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Information has been received from a registered nurse concerning her daughter with frequently injection site reaction after unspecified vaccination who was vaccinated with MMR II (Lot# not reported). After vaccination with MMR II, the patient experienced an injection site reaction of redness and hardness and a fever. The outcome of adverse event was unknown. It was not reported whether the patient sought medical attention. This is one of several reports receive from the same resource. Additional information has been requested.

0No event

Gave bivalent booster instead of monovalent

0No event

Shoulder and arm pain, swelling for over 2 weeks after vaccination (not yet resolved)

0No event

Sore arm, red raised for a week or so after the vaccine which then turned into a golf ball sized bump on the arm which hurts at times of movement

0No event

left axillary lymphadenopathy noted on CDC website as "unsolicited adverse event"

0No event

This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-MAR-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.

0No event

Have medium pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 30th March 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In March 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Age at vaccination was not reported. The patient received Bexsero yesterday from the date of reporting and had medium pain as side effect. The reporter wanted to know was it safe to take for pain reduction as tylenol or ibuprofen.

0No event

Progression of labor; Preterm premature rupture of membranes; Delivery at 33.6 weeks of gestation; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 25-Mar-2020, concerning a 37-year-old, pregnant female subject, of body weight: 132 lbs, height: 65 inches and body mass index (BMI): 22, enrolled in a prospective observational safety study. The subject's medical history was not reported. It was noted that the subject had advanced maternal age. The subject's concomitant medications included multivitamins (vitamins nonspecific) as vitamin supplementation, and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccination. The subject's obstetrical history noted that the subject had one previous full-term live birth. The subject had no history of offspring with major congenital malformation (MCM). The subject had no relevant maternal or paternal medical history. The subject did not use tobacco, illicit drugs or alcohol during pregnancy. The subject's last menstrual period (LMP) date was reported as 09-Jul-2019. The subject's estimated delivery date (EDD) and corrected estimated date of delivery (CEDD) were reported as 14-Apr-2020. The type of pregnancy was singleton. On 17-Sep-2019, at approximately ten weeks of gestation (calculated per LMP), the subject was administered Flucelvax QIVc (Flu Vaccine Cell Subunit QIV NVD) [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, batch number: 261200, anatomical location, route of administration and expiration date: not reported] (explicitly coded as ‘Vaccine exposure during pregnancy') for influenza immunisation. On the same day, the subject underwent Maternit 21 test, and no MCM was noted. On 15-Oct-2019, the subject underwent ultrasound, and no MCM was noted. On 30-Oct-2019, the subject underwent maternal serum alpha-fetoprotein screening (MSAFP/serum markers), and no MCM was noted. On 20-Nov-2019, the subject underwent anatomy ultrasound, and no MCM was noted. On an unspecified date, an unknown amount of time after vaccination, the subject's pregnancy status was collected, and it was noted that the pregnancy was complicated with preterm premature rupture of membranes and progression of labor. At gestational age of 33.6 weeks (as reported), the subject vaginally delivered live birth male neonate. The neonate's birth weight was 2240 g, while head circumference and length were not provided. The appearance, pulse, grimace, activity and respiration (APGAR) scores were 8 (one minute), 9 (five minutes), and APGAR score for ten minutes was not reported. There were no major MCMs identified at birth. At the time of this report, the outcome of the events ‘preterm labor', 'precipitate labor' and 'preterm premature rupture of membranes' was not reported. The events of 'preterm labor', 'precipitate labor' and 'preterm premature rupture of membranes' were assessed as serious due to criteria of medical significance, per company. The reporter did not provide causality assessment. This case is linked to the case 202002619, the corresponding baby case. Company comment: A 37-year-old pregnant female subject developed premature labour, precipitate labour, preterm premature rupture of membranes after vaccination with the suspect product Afluria Quadrivalent for influenza immunisation. Reportedly, at gestational age of 33.6 weeks (as reported) the delivery occurred. Chronology seems compatible. On 15-Oct-2019, a month after vaccination, the subject underwent ultrasound, and no MCM was noted. The subject's medical history was not reported. It was noted that the subject had advanced maternal age. The subject's concomitant medications included multivitamins (vitamins nonspecific) as vitamin supplementation, and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccination. With information presented, causality is assessed as unlikely related for all events (except for Exposure during pregnancy which is assessed as not related per company conventions) considering concomitant medications, advanced maternal age and ultrasound analysis.; Sender's Comments: A 37-year-old pregnant female subject developed premature labour, precipitate labour, preterm premature rupture of membranes after vaccination with the suspect product Afluria Quadrivalent for influenza immunisation. Reportedly, at gestational age of 33.6 weeks (as reported) the delivery occurred. Chronology seems compatible. On 15-Oct-2019, a month after vaccination, the subject underwent ultrasound, and no MCM was noted. The subject's medical history was not reported. It was noted that the subject had advanced maternal age. The subject's concomitant medications included multivitamins (vitamins nonspecific) as vitamin supplementation, and Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) as vaccination. With information presented, causality is assessed as unlikely related for all events (except for Exposure during pregnancy which is assessed as not related per company conventions) considering concomitant medications, advanced maternal age and ultrasound analysis.

0No event

Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves two-year old female patient who received 0.5 mL dose of FLUZONE QUADRIVALENT (batch number UI996AB, expiry date 30 June 2019) in right thigh on 09 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.

0No event

Dizziness, balance, pressure in head, confusion, given dizzy medicine, then antibiotics for ear infection, then sent to neurologist for further testing

0No event

vertigo; dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and DIZZINESS (dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). At the time of the report, VERTIGO (vertigo) and DIZZINESS (dizziness) outcome was unknown. No concomitant and treatment information were reported by the reporter. Company Comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

4HOSPITAL

big welt; injection site is red and itchy; injection site is red and itchy; swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 038A21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. At the time of the report, VACCINATION SITE URTICARIA (big welt), VACCINATION SITE PRURITUS (injection site is red and itchy), VACCINATION SITE ERYTHEMA (injection site is red and itchy) and VACCINATION SITE SWELLING (swelling in the arm) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Concomitant drug was not reported. Treatment included antibacterial cream. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021 and does not contain any new information

0No event

pt recvd flu vax pt exp arm pain;

0No event

pt recieved his smallpox vaccination in the right arm and it was covered with an occlusive dressing. Approx. 48 hours later he noticed a vaccinia lesion on his left arm that then progressed through the same stages as the vaccination site. He stated he had never removed the originally applied dressing at the time he discovered the lesion on the left arm

0No event

11 year old was administered PEDIARIX; Wrong vaccine administered; extra dose administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 15th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comments: Reporter was office manager and medical assistant. The reporter reported that a 11 year old patient received a dose of Pediarix on the day of reporting. No other symptoms were reported. The patient received Pediarix instead of the patient's Tdap dose. The patient was up to date on their IPV and Hepatitis B vaccination series. The administration of Pediarix was the patient's 5th dose of Hepatitis B. The reporter consented to follow up. Patient's initials were unavailable at the reporting time. Additional Supportive Information: The pharmacist stated that a 11 year old patient received an Pediarix dose instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The administration of Pediarix was the patient's 5th dose of Hepatitis B, which led to extra dose administered. Per package insert Pediarix was approved as a 3 dose series for 6 weeks of age through 6 years of age. This case is linked with case US2022060303 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022060303:Same reporter

0No event

Injection site pain, redness. Patient has skin peel from elbow to shoulder (described like a bad sunburn). Also had a rash on arms and severe itching on scalp

0No event

Atypical Measles-- MMR given 8/19/2002 Measles diagnosed 8/30/2002

0No event

After receiving the vaccine and within 2 days I felt tired and had muscle aches. My arm was sore where the shot was given. Around 4/16/2021 I got a terrible head cold, congestion, sinus pressure, headache and plugged up ears. This lasted about 2 weeks. Then got sick again with same symptoms on 8/2/2021 for about 2 weeks. Then got sick again on 12/27/2021 with the same symptoms for about 2 weeks. Sick again on 2/23/2022 same symptoms for about 10 days. I am usually a very healthy person and never get this sick so many times. Makes me think it's from the vaccine but not sure and just wanted to inform you of the history of illnesses.

0No event

Abdominal pain began late Sunday (04/04/2010) and progressively became worse until it became severe in the early morning hours of Thursday, 04/08/2010. Went to the ER and was given a diagnosis of pancreatitis of unknown origin (patient does not drink alcohol and had no signs of gallbladder disease)

2ER_VISIT, HOSPITAL

Upper arm pain which is sharp and severe.

0No event

really uncomfortable, my stomach is alarming; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (COVID Vaccine, manufacturer not clarified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included hypertension, diabetes, atrial fibrillation. The patient had some concomitant medications. When probed for any concomitant, patient stated, that was her other concern. She was seeing there was an issue with if you won't blood thinner (further not clarified). Patient stated, she got her own injection (COVID Vaccine) on Friday and It was not been major but she had been to the bathroom since Friday and she was change her diet or anything. This was really uncomfortable, her stomach was alarming. Patient asked if that was normal. Outcome of the event was not reported. Pfizer is a marketing authorization holder of COVID Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID Vaccine has submitted the same report to the regulatory authorities. Information on the lot/batch number has been requested.

0No event

Interviews and comprehensive review of his medical records identified two AVA vaccinations were given in 1/18/1991, and 1/25/1991. He remembered no adverse events. The series was started in 1998 with AVA #1 being given 7/23/1999, AVA #2 on 8/06/1999, and #3 on 8/20/1999. He advised these 3 shots resulted in a sore arm and some nausea that lasted a few days. He also complained of nodular formation to sequential vaccine (#2-3) sites that resolved in less than 1-2 weeks post vaccination. He also described an itchy red scaly patch-like rash to #2 &3 vac sites, to his back (right kidney region), and perineal area 1 week post vaccination lasting 1-2 weeks that he self treated with CORTISONE 10% cream. He stated this rash was similar to previous rashes he experienced since October 1990. In 1990, he was diagnosed with contact dermatitis; and on 08 March 1995 he was diagnosed with recurring acne, lichen plaque, and folliculitis per dermatology. He also c/o bilateral knee pain secondary to fractures and PFS. AVA #4 was given 1/24/2000 without exacerbation of these conditions. AVA #5 was given on 4/8/2003 along with a typhoid and IPV vaccinations. He advised approximately 1.5 hours post vaccination he felt woozy, hot, had tunnel vision, decrease in appetite, loss of peripheral vision, fatigue and other flu-like symptoms. Symptoms lasted 1-4 days. 5/21/2003 SPV given w/o reaction. Symptoms returned in June 2003 and on Mefloquine. He also had nightmares. Symptoms resolved after Mefloquine d/c. May 2006 c/o 2 month hx prn loss smell/taste. Was on AFRIN nasal spray for URI. Eval by ENT 9/06 suspected end organ damage. Subsequent evaluations by neurology, ENT, & PCP documented history of chronic sinus allergy problems since childhood with worsening congestion. CT scan head/sinuses 6/2/06 and MRI brain 6/26/06 with gadolinium were normal...no nasal/sinus polyps, thrombi, air-fluid collections or any abnormalities identified. Lab studies included normal TSH, CMP, ESR, FT4 and negative H. Pylori. UGI, w/KUB for heartburn identified small hiatal hernia, no reflux or polyps.

4HOSPITAL

PT presented to the pharmacy on 8-5-19 with a rash on arms, legs and chest. Worse on left side of body. small spots not itchy, larger patches were. She stated it started approximately on 8-3-19. She had had poison ivy recently but waited until rash had cleared to get vaccination, does not believe she was re-exposed. She will be checking in with her doctor on 8-6-19.

0No event

first several days, felt terrible, headaches, fever, fatigue, etc. within a couple of months, irregular menstrual issues and bleeding, and pain in the abdominal area. Scans showed a polyp and a biopsy showed stage 2 uterine cancer.

4HOSPITAL

felt warm, dizzy, lightheaded

0No event

Hives localized to injection site 2 hrs post admin, then generalized hives for 10 days.

1ER_VISIT

Client woke up following morning with right ankle swollen so much he could hardly walk. Used heat, TYLENOL, MOTRIN with relief. No recent injury to ankle. States he does not have money to be seen by MD- vaccine required by employees.

0No event

Expired flu vaccine. The patient was re-evaluated, and no complaints were voiced.

0No event

Experienced strong symptoms of usually well-controlled major depressive disorder, including feelings of worthlessness/helplessness/hopelessness and intrusive thoughts. Experience began while in bed awaiting sleep, ca. 11:00 p.m. Used CBT and DBT distress tolerance techniques to calm down enough to go to sleep by 1:30 a.m. Mood still unsettled in the morning, but severe distress has passed.

0No event

pt describes flu like symptoms for 2 days, excessive redness/swelling, as well as a cold sore/blister outbreak on lips and face.

0No event

Dyspnea developed one day after vaccination. Symptoms have persisted until today, when she presented to office

0No event

Error: Expired Product Administered-

0No event

THE RING FINGER ON MY RIGHT HAND HAS DEVELOPED A CYST LIKE HARD BUMP AT THE BASE OF MY FINGER AND IT IS BECOMING PAINFUL.

0No event

I remember I developed a fever and chills and muscle aches. I also had a huge red circle/lump on the injection site. Fever for only a day or two. Rash stayed about a week or two after the other symptoms faded. The lump was raised a little bit and was about 4 inches diameter and mostly like a rash but was sore more than itchy.

0No event

Myalgia, Fever, CHILLS, REDNESS AT RIGHT DELTOID Narrative: Other Relevant History:

0No event

Immediatly following the vaccine of the Gardisil or HPV she lost partial hearing and had leg paralysis. She fainted and felt nauseated. She was excused to leave less than 10 minutes later. Less than 2 hours later the leg paralysis returned as did the fainting and nausea. The ER doctor stated she had severe low blood pressure that could be causing the inability to use her legs.

1ER_VISIT

This case was reported by a physician via call center representative and described the occurrence of allergy in a 69-year-old female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to Hepatitis B vaccine. Additional details were reported as follows: The age at vaccination was not reported.

0No event

had COVID after having Pfizer COVID vaccines; had COVID after having Pfizer COVID vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 76-year-old male patient received BNT162b2 (BNT162B2), in Nov2020 as dose 1, single (Lot number: EL8982), in arm, on 14Feb2021 as dose 2, single (Lot number: EN9581), in arm and on 06Jan2022 as dose 3 (booster), single (Lot number: PJ8757, Expiration Date: Feb2022) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Stroke", start date: 2014 (unspecified if ongoing), notes: Stroke, is thinking this was about 8 years ago in about 2014; "Heart attack" (unspecified if ongoing), notes: Heart attack; "pacemaker placed", start date: 2017 (unspecified if ongoing), notes: pacemaker placed 6 years ago; "operations he has had was his tonsils and adenoid" (unspecified if ongoing), notes: the only operations he has had was his tonsils and adenoid at age 12.; "operations he has had was his tonsils and adenoid" (unspecified if ongoing), notes: the only operations he has had was his tonsils and adenoid at age 12. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "had COVID after having Pfizer COVID vaccines". The patient underwent the following laboratory tests and procedures: Lumbar puncture: Unknown results, notes: they did pre-diagnosis was a spinal tap; Magnetic resonance imaging: Unknown results, notes: they did several MRIs on him before the diagnosis. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient treated with Paxlovid. Pfizer COVID vaccines: 1st dose administered probably in Nov2020 but they did not write the date on his card and it has lot EL8982; 2nd dose was on 14Feb2021 with lot EN9581; 3rd dose was on 06Jan2022 with lot PJ8757 and thinks that is the lot with this handwriting and expiry date of Feb2022; also has written for the 3rd booster dose looks like #or C and think E 409 then 00; they did not include the NDC or other expiry dates for his patient card. Prior Vaccinations (within 4 weeks) was None. Patient remembers the Pfizer COVID booster dose was administered to him around 11:00am and all of his COVID vaccines were in his arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300076344 Same patient/vaccine, different dose/event;

0No event

Patient was contacted about coming in to receive second dose and family member had informed us that she had passed away from COVID two weeks after vaccine was given.

3DIED

redness at site of injection, fatigue, body aches and chills that lasted until 12/25/20 and subsided without treatment

0No event

07/15/2021 patient became diaphoretic, nauseous and vomiting. Became hypotensive with BP 61/37. Sent to ED. Pt admitted to ICU for large subcapsular left renal hematoma with extravasation; large perinephric hematoma. Hematoma and inflammation extend into left pelvis; largest area of clot measuring 8.5 cm. No evidence of trauma or tumor. Pt also dx with Acute Kidney Injury. INR was 3.3. Pt treated with Kcentra, 2 units FFP and 2 units PRBCs.

2ER_VISIT, HOSPITAL

A report was received from a health care professional who was also the consumer on 10/21/2003 concerning a 46 year old male vaccinee who experienced swelling and discomfort at the lymphatics 6 days after receiving Fluvirin on 10/14/2003. On 10/20/03 the vaccinee began to experience swelling and discomfort at the lympatics located at the left anterior axilla that also involved the left breast. The vaccine in the left deltoid. The out come of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 10/29/2003: A follow up was received from the effected and reporting health care professional indiciating that the lymphadenopathy under the axilla had slightly decreased. Swelling at the breast persists. Additionally the reporter reports pleuritic chest pain which has worsened and describes the pain like a costochondritis. A chest X-ray was performed on 10/28/2003 to rule out causes of chest pain. Update 2, 11/14/2003: Internal review indicated that these reactions were medically significant. Update 3, 11/17/2003: Further internal medical review indicated that these reactions were not medically significant. Update 4, 12/22/2003: Follow up information received from the health care professional inidicated that the adverse events began on 10/21/03. The axillary lymph nodes clinically resolved three and a half weeks later. However the pleuritic chest pain remains on going with slight improvement. The health care professional has assessed the relationship of the vaccine to the lymphadenopathy as probable.

0No event

Felt lethargic, diaphoretic; didn't check temp. Felt worse over the week, so called in sick 2/10, 2/11, tried to work 2/12, 2/13, and 2/14 but went home early all 3 days. Felt back to normal 2/16.

0No event

This spontaneous report as received from a healthcare student, refers to a 20 year old female patient, with none pertinent medical history or drug reaction allergies. It was reported that when the patient had 13 years old (approximately in 2006), she received the first dose of GARDASIL (Lot # not reported) (dose and route not reported) and received the second dose when she had 14 years old (approximately in 2007). Concomitant therapies included doxepin hydrochloride, ZYRTEC and BENADRYL. The reporter stated the patient developed what was described as chronic idiopathic urticarial sometime after the second dose of GARDASIL (unspecified time frame or date for the development of the chronic idiopathic urticarial). The student reported that the patient had been having intermittent urticarial and angioedema since April 2013. The patient was admitted to the hospital on 07-AUG-2013 with symptoms of chest pain, swelling of the lips and itching. The patient received treatment for the adverse events including SOLU-MEDROL injection, famotidine oral and BENADRYL oral. While hospitalized, the patient was tested for unspecified blood tests including a complete blood count (CBC) and basic metabolic panel (BMP) (results not reported). At the time of the report, the patient's outcome was recovering. Additional information has been requested.

2ER_VISIT, HOSPITAL