverse reaction. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, MNQ, TDAP, VARCEL
Symptoms: Blood iron, Exposure during pregnancy, Full blood count, Laboratory test, No adverse event
Clinical narrative: This spontaneous retrospective pregnancy report as received from a physician, for GARDASIL and VARIVAX (Merck), two Pregnancy Registry products, concerning a 17 year old female patient with no pertinent medical history and drug reactions/allergies. On 01-NOV-1996, patient was vaccinated with first dose of VARVIAX (Merck) (Lot #, exp date, dose/frequency, route and duration were unspecified). On 04-AUG-2009, patient was vaccinated with first dose of GARDASIL (Lot #, exp date, dose/frequency, route and duration were unspecified). Unspecified Pregnancy test was performed in January of 2013 with LMP of 04-DEC-2012 and EDD of 10-SEP-2013. On 25-FEB-2013, the patient was vaccinated with second dose of GARDASIL (Lot # reported as 0131AE, exp date, dose/frequency, route and duration were unspecified) and second dose of VARIVAX (Merck) (Lot # H006538, exp date, dose/frequency, route and duration were unspecified) while pregnancy. Concomitant therapies included INFANRIX, HAVRIX and MENACTRA all were administered on 25-FEB-2013. Initial exposure to GARDASIL was at 12 week(s). No adverse event reported. Patient had sought medical attention via office contacting. Blood tests including a CBC, Iron level and STD test were performed with no result provided. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, MNQ, TDAP, VARCEL
Symptoms: Blood iron, Delivery, Exposure during pregnancy, Full blood count, Laboratory test
Clinical narrative: This spontaneous retrospective pregnancy report as received from a physician, for GARDASIL and VARIVAX (Merck), two Pregnancy Registry products, concerning a 17 year old female patient with no pertinent medical history and drug reactions/allergies. On 01-NOV-1996, patient was vaccinated with first dose of VARVIAX (Merck) (Lot #, exp date, dose/frequency, route and duration were unspecified). On 04-AUG-2009, patient was vaccinated with first dose of GARDASIL (Lot #, exp date, dose/frequency, route and duration were unspecified). Unspecified Pregnancy test was performed in January of 2013 with LMP of 04-DEC-2012 and EDD of 10-SEP-2013. On 25-FEB-2013, the patient was vaccinated with second dose of GARDASIL (Lot # reported as 0131AE, exp date, dose/frequency, route and duration were unspecified) and second dose of VARIVAX (Merck) (Lot # H006538, exp date, dose/frequency, route and duration were unspecified) while pregnancy. Concomitant therapies included INFANRIX, HAVRIX and MENACTRA all were administered on 25-FEB-2013. Initial exposure to GARDASIL was at 12 week(s). No adverse event reported. Patient had sought medical attention via office contacting. Blood tests including a CBC, Iron level and STD test were performed with no result provided. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, MNQ, TDAP, VARCEL
Symptoms: No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous retrospective pregnancy report as received from a physician, for GARDASIL and VARIVAX (Merck), two Pregnancy Registry products, concerning a 17 year old female patient with no pertinent medical history and drug reactions/allergies. On 01-NOV-1996, patient was vaccinated with first dose of VARVIAX (Merck) (Lot #, exp date, dose/frequency, route and duration were unspecified). On 04-AUG-2009, patient was vaccinated with first dose of GARDASIL (Lot #, exp date, dose/frequency, route and duration were unspecified). Unspecified Pregnancy test was performed in January of 2013 with LMP of 04-DEC-2012 and EDD of 10-SEP-2013. On 25-FEB-2013, the patient was vaccinated with second dose of GARDASIL (Lot # reported as 0131AE, exp date, dose/frequency, route and duration were unspecified) and second dose of VARIVAX (Merck) (Lot # H006538, exp date, dose/frequency, route and duration were unspecified) while pregnancy. Concomitant therapies included INFANRIX, HAVRIX and MENACTRA all were administered on 25-FEB-2013. Initial exposure to GARDASIL was at 12 week(s). No adverse event reported. Patient had sought medical attention via office contacting. Blood tests including a CBC, Iron level and STD test were performed with no result provided. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test normal, Eye allergy, Muscular weakness, Myalgia
Clinical narrative: This spontaneous report was received from an unspecified reporter regarding a 65 year old female patient with neosporin allergy and shellfish allergy. The patient's medical history included asthma and arthritis. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). No concomitant medications were reported. On 28-DEC-2012, the patient experienced muscle pain and weakness in lower part of legs and now in arms, rash in various parts of body, notices it first on neck and arms, some kind of allergy with eyes and severe joint pain. Patient received TYLENOL (reported as TYLENOL) for pain. Patient sought medical attention. Doctor did six different blood tests which all came back negative. The outcome of the events were reported as not recovered. The relatedness of the events with ZOSTAVAX was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from an unspecified reporter regarding a 65 year old female patient with neosporin allergy and shellfish allergy. The patient's medical history included asthma and arthritis. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). No concomitant medications were reported. On 28-DEC-2012, the patient experienced muscle pain and weakness in lower part of legs and now in arms, rash in various parts of body, notices it first on neck and arms, some kind of allergy with eyes and severe joint pain. Patient received TYLENOL (reported as TYLENOL) for pain. Patient sought medical attention. Doctor did six different blood tests which all came back negative. The outcome of the events were reported as not recovered. The relatedness of the events with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. She was reporting that the patient received the first two doses of GARDASIL (lot # unspecified) on 10-OCT-2007 and 11-DEC-2007. The patient was in the office to get the third dose on 25-MAR-2013. No adverse effect reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 82 years old female patient with poor metabolizer of drugs and medical history of polio. On unspecified date, the patient started therapy with statin (unspecified) (dose, route an indication not provided). No concomitant medications were reported. The pharmacist reported that on unspecified date, a patient developed muscle pains while taking an unknown statin. The pharmacist did not know the name or manufacturer of the statin and had no details of the adverse experience. The outcome of muscle pain was unknown. The relatedness for muscle pain was unknown for statin (unspecified). Follow-up information has been received from the pharmacist who stated that even though the patient was on a statin therapy (unspecified), the patient also received a dose of ZOSTAVAX (lot#, dose and route not reported) in December 2012 and complained of muscle pain couple days later. At the time of reporting, the outcome of muscle pain was unknown. The relatedness for muscle pain was unknown for ZOSTAVAX and statin (unspecified). Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: FLU3, HEP, MMR
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Rash/hives on neck, trunk, axilla, face, no open lesions x 2 weeks. Low-grade fever (<100*) x2 days. Took PO diphenhydramine 25mg & PO acetaminophen x 3 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Burning sensation, Pruritus, Skin irritation
Clinical narrative: Mother noticed that patient was scratching and complaining of burning/itching sensation.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Gait disturbance, Vision blurred, Visual impairment
Clinical narrative: Dizziness, trouble walking, trouble focusing, trouble seeing.  Lasted X 6 days.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Patient reports that the pain after vaccination didn't go away fully, his shoulder became more painful while lifting his arm and stiff as well.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt called today 3/27/13 - reported red, swollen, pain, itchy, warm to touch at the injection site. Increased thirst. Advise pt to take Ibu/ALEVE & BENADRYL and drink lots of water and watch it.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Thirst
Clinical narrative: Pt called today 3/27/13 - reported red, swollen, pain, itchy, warm to touch at the injection site. Increased thirst. Advise pt to take Ibu/ALEVE & BENADRYL and drink lots of water and watch it.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Limb discomfort, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Patient reported adverse effects on 3/28/2013 at pharmacy, for the first time. Patient had discomfort in arm along with incomplete range of motion. Patient sought attention of 2 specialists, prescription meds & MRI, in addition to an injection, to ease her pain. Adverse event was reported on 3/21/2013 at pharmacy. I do not know when the adverse events started.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Sudden onset one day after shingles vaccination; 6cm area of raised, hot red area on L arm, with surrounding paler erythematous border. Tender to touch.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving 3 of 5 vaccines. She recovered quickly and then received her final 2 vaccines without further incident.
Age: 54.0
Sex: F
Vaccine: PER, TD
Symptoms: Activities of daily living impaired, Asthenia, Asthma, Chills, Erythema
Clinical narrative: Extreme swelling, pain and redness entire upper arm not reducing for 1 week. Fever, chills extreme weakness, muscle aches for 3 days. Unable to function, only able to lie down and rest/sleep for 3 days. Activate Asthma at 24hrs post injection, which had been well controlled needing nebulizer treatment.
Age: 54.0
Sex: F
Vaccine: PER, TD
Symptoms: Extensive swelling of vaccinated limb, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Extreme swelling, pain and redness entire upper arm not reducing for 1 week. Fever, chills extreme weakness, muscle aches for 3 days. Unable to function, only able to lie down and rest/sleep for 3 days. Activate Asthma at 24hrs post injection, which had been well controlled needing nebulizer treatment.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cyanosis, Dizziness, Dyspnoea, Erythema, Fall
Clinical narrative: Felt dizzy, short of breath during class; went to school nurse's office and fell to floor nearly fainting, pale, fast pulse, lips swollen and red/blue, nauseated.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Heart rate increased, Lip swelling, Nausea, Pallor
Clinical narrative: Felt dizzy, short of breath during class; went to school nurse's office and fell to floor nearly fainting, pale, fast pulse, lips swollen and red/blue, nauseated.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Felt dizzy, short of breath during class; went to school nurse's office and fell to floor nearly fainting, pale, fast pulse, lips swollen and red/blue, nauseated.
Age: 1.03
Sex: M
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Local reaction
Clinical narrative: Local reaction, redness with 2 welts at injection site.  No respiratory distress.  Provider ordered Benadryl po, given at 4:55 PM. Patient observed for 40 minutes. Provider examined and discharged patient.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient broke out with severe shingles over her right face and eye 1 day after receiving the Zostavax injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Patient call pharmacy to report redness and "lump" that is 5" long and 2" wide at injection site. No other sx or complaints.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pruritus, Purulent discharge
Clinical narrative: Redness, itchy and pus at site of injection.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hypotonia, Vomiting
Clinical narrative: 9 hours after vaccinated - onset of vomiting. Became limp  -ER visit. IV fluids & antiemetic administered. Discharged. Doing well today.
Age: 10.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5 1/2 cm area of redness to (Lt) upper arm; 2nd raised, slightly red area, 2 cm x 3 1/2 cm to immediate (Rt) of above injection site; afebrile; s/s began 3/28/13 AM and increased during day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Pt hd a large rash and swelling of approximately 3" diameter after administration. She has since recovered.
Age: 0.52
Sex: F
Vaccine: HIBV
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 6 month old female patient. On 05-MAR-2013 the patient was vaccinated with the first dose of LIQUID PEDVAXHIB, lot number reported as (0419AE), expiration date (17-AUG-2014), dose, route of administration and anatomical location were not reported. The medical assistant reported that a patient received a first dose of LIQUID PEDVAXHIB and developed an injection site reaction which was a "small knot" at the injection site. The outcome of injection site reaction was reported as recovered/resolved. This case was reported as the 5th of 5 reports from that office. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Skin rash on arms, back, abdomen and itching.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to patients of unknown age. On an unknown date, no more than 10 patients were vaccinated with doses of improperly stored GARDASIL, (lot number, expiry date and route was not reported) which were exposed to 26 Fahrenheit from 28-NOV-2012 to 15-MAR-2012. Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via MedWatch form (MK25772) refers to a 65 year old female patient. Patient had no previous allergies. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX lot # J000433 exp date 10-APR-2014, subcutaneous for shingles. The patient did not receive any live vaccines within the last 28 prior to receiving ZOSTAVAX. There was no concomitant medication and it was unknown if there was any relevant past drug history. On 21-MAR-2013, the patient experienced red flare around the site of the injection. It was unknown if there was any relevant laboratory data. The outcome of red flare around the site of the injection was unknown. The relatedness for red flare around the site of the injection was not reported for ZOSTAVAX. Additional information is not expected. This case was linked to MedWatch form MK25773 (same reporter).
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative. The pharmacist inquired "Can a patient get cold sores after getting ZOSTAVAX (lot # unspecified) vaccine?" The company representative was not sure if a patient was involved. The outcome of cold sores was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant who administered vaccines refers to a patient of unknown age. The medical assistant noted that the patient was intramuscularly administered the first and second doses in the GARDASIL (dose and lot # not reported) vaccination series on 08-MAR-2012 and 20-MAR-2013, respectively. No adverse effect reported. It was unspecified if the patient had sought medical attention. Action taken and causality of GARDASIL were not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Approximately on an unknown date in 2012 (reported as over one year ago) the patient was vaccinated with doses 1, GARDASIL (lot #, expiration date and route not reported). Approximately on an unknown date in 2012 (reported as over one year ago) the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported). The patient was new to the office. The patient received dose 3, GARDASIL (lot #, expiration date and route not reported) on 26-MAR-2013 (reported as today) which was late. No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. On an unknown date in 2011, the patient was vaccinated with dose 1, GARDASIL (lot # expiration date and route not reported0. On 20-MAR-2013 the patient was vaccinated with dose 2, GARDASIL (lot #, expiration date and route not reported). No adverse event reported. The health care worker did not wish follow-up for a safety report for herself or the physician. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fibromyalgia
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter, a 15 year old female patient. In April and July 2012 the patient was vaccinated with GARDASIL (lot # not reported). The patient was diagnosed with fibromyalgia. Adverse event onset date was reported as July 2012. It was unspecified whether the patient sought for medical attention. The outcome of fibromyalgia was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old female patient without pertinent medical history. The patient had no drug reactions or allergies. The patient was not pregnant. On 15-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H015863, expiration date 24-MAR-2015) (the physician stated the lot number for the GARDASIL in question was either "H-zero-15863" or "H-letter O-15863") (dose, route and injection site were not reported). Concomitant therapies included amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL and XANAX. On 16-MAR-2013 the patient developed itchy rash on her face, arms and legs after receiving her first dose of GARDASIL. There was no laboratory diagnostics study performed. Treatment BENADRYL was given for adverse event. The action taken, causality and outcome were not provided at the time of the report. The patient sought unspecified medical attention. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a 82 year old female patient refers to herself with a reaction to a pain medication. On an unknown date in June 2012 the patient was vaccinated with ZOSTAVAX (lot # was not reported). On 14-FEB-2013 the patient experienced developed shingles. It started as a pain in her side; then she saw a rash. The rash reached from around her chest to her back. There was a burning sensation, though she said it was fading. There was no lab diagnostic studies performed. The patient went to clinic for medical attention. Treatment was given for the adverse event. The outcome of consumer developed shingles was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site inflammation, Injection site pustule, Injection site rash
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Mar-2013) concerns a 52 year old female patient with allergy to sulfa drugs. On ??-Sep-2012, the patient received flu vaccine (batch and manufacturer unspecified). On the same day ZOSTAVAX was given in the same arm. On ??-Sep-2012, the patient developed an injection site reaction; swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalised for 2 days and was sent to ICU (intensive care unit). The patient was treated with vancomycin and unspecified pain medications. The event outcome was unknown.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Intensive care
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Mar-2013) concerns a 52 year old female patient with allergy to sulfa drugs. On ??-Sep-2012, the patient received flu vaccine (batch and manufacturer unspecified). On the same day ZOSTAVAX was given in the same arm. On ??-Sep-2012, the patient developed an injection site reaction; swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalised for 2 days and was sent to ICU (intensive care unit). The patient was treated with vancomycin and unspecified pain medications. The event outcome was unknown.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Mar-2013) concerns a 52 year old female patient with allergy to sulfa drugs. On ??-Sep-2012, the patient received flu vaccine (batch and manufacturer unspecified). On the same day ZOSTAVAX was given in the same arm. On ??-Sep-2012, the patient developed an injection site reaction; swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalised for 2 days and was sent to ICU (intensive care unit). The patient was treated with vancomycin and unspecified pain medications. The event outcome was unknown.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Intensive care, Rash pustular
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Mar-2013) concerns a 52 year old female patient with allergy to sulfa drugs. On ??-Sep-2012, the patient received flu vaccine (batch and manufacturer unspecified). On the same day ZOSTAVAX was given in the same arm. On ??-Sep-2012, the patient developed an injection site reaction; swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalised for 2 days and was sent to ICU (intensive care unit). The patient was treated with vancomycin and unspecified pain medications. The event outcome was unknown.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Headache, Hypoaesthesia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Numbness on R side of face, intense head ache, loss of feeling in R side of nose, lips, tongue tip, drooping right side of face, inability to close R eye. Diagnosed as Bell's Palsy at Hospital 03/28/2013 Rx:500mg FAMCICLOVIR//20MG PREDNISONE.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paraesthesia, Tinnitus, VIIth nerve paralysis
Clinical narrative: Numbness on R side of face, intense head ache, loss of feeling in R side of nose, lips, tongue tip, drooping right side of face, inability to close R eye. Diagnosed as Bell's Palsy at Hospital 03/28/2013 Rx:500mg FAMCICLOVIR//20MG PREDNISONE.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Eyelid function disorder, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Numbness on R side of face, intense head ache, loss of feeling in R side of nose, lips, tongue tip, drooping right side of face, inability to close R eye. Diagnosed as Bell's Palsy at Hospital 03/28/2013 Rx:500mg FAMCICLOVIR//20MG PREDNISONE.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eyelid function disorder, Headache, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Numbness on R side of face, intense head ache, loss of feeling in R side of nose, lips, tongue tip, drooping right side of face, inability to close R eye. Diagnosed as Bell's Palsy at Hospital 03/28/2013 Rx:500mg FAMCICLOVIR//20MG PREDNISONE.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Abnormal behaviour
Clinical narrative: This spontaneous report as received from a health professional (healthcare worker) refers to approximately 5 year old male patient. On 25-MAR-2013, the patient was vaccinated with a second dose of (merck) VARIVAX (Lot number was reported as H0184449, expiry date was 09-OCT-2014, route and dose were not reported) and a second dose of M-M-R II (Lot number was reported as H015826, expiry date was 24-AUG-2014, route and dose were not reported) concomitantly. The patient had received his first doses of (merck) VARIVAX (lot number expiry date, route and dose were not reported) and M-M-R II (lot number expiry date, route and dose were not reported) on 29-JAN-2009. Approximately on an unknown date in March 2013, the patient experienced unusual, defiant and crazy behavior. No laboratory test performed. The patient sought medical attention (Phone call to office). The outcome of unusual, defiant and crazy behavior was reported as not recovered/not resolved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Abdominal discomfort, Blindness, Dizziness, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Immediately following immunization, reported loss of vision, light headed, upset stomach, ringing in ears, loss of breath.  At 10:30 pm - identified small hives on skin on leg and arm.
Age: 14.0
Sex: F
Vaccine: HPVX, MEN
Symptoms: Tinnitus, Urticaria
Clinical narrative: Immediately following immunization, reported loss of vision, light headed, upset stomach, ringing in ears, loss of breath.  At 10:30 pm - identified small hives on skin on leg and arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Myalgia, Papule, Pruritus
Clinical narrative: This spontaneous report was received from a 72 year old registered nurse(who is also the patient) regarding herself. The patient has arthritis and no drug allergies or reactions. On 27-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included TYLENOL, valacyclovir hydrochloride and HYDROCODONE. On 18-MAR-2013, the patient developed shingles like symptoms. The patient reported that since 18-MAR-2013, she has been experiencing spinal column itching, severe pain in joints and muscles and a shingles like rash with one papule noted on un unspecified area of her back. The patient had been to the physician and was told that she has full blown shingles. The physician prescribed valacyclovir, hydrocodone and TYLENOL to treat the symptoms. The patient reported that she was experiencing less pain after the treatment. There were no laboratory tests performed. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: VSS. Generalized urticaria developed within 24 hours of vaccination. Seen at clinic within 72 hrs of rash development. Urticaria and pruritus very intense. Treated with tapering doses of prednisone and BENADRYL.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nervous system disorder, Psychogenic seizure, Wheelchair user
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 13 year old female patient. On an unknown date, the patient was vaccinated with a second dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date, the patient developed pseudo-seizures (disability), other central nervous system issues (disability) and headache (disability) 2 weeks after receiving the second dose of GARDASIL. Due to these adverse events the patient had to use a wheel chair. The outcome of the reported events were not recovered. The patient sought medical attention (patient saw the physician). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. On 18-MAR-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous. Dose, dose number and lot number were not reported. The physician reported that the patient developed shingles after vaccination. The patient sought medical attention via a phone call. The outcome of shingles was reported as not recovered/not resolved. Reporter causality assessment was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient over 60 years old. The patient's medical history included bad case of shingles 3 years ago approximately on an unknown date in 2010. On 23-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported) as she didn't want to go through shingles again. No concomitant medications were reported. On 24-MAR-2013, the patient experienced itching, swelling and redness around the injection site. Pharmacist stated that the injection site reaction was above the elbow and "the size of an aluminum coke can top". The swelling was sideways more so the patient was referred back to their unspecified physician. The patient was given ZOSTAVAX at another pharmacy. No laboratory diagnostics studies were performed. The outcome of itching, swelling and redness around the injection site was reported as recovering. Additional information is not expected.