chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Lethargy, Pyrexia, Rash
Clinical narrative: Fevers to 102 for 1st 2 days, lethargy. Fevers again day 5-7 after vaccine, then rash day 11 after vaccine plus still lethargic.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall
Clinical narrative: Vaccines were given. Patient was sitting on the bed, appeared well. He asked for a glass of water. I left to fill a glass. When I returned, patient was on the floor. He was awake and talking. Could not remember exactly what happened. His mother was at his head. Patient remained on the floor resting for < 5 min. sat up and drank water. No apparent distress. Physician evaluated. Pt steady on feet before leaving clinic. No questions.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Chills, Convulsion
Clinical narrative: This was unwitnessed by medical professional and not followed up via appointment by mother.  Mom and Dad both state that after 2mos shots pt had "seizure" activity without fever.  2-3 short episodes that parents found very concerning.  Resulted in delay of subsequent vaccines until age 5.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling, itching to Rt Arm at injection site.
Age: 0.89
Sex: F
Vaccine: IPV, PNC13
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Fever of 101 F-103 F, lethargy, loss of appetite for 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: Shortly after admin of Zostivax, pt felt malaise since then.  She has shingle outbreak on right side of side and hip area & back of neck.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain, tenderness, redness & swelling of the left upper arm where the Tdap (Adacel) vaccine was administered, pt states that she also had a fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING WITH REDNESS, WARM TO TOUCH TO LEFT UPPER ARM.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint range of motion decreased, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Woke up on 11/14/13 numbness and tingling and completely tightened up on left side of body (stiff neck) lack of range of motion left hip/leg.  Second week of December 2013 numbness/tingling felt into left side of face/jaw/ear. (was basically entire left side of body by now)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Oval rash 3x1; following day, rash extended to 9x4 (center raised & darker).
Age: 1.24
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Agitation, Crying, Emotional distress
Clinical narrative: Non-Stop Crying, Highly Agitated, Not Able to Soothe, Pushes Away when I am usually the only one who can calm. The day he received vaccination he took a short nap after his appointment and cried pretty much non-stop from around 1:00 pm until we laid him down for bed at 9:30 pm; he only calmed down long enough to eat his dinner. Today, the day after being vaccinated, he seemed fine until around 9:30 am then cried on and off until his nap, around 12:00 pm. Then he was hysterically non-stop crying from 6:00 pm until 9:30 pm and counting. He was laid down for bed at 8:30, but he keeps cycling from sleeping to crying, which he does not usually do.
Age: 0.48
Sex: M
Vaccine: MMR
Symptoms: Crying, Erythema, Screaming
Clinical narrative: Crying, high pitched screaming, pulling hair out, bright red cheeks.  We were told to give him Tylenol.  That did not help at all.  He screamed and cried all night long and into the next afternoon.
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Double cortex syndrome, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous report as received from a consumer refers to is daughter, a currently 4 year old female patient with no pertinent medical history or drug reactions/allergies. On an unspecified date in 2011, the patient was vaccinated with M-M-R II INJ, subcutaneously (dose and lot number not provided). No co-suspect therapies were provided. There was no concomitant medication. The reporting consumer stated that approximately five months after receiving M-M-R II, the patient had a seizure (date not specified). The patient experienced a second seizure approximately three to four weeks after the first seizure. The patient had a Nuclear magnetic resonance imaging (MRI) scan (date not specified), which was determined to be normal. In a follow-up MRI (after an unspecified interval), the patient was diagnosed with Band Heterotopia. It was reported that the event caused hospitalization (dates not provided). At the time of the report, the outcome of the event was reported as not recovered/not resolved. Upon internal review, the event "the patient was diagnosed with Band Heterotopia" was considered as medically significant. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Aphonia, Lower respiratory tract infection, Nasopharyngitis, Oral herpes
Clinical narrative: This spontaneous report as received from a consumer refers to a 64 year old female patient with high sensitivity to drugs (unspecified names, doses/frequencies and manufacturers). On 10-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported). Other suspect therapies included PNEUMOVAX 23 (Lot # not reported) (dose and route not reported) applied on the same date. Concomitant therapy was not reported. On 24-DEC-2013 (reported as two weeks after receiving the vaccines) the patient experienced severe head and chest colds, fever blisters and loss of voice for four months. The patient did not seek medical attention. No treatment was given for the adverse events. The outcome of fever blisters, severe chest colds and severe head colds and loss of voice was reported as recovered in approximately April 2014 (reported as for four months after receiving the ZOSTAVAX and PNEUMOVAX 23). Upon internal review the loss of voice was considered an other important medical event. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous report was received from an office manager who was the wife of the physician, via a sales representative, regarding his 17 year old son with a preexisting asthma and no known drug reactions/allergies. At the same visit, on an unknown date, within the last few months, the patient received a dose of VARIVAX (Merck) (dose, route, lot # and expiry date were not provided). Other suspect therapy included a dose of MENACTRA (dose, route, lot # and expiry date were not provided). Concomitant medications were unknown. It was reported that the patient who was a track runner, began to have exacerbations in his preexisting asthma one week after receiving the dose of VARIVAX (Merck) and MENACTRA. The reporter stated that her son had to start taking unspecified relief medications and a breathing treatment for the asthma after a running episode. No laboratory diagnostic test was performed. At the time of the report, the patient had not recovered from the event. The relatedness between the event and suspect therapies were not provided. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Grimacing, Tonic clonic movements
Clinical narrative: Pt had possible rxn. approx. 12 hrs. after the vaccines. Multiple spells of tonic arm flexure with facial grimacing. No LOC. No emesis. No incontinence. No postictal events. Pt had temp 101+ degrees 12 hr. after vaccines.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. Medical history or currents conditions were not reported. In 2014, (reported as whiting the last three months) the patient was vaccinated with M-M-R II injection, dose number unknown. Concomitant therapies were not reported. The consumer reported that the patient feels she may be pregnant. No confirmed by an physician. No other adverse symptoms were reported. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Crying, Dyspnoea, Heart rate irregular, Hot flush
Clinical narrative: With in 10 minutes of receiving the shot vomited in class, hot flashes, pale. Apical pulse 120-130  irregular. Stomach ache, SOB, B/P 120/80 -90/68 crying and restless Epi Jr Rt thigh and 13 mins later. Called amb prior to Epi.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Restlessness, Vomiting
Clinical narrative: With in 10 minutes of receiving the shot vomited in class, hot flashes, pale. Apical pulse 120-130  irregular. Stomach ache, SOB, B/P 120/80 -90/68 crying and restless Epi Jr Rt thigh and 13 mins later. Called amb prior to Epi.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Myalgia
Clinical narrative: Patient reports today, 2 days after she got the vaccine here, she developed muscle pain on the back and on left side of the abdomen which is persisting - went to Dr on 4/30. Was given Tramadol 50 mg Rx - dispensed today.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site swelling, Local swelling, Pruritus
Clinical narrative: Pt. received a Tdap in (R) and MENACTRA in (L) mom called 4-30-14 stating the (L) arm was swollen up to the size of baseball, red and itchy the Tdap was also swollen mom advised to go to urgent med to have it looked at.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a patient of unknown age. Medical history was not reported. The patient was vaccinated with the first, second and third dose of GARDASIL (routes, lot numbers and expiration dates not reported), on 16-FEB-2012, 07-DEC-2012 and 20-FEB-2013 respectively. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were provided. The nurse reported that on 24-APR-2014, the patient received the first dose of PROQUAD (route and lot number not provided) and the first dose of VARIVAX INJ (route and lot number not provided). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, strength, lot number, expiration date and route were not reported). The register nurse mentioned an unknown number of patients may have received RECOMBIVAX HB that were improperly stored on an unknown date. No adverse effects reported. The registered nurse also reported current stock of RECOMBIVAX HB (not supported) (supported) in fridge at 34F for 5 months (150 days or 3600 Note: hours) due to a problem with the min and max thermometer not being reset. At the time of the report the outcome was unknown. Additional information has been requested. The case is one (1) of two (2) reports from the same reporter (1404USA012815).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse concerning an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, strength, lot number, expiration date and route were not reported). The register nurse mentioned an unknown number of patients may have received GARDASIL that were improperly stored. No adverse effects reported. Also the register nurse reported that current stock of GARDASIL (in fridge at 34F for 5 months (150 days or 3600 Note: hours) due to a problem with the min and max thermometer not being reset. At the time of the report the outcome was unknown. Additional information has been requested. These case is one (1) of two (2) reports form the same reporter (1404USA013469).
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Laboratory test, Pain, Swelling
Clinical narrative: This is a spontaneous report that has been received from the patient's mother concerning a 7 year old male patient. On 21-APR-2014 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, once shot, unspecified route of administration, for born with no spleen. Penicillin was reported as a concomitant medication. There were not medical history and drug allergies. The patient's mother reported that on 21-APR-2014 (also reported as a half an hour after receiving PNUEMOVAX 23) the patient started to become red, swollen and was in pain. It became progressively worse over time went by. BENADRYL and TYLENOL were given as treatment for the patient started to become red, swollen and was in pain. Laboratory diagnostics studies were performed. The patient sought medical attention. The outcome of the patient started to become, swollen and was in pain, was reported as recovering/resolving (also reported as only now the patient seems like he is recovering from the adverse events). Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 13 year old patient were vaccinated with a dose of GARDASIL (Lot#: 0459AE, expiration date: 13-DEC-2014) (dose, frequency, dose number and route were not reported). The patient was vaccinated with a dose of an improperly stored GARDASIL. No adverse effects reported. This is one of two reports received from the same reporter MARRS#: 1404USA005700. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M increased, Rash generalised
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 17 year old female patient with no medical history and no drug reactions/allergies. On 09-APR-2014 the patient was vaccinated with VARIVAX (Merck) (Lot# reported as J009166 and unspecified expiration date), 0.5 ml, subcutaneous. Concomitant therapies included ADDERALL. On 22-APR-2014, the patient was seen in the office with a "generalized rash all over her body". The patient had blood drawn at an unspecified LabCorp on 23-APR-2014. The nurse stated they received the results of the blood work on 24-APR-2014 which showed "varicella zoster IgG was low at less than 135 and varicella zoster IgM was high at 1.68". The nurse stated "our physicians determined that the rash was a reaction to the varicella vaccine and not a reported case of chickenpox". When asked the patient's present status the nurse stated, "we told her to call if things worsened or if it didn't go away in a few days. We haven't heard back from her". No treatment was given for the event. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Circumstance or information capable of leading to medication error, Erythema, Swelling
Clinical narrative: Extreme redness and swelling. (Child pulled at needle while vaccine was being given).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain, Erythema, Localised oedema, Pain, Syncope
Clinical narrative: Patient experienced a syncopal episode after administration  of the MENACTRA vaccine. She also experienced edema, pain and erythema (2" x 3") waking her at 3:15AM, also (L) axillary pain (resolved).
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt. c/o pain at the site of inj. to (L) deltoid starting 8-10 hrs. after inj. Pain was described as "debilitating". No other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: (L) upper leg cellulitis - treated with Abx.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash with red itchy raised skin about 3" in width and length.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Bilirubin conjugated normal, Blood bilirubin increased, Jaundice
Clinical narrative: This is a follow-up to a previously submitted VAERS report 501871-1. Delivered health infant son on 27 APR. Had elevated bili on 28 APR; normal exam, except for jaundice at 3 day-old visit.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Balance disorder, Decreased appetite, Irritability, Poor quality sleep
Clinical narrative: Fussy baby, lost of balance, no sleeping, no hungry, right eye twitchy, weak right arm, hand, and leg, brain inflammation, lot of pain, and more.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Balance disorder, Blepharospasm, Central nervous system inflammation, Decreased appetite, Hemiparesis
Clinical narrative: Fussy baby, lost of balance, no sleeping, no hungry, right eye twitchy, weak right arm, hand, and leg, brain inflammation, lot of pain, and more.
Age: 1.09
Sex: M
Vaccine: HEPA, MMR, VARCEL, MMR, VARCEL
Symptoms: Insomnia, Irritability, Pain
Clinical narrative: Fussy baby, lost of balance, no sleeping, no hungry, right eye twitchy, weak right arm, hand, and leg, brain inflammation, lot of pain, and more.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain
Clinical narrative: Local pain and erythema.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Mild local erythema and pruritis left deltoid area.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: General symptom
Clinical narrative: Twenty-Seven (27) months of Medical Records Can Be Provided.  Symptoms have persisted to the present time. No prognosis. No definitive treatment.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Alopecia, Anxiety, Arthritis, Blood pressure increased, Dysphonia
Clinical narrative: Twenty-Seven (27) months of Medical Records Can Be Provided.  Symptoms have persisted to the present time. No prognosis. No definitive treatment.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Headache, Heart rate increased, Hemiparesis, Hyperhidrosis
Clinical narrative: Twenty-Seven (27) months of Medical Records Can Be Provided.  Symptoms have persisted to the present time. No prognosis. No definitive treatment.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Insomnia, Local swelling, Mental impairment, Mobility decreased
Clinical narrative: Twenty-Seven (27) months of Medical Records Can Be Provided.  Symptoms have persisted to the present time. No prognosis. No definitive treatment.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal stiffness, Oral mucosal blistering, Paraesthesia, Pyrexia, Vision blurred
Clinical narrative: Twenty-Seven (27) months of Medical Records Can Be Provided.  Symptoms have persisted to the present time. No prognosis. No definitive treatment.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: EXCRUCIATING pain in left shoulder. Unable to lift arm, unable to sleep.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a healthcare worker via a physician referring to a patient of unknown age and gender (demographics not reported). It was reported that on an unknown date in 2009 the patient was vaccinated with PNEUMOVAX 23 (lot# not reported). No other concomitant therapies were reported. On an unknown date the reporter stated that patient was in need of surgery (medically significant) for unspecified medical condition. The healthcare worker stated that the medical condition was not pre-existing when PNEUMOVAX 23 was administered. There was no PQC reported. The reporter enquired if PNEUMOVAX 23 was company's product and if it was available in the year 2009. The outcome the events was unknown. The causality of the events was unspecified. Upon internal review, the event of 'in need of surgery' was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (Merck) Lot # J006804 (Expiry: 30-MAY-2015) (0.5 ml once) subcutaneous was stored at 1C for 150 hours. No adverse effects reported. No further information provided. This case is linked to the case 1405USA000972 and 1405USA000973 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 29-OCT-2008 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. The patient received the 2nd dose of GARDASIL 08-JAN-2009 and the 3rd dose of GARDASIL on 19-MAR-2014. (Consider inappropriate schedule of vaccine administration.) Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness
Clinical narrative: When patient being scheduled for next appointment, reported feeling dizzy.  Nurse assessed patient vital signs with BP 86/60.  Otherwise normal assessment except for pt reports of dizziness.  Nurse continued assessment and BP increased to 96/60.  Pt reported BP "usually runs low".
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date, the patient experienced shingles shortly after receiving ZOSTAVAX. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-JUN-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB 2.5 mcg/0.5ml (dose, route, lot # and expiration date were not provided). On 01-FEB-2014, the patient was vaccinated with the second dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The physician inquired if the patient needed to restart the series or if the patient could receive the third dose. It was unknown if the patient sought medical attention. No adverse symptoms were reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 injection (lot #, expiry date, dose, route and indication unknown). The pharmacist mentioned on an unknown date the patient developed an unspecified reaction to PNEUMOVAX 23. The pharmacist mentioned this adverse event might have been previously reported. The outcome of unspecified reaction was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a female child patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous unspecified which thigh that which was improperly stored. No adverse effects reported. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The reporter stated that the patient received an expired dose of PNEUMOVAX 23m batch # HJ006082 (which corresponds to lot # 0744AE) with expiry date 12-APR-2014. Dosing information and route of administration were not provided. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a physician via Pfizer refers to a patient of unknown age. Medical history and current condition of the patient was unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route unspecified), lot number was not reported. On an unknown date the patient experienced allergy. The physician was asking if the patient was allergic to PNEUMOVAX 23 are they allergic to PREVNAR? The outcome of allergy was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Neck pain
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age. No details or demographics were provided for the patient. On an unknown date, the patient was vaccinated with ZOSTAVAX, dose (unknown) and router of administration (unknown). No concomitant medications were reported. On an unknown date (also reported as the next day), the patient developed rash at the injection site and pain in her neck. No details given for which pharmacist administered the ZOSTAVAX vaccine. No time frame was provided. No further symptoms or treatments provided. Action taken with respect to ZOSTAVAX was not applicable. No Product quality complaint was involved. The outcome of events was unknown. Causality was not provided. No further adverse event information was provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a 60 years old male patient. On an unknown date in approximately December 2013 (also reported as 4 months ago), the patient was vaccinated with ZOSTAVAX, dose (unknown) and route of administration (unknown). Other suspect therapy was an unspecified flu shot (cannot rule out) AFLURIA administered on an unknown date in approximately December 2013 (also reported as 4 months ago). No concomitant medications were reported. On an unknown date, the patient developed Bell's palsy. The patient was not hospitalized. Action taken with respect to ZOSTAVAX and AFLURIA was not applicable. No Product quality complaint was involved. The outcome of Bell's Palsy was unknown. Causality was not provided. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site extravasation
Clinical narrative: This spontaneous report was received from a pharmacist refers to two patients of unknown age and unknown gender. On an unknown date the two different patients were vaccinated with ZOSTAVAX (dose, route, indication, and lot # not provided) in the arms. The pharmacist had observed ZOSTAVAX leak or trickle from the injection site of the two patients' arms immediately after administration of ZOSTAVAX (after the needle had been removed from the patients arm). No adverse effect reported. Action taken with ZOSTAVAX was not reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: ANTH
Symptoms: Chest discomfort, Epistaxis, Hypertension, Tuberculin test
Clinical narrative: Information was received on 17APR2014 from an employee on behalf of five consumers. This is case 2 of 5. On 11MAR2014 a consumer (age / gender unspecified) received immunization with BIOTHRAX (lot FAV365). Subsequently the individual experienced hypertension, chest tightness and a bloody nose which led to hospitalization. The reporter requested that the product be tested for possible contamination. No further information provided. Further information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Child fainted.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Seizure like phenomena
Clinical narrative: AS SOON AS VACCINE WAS ADMINISTERED, CHILD'S MUSCLES, LIMBS STIFFENED UP FOR A FEW SECONDS, LOOK SEIZURE LIKE, NURSE YELLED FOR DR AND CHILD CAME OUT OF TRANCE.
Age: 1.76
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Mouth ulceration, Parvovirus B19 test, Pruritus
Clinical narrative: Severe generalized body rash 10 days following vaccination. Mother reports patient "felt warm" for a couple days before breakout on 04/27/14. Rash red and raised, causing some itching, small ulcer on buccal mucosa. Patient afebrile. Treated at home with Aveeno oatmeal baths and Benadryl P.O. Patient examined in our office on 04/29 and again on 05/01/14. Rash improving significantly. Mother advised to keep patient away from children for 4 days after disappearace of rash and until labs return. Report any mental status changes or body aches and pains to our office.
Age: 1.76
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Skin warm
Clinical narrative: Severe generalized body rash 10 days following vaccination. Mother reports patient "felt warm" for a couple days before breakout on 04/27/14. Rash red and raised, causing some itching, small ulcer on buccal mucosa. Patient afebrile. Treated at home with Aveeno oatmeal baths and Benadryl P.O. Patient examined in our office on 04/29 and again on 05/01/14. Rash improving significantly. Mother advised to keep patient away from children for 4 days after disappearace of rash and until labs return. Report any mental status changes or body aches and pains to our office.
Age: 41.0
Sex: U
Vaccine: ANTH, TYP
Symptoms: Dizziness, Hallucination, Heart rate increased, Hypertension
Clinical narrative: Information was received on 17APR2014 from an employee on behalf of five consumers.This is case 1 of 5. On 08MAR2014 a consumer (age / gender unspecified) received immunization with BIOTHRAX (lot FAV349) and Typhoid vaccines. Subsequently the individual experienced dizziness, hypertension, rapid pulse and hallucinations which resulted in hospitalization. The reporter requested that the product be tested for possible contamination. No further information provided. Further information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication
Clinical narrative: This spontaneous report as received from health care worker via company representative refers to a patient of unknown age. There were no pertinent medical history, concurrent conditions and drug reactions/allergies reported. On an unknown date the patient was vaccinated with ROTATEQ orally, (frequency, dose number, lot # not reported). No concomitant medication reported. The health care worker stated that an increased number of patients seem to be spitting out partial doses of ROTATEQ with greater frequency than before. No patient specific information available. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Malaise, Paraesthesia, Pruritus
Clinical narrative: This spontaneous report as received from a female consumer of unknown age refers to herself. The patient reported that she received a dose of ZOSTAVAX "4 to 5 days ago" (on approximately 17-APR-2014), (dose, route, lot # and expired date were not reported). The patient reported that since receiving the vaccine (time frame for the onset of the event not specified), on approximately 17-APR-2014, she was experiencing itching, tingling and numbness. The patient stated she was not "feeling well" and would be contacting the pharmacy where the vaccine was administered. The patient did not seek medical attention. The outcome of adverse events was reported as not recovered/not resolved. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old male patient. The patient's pertinent current condition included skin cancer. On 10-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX , 0.65 ml/once, lot # J011549, expiration date 19-DEC-2014, subcutaneously. Approximately on 13-APR-2014, within three days, the patient developed itching on palms and between his fingers. No treatment was given for the event. The patient did not seek medical attention. Event remained ongoing and patient would be consulting dermatologist in the future. The outcome of event was reported as not recovered/not resolved. The causality between event and therapy was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dermatitis contact
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with poison ivy. On 16-APR-2014 the patient was vaccinated with ZOSTAVAX, lot # J011335, expiry date 13-DEC-2014, 0.65 ml, subcutaneous. Pharmacist reported the patient had poison ivy, prior to receiving ZOSTAVAX; however, poison ivy worsened. Pharmacist stated that the patient received a betamethasone 30mg injection two days later after receiving ZOSTAVAX vaccination for poison ivy (18-APR-2014). The outcome of poison ivy had worsened was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (Merck) Lot # J012151 (Expiry: 28-SEP-2015) (0.5 ml once) subcutaneous was stored at 1C for 150 hours. No adverse effects reported. No further information provided. This case is linked to the case 1405USA000004 and 1405USA000972 (Same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (merck) Lot # J007028 (Expiry: 05-JUN-2015) (0.5 ml once) subcutaneous was stored at 1C for 150 hours. No adverse effects reported. No further information provided. This case is linked to the case 1405USA000004 and 1405USA000973 (Same reporter link). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 75 year old male patient refers to himself. The patient had history of shingles (date not reported) and unspecified problems with blood pressure and cholesterol. No allergies or reactions to the drugs were reported by the patient. ON an unknown date in 2007, the patient was vaccinated with ZOSTAVAX (vaccine administered once; dose, administration site and route of administration: unknown) (LOT # and expiration date: not specified) after he had shingles (date not reported). No concomitant medication was taken at that time by the patient. He stated that then he got shingles again, 2 years ago, approximately in April 2012, and hot shingles again about 6 months ago, approximately in November 2013, after getting the vaccine. The patient had sought medical attention and had received unspecified antivirals for treatment. The outcome of shingles was not reported. The relatedness of shingles and ZOSTAVAX was not reported. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 60 year old female patient. The patient medical history included high blood pressure, drug reaction/allergies to penicillin and novocaine. Concomitant therapies included aspirin. On 28-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J013135 expiration date 17-JAN-2015, route subcutaneous to prevent shingles. On 30-APR-2014, 3 days after onset of therapy the patient developed red baseball-sized knot surrounded by halo at the site of ZOSTAVAX injection. The outcome of red baseball-sized knot surrounded by halo at the site of ZOSTAVAX injection is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot # J013277, expired date: 08-JUN-2015) was administered to a 17 year old patient on 26-FEB-2014. This case was linked to 1405USA001665, 1405USA001164, 1405USA001163, 1405USA001161, 1405UA001166 and 1403USA007265. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 17-JUN-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. Lot number was not reported. The patient was vaccinated with dose 2, on 20-AUG-2013 and with dose 3, on 24-OCT-2013. No adverse effect was reported. Action taken regarding to the use of GARDASIL was not reported. The outcome of first dose of GARDASIL was administered on 17-JUN-2013, second dose on 20-AUG-2013 and third dose on 24-OCT-2013 and no adverse effect was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Age: 21.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot# J009788,expired date: 17-MAR-2016) was administered to a 21 year old patient on 05-MAR-2014. This case was linlked to 1405USA00161, 1405USA001164, 1405USA001163, 1405USA001162, 1405USA001166 and 1403USA007265.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and gender. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up was linked to 1405USA001161, 1405USA001164, 1405USA001163, 1405USA001162, 1405USA001166 and 1403USA007265. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot# J006850,expired date:31-MAR-2015(reported as 10-JUN-2015)) was administered to a 11 year old patient on 28-FEB-2014. This case was linked to 1405USA001165, 1405USA00164, 1405USA001161, 1405USA1162, 1405USA001166 and 1403USA007265. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecifide number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated swith GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot# J006850, expired date: 31-MAR-2016) was administered to a 9 year old patient on 03-MAR-2014. This case was linked to 1405USA001165, 1405USA001161, 1405USA001163, 1405USA001162, 1405USA001166 and 1403USA007625. Additional information has been requested.
Age: 0.23
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to 2 patients of unknown age (siblings). No pertinent medical history or drug reactions/allergies were provided. On 21-JAN-1999, the patients were vaccinated with their first dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided). On 24-FEB-1999, the patient were vaccinated with their second dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided). No co-suspect or concomitant therapies were reported. The nurse reported that, on an unknown date in 2005, both patients had negative (not immune) hepatitis b titers, and on 10-MAY-2013, the patients received their dose of RECOMBIVAX HB 5 MCG/0.5ML, lot # H017304, expiration date 11-JUN-2015 (route not provided). At the time of the report, the outcome for the event "Both patients had negative (not immune) hepatitis B titers" was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot # J010396, expired date: 16-FEB-2015) was administered to a 23 year old patient on 25-FEB-2014. This case was linked to 1405USA01165, 1405USA001164, 1405USA001163, 1405USA001162, 1405USA001166 and 1403USA007265. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. Route, dose, dose number and lot number were not reported. On an unknown date the patient received ZOSTAVAX while he had an active case of shingles. No adverse symptoms were reported. Action taken regarding to the use of ZOSTAVAX was not reported. The outcome of patient received ZOSTAVAX while he had an active case of shingles and no adverse symptoms were unknown. Reporter causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that on 30-APR-2014 the patient was vaccinated with expired ZOSTAVAX strength 0.65ml, lot # J001006 expiration date 24-APR-2014, route subcutaneous in the right arm. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the third dose of GARDASIL (dose and lot number not provided), 1 single shot intramuscularly. On an unknown date after the third shot of GARDASIL, the patient experienced fatigue. There was no mention of the 1st and 2nd shots. The outcome of fatigue was unknown. The causal relationship was not provided. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Axillary pain, Injection site erythema, Injection site nodule, Injection site pain, Myalgia
Clinical narrative: on 2/6/2014 12 noon - Patient reported that the night of the PPSV injection he felt a "knot" in his (L) deltoid, (+) pain (L) arm pit. Stretched with a towel - hard a "pop". Know went away then noticed a red area upper (L) arm 50 cent size toward armpit. (+) muscle soreness. Took TYLENOL/Ibuprofen d/t wisdom teeth coming in. Noted 50 cent size nonraised red area. Denied itching, (+) muscle soreness between (L) delt and axilla - no redness at injection site. Advised to continue TYLENOL/Ibuprofen. Take BENADRYL and see me next day. On 2/7/14 04:30 muscle soreness gone - unless touch area or move a certain way. Color faded almost completely away even without taking BENADRYL ("BENADRYL makes me sleep too much").
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site 3/26/14 - Showed Infection Prevention Coordinator pic taken. Vist by her to use warm packs and BENADRYL. 3/27/14 16:10 I spoke w/patient on phone. She said she never used BENADRYL; did warm packs. Swelling and redness has gone down on it's own. Denies fever.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA
Symptoms: Blister, Erythema, Secretion discharge, Skin hyperpigmentation, Swelling
Clinical narrative: MILDLY RED AND SWOLLEN, LATER IN DAY DARK ERYTHEMA AND HYPERPIGMENTATED, TODAY THIS A.M BLISTERS AND OOZING SWELLING PROGRESSING THIS A.M SILVADENE DRESSING BENADRYL IN THE OFFICE, PREDNISOLONE AND KEFLEX PRESCRIPTION.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Induration, Injection site pain, Pain
Clinical narrative: Generalized aches, weakness, chills X 24 hr, with firmness and slight calor, minamally tender at injection site.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Skin discolouration
Clinical narrative: Generalized aches, weakness, chills X 24 hr, with firmness and slight calor, minamally tender at injection site.