chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Feeling hot, Induration, Pruritus
Clinical narrative: Redness, induration, itching, discomfort. Seen 5/16/13 for increasing size up to 5.5 cm, warmth, tenderness, redness induration, itching- placed on Benadryl cream and hydrocortisone cream and oral prednisone 20mg BID x 5days.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Redness, induration, itching, discomfort. Seen 5/16/13 for increasing size up to 5.5 cm, warmth, tenderness, redness induration, itching- placed on Benadryl cream and hydrocortisone cream and oral prednisone 20mg BID x 5days.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Biopsy, Body temperature increased, Cellulitis, Haematoma, Injection site erythema
Clinical narrative: 4/24 Pneumovax vaccine given. 4/25 Patient developed swelling, redness, and pain in 3 x 5 area of left deltoid (arm) where vaccine given. Temp 102 degrees F. 4/26 Seen in clinic: u/s, needle aspirate done. Most likely hematoma, but cover for cellulitis. Clindamycin x 5 days, ibuprofen, hot packs, diphenhydramine as needed.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Ultrasound scan
Clinical narrative: 4/24 Pneumovax vaccine given. 4/25 Patient developed swelling, redness, and pain in 3 x 5 area of left deltoid (arm) where vaccine given. Temp 102 degrees F. 4/26 Seen in clinic: u/s, needle aspirate done. Most likely hematoma, but cover for cellulitis. Clindamycin x 5 days, ibuprofen, hot packs, diphenhydramine as needed.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein increased, Chills, Full blood count, Injection site erythema, Injection site pruritus
Clinical narrative: 5/01 Seen in ER for itchy red rash on medial upper right arm where Pneumovax was given previous day. 05/02 Recheck in ER: Patient describes chills but no fever. Pred 20mg for 5 days. Thought to be a local inflammatory reaction.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Red blood cell sedimentation rate normal
Clinical narrative: 5/01 Seen in ER for itchy red rash on medial upper right arm where Pneumovax was given previous day. 05/02 Recheck in ER: Patient describes chills but no fever. Pred 20mg for 5 days. Thought to be a local inflammatory reaction.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Ataxia, Blood creatinine, Blood electrolytes, Blood potassium increased, Blood urea
Clinical narrative: Initial visit to Emergency Department (ED)on 05/12/2013 for swollen tongue and rash located on nipple line to neck. Prednisone given, released. Follow up on 05/13/2013 with wide based ataxic gait observed with macular papular rash on nipple line to neck. Normal Sinus Rythm and rate per EKG. Reflexes hyperific or unable to elicit. Transferred via ambulance to ED. Hyperkalemia per lab report, per hospital report SM is stable but hyperkalemia has not resolved. Remains hospitalized.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram normal, Gait disturbance, Hyperkalaemia, Monocyte count, Rash maculo-papular
Clinical narrative: Initial visit to Emergency Department (ED)on 05/12/2013 for swollen tongue and rash located on nipple line to neck. Prednisone given, released. Follow up on 05/13/2013 with wide based ataxic gait observed with macular papular rash on nipple line to neck. Normal Sinus Rythm and rate per EKG. Reflexes hyperific or unable to elicit. Transferred via ambulance to ED. Hyperkalemia per lab report, per hospital report SM is stable but hyperkalemia has not resolved. Remains hospitalized.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Reflexes abnormal, Swollen tongue
Clinical narrative: Initial visit to Emergency Department (ED)on 05/12/2013 for swollen tongue and rash located on nipple line to neck. Prednisone given, released. Follow up on 05/13/2013 with wide based ataxic gait observed with macular papular rash on nipple line to neck. Normal Sinus Rythm and rate per EKG. Reflexes hyperific or unable to elicit. Transferred via ambulance to ED. Hyperkalemia per lab report, per hospital report SM is stable but hyperkalemia has not resolved. Remains hospitalized.
Age: 44.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: Initial visit to Emergency Department (ED)on 05/12/2013 for swollen tongue and rash located on nipple line to neck. Prednisone given, released. Follow up on 05/13/2013 with wide based ataxic gait observed with macular papular rash on nipple line to neck. Normal Sinus Rythm and rate per EKG. Reflexes hyperific or unable to elicit. Transferred via ambulance to ED. Hyperkalemia per lab report, per hospital report SM is stable but hyperkalemia has not resolved. Remains hospitalized.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Swelling
Clinical narrative: Patient c/o right arm deltoid pain post vaccination for Pneumovax. Pt c/o of lack of mobility, swelling, severe to extreme pain, on pain scale 1-10, 10 being worse. He verbally says: " pain is an eleven". Pt denies fever or chills. Has been taking 2 tab Vicodin 5/500 mg yesterday this did not relief the pain. Negative for HA, nausea. Pt was seen by Dr and a venous duplex of his UE was ordered.
Age: 0.65
Sex: M
Vaccine: DTAP, IPV
Symptoms: Irritability, Pyrexia, Skin discolouration
Clinical narrative: Fever 104.6 rectally, discoloration of skin bilaterally on legs, irritability for 3 hours post vaccination.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Blood culture, Culture wound, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: Erythematous area approximately 10 centimeters and warm to touch. Swelling of supraclavicular node cellulitis and abcess at site of vaccination. Keflex and clindamycin, and motrin given. Service member seen by provider a few days later and was determined that a robust take was experienced.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Metabolic function test, Robust take following exposure to vaccinia virus, Skin warm, Vaccination site abscess
Clinical narrative: Erythematous area approximately 10 centimeters and warm to touch. Swelling of supraclavicular node cellulitis and abcess at site of vaccination. Keflex and clindamycin, and motrin given. Service member seen by provider a few days later and was determined that a robust take was experienced.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site cellulitis
Clinical narrative: Erythematous area approximately 10 centimeters and warm to touch. Swelling of supraclavicular node cellulitis and abcess at site of vaccination. Keflex and clindamycin, and motrin given. Service member seen by provider a few days later and was determined that a robust take was experienced.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: 5x2.5cm local reaction at vaccine site on R thigh. Firm, erythematous, warm to touch, slightly tender to palpation, well defined.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt administered PNEUMOVAX  on 5/14/13; erythema and edema at injection site; warm to touch. Tx- KEFLEX, warm compress BENADRYL.
Age: 34.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in right arm, and shoulder pain. Pt can't lift arm as high as usual. Pain started 5/7/13 and has been getting a little worse as of 5/13/2013.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Angiogram, Arthralgia, Asthenia, Blood creatine phosphokinase, Chest X-ray
Clinical narrative: Patient reported joint pain and muscular aches, fever 3-4 days post vaccination. ED visit on 05/1152013 and released with diagnosis of cellulitis at the vaccination site, pt was given antibiotics and released. Second visit to ED on 05/13/2013 with dyspnea with exertion, chest palpitations, mild rash on neck, generalized weakness, papules on neck area, redness at vaccine site. Evaluated at hospital and released.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea exertional, Electrocardiogram, Fibrin D dimer, Full blood count, Injection site erythema
Clinical narrative: Patient reported joint pain and muscular aches, fever 3-4 days post vaccination. ED visit on 05/1152013 and released with diagnosis of cellulitis at the vaccination site, pt was given antibiotics and released. Second visit to ED on 05/13/2013 with dyspnea with exertion, chest palpitations, mild rash on neck, generalized weakness, papules on neck area, redness at vaccine site. Evaluated at hospital and released.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: International normalised ratio, Metabolic function test, Myalgia, Palpitations, Papule
Clinical narrative: Patient reported joint pain and muscular aches, fever 3-4 days post vaccination. ED visit on 05/1152013 and released with diagnosis of cellulitis at the vaccination site, pt was given antibiotics and released. Second visit to ED on 05/13/2013 with dyspnea with exertion, chest palpitations, mild rash on neck, generalized weakness, papules on neck area, redness at vaccine site. Evaluated at hospital and released.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Prothrombin time, Pyrexia, Rash, Red blood cell sedimentation rate, Troponin increased
Clinical narrative: Patient reported joint pain and muscular aches, fever 3-4 days post vaccination. ED visit on 05/1152013 and released with diagnosis of cellulitis at the vaccination site, pt was given antibiotics and released. Second visit to ED on 05/13/2013 with dyspnea with exertion, chest palpitations, mild rash on neck, generalized weakness, papules on neck area, redness at vaccine site. Evaluated at hospital and released.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site cellulitis
Clinical narrative: Patient reported joint pain and muscular aches, fever 3-4 days post vaccination. ED visit on 05/1152013 and released with diagnosis of cellulitis at the vaccination site, pt was given antibiotics and released. Second visit to ED on 05/13/2013 with dyspnea with exertion, chest palpitations, mild rash on neck, generalized weakness, papules on neck area, redness at vaccine site. Evaluated at hospital and released.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash
Clinical narrative: Rash and inflammation. No tx aware of.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Crying
Clinical narrative: Crying every hour. Tmax 103.2 at 0300 5/14/13.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Asthenia, Dizziness, Micturition urgency, Nausea
Clinical narrative: Dizziness, general weakness, nausea, feeling need to go to the bathroom right away.
Age: 0.18
Sex: M
Vaccine: 6VAX-F, RVX
Symptoms: Haematochezia
Clinical narrative: Persistent large amounts of blood in baby's stool after 2 month vaccines. Blood worsened after 4 month vaccines. Nursing mother went on total elimination diet suspecting food allergies, refused 6 month rota-virus vaccine and later added all foods including dairy back in to nursing mother's diet when baby was 7 months. No reaction was observed when all foods were added back into diet. Believe bloody stools were caused from rotavirus vaccine.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Balance disorder, Computerised tomogram, Dizziness, Fatigue, Headache
Clinical narrative: 5/10/13 Headache at 11:00 PM. 5/11/13 Fatigue and muscle aches. 5/12/13 Sudden onset pressure Headache at 11:00 am did not subside until PM on 5/15/11 after ER visit. 5/13/13 Light headed, occasional dizzy. 5/14/13 HA, Dizzy numb and tingly face and hands. 5/15/13 Dizziness worse, headache continues, balance off. 5/14/13 sent to clinic given Steroid. 5/15/13 went to ER CT done, given IV fluid, Toradol and Antivert.
Age: 51.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: 5/10/13 Headache at 11:00 PM. 5/11/13 Fatigue and muscle aches. 5/12/13 Sudden onset pressure Headache at 11:00 am did not subside until PM on 5/15/11 after ER visit. 5/13/13 Light headed, occasional dizzy. 5/14/13 HA, Dizzy numb and tingly face and hands. 5/15/13 Dizziness worse, headache continues, balance off. 5/14/13 sent to clinic given Steroid. 5/15/13 went to ER CT done, given IV fluid, Toradol and Antivert.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED ADULT DOSE OF HEPATITIS A VACCINE (1.0ML). PATIENT ALSO RECEIVED 2 DOSES OF VARICELLA VACCINE. RN AND MD NOTIFIED ABOUT PATIENT PATIENT'S VITALS STABLE. MD ASSESSED PATIENT.
Age: 1.87
Sex: M
Vaccine: HEP, HEPA, HIBV, IPV, MMR, PNC13, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None - Tdap was inadvertantly administered instead of DTaP.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Autism diagnosis.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Quarter sized area of redness, swelling and warmth of skin around shot injection site. Mom and maternal grandfather have had similar reactions to tetanus shots in the past. Patient had not had previous reactions to the tetanus shot. This was her fifth tetanus vaccine.
Age: 0.16
Sex: F
Vaccine: ANTH
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Auto-inoculation, swelling, lymphadenopathy.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Pt. stated she passed out at the grocery store about 15 mins after receiving vaccine. Lost conciousness appox. 10 secs. Retured to the clinic for reporting an assessment.
Age: 1.16
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Experienced low grade fevers for days after vaccine and experience a high fevers (105) several days after vaccine.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Injection site mass, Oedema peripheral, Pruritus
Clinical narrative: My arm swelled up and was red and hot and itched, and had a huge lump where the shot was given. I took Benadryl and rubbed some cream on it, to stop the itching and burning.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: My arm swelled up and was red and hot and itched, and had a huge lump where the shot was given. I took Benadryl and rubbed some cream on it, to stop the itching and burning.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: 5/15/13 pt presented w/erythema (9cmx5cm), swelling, pain, fever, chills, fatigue, and stiffness.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: 5/15/13 pt presented w/erythema (9cmx5cm), swelling, pain, fever, chills, fatigue, and stiffness.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling, possible infection. MD prescribed KEFLEX 500 ml.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Herpes zoster, Paraesthesia, Rash
Clinical narrative: Patient started experiencing pain/tingling under his right armpit and inner right arm, and on his back. This presented before a rash appeared. He saw his doctor and on 5/13/13 picked up prescriptions to treated shingles.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Pt started itching almost immediately. She was given 25mg diphenhydramine with instructions, to contact us and/or Dr if itching was not alleviated.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Headache, Ocular hyperaemia
Clinical narrative: H/A, T 102.8 po, bilat. scleral redness. Referred to PCP.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Cough, Hyperhidrosis, Urticaria
Clinical narrative: Urticaria on neck. Sweaty. Cough
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythematous 2.5 cm area of induration on posterior right arm (deltoid). Treatment plan: ibuprofen and ice pack.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: At 3:15 pm 5/16/2013, vaccine was administered at IM route in (L) arm. Approx 5 minutes later patient fainted. Kept patient in office, no head injury; when able patient walked out on own.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 103 degrees rectally night of immunizations and the next morning. Goes down w/TYLENOL.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Lymphadenopathy, Pruritus
Clinical narrative: Redness / erythema in 24 hours, itching within 12 hours, swelling at injection site and (R) axillary node, non resolving.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: After administrative of 3 vaccines patient was observed to turn pale and referred feeling a little bit dizzy. He was placed and the stretcher vitals assessed and left under observation. After 10 to 15 mins. he was sit. it and symptoms were resolve. Vitals remained stable all the time.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine given.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient woke up day after receiving vaccine with a few spots on her body. Thought she had shingles so went to doctor. Talked to doctor, he said he didn't think it was shingles but treated her with acyclovir and mupirocin.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine given.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection left tricep.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Injury, Loss of consciousness, Syncope
Clinical narrative: Patient fainted about 1 min and 30 seconds after injection. Pt. regained consciousness about 10-15 seconds later. She was sent to the ER due to injuries sustained by the fall.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Jaw fracture, Laceration, Syncope, Tooth injury
Clinical narrative: Patient fainted about 1 min and 30 seconds after injection. Pt. regained consciousness about 10-15 seconds later. She was sent to the ER due to injuries sustained by the fall.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Pt states she had shingles "a long time ago" and was given a shot and a cream. The shingles episode resolved in several weeks and the rash was 3-4 small spots on her neck. On 5/1/13 she received ZOSTAVAX. 5/16/13 she called and stated she has 2-3 raised spots in same place as the original rash and it is "a bit itchy".
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth to (R) upper arm at injection site. No treatment.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, itching to injection site. No treatment.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Acute onset swelling, redness and warmth to left bicep area surrounding identified site of injection above in generalized distribution of bicep extending to shoulder approximately 5 cm area of induration centrally.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Pt had circular slightly raised are of red inflamed tissue at injection site. It was 1.5-2" in diameter. Pt reported no significant pain at the site. Pt was advised to keep an eye on it and report if no improvement in a few days.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers an unknown number of patients of unknown age. The physician reported that the unknown number of patients might have received improperly stored GARDASIL from 21-JAN-2011 to present. No adverse event reported. This is one of several reports from the same reporter (Other MARRS# 1305USA009039, 1305USA010281, 1305USA010282, 1305USA010283). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age who on approximately 08-APR-2013 about a month ago was vaccinated with ZOSTAVAX (dose, route, application site unspecified). On approximately 01-MAY-2013 within the past week 2 patients presented to physician's office with an active case of shingles in the occipital region. The outcome of shingles in the occipital region was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified number of patients, who on unknown dates were vaccinated with improperly stored GARDASIL (doses, routes and lot # not reported). No adverse events were reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Oral pain
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 57 year old female patient with no pertinent medical history reported. On 01-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000429, expiration date 10-APR-2014) (0.65 ml, subcutaneous, anatomical location not provided). No other suspect therapies or concomitant medications were reported. Approximately on 06-MAY-2013 (reported as 7 days ago) the patient experienced mouth soreness after administration of ZOSTAVAX. The pharmacist stated the patient described the reaction and said "it felt like a cold sore, it was not visible but it was moving around her mouth" The pharmacist also stated that the patient rate the pain at 5 on a 0-10 scale. The outcome for mouth soreness was unknown at the time of the report. The patient was given treatment with unspecified "over the counter remedies". The patient did not seek medical attention. The reporting pharmacist did not assess the relatedness between ZOSTAVAX and mouth soreness. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 09-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000436, exp. 10-APR-2014, 0.65 ml, subcutaneous. In May 2013 the patient experienced "bad swelling, warm to touch and redness" of upper arm after the patient received ZOSTAVAX, at the pharmacy. The patient sought medical attention by contacting physician and was treated with BENADRYL and ice topically. At the time of reporting, the outcome was unknown. The pharmacist explained adverse event was reported to VAERS. Pharmacist requested lot checker for ZOSTAVAX (lot # J000436, exp. 10-APR-2014). This is one of the several reports from the same reporter (MARRS #1305USA009034, 1305USA008554 and 1305USA008498). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 09-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000436, exp. 10-APR-2014, 0.65 ml, subcutaneous. In May 2013 the patient experienced "bad swelling, warm to touch and redness" of upper arm after the patient received ZOSTAVAX, at the pharmacy. The patient sought medical attention by contacting physician and was treated with BENADRYL and ice topically. At the time of reporting, the outcome was unknown. The pharmacist explained adverse event was reported to VAERS. Pharmacist requested lot checker for ZOSTAVAX (lot # J000436, exp. 10-APR-2014). This is one of the several reports from the same reporter (MARRS #1305USA009034, 1305USA008554 and 1305USA008498). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On unknown dates, the patient was administered the doses of GARDASIL (lot number not reported) (dose not reported, intramuscular route). Concomitant medications were not reported. The dates of administration of GARDASIL were in accordance to the prescribing information. On an unspecified date after the completion of GARDASIL vaccination, the patient tested positive for HPV through a Pap Smear. The medical assistant was unable to identify the strain of HPV in which the unspecified patient was tested positive for. The patient did not sought medical attention. There was no treatment given for the adverse event. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: HEP, HEPA, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding an unspecified number of patients of unspecified age and gender with no pertinent medical history reported. The reporter stated that GARDASIL, RECOMBIVAX HB and VAQTA that underwent an unsupported temperature excursion were administered to an unspecified number of patients on unspecified dates (lot numbers and expiration dates not reported) (dose, frequency, and route were not reported). No patient contact details were available. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. The pharmacy student reported that on 06-MAY-2013 the patient was administered an expired dose of PNEUMOVAX23 (dose, indication route and lot number were not provided). No adverse effect reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a nurse regarding a 62 years old female patient with an unspecified cancer in remission. On 29-APR-2013 the patient was vaccinated with a ZOSTAVAX (lot number and expiration date not reported), (subcutaneous, single dose, dose not specified). No other suspect therapies were reported, no other concomitant medications were reported. The nurse reported that the patient developed blisters around the injection site after administration of ZOSTAVAX on 29-APR-2013. The blisters developed immediately after the patient left the doctor's office as she was driving to a previously scheduled office visit with her unspecified oncologist. The oncologist prescribed VALTREX. The outcome for blisters around injection site was unknown at the time of the report. No lab diagnostics studies were performed. It was reported that the patient sought medical attention by an office visit. The reporting nurse did not assess the causality between ZOSTAVAX and blisters around the injection site. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient (gender unknown). On 13-MAY-2013 the patient was vaccinated with two doses of GARDASIL (lot # H020002) (dose not reported, intramuscular route in the left arm). Concomitant therapy was not reported. The patient had not demonstrated or reported any adverse effects. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a female patient of unknown age with high blood pressure. On an unknown date the patient was vaccinated with GARDASIL (strength, formulation, lot#, dose/frequency, route and duration were unspecified). Patient developed facial numbness on the same day of the vaccination. Patient had sought medical attention via calling the office. No lab diagnostics studies were performed. The outcome of facial numbness was reported as recovered (date unspecified). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PNC
Symptoms: Chills, Urticaria
Clinical narrative: Chills. Wheal 6.75 cm x 9.5 cm diameter.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a mother patient refers to female patient of unknown age. On an unknown date the patient was vaccinated with the first and second dose of GARDASIL (dose, route and lot # not reported). The patient's mother stated that the patient received two of the three doses in the series of GARDASIL. On an unknown date the second dose was administered with "five month passed the expiration date". Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a patient's mother refers to a female patient who at the age of 15 years old in approximately 2010 was vaccinated with GARDASIL dose 1, (dose and application site unspecified) (lot and exp date unspecified). The reporter stated that at the reporting time the patient was eighteen years of age, but has only received one dose of the vaccine, and dose prescribing information. No adverse effect was reported. The patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report as received from an unknown age, female healthcare worker who is also the patient reporting on herself with no pertinent medical conditions reported. Approximately on 13-MAY-2012 (reported as about one year ago) the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported) (dose, route and anatomical location not reported). No other suspect therapies or concomitant medications were reported. On an unknown date approximately in 2012 the patient developed redness and swelling on her arm. She had the symptoms for one week and completely recovered. No treatment information was reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On 03-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000436, expiration date 10-APR-2014) (0.65 ml dose, once, subcutaneous route). Concomitant therapy was not reported. In 2013 after received the ZOSTAVAX, the patient experienced bad swelling, warm to touch and redness of upper arm. It was not known if the physician could be contacted. The patient had a treatment with ice topically and BENADRYL. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On 03-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000436, expiration date 10-APR-2014) (0.65 ml dose, once, subcutaneous route). Concomitant therapy was not reported. In 2013 after received the ZOSTAVAX, the patient experienced bad swelling, warm to touch and redness of upper arm. It was not known if the physician could be contacted. The patient had a treatment with ice topically and BENADRYL. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a consumer's mother referring to her 25 years old female daughter with no pertinent medical history or drug reactions or allergies. In April 2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies were reported, there was no concomitant medications. The reporter stated that the patient fainted within minutes of getting her first dose of GARDASIL. It was reported that the patient recovered on an unspecified date. No treatment was given for the event. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by seeing a doctor. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 71 year old male patient with diabetes, gout and no drug reactions or allergies. On 30-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as H020846, expiration date 20-FEB-2014). Concomitant therapies included LANTUS, insulin, simvastatin (manufacturer unknown) and aspirin. The physician reported that "recently", on 14-MAY-2013, the patient developed shingles, There were no lab diagnosis or studies performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Developed cellulitis around injection site started on antibiotc and cleared in 24-48 hours.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives began on (L) deltoid, became all over body by afternoon. Took antihistamine.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Herpes virus infection, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old male patient. Approximately in April 2013 the patient was vaccinated with GARDASIL (Lot # not reported) (dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. The physician reported that the patient developed a per-oral rash within 1 week of administration of GARDASIL on an unspecified date 1 month ago. The rash then spread to the patient's neck and hands. The patient was initially diagnosed with herpes by unspecified pediatrician and treated with VALTREX. The symptoms did not improve and the patient was referred for evaluation and has been prescribed an unspecified corticosteroid medication. Lab diagnostics were not performed. The outcome of the patient was initially diagnosed with herpes was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # H013949 and exp date 31-OCT-2013) subcutaneous (dose not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patient experienced developed cellulitis-like reactions after receiving ZOSTAVAX. The patient was treated by an unspecified physician by telephone. The patient received unspecified oral biotics. The outcome of developed cellulitis-like reactions after receiving ZOSTAVAX was unknown. It was reported that other two patients had cellulitis with ZOSTAVAX and was seen by a physician (MARRS 1305USA004281). This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # H013949 and exp date 31-OCT-2013) subcutaneous (dose not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patients experienced developed cellulitis-like reactions after receiving ZOSTAVAX. The patients had gone to emergency room (unspecified hospital) and were treated. The patients received unspecified oral biotics. The outcomes of developed cellulitis-like reactions after receiving ZOSTAVAX were unknown. It was reported that other patient had cellulitis with ZOSTAVAX (MARRS 1305USA010061). This is one of several reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: 0602This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On 13-MAY-2013 the patient was vaccinated with second dose of VARIVAX (merck) (lot # 0602AA, expiration date 26-APR-2013) intramuscular (dose and anatomical location unspecified). The physician assistant reported that was administered an expired dose of VARIVAX (merck) on 13-MAY-2013. The physician assistant noted that this was the second dose of VARIVAX (merck) the patient had been administered. It was not known when the first dose of VARIVAX (merck) as administered. No adverse effect reported. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot # and expiration date unspecified) injection, 0.5 ml, subcutaneous. The Registered Nurse reported that the patient had received two doses of VARIVAX (Merck) on unspecified dates, however the patient's varicella titer was 0.9 after having received the required doses of VARIVAX (Merck). Patient did not seek medical attention, treatment was not given. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 1.36
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician refers to a 16 month old healthy female patient with no allergies. On 30-APR-2013 the patient was vaccinated with a 0.5ml dose of VARIVAX (merck) (lot number unspecified) subcutaneous in the left arm. There was no concomitant medication. The patient presented to the physician office today with a rash at the injection site with red bumps that reportedly started 2 days ago, on 08-MAY-2013. The physician described the reaction as "an area of erythema at the injection site about 1 centimeter, with 3 red spots containing vesicles." There was no lab diagnostic studies performed. The patient used a cold compress for the treatment of the events. The outcome of the patient was unspecified. 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 healthcare worker refers to a female patient of unknown age. On 07-SEP-2007 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. The healthcare worker stated that the patient received the first dose of GARDASIL when she was 22 years old. The patient was in the office to see if she's eligible to receive the second dose. No adverse effect reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Information has been received from a pharmacist, for varicella virus vaccine live (Merck), a Pregnancy Registry Product, concerning a 32 year old female who on 03-OCT-2011 was vaccinated with first dose of virus vaccine live (Merck) (lot number unknown). The pharmacist reported that a female patient was approximately 3.5 weeks pregnant at the time of vaccination with varicella virus vaccine (Merck). The patient's last menstrual period (LMP) was approximately 08-SEP-2011 and estimated delivery date (EDD) would be 14-JUN-2011. The patient's pregnancy was confirmed by pregnancy test (type unspecified). At the time of reporting, the patient's pregnant gestation was 5 weeks. No adverse effect(s) reported. Pregnancy outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Age: 50.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Joint swelling, Mobility decreased, Rash
Clinical narrative: Rec'd hep A and MMR vaccine on 4/24/13. On 5/8/13 called us to c/o fading rash and (L) knee swelling. Stated knee is 2x bigger than (R) knee and that his is unable to climb stairs. Was instructed to see M.D. 5/9/13 P.C. to client. He did not go to M.D. and reports that he is all better today. Is scheduled for 2nd MMR. Told to check with PHD if he has concerns about receiving 2nd MMR. 5/8/13 was a rainy day, but pt states no hx. arthritis.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 25-APR-2013 the patient was vaccinated with M-M-R II lot # 669672/0155AA,  0.5 ml, subcutaneous. This vaccine was expired on 01-FEB-2013. The patient was not experiencing any known symptoms. No further information was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Photophobia
Clinical narrative: This spontaneous report as received from a company representative refers to a 64 year old male patient. On 10-APR-2013 (reported as approximately 4 weeks prior to report), the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number and expiry date not provided). On 10-APR-2013 (reported as within one day), 1 day after receiving the ZOSTAVAX the patient experienced sensitivity to light. The outcome of sensitivity to light was reported as recovering/resolving. The action taken with ZOSTAVAX was not applicable. The reporter did not assess the relationship of the event to ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The nurse reported that improperly stored ROTATEQ might have been administered during the month of April 2013 (exact date unspecified) to an unspecified number of patients (dose, route and lot # unknown). No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a couple of patients of unknown age and gender (anonymous, exact number of patients unspecified). On unknown dates the patients were vaccinated with a dose of ZOSTAVAX (route, concentration, and lot number unknown) for shingles vaccination. On unknown dates the patient got shingles after receiving ZOSTAVAX. The patient's didn't seek for medical attention. The outcome of shingles after receiving ZOSTAVAX was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received on a 71 year old female patient reporting on herself with no pertinent medical history and no drug reactions or allergies. On 02-FEB-2013 the patient was vaccinated by an unspecified pharmacist with ZOSTAVAX (lot number and expiration date not provided) (dose, and route were not specified) "because her doctor wanted her to get it". No other suspect therapies were reported, concomitant therapies included SYNTHROID. The patient reported that after she received ZOSTAVAX on 02-FEB-2013, half of her arm was beat red and swollen until the third week in April 2013 (approximately 15-APR-2013) and now, was still red and there was a hard knot, a giant goose egg, that hurts. The patient's present status was reported as not recovered. The patient reported she was seen by both her physician and unspecified pharmacist, however no treatment was given by either. No laboratory studies were performed. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Nodule, Oedema peripheral, Pain
Clinical narrative: This spontaneous report was received on a 71 year old female patient reporting on herself with no pertinent medical history and no drug reactions or allergies. On 02-FEB-2013 the patient was vaccinated by an unspecified pharmacist with ZOSTAVAX (lot number and expiration date not provided) (dose, and route were not specified) "because her doctor wanted her to get it". No other suspect therapies were reported, concomitant therapies included SYNTHROID. The patient reported that after she received ZOSTAVAX on 02-FEB-2013, half of her arm was beat red and swollen until the third week in April 2013 (approximately 15-APR-2013) and now, was still red and there was a hard knot, a giant goose egg, that hurts. The patient's present status was reported as not recovered. The patient reported she was seen by both her physician and unspecified pharmacist, however no treatment was given by either. No laboratory studies were performed. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. On 30-APR-2013, "7 days ago", the patient was vaccinated with ZOSTAVAX (lot # J000427, exp date 10-APR-2014). After receiving ZOSTAVAX, in approximately May 2013, the patient developed rash with watery blisters in the hair and scalp region. The outcome of rash with watery blisters in the hair and scalp region is unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Acne, Burning sensation, Erythema, Headache, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. On 30-APR-2013, "7 days ago", the patient was vaccinated with ZOSTAVAX (lot # J000427, exp date 10-APR-2014). After receiving ZOSTAVAX, in approximately May 2013, the patient developed rash with watery blisters in the hair and scalp region. The outcome of rash with watery blisters in the hair and scalp region is unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. On 30-APR-2013, "7 days ago", the patient was vaccinated with ZOSTAVAX (lot # J000427, exp date 10-APR-2014). After receiving ZOSTAVAX, in approximately May 2013, the patient developed rash with watery blisters in the hair and scalp region. The outcome of rash with watery blisters in the hair and scalp region is unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Headache, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. On 30-APR-2013, "7 days ago", the patient was vaccinated with ZOSTAVAX (lot # J000427, exp date 10-APR-2014). After receiving ZOSTAVAX, in approximately May 2013, the patient developed rash with watery blisters in the hair and scalp region. The outcome of rash with watery blisters in the hair and scalp region is unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Severe swelling. Redness. Itching. Warm to touch.