chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: This spontaneous report as received from a 60 year old female retired nurse refers to herself with no drug reactions/allergies. The patient's medical history included rosacea. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot# not reported). Concomitant therapy included METROLOTION, 80 mg aspirin and ESTHEDERM patch. Sometime during the first week or second week of October, 2013, she developed pain in an area approximately the size of a half dollar that was very sensitive, "as if was a sting from a hornet". There was no redness or evident skin involvement and the pain moved from her back to her front, involving her left breast. She had burning pain on her skin surface, with excruciating sensitivity, stabbing pain in her left breast, excruciating pain in left nipple and in the ganglion under her left armpit. She further stated she couldn't wear a bra due to extreme sensitivity. At this time, the pain had mostly diminished with occasional burning pain at the original site on her back and stinging pain in left nipple. However, there was numbness under armpit and continuing neuropathy from her nipple line to above her pubic area on her left side. Patient sought medical attention by seeing her physician for further consultation. She stated she had information that she might need to have a spinal tap done for verification of disease involvement. TYLENOL and MOTRIN was given as treatment. And there was no lab diagnostics studies performed. The reporter considered the adverse events to be disability. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered Nurse via Company representative refers to a 2 year old patient. On an unknown date, the patient was vaccinated with PNEUMOVAX23 route reported as "injection" and dose of 0.5 mL, reported as "standard dose", (lot and indication were not reported). On an unknown date the patient had a "horrible reaction" which is believed to be "cellulitis". On unknown date, the patient sought medical attention and was hospitalized for 3 days and then discharged. Therapy with PNEUMOVAX23 was continued. The outcome of had a "horrible reaction" which is believed to be "cellulitis" was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In 2013 ("several weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX vial, 0.65 ml/ once, subcutaneous for physician recommended (lot# and expire date not reported). In 2013 ("several weeks ago"), after the patient received ZOSTAVAX, she collapsed, her eyes were "flickering" and she was "totally out". The pharmacist stated a "rescue squad" was called and took the patient to an emergency room. The patient was not admitted to the hospital. No treatment was given for the adverse event. At the time of reporting, the pharmacist also stated that the patient was "ok now" but did not know the specific recovery date. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to an unspecified friend of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced shingles. The outcome of shingles was unknown. The relationship between event was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Herpes virus infection, Incomplete course of vaccination, Vulvovaginal pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers female patient of unknown age. On an unspecified date the patient was experienced vaginal pain with was diagnosed as a herpetic lesion after receiving her second dose of GARDASIL (lot# unspecified) (dose, frequency and location unspecified) on an unspecified date. The date of the first and second dose of GARDASIL were both unspecified. The patient would not receive the third dose of GARDASIL. Unspecified topical ointment was given to treat the event. The patient had sought medical attention via saw the physician. No lab diagnostic studies were performed. On an unspecified date, the patient recovered from the event. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 54 year old female patient with allergy to codeine and allergy to "sulfa drugs". The patient's medical history included chronic history of shingles recurrence. On 26-Nov-2013, the patient was vaccinated with ZOSTAVAX 19400 plaque forming unit (PFU) lot # J006158, expiration date: 30-AUG-2014 (dose and route were not reported) for preventions of shingles recurrence. Concomitant therapies included Zoloft, Zolpidem and Valtrex. On 03-DEC-2013, the patient experienced shingles again. The nurse reported that the patient was prescribed Valtrex the same day that she received ZOSTAVAX but did not know if the patient was using the medications at that time. Treatment was not given for shingles. Lab studies were not performed. The patient called her doctor's office to seek medical attention. The outcome of the patient experiencing shingles again was reported as not recovered. Causality was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a Registered Medical Assistant concerning a 63 year old female patient with hypercholesterolemia and hypertension and no drug reactions/allergies. On 05-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J004267; expiration date 12-JUL-2014), 0.5 ml, subcutaneous in the left deltoid. Concomitant therapies included Crestor and Clinoril. It was reported that a patient who received ZOSTAVAX contacted her practice to report that she began to develop a rash on her back. On 13-NOV-2013, the patient was examined by another physician, since the primary physician was not in the office, who diagnosed the patient's rash as a shingles-like vesicular rash. The physician prescribed Valacyclovir 1 gram three times a day for seven days for the patient. The reported did not know if the patient had fully recovered. The patient did not report any discomfort. No laboratory tests were performed. Patient's outcome was reported as recovering/resolving. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash, Rash vesicular, Skin lesion
Clinical narrative: Vesicular appearing rash to face and upper chest < 50 lesions.
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 injections 25/0.5 Y. On an unknown date the patient's biceps swelled a lot within one day of receiving PNEUMOVAX23 and the patient's pain was so great that she could not lift her arm. The patient sought medical attention (contacted the pharmacist). The outcome of the event was unknown. Reporter's causality was not provided. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Pt experienced (L) deltoid pain with no redness, edema, rash or fever immediately after receiving the flu shot. 3 weeks later, she remains with pain and weakness to (L) arm.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Called patients mother to let her know.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Muscle spasms, Pain, Pain in extremity, Pyrexia
Clinical narrative: Swelling, pain, fever starting the evening of 11/27/2013 after receiving the flu shot. Pain in left arm radiating down left arm. Swollen left leg and muscle spasms. Patient went to an urgent care center where an antibiotic was prescribed. Employee then saw an orthopedic surgeon who prescribed prednisone, Percocet and physical therapy.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Swelling, pain, fever starting the evening of 11/27/2013 after receiving the flu shot. Pain in left arm radiating down left arm. Swollen left leg and muscle spasms. Patient went to an urgent care center where an antibiotic was prescribed. Employee then saw an orthopedic surgeon who prescribed prednisone, Percocet and physical therapy.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness and pain started in my left thumb on 10/07. Numbness was constant and the shooting pain would come and go based on my activity level. The pain and numbness only bothered me during the daytime, never at night. By 10/10 the numbness had spread to include my whole left hand and wrist. My left hand also was very weak. The pain increased in intensity and the sharp pain was constant during waking hours on 10/10. This continued till 10/13 when the numbness started to spread up my arm to my shoudler and the shooting pains now included my elbow to my wrist. Over the next several weeks I self treated with Ibuprofen 800mg 4 times daily. The numbness, weakness and pain did subside over time. At this point I still have weakness in the left hand and still have to modify my behaviors to prevent the shooting pains.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Urticaria rash to trunk, face, neck, arms and legs began 20 hours after vaccinations were administered.  Parent spoke with physician on 12/07/2013 to report the rash.  Instructed parent to begin Benadryl 1/2 tsp every 6 hours for next 24 hours.  Spoke with parent again on 12/08/2013 and rash was still present and becoming more erythmatous.  Ordered Prednisolone 1mg/kg divided to twice a day for 3 days.  Mom has taken pictures of this reaction and will keep those to show Allergist.
Age: 34.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Diarrhoea
Clinical narrative: Explosive watery diarrhea that have since resolved.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site induration
Clinical narrative: Extreme headache, nausea, diarrhea, body aches, muscle weakness, extreme fatige, fever, chills. Pain, swelling and hardening at the injection site. Swelling at injection site larger than a golf ball.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Muscular weakness, Nausea, Pain
Clinical narrative: Extreme headache, nausea, diarrhea, body aches, muscle weakness, extreme fatige, fever, chills. Pain, swelling and hardening at the injection site. Swelling at injection site larger than a golf ball.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Extreme headache, nausea, diarrhea, body aches, muscle weakness, extreme fatige, fever, chills. Pain, swelling and hardening at the injection site. Swelling at injection site larger than a golf ball.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Iritis, Photophobia
Clinical narrative: Eye tenderness, sensitivity to light, pain with light - diagnosed as iritis - went to doctor on 12/7/2013 and again on 12/9/2013 - diagnosis of iritis and prescription of prednisolone acetate ophthalmic solution and cyclopentotlate drops.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bacterial test negative, Borrelia test negative, HIV test negative, Hypoaesthesia, Paraesthesia
Clinical narrative: 11/13/13 ED visit numbness and tingling all over.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Gastrointestinal tube insertion, Guillain-Barre syndrome, Heart rate increased, Hypoaesthesia
Clinical narrative: 11/13/13 ED visit numbness and tingling all over.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypokinesia, Immunoglobulin therapy, Intensive care, Mechanical ventilation, Nuclear magnetic resonance imaging
Clinical narrative: 11/13/13 ED visit numbness and tingling all over.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paralysis, Plasmapheresis, Pneumothorax
Clinical narrative: 11/13/13 ED visit numbness and tingling all over.
Age: 0.91
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure about 3-4 hours after immunization.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 29-NOV-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneous (lot # and expiration date were not provided). In approximately November 2013, the patient went back to pharmacy to visit the healthcare professional and showed him the hives-like rash at the injection site. Hydrocortisone was given as treatment for the adverse event. The outcome of hives-like rash at the injection site was unknown. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: DTP
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Pt calls to report generalized red rash since last Friday. Started in antecubital space of left arm and has progressed to cover bilat arms, chest and abd, back, buttocks, and lower extremities to calves. Denies throat swelling, breathing diff, or fever. States rash is red, raised, and itchy. States looks like mosquito bites. Pt states rec'd TDaP at clinic on Thurs and wonders if injection could have caused rash. Pt is not using any OTC tx.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Received vaccine 12-9-13, woke with rash covering body 12-10-13.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site rash
Clinical narrative: Red scaling rash at site of vaccine. Increased in size over 3 days and stabilized. Treatment with topical Hydrocortisone and cool compresses.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Malaise, Photophobia, Pyrexia
Clinical narrative: Severe headache, fever, photophobia, very sick.
Age: 48.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Catheterisation cardiac, Catheterisation cardiac abnormal, Chest pain, Coronary angioplasty, Intensive care
Clinical narrative: Chest pain, went to ER.  Admitted to ICU with a heart attack, on 09/20/2004 under went a heart catheterization and balloon angioplasty to open up the coronary artery.  Troponin level was elevated.  D/c 'ed from the ICU two days later.
Age: 48.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Myocardial infarction, Troponin increased
Clinical narrative: Chest pain, went to ER.  Admitted to ICU with a heart attack, on 09/20/2004 under went a heart catheterization and balloon angioplasty to open up the coronary artery.  Troponin level was elevated.  D/c 'ed from the ICU two days later.
Age: 48.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Catheterisation cardiac abnormal, Chest pain, Coronary angioplasty, Coronary artery disease, Intensive care
Clinical narrative: Chest pain, went to ER.  Admitted to ICU with a heart attack, on 09/20/2004 under went a heart catheterization and balloon angioplasty to open up the coronary artery.  Troponin level was elevated.  D/c 'ed from the ICU two days later.
Age: 49.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Catheterisation cardiac, Catheterisation cardiac abnormal, Chest pain, Coronary angioplasty, Intensive care
Clinical narrative: Chest Pain, went to ER.  Admitted to ICU,  under went a heart catheterization and balloon angioplasty to open up the coronary artery the next day.  Troponin level was elevated.  D/c 'ed fron the ICU two days later.
Age: 49.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Myocardial infarction, Troponin increased
Clinical narrative: Chest Pain, went to ER.  Admitted to ICU,  under went a heart catheterization and balloon angioplasty to open up the coronary artery the next day.  Troponin level was elevated.  D/c 'ed fron the ICU two days later.
Age: 49.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Catheterisation cardiac abnormal, Chest pain, Coronary angioplasty, Coronary artery disease, Intensive care
Clinical narrative: Chest Pain, went to ER.  Admitted to ICU,  under went a heart catheterization and balloon angioplasty to open up the coronary artery the next day.  Troponin level was elevated.  D/c 'ed fron the ICU two days later.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus
Clinical narrative: Patient states that reaction started that day at later time, itchiness, redness, etc.  However, reporting today, patient claims today she has full blown shingles, which she feels was triggered by the vaccination on 10/25/13.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site reaction, Pain, Skin lesion
Clinical narrative: Patient states that reaction started that day at later time, itchiness, redness, etc.  However, reporting today, patient claims today she has full blown shingles, which she feels was triggered by the vaccination on 10/25/13.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test abnormal, Muscle atrophy
Clinical narrative: Loss of energy, blood work decline.  Prior to shot, Blood work done for NCAA athlete.  After 2 shots of Gardasil, child became weak, no energy, loss of muscle, blood work came back horrible where blood work prior to vaccine, showed perfect athlete.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swollen tongue
Clinical narrative: PATIENT CALLED THE CLINIC AT APPROXIMATELY 2:30 TO STATE THAT HER FACE WAS RED AND HER TONGUE FELT SWOLLEN. PATIENT WAS ADVISED TO SEEK IMMEDIATE MEDICAL ATTENTION FOR EVALUATION AND TREATMENT. PATIENT WAS SEEN AND TREATED IN URGENT CARE.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Echocardiogram, Electrocardiogram, Electroencephalogram, Gaze palsy, Head injury
Clinical narrative: Pt standing with mother in hallway of office after receiving DtaP #5, IPV #4, and MMR #2. Pt had syncope episode and hit occiput on wood floor. Pt then had tightening of arms and eyes rolled back in head.  Pt carried to exam table where vitals were pulse ox 98%, HR- 93 bpm, BP- 109/64. "Seizure- like activity" lasted approximately 2 minutes and then patient opened eyes and was responsive. Pt continued to be sleepy. Sent pt to ER with mom via personal car.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Nuclear magnetic resonance imaging brain, Seizure like phenomena, Somnolence, Syncope
Clinical narrative: Pt standing with mother in hallway of office after receiving DtaP #5, IPV #4, and MMR #2. Pt had syncope episode and hit occiput on wood floor. Pt then had tightening of arms and eyes rolled back in head.  Pt carried to exam table where vitals were pulse ox 98%, HR- 93 bpm, BP- 109/64. "Seizure- like activity" lasted approximately 2 minutes and then patient opened eyes and was responsive. Pt continued to be sleepy. Sent pt to ER with mom via personal car.
Age: 20.0
Sex: M
Vaccine: TTOX
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Peripheral coldness
Clinical narrative: DONOR WAS WAITING REQUIRED 15 MIN POST IMMUNIZATION PERIOD WHEN APPEARED PALE AND DIAPHORETIC, SKIN WAS COOL TO TOUCH. DONOR HAD LOC OF APPROX 10 SECS. DONOR ASSISTED INTO RECLINING POSITION ICE PACKS APPLIED TO CHEST AND NECK, AND FEET ELEVATED. VS TAKEN PRIOR TO IMMUNIZATION, DURING REACTION AND PRIOR TO RELEASE ALL WNL. DONOR RECOVERED QUICKLY. GIVEN CRACKERS AND H2O AFTER A&O x3. TOTAL APPROX TIME OF REACTION EVENT 20 MIN FROM ONSET TO RECOVERY/RELEASE.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash to upper chest, no hives or swelling of ears or lips, no difficulty breathing.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient diagnosed with shingles outbreak on 10-16-13 when she went to the hospital.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Received MENVEO injection and PPD 12/4/13. Pt. started to complain of dizziness about 18 hours after injection. Denied cold symptoms, fever, vomiting, diarrhea. Mother felt dizziness was related to vaccine. Follow-up the next day - pt. had recovered completely.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Admin flu vaccine high dose PFS (FLUZONE) (L) U4790AA/Exp. date 30 June 14 - Lt deltoid IM on 12-9-13 at 5pm. Subject called and stated at 1230pm on 12-10-13 approx. 12 hrs post vaccination developed "localized oval" area below injection site that was slightly raised/warm to touch. Vaccinated without incident last year similar reaction 2 yrs ago. Refused medical f/u. Referred to PCP to monitor.
Age: 1.03
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Crying, Irritability
Clinical narrative: Rec'd immunizations 12/7/11. Mother notes 12-8-11 until approximately 3-1-12 increased irritability, crying and inability to be put down. She then returned to baseline - happy, playful and able to be put down as she was prior to 12/7/11.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt called and stated that MD said that she has the shingles due to vaccine. Rash on neck and face and forehead on left side.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Lethargy, Vomiting
Clinical narrative: 12/9/13 lethargy, vomiting began 15-30 minutes after vaccines given.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema
Clinical narrative: Patient reported swelling of eyes, lips and throat. She visited her primary physician and was treated with DECADRON and ALAVERT.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blood culture, C-reactive protein, Erythema, Full blood count, Injection site erythema
Clinical narrative: Multiple red blanching some slighlty thick red patches and macules all over but mostly on his trunk on extremities. He has it too on his palms and soles. No felt swelling at this time. Some patches are dark reddish on the left anterior thigh. No purpura, no petechia noted. Mother is concerned his rashes have spread. He has fever for 2 days now. He is itchy. He almost had anaphylaxis.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Macule, Pallor, Pruritus, Pyrexia, Rash
Clinical narrative: Multiple red blanching some slighlty thick red patches and macules all over but mostly on his trunk on extremities. He has it too on his palms and soles. No felt swelling at this time. Some patches are dark reddish on the left anterior thigh. No purpura, no petechia noted. Mother is concerned his rashes have spread. He has fever for 2 days now. He is itchy. He almost had anaphylaxis.
Age: 6.0
Sex: M
Vaccine: DTAP, FLUN4, HEPA
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: Localized erythema, no edema, mild firmness to right upper arm; some occasional itching symptoms began 12/8/13. Provider gave advice regarding treatment for itching and instructed to return if experiencing trouble breathing. Patient came in on 12/9/13 for a doctor visit.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swollen around the area of injection (left arm).
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3, HPV4
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 2 doses of a flu shot on the same day.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dyspnoea, Wheezing
Clinical narrative: Chest pain. Had hard time breathing, wheezing, took inhaler to help symptoms.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Passed out a few seconds. Syncope - for a few minutes --> 1 hour - patient also didn't eat breakfast that day and said had this reaction after injections before - Felt better after sitting awhile and having orange juice and peanut butter crackers.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal disorder, Pain
Clinical narrative: Seven to ten days after vaccine administration, the pt started developing musculoskeletal problems (legs and arms). Less movement = increased pain. He has started using pain meds and muscle relaxers to relieve the pain.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site rash, Muscular weakness, Paraesthesia, Rash
Clinical narrative: Numbness and prickly feeling throughout arm and hand (Rt) weakness in affected arm and hand. Mild rash around site and on abdomen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Patient presented back to the pharmacy on 12-9-13 with redness in the arm and slight swelling. Arm felt a little feverish, but only at the site of injection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage.
Age: 72.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Developed right deltoid pain and redness.  Also right head, neck, and right posterior flank band like severe sharp, burning, pain to very light touch.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: The morning after I received the flu shot, I awoke with a sore arm and shoulder and the pain became worse every day after that. I was unable to lift my arm and shoulder. I couldn't work at my cleaning job. This has continued to date.  I called the pharmacist and he suggested giving it time. It is still painful and I haven't been able to return to work...but I have had no relief to date.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No reactions occurred.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient received a ZOSTAVAX on 11/12/13. A few days later she developed shingle-like rashes on her scalp and forehead. She was treated w/ VALTREX.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Vaccine ordered by provider, took wrong vial out of fridge and gave to another nurse to administer pt. wrong vaccine given to nurse to administer.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Flushing, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Her left arm swelled > 5 inches around the site of injection and was very red. Face was flushed with fever and child for almost 24 hours. Redness still > 4 inches around site still on 12/8/13.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Pain
Clinical narrative: Patient described becoming "achy" all over and had "typical flu symptoms" over a 2 week period.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality coordinator who reported that an unspecified number of patients were administered an unspecified number of PNEUMOVAX23, from 24-SEP-2013 to 31-OCT-2013, that were exposed to temperatures as high as 55F to 126 hours and 55 minutes and as low as 29F for 188 hours which was not supported. No adverse events were reported. This is one of several reports from the same reporting source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with allergy to penicillin and Cephalosporin's and who on 26-NOV-2013, was vaccinated with a dose of ZOSTAVAX (lot # J0083808) (dose and route not reported). Concomitant therapies included Losartan potassium (manufacturer unknown), Coumadin, Hydrochlorothiazide (manufacturer unknown), Simvastatin (manufacturer unknown) and Amlodipine. The pharmacist reported that on 05-DEC-2013, the patient developed an itchy rash on her face and stomach following the administration of ZOSTAVAX. Prednisone and Benadryl were given as a treatment for the experience. No lab diagnostic studies were performed. At the time of the report, the patient was recovering. The relatedness for itchy rash on face and stomach and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality coordinator who reported that an unspecified number of patients were administered an unspecified number of doses of GARDASIL, from 24-SEP-2013 to 31-OCT-2013, that were exposed to temperatures as high as 55F for 126 hours and 55 minutes and as low as 29F for 188 hours which was not supported. No adverse events were reported. This is one of several reports from the same reporting source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a quality coordinator who reported that an unspecified number of patients were administered an unspecified number of doses of ROTATEQ, from 24-SEP-2013 to 31-OCT-2013, that were exposed to temperatures as high as 55F for 126 hours and 55 minutes and as low as 29F for 188 hours which was not supported. No adverse events were reported. This is one of several reports from the same reporting source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to a patient of unknown age and gender who 3 years ago, approximately on 2010, the patient was vaccinated with a dose of ZOSTAVAX (lot not reported). On 2010, the patient developed a rash and the worst case of shingles ever, after having ZOSTAVAX administered. The outcome of the worst cast of shingles ever and rash was unknown. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dry mouth, Dry throat, Feeling jittery, Gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 year old female patient with no pertinent medical history or drug reactions/allergies. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX in the right arm. The patient received the vaccination without prescription. Route of administration, dose number, lot number and expiry date were not reported. The product circular number was reported as uspi-v211-i-1309r017. Concomitant therapies included blood pressure medications which included Lisinopril (manufacturer unknown) and Amlodipine, and unspecified diuretic medication. On 26-JUL-2013, 5 days after onset of therapy the patient experienced dry throat, anxiety, nausea, jitteriness, abdominal agitation and dry mouth. The patient contacted her physician who did not prescribed the vaccination with ZOSTAVAX. The physician only changed the patient's blood pressure medications (nor further specified) and did not feel that these changes were related to the adverse events. The outcome of dry mouth, anxiety, jitteriness, nausea, abdominal agitation and dry throat was reported as not recovered/not resolved. This case was linked to case 1311USA011732 based on the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 year old female patient with no pertinent medical history or drug reactions/allergies. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX in the right arm. The patient received the vaccination without prescription. Route of administration, dose number, lot number and expiry date were not reported. The product circular number was reported as uspi-v211-i-1309r017. Concomitant therapies included blood pressure medications which included Lisinopril (manufacturer unknown) and Amlodipine, and unspecified diuretic medication. On 26-JUL-2013, 5 days after onset of therapy the patient experienced dry throat, anxiety, nausea, jitteriness, abdominal agitation and dry mouth. The patient contacted her physician who did not prescribed the vaccination with ZOSTAVAX. The physician only changed the patient's blood pressure medications (nor further specified) and did not feel that these changes were related to the adverse events. The outcome of dry mouth, anxiety, jitteriness, nausea, abdominal agitation and dry throat was reported as not recovered/not resolved. This case was linked to case 1311USA011732 based on the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: This spontaneous report as received from a consumer refers to her husband, a male patient of unknown age. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX. Indication, dose number, lot number, expiry date, anatomical location and route of administration were not reported. On 22-AUG-2013, reported as 1 month after the vaccination date the patient experienced genital herpes. The patient was treated with unspecified medication and recovered from the event of an unknown date. The outcome of genital herpes was reported as recovered/resolved. This case was linked to case 1311USA009500, based on the same reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender who on an unknown date, was vaccinated with 1st and 2nd dose of RECOMBIVAX HB (lot# not reported). Medical assistant additionally reported that patient has not received dose three of RECOMBIVAX HB yet, and it has been eight months. No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Pain in extremity
Clinical narrative: This spontaneous report has been received from a consumer concerning her daughter of unknown age with cardiac arrhythmia, epilepsy and sensitive to yeast. On an unknown date the patient was vaccinated with the first dose of GARDASIL, (dose, route and lot# not reported). Concomitant therapy was not reported. On an unknown date the patient experienced pain in her arm that moved down to her lower back in the base of the spine. The outcome of pain in her arm that moved down to her lower back in the base of the spine was unknown. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer reporting on herself refers to a 69 year old female with no allergies. The patient's medical history included arthritis, back pain, ear pain and breast cancer. The patient stated that at an unspecified time in the past she took ARMIDEX (Manufacturer unspecified) and it made her fell sick and caused pain in her joints. She also stated that Tamoxifen (Manufacturer unspecified) made her dizzy. On an unspecified date between May or June of 2013 MAY-2013, the patient reported that she developed shingles over her left eye a week or two after her husband received ZOSTAVAX. She believes it (shingles) was caused by touching the ZOSTAVAX injection site of her husband's arm after he received ZOSTAVAX. On 25-NOV-2013, the patient was vaccinated with ZOSTAVAX (Dose, route and lot # were not provided). Concomitant therapies included PERCOCET and Methadone Hydrochloride. In November 2013, the patient stated that she developed redness, swelling and soreness of her left arm, at the injection site after receiving ZOSTAVAX. The patient stated that she received ZOSTAVAX to prevent a second outbreak of shingles. The outcome of shingles caused by touching the injection site of her husband's arm is unknown. The outcome of redness, swelling and soreness of her left arm, at the injection site was reported as not recovered. No laboratory tests were performed. The primary reporter considered shingles to be related with ZOSTAVAX. This case is linked to 1311USA012678 (husband experience), from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of currently 60 years. Patient's medical history and drug reactions were not provided. On an unknown date the patient was vaccinated with MMR II (dose, duration and lot were not reported) for traveling out of country". Other suspect therapies included HEPATITIS A virus vaccine (manufacturer unknown), MENINGOCOCCAL vaccine (manufacturer unknown), POLIOVIRUS vaccine inactivated (manufacturer unknown) and YELLOW FEVER virus vaccine (manufacturer unknown).  On an unknown date, the patient experienced developed joint pain. The patient did not see medical attention. The outcome of developed joint pain was reported as recovering/resolving. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Ear pain, Herpes zoster, Musculoskeletal stiffness, Neck pain
Clinical narrative: This spontaneous report was received from a 64 year old female patient reporting on herself. The patient's medical history included hysterectomy about 22 years ago and acute pancreatitis due to congenital defect. On 18-SEP-2009, the patient was vaccinated with a dose of ZOSTAVAX, (Lot # reported as NDC 00649630). Concomitant therapies included estradiol, LORTAB and ADVIL. On 03-SEP-2013, the patient experienced shoulder fracture. On 08-NOV-2013, the patient woke up with a stiff neck with shooting pain up. This was followed with a rash and blister started on the 18th. She went to the doctor on 19-NOV-2013 and was diagnosed with shingles. The patient also reported that she still had blisters that keep coming out on her hairline and ear on left side of the scalp, neck and ear area. She said she was also experiencing sharp pains in her ear. The patient was treated with an antiviral medicine. An MRI was performed on 16-OCT-2013 (results nor provided). An X-Rays were performed on 02-OCT-2013, 06-NOV-2013 and 16-NOV-2013 (results nor provided). The outcome of the events (shingles and ear pain) was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Rash, Upper limb fracture, X-ray
Clinical narrative: This spontaneous report was received from a 64 year old female patient reporting on herself. The patient's medical history included hysterectomy about 22 years ago and acute pancreatitis due to congenital defect. On 18-SEP-2009, the patient was vaccinated with a dose of ZOSTAVAX, (Lot # reported as NDC 00649630). Concomitant therapies included estradiol, LORTAB and ADVIL. On 03-SEP-2013, the patient experienced shoulder fracture. On 08-NOV-2013, the patient woke up with a stiff neck with shooting pain up. This was followed with a rash and blister started on the 18th. She went to the doctor on 19-NOV-2013 and was diagnosed with shingles. The patient also reported that she still had blisters that keep coming out on her hairline and ear on left side of the scalp, neck and ear area. She said she was also experiencing sharp pains in her ear. The patient was treated with an antiviral medicine. An MRI was performed on 16-OCT-2013 (results nor provided). An X-Rays were performed on 02-OCT-2013, 06-NOV-2013 and 16-NOV-2013 (results nor provided). The outcome of the events (shingles and ear pain) was reported as not recovered/not resolved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Hypersensitivity, Underdose
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 69 year old patient of unknown gender, no obese. On 01-NOV-2013, the pharmacist administered ZOSTAVAX (lot # H016230; exp. Date: 30-NOV-2013) 0.65 ml, subcutaneous for shingles prevention to the patient, using 5/8 inch needle at 45 degree angle and contents "came streaming down patient's arm" resulting in less than full dose received. Patient received an unspecified flu shot "not long ago without any incident". At the time of the report, the patient was "doing fine". Follow up information as received from the pharmacist refers to the male patient who was a teacher. The patient was vaccinated with the first dose ZOSTAVAX at the arm at 10:00 AM on 01-NOV-2013. It was reported that part of dose ran down arm. (The patient) contact doctor and was told to revaccinate in 2 days. The patient developed an allergic reaction in 24 hours and revaccination was canceled. The patient did not require emergency room/doctor visit. The outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. The patient did not have any drug reactions/allergies. On 12-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneous (lot # J006828, expiry date 14-SEP-2014). No concomitant medications were reported. The pharmacist reported that after being administered ZOSTAVAX, the patient developed redness at the injections site on an unspecified date in November 2013. The patient was still having this redness at the injections site at the time of reporting. No lab tests were performed. The patient sought medical attention by calling the pharmacist. Reporter causality was not provided. No patient contact details were available. No further information was provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a 61 year old female consumer reporting on herself. Current condition included hypothyroidism. On 03-DEC-2013 9also reported as a couple of days ago) the patient was vaccinated with ZOSTAVAX, 1 dose in the left arm for prevention of shingles (route and dose number unspecified). Concomitant therapies included Synthyroid and hormones (unspecified). On 03-DEC-2013, (also reported as yesterday), when the patient woke up noticed a rash, pain, tenderness and feeling a knot at the injections site. The redness at the site of the injections is approximately 2' by 2' in the left arm. The patient outcome was unknown. The patient did not seek medical attention and lab test were not performed. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2013US083983 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 490590) website on 06 Aug 2013 and a follow up received from Quality Assurance Department (reference number: 245455) on 29 Nov 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12011 and expiry date: Feb 2014) intramuscularly into left deltoid and BOOSTRIX (batch number: AC52B089AA, other manufacturer) intramuscularly into left deltoid on 27 Mar 2013. On 28 Mar 2013, 24 hours after vaccination, he developed slight cellulitis in the application site of MENVEO. He was told to do cold compresses at the MENVEO site and to take BENADRYL. He had no fever. The site was marked with pen and he was told to meet a physician if the size of site is getting bigger. His mother understood the plan. The outcome of event was reported as recovered as of unspecified date. No seriousness and causality was provided for the event. Based on the investigation performed, the QA department stated that, the MENVEO vaccine (batch number: M12011) was manufactured in accordance with the approved internal procedure and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 245455) on 29 Nov 2013: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Application site cellulitis
Clinical narrative: Case number PHHY2013US083983 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 490590) website on 06 Aug 2013 and a follow up received from Quality Assurance Department (reference number: 245455) on 29 Nov 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12011 and expiry date: Feb 2014) intramuscularly into left deltoid and BOOSTRIX (batch number: AC52B089AA, other manufacturer) intramuscularly into left deltoid on 27 Mar 2013. On 28 Mar 2013, 24 hours after vaccination, he developed slight cellulitis in the application site of MENVEO. He was told to do cold compresses at the MENVEO site and to take BENADRYL. He had no fever. The site was marked with pen and he was told to meet a physician if the size of site is getting bigger. His mother understood the plan. The outcome of event was reported as recovered as of unspecified date. No seriousness and causality was provided for the event. Based on the investigation performed, the QA department stated that, the MENVEO vaccine (batch number: M12011) was manufactured in accordance with the approved internal procedure and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 245455) on 29 Nov 2013: Updated batch review report.
Age: 18.0
Sex: M
Vaccine: HPV4, MMR, MNQ, HPV4, MMR, MNQ
Symptoms: Hyperhidrosis, Vision blurred
Clinical narrative: Case number PHHY2013US127758 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498321) website on 11 Nov 2013, with a follow up received from the QA department (264315) on 15 Nov 2013, with a follow up received from the QA department on 29 Nov 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M11077) intramuscularly, GARDASIL (other manufacturer, batch number: H014645) intramuscularly and MMR II (other manufacturer, batch number: H010134) subcutaneously on 29 Jul 2013. On the same day, after vaccination, he became diaphoretic and developed dizziness and blurred vision. And his blood pressure was reported as 74/42 at 10:53 am, 84/44 at 10:58 am and 110/54 at 11:03 am. It was reported that this was atypical reaction for this patient. Outcome of the events was reported as recovered on the same day. Seriousness and causality were not reported for the events. Based on the batch review, it was stated that the concerned MENVEO batch number M11077 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the QA department on 15 Nov 2013: Updated QA reference number (264315) only. Significant follow up received from the QA department on 29 Nov 2013: Updated batch report.