chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Chills, Depressed level of consciousness, Dizziness, Pyrexia
Clinical narrative: Client reports that a few hours after receiving the Typhoid vaccine she started to feel dizzy and like she was going to "pass out". She also reports feeling feverish with chills. Client reports that she stayed at a store for over 2 hours because she felt too dizzy and weak to walk to her car. Client did not know if she was running a fever because she did not have a thermometer available to check her temp.
Age: 63.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Blood glucose normal, Disorientation, Feeling abnormal, Hyperhidrosis
Clinical narrative: Pt awoke feeling disoriented and sweating profusely. Pt checked blood glucose levels which were within normal limits. Pt states feeling "in a fog" throughout the day. Pt states all symptoms were gone the next day.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Decreased appetite, Dizziness, Headache
Clinical narrative: Pt stated approx. 12 hours after receiving the Hep A vac, she experienced dizziness.  Also, approx. 2 hours after injection, pt had a lack of appetite. Nov 12, Pt stated she only has a mild headache.  Denied any localized reaction at site.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Rash, Renal pain
Clinical narrative: Pain in left kidney area that did not intensify or diminish after onset. After two days pain traveled in a band around to the left abdomen region. Rash developed on abdomen on seventh day. Doctor visit. Prescribed anti-viral 5x/day for one week. After one week proscribed second type of anti-viral 3x/day for one week. By this date (11/20/2015) pain has subsided, rash is gone. Pain was never very intense (2 out of 10).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Swelling
Clinical narrative: Pain, swelling, rash about 3 1/2 inches in diameter.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Adverse reaction
Clinical narrative: Vaccinated on August 21, 2015. Symptoms began on Sat. AM, September 19, 2015.
Age: 24.0
Sex: F
Vaccine: FLU3, HEPA, HPV9
Symptoms: Erythema, Injection site erythema, Oral pruritus, Pain in extremity, Throat tightness
Clinical narrative: 1:45 pm pt. received DEPO, HepA, GARDASIL and flu - five minutes later (R) arm was red around injection site. Pt. reported throat feeling like it was closing up. 1:51 pm - administered BENADRYL 25mg po. 2:00 pm - (L) arm started turning red where flu was given. Pt. started c/o mouth itching also redness noted at (R) breast. BENADRYL administered 25mg po again. 2:10 pm - c/o hands itching and hurting, states throat feels it is slowly opening. 2:14 pm - redness resolved (L) arm and redness at (R) breast slowly resolving, redness red arm decreasing. 2:25 pm states hands no longer itching, states throat completely open now. 2:50 pm states hands no longer hurting, throat remains open redness all areas resolved. 3 pm pt. remains stable. 3:15 pm - pt remains stable. Pt. instructed to call MD if any further problems noted and to call 911 if throat starts closing up or has difficulty breathing. Pt voiced understanding. 4:05 pm pt. discharged in stable condition with no further complaints with ride. Vital signs were checked after 15 minutes and were WNL and at no time was pt. in respiratory distress.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient states "the issue is in my shoulder, the pain started the evening of the shot and has been relatively persistent since then. Pain comes when I lift my elbow horizontally, and is worst when my arm is inactive. Moving my arm at all hurts when waking up."
Age: 17.0
Sex: M
Vaccine: YF
Symptoms: Rash pruritic, Swelling
Clinical narrative: 4 days later broke out in itchy rash and raised areas. Took Benadryl and got relief and sleep. Called me this morning at 11:45 a.m. Recommended see MD. Benadryl most likely not strong enough to neutralize out reaction.
Age: 31.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Patient called and said she had a rash on her stomach. She talked with her doctor who was very upset she got the vaccine. He is treating her with antibiotics and plans to admit her to the hospital for observation and to give her Varizig.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient developed swollen, warm, reddened area about 10 minutes after vaccines given.  Advised mom to apply warm compress and monitor as well as give pt pain relief med once they get home.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: Patient was injected an expired vaccine.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient was injected an expired vaccine.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia, Rhinorrhoea, Sleep disorder
Clinical narrative: MUSCLE PAIN, RUNNY NOSE, LOW GRADE FEVER.  MUSCLE PAIN INTERFERED WITH SLEEP.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation at injection site.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called the pharmacy to inform that since she received the shot she has experienced an ongoing pain on her arm. This has been going on for 2+ months. There is no redness or nodules. No other symptoms except for pain.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Oral pain, Pyrexia, Rash generalised, Stomatitis, Streptococcus test
Clinical narrative: Vomiting and fever on 11/15.  11/18 mouth hurting and sores in mouth.  11/19 rash all over. Saw MD.  Tested for strep.  R/O Hand/foot/mouth disease.  Not sure if a reaction to shots or not.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting and fever on 11/15.  11/18 mouth hurting and sores in mouth.  11/19 rash all over. Saw MD.  Tested for strep.  R/O Hand/foot/mouth disease.  Not sure if a reaction to shots or not.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC, FLU3
Symptoms: Cough
Clinical narrative: PT REPORTS OF MILD COUGH BEFORE THE IMMUNIZATION. PT REPORTS OF VERY SERIOUS COUGH THAT STARTED ABOUT 3 HOURS AFTER THE VACCINE WAS ADMINISTERED AND LASTED THOROUGHOUT EVENING. PT REPORTS COUGH SUBSIDED AFTER 3 TO 4 DAYS.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash erythematous, Swelling
Clinical narrative: Child was noted to have red raised rash, with patches of white swollen areas on abdomen, legs and back. Mom gave child Certizine medication and with in 1 to 2 hrs rash had mostly resolved.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild case of shingles.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Patient came in with a rash that was approximately 3"x3". Patient stated that the rash was itchy. Pharmacist on duty informed patient to take liquid Benadryl and call MD regardless if it improved or not.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Muscle swelling, Skin warm, Tenderness
Clinical narrative: Swollen muscle, warm to touch, tenderness, hard area (2") at injection site, slight erythema. Using ice packs and seems to be resolving.
Age: 67.0
Sex: F
Vaccine: DTOX, UNK
Symptoms: Headache
Clinical narrative: Headache.
Age: 49.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Fever of 102, swelling and redness around injection site, nausea.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt came in on 11/20/15 and said that the day after he got the vaccine he had signs/symptoms of shingles so went to MD.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Guillain-Barre syndrome, Intensive care
Clinical narrative: General weakness, unable to walk in ICU Dx Guillain-Barre syndrome.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Excessive eye blinking, Tic
Clinical narrative: 3 days after taking FLU MIST he developed facial tics and excessive blinking. Sx seemed to be improving as of 11/20/15.
Age: 4.0
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever to 104 day of vaccines lasted 2 days. Redness, swelling, pain at site.
Age: 63.0
Sex: U
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Severe arm pain body aches.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Patient reported. Reaction to PREVNAR. Arm got itchy and then upper arm got red.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Rash pruritic
Clinical narrative: Pt thinks he developed a rash after receiving yellow fever vaccine approx 3 weeks ago. Not sure, but he might have had the rash before this shot. Rash is more notable on tops of feet, knees, and right hip. Rash is itchy. Denies fever, cough nose bleeds. Cream 0.05% applied to affected areas bid given topical.
Age: 4.0
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Antibody test negative, Streptococcus test, VIIth nerve paralysis
Clinical narrative: 11-15-15 right facial droop dx with Bell's palsy. Started on amox and steroids pending Lyme titer. Titer negative abx stopped.
Age: 76.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Shingles outbreak in area of vaccine starting about 1 week after vaccine, tx with acyclovir. Also had outbreak on back.
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Diarrhoea, Dysuria, Lip swelling, Peripheral swelling, Swelling face
Clinical narrative: Wed. 11-18-15 mom noticed nasal passages and area above lips swollen. Mom gave multi-symptom cold/flu with antihistamine med. Thurs 11-19-15 more swelling of lips and (R) side of face. Taken to hospital. Given BENADRYL 2.5 ml (6.25 mg). Fri. 11-20-15 to see local medical provider. Both sides face swollen "puffy" and hands. Given BENADRYL again. No cough, no temp. Did have diarrhea. C/o painful urination.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Generalised erythema, Pyrexia, Rash erythematous
Clinical narrative: Generalized erythema rash with low grade fever. Symptomatic management of low grade fever and reassure parents.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Flushing, Immediate post-injection reaction
Clinical narrative: Patient reported to RN that she felt lightheadedness and flushed immediately after receiving the injection. Patient denied any wheezing or SOB. Administered BENADRYL 25mg (1 dose) prophylactically. Patient's symptoms were completely gone 30 min after injection.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: Fever, body aches, swelling around injeciton site, malaise.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swollen site of injection.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Vomiting, Wrong drug administered
Clinical narrative: Fever 101.9 and vomiting. DTaP (INFANRIX) given to a 11 y/o instead of Tdap.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever and fussy couple hours after admin.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site redness, warmth, and itching. Symptomatic treatment with antihistamine and cool compass.
Age: 9.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: C-reactive protein increased, Cellulitis, Nuclear magnetic resonance imaging abnormal, White blood cell count normal
Clinical narrative: Cellulitis of left arm seen at ER on 11-08-15 had MRI of left upper extremity, blood work, meds cetirizine, clindamycin, cefdinir.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Reported to our facility that was admitted to Hospital approximately 3 wks ago for Guillain Barre. Transferred this week to another hospital.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Red, hot, bump on right upper arm soreness upon use.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash
Clinical narrative: 11-11-15 - stated getting sore. 11-13-15 - rash developed. 11-16-15 - rash size of upper deltoid area - patient medicating w/OTC BENADRYL. 11-20-15 - redness and rash gone - patient.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient was given second flu shot (AFLURIA) instead of PNEUMOVAX. No adverse event - reporting for documentation.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Fatigue, Syncope
Clinical narrative: Syncope the day after vaccine. She has episodes of fatigue, dizziness starting after the first vaccine GARDASIL 5/15. Previously healthy.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Headache, Hypoaesthesia, Laboratory test normal, Muscular weakness
Clinical narrative: Low grade headache and nausea started shortly after the vaccine administration. On 11/12, started to have bright flashing vision and numbness in right knee with leg weakness. Also experienced twitching of eye muscles and odd sensation in right forearm. Father and sister also got flu shot at same time with no issue.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Photopsia
Clinical narrative: Low grade headache and nausea started shortly after the vaccine administration. On 11/12, started to have bright flashing vision and numbness in right knee with leg weakness. Also experienced twitching of eye muscles and odd sensation in right forearm. Father and sister also got flu shot at same time with no issue.
Age: 31.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site induration
Clinical narrative: Patient called our clinic requesting information about the vaccines she was given at our clinic. She said she'd had BOTOX injections and they hardened. She went to her dermatologist who told her she shouldn't have had the BOTOX and vaccines - that the package inserts stated this contraindication. Our research has not found this information. We have no other information. we have not been able to reach this patient. 3 attempts were made.
Age: 3.0
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Induration, Injection site erythema, Injection site reaction, Injection site swelling, Mass
Clinical narrative: PREVNAR 13 - reaction on right thigh - local 50 cent piece size red, swollen, blotchy, no systemic reaction noted. Mother noticed hard lump next day but recommended ice/heat, ADVIL age appropriate.
Age: 3.0
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Rash macular
Clinical narrative: PREVNAR 13 - reaction on right thigh - local 50 cent piece size red, swollen, blotchy, no systemic reaction noted. Mother noticed hard lump next day but recommended ice/heat, ADVIL age appropriate.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. On 21-SEP-2015, the patient was vaccinated with one improperly stored dose of GARDASIL 9 (lot # L016428, expiration date 04-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored GARDASIL injection, lot # K010215; expiry: 05-MAY-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No symptoms reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. In 2012 the patient was vaccinated with the first dose of RECOMBIVAX HB injection "10 Y" (strength, dose, route, lot# and expiration date not reported). Then the second dose (strength, dose, route, lot# and expiration date not reported) was administered on an unknown date in September 2015 for the same indication. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-NOV-2015 (today), the patient was inadvertently administered a dose of ZOSTAVAX lot # L003217 and expiry date of 30-APR-2015 (unknown route and dose) instead of the intended dose of VARIVAX (Merck). No adverse effects were reported. No product confusion was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, he patients were vaccinated with improperly stored doses of VAQTA 50/1.0 U/ML injection (lot # L018499, expiration 23-SEP-2016; lot # L028666, expiration 20-OCT-2016 and reported lot # K023529, expiration date 04-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to a 15 years old female patient. Pertinent medical history and drug reactions/allergies were not reported. The patient received the first dose in the series of three of GARDASIL (0.5 ml, intramuscularly, lot# and expiration date were not reported) on an unspecified date in July 2015 and received a second dose on an unspecified date in October 2015 and then the third dose 1 month later, on an unspecified date in November 2015 (inappropriate schedule of drug administration). Concomitant drug was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 30-JUL-2015 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, lot# and expiration date were not reported). The second and third doses were vaccinated on 02-OCT-2015 and 18-NOV-2015 respectively (strength, dose, route, lot# and expiration date were not reported) for the same indication. No adverse effect was reported for the patient. This is one of two reports received from the same reporter. Additional information is not expected as the physician is not allowed to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date patient was vaccinated with GARDASIL (strength, dose, route, lot# and expiration date were not reported). On an unknown date the patient experienced an unspecified reaction following administration of GARDASIL. Outcome of the event was unknown. Causality assessment was not reported. This is one of two reports received from the same reporter. Additional information is not expected as the physician is not allowed to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the unspecified number of patients were vaccinated with oral, ROTATEQ, Lot # K017576, expiration date 12-JUN-2016 (dose number, strength, dose were not reported). It was reported that suspect vaccine had been given in immunization series and had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. On 25-SEP-2015, the patient was vaccinated with one improperly stored dose of GARDASIL 9 (lot # L014415, expiration date 21-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L010595, expiration date 10-SEP-2016, dose and route unknown). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Nausea, Poor quality sleep
Clinical narrative: Information has been received from a 62 years old female patient referring to herself. Pertinent medical history and drug reactions/allergies were not reported. On 17-NOV-2015 the patient was vaccinated with 1 injection of ZOSTAVAX (dose, route, lot# and expiration date were not reported) in the left arm for prevention of shingles. Concomitant drug was not reported. After she received the vaccination, the patient felt really weak and did not sleep well on an unknown date in November 2015. In the morning of 18-NOV-2015, the patient was feeling nausea but it was easing up. Outcome of the events of feeling weak and not sleeping well was not reported. The causality was not reported. Additional information is not expected as there was no contact information.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal chest pain, Rash
Clinical narrative: Pain/discomfort started 11/14/15 in back/rib cage. Rash started to appear on back/front 11/18/15. Patient was started on valacyclovir 1 gm on 11/19/15 Q 8 hours x 7 days.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Information has been received from a male consumer of unknown age referring to himself. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 10-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX (frequency reported as one time vaccine; lot # and dose unspecified). on the same day, the patient's arm was hurt after getting vaccine for 2-3 hours where the vaccine was given. The outcome of the event was unknown. The causality of the event and ZOSTAVAX was not provided. Additional information is not expected as contact details were not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 50 year old female patient with diabetes, hypertension, hypercholesterolaemia and cardiac stents. The patient had no allergies and no drug reactions. On 03-NOV-2015, the patient was vaccinated with a single dose of ZOSTAVAX injection, subcutaneously in the left arm, lot # L021612, expiration date: 10-SEP-2016 (exact dose was not reported). On 06-NOV-2015, the patient developed blisters at the injection site. The patient sought medical attention- she came to pharmacy. The outcome of blisters at the injection site was reported as not recovered. The relatedness between the vent of blisters at the injection site and ZOSTAVAX was not reported. Additional information is not expected, because the reporter refused additional contact.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 18-NOV-2015 the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (lot # J013904 with expiration date 30-OCT-2015; strength, dosage and route unspecified). No adverse effects were reported. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site nodule, Injection site pain, Pain
Clinical narrative: 3-4 inch red circle surrounding small knot on upper arm around injection site - painful to touch and move arm - MD diagnosed with shingles. Vaccine given 3 wks prior.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 16-OCT-2014, the patient was vaccinated with ZOSTAVAX (lot number and expiration date were not available to the pharmacist at this time, strength, dosage and frequency unspecified). On 13-NOV-2015 the patient was vaccinated with ZOSTAVAX (lot # L028281 with expiration date of October 2016; strength and dosage unspecified) (extra dose administered). The patient had not reported an adverse experience. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the unspecified patients were vaccinated with (Oka-Merck) PROQUAD lot # K011314, expiration date 14-FEB-2016 and lot # L006390, expiration date 25-AUG-2016 (total of 9 doses, number of each lot administered were not specified) (dose, strength, route of administration were not reported). It was reported that suspect vaccine had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) upper arm sore, red, swollen. No temp change. Improving slowly with ice and steroid taper.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm, red, sore, temp increase and swollen. Size at evaluation 3 x 4". Improving in all aspects.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Severe headache, fever 102 per mom, chills, relief from MOTRIN.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Local erythema.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Blood pressure increased, Cellulitis, Erythema, Injection site inflammation, Injection site warmth
Clinical narrative: C/O swelling - redness after injection. Increased BP. Pain (L) deltoid. Went to ER - dx with BENADRYL 11/19/15. 11/20 - more inflammation to site - very hot to touch 4.5 x 4.5. T = 99.8. Seen in ER - ? cellulitis Sent home.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: C/O swelling - redness after injection. Increased BP. Pain (L) deltoid. Went to ER - dx with BENADRYL 11/19/15. 11/20 - more inflammation to site - very hot to touch 4.5 x 4.5. T = 99.8. Seen in ER - ? cellulitis Sent home.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash
Clinical narrative: Rash on trunk/upper extremities/lower extremities 24-36 hours after vaccination.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 47-year-old female patient who received BOOSTRIX (batch number KP95K, expiry date 3rd December 2017). On 9th November 2015, the patient received BOOSTRIX .5 ml. On 10th November 2015, 1 days after receiving BOOSTRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to BOOSTRIX. Additional details were received as follows: On 10th November 2015, the patient was feverish. The patient experienced fever of 101 degree F and then it was increased to 103 degrees F. The patient has been experiencing fever for a week after vaccination.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Administration site pain, Joint range of motion decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Sore arm, cannot rotate arm above head. Described as a "dead arm". States she seeing MD soon to check it out.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm, cannot rotate arm above head. Described as a "dead arm". States she seeing MD soon to check it out.
Age: 1.08
Sex: F
Vaccine: FLUX, MMR, PPV, VARCEL
Symptoms: Fatigue, Pyrexia, Rash erythematous
Clinical narrative: Red spots were first seen on the back of the neck at collar level. Upon closer inspection, red spots were noted all over trunk area including: back and chest areas. At the time rash was first noticed, rash spots were only on trunk, extremities appeared clear of spots. Child had slight fever earlier in the morning, but I did not take a temperature. As of current reporting date and time, 12:49 AM on 11-21-2015, child has red spots, rash, on tops of feet, hands, even on the palms, torso, legs, neck, back, scalp, face, ears, but very few on calves and shins, and none on the bottom of her feet. The areas of concentration, or large number of spots are the chest, back, neck, and face. No medication has been given as child appears to not be in pain or uncomfortable, just slightly more tired than usual.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local reaction/erythema at injection site.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Malaise, Pyrexia, Tremor
Clinical narrative: GENERALIZED FEVER AND MALAISE ESCALATED RAPIDLY TO 104.5-104.9 FEVER. PROFUSE SHAKING, SHORTNESS OF BREATH, DIZZINESS. ATTEMPTED HOSPITALIZATION BY VISITING ER THAT COULD NOT SEE ME FOR HOURS. I RETURNED HOME WITHOUT SEEING ANY MD. I  SUBMERGED MY HEAD IN COLD WATER IN ATTEMPT TO PREVENT NEUROLOGICAL AND TISSUE DAMAGE DUE TO DANGEROUSLY HIGH TEMPERATURE.  1000MG OF TYLENOL & 800MG IBUPROFEN TAKEN Q6-8H.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Severe neck and left shoulder pain radiating into the area of the injection site on left arm.  Neck stiffness. Being treated with OTC pan medication currently.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pain redness itching lump and heat at and 1/4" around injection site. Each day since the lump redness and itching area has expanded. Currently encompasses a 3-4 inch area at and around site. Itching currently not as severe but involves a larger area and is not constant.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in shoulder and upper arm. Pain gradually increased over the following week, making sleep and simple daily tasks difficult. Pain has worsened to extreme levels....must take Tylenol everyday. Shoulder pain seems to be the worst in the morning.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: DIZZINESS.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: Fever, chills, aches, dizziness, weakness, headache, no appetite. Took Tylenol and Advil.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, chills, aches, dizziness, weakness, headache, no appetite. Took Tylenol and Advil.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia
Clinical narrative: Patient report trouble swallowing about 20 minutes after vaccine.  Patient was given 50mg of oral Benadryl and observed for further complications.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pain, Injection site rash
Clinical narrative: Patient is experiencing a rash the size of a bandaid at the injection site.  The area is irritating, small rash like appearance and a bit painful.  It has not spread, gotten bigger, or worsened since it was noticed.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Patient stated on the evening of 11/19/2015 that her arm felt sore and came back to the pharmacy on 11/21/2015 at 3 PM with pain, redness, and swelling at the injection site. Counseled the patient to take ibuprofen, Benadryl, and to ice the area and to call her physician.  Also advised the patient to seek urgent care if symptoms worsen.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe swelling, erythema and tenderness from LEFT deltoid to below LEFT elbow. Treated with Prednisone 10 mg po daily x 5 days; Doxycycline 100 mg po BID x 10 days. Cool/ice packs, and rechecks.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: Rash right upper arm. No fever. Rash faded over 14 days. Took prescribed.  Cephalexin 500 mg capsules to prevent cellulitis.
Age: 82.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Per Pt's daughter, He started experiencing a sharp pain in his left arm preventing motion from side to side and raising above head. Pt did not sleep last night and taking a Norco did not help with the pain.  Pain is a 5/10.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site nodule, Injection site swelling, Peripheral swelling
Clinical narrative: Patient experienced swelling at the injection site 24 hours after the Zostavax vaccination. There was a hard nodule at the injection site that has alrady gone away. There was no fever. His arm was significantly swollen and red. He applied hydrocortisone to the rash for relief. He is going to see is PCP on Tuesday for evaluation.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Had shingles, flu and pneumonia vaccines. That afternoon got a massive headache, 101 temperature, chills, aches, vomiting cannot keep water down for two days. Next day. Headache and sight of injection the arm went into spasms and sharp pains. Next day: Skin is stinging on face and have very sore throat. Today: Still have stinging but moved to top of my head. Painful to touch. Developed a blister on lip with what appeared to be a puslike substance in middle. (I have never had cold sores before). Very exhausted still. Have read on line some people having same reaction as me.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site reaction, Lip blister, Muscle spasms, Oropharyngeal pain, Pain
Clinical narrative: Had shingles, flu and pneumonia vaccines. That afternoon got a massive headache, 101 temperature, chills, aches, vomiting cannot keep water down for two days. Next day. Headache and sight of injection the arm went into spasms and sharp pains. Next day: Skin is stinging on face and have very sore throat. Today: Still have stinging but moved to top of my head. Painful to touch. Developed a blister on lip with what appeared to be a puslike substance in middle. (I have never had cold sores before). Very exhausted still. Have read on line some people having same reaction as me.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Pain of skin, Tenderness, Vomiting
Clinical narrative: Had shingles, flu and pneumonia vaccines. That afternoon got a massive headache, 101 temperature, chills, aches, vomiting cannot keep water down for two days. Next day. Headache and sight of injection the arm went into spasms and sharp pains. Next day: Skin is stinging on face and have very sore throat. Today: Still have stinging but moved to top of my head. Painful to touch. Developed a blister on lip with what appeared to be a puslike substance in middle. (I have never had cold sores before). Very exhausted still. Have read on line some people having same reaction as me.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: I have excruciating pain in the arm that the flu shot was given. I have almost no range of motion and am unable to do everyday activities. For example getting dressed & undressed, driving, carrying groceries, picking up my nieces and nephews and the list goes on. I have tried taking otc pain relievers, heat/cold compresses, tiger balm patches, massages nothing is helping me out for more than 30 minutes to a hour. At night I wake up in tears because the pain is so unbearable. I am wondering what went wrong with this years flu shot to cause so many people to have this issue with shoulder pain and how long will we have to live with it??
Age: 28.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Tendonitis
Clinical narrative: Patient was diagnosed by primary care and specialist w/rotator cuff tendonitis - was told to ice, rest and take anti-inflammatory.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site mass
Clinical narrative: Inflammation/lump formation at the site of injection at the deltoid region of left upper arm. No discomfort.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Dizziness, Headache, Phonophobia, Somnolence, Syncope
Clinical narrative: Pt. fainted within 5-8 minutes of IM vaccinations. Since that date he has complained most days of headaches, lightheadedness, dizziness phonophobia and needing to sleep more. Symptoms do not occur during exercise.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient developed a large red rash (approximately 10 1/2 inches x 5 1/2 inches) the day after administration of the vaccine. It was red and warm, but patient reported no pain. Her doctors office told he to take BENADRYL for a couple of days. Patient reported to me that she forgot to take the medication, but the rash healed. She was seen by her physician's nurse for routine testing of INR for her warfarin when she reported the rah. The nurse notified me and requested that I fill-out this form.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site swelling, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 4-6" swelling around injection site with bumpy appearance - Resolved after antibiotic treatment from approx. day 4-5 to 11-12. Record from urgent care requested. 11/215 Returned for VAR #2, reports she had a "staph infection" from last dose. Per pt grandmother, pt's arm was red, hot, swollen and painful. She was "put on something for 203 weeks". Grandmother and patient did not known the name of the medication. Patient grandmother reports this was confirmed by urgent care via a "test", though she does not know which one nor which provider was seen. Recommended that parents of patient contact provider and get clearance for second VAR; then update public health. No vaccinations given today. 11/4/2015 Mother called r/t July reaction to varicella. States daughter had swelling that started same day as vaccination but got bigger and more painful a few days later. No fever but hot, painful and swollen, and "skin had bumps under swelling" 4 x 6 inches at the largest. Treated daughter with TYLENOL and BENADRYL by self. Took daughter to urgent care plus 4-5 days post vaccination and was told she had a "staff infection". No testing was done. UC told mom to tell us to use the "orange cleaner" instead of alcohol swabs. Daughter was put on antibiotic (she can't remember name) and 2-3 days later started resolving. Mom states she needs 2nd dose for school. Child has no healthcare provide. Referred to pediatricians to establish care, to discuss enrolling in an insurance plan. I advised mom I'd file a VAERS, copy to her. Called employee at school and left message to offer a conditional attendance form until ascertained what kind of a reaction this was.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Staphylococcal infection
Clinical narrative: 4-6" swelling around injection site with bumpy appearance - Resolved after antibiotic treatment from approx. day 4-5 to 11-12. Record from urgent care requested. 11/215 Returned for VAR #2, reports she had a "staph infection" from last dose. Per pt grandmother, pt's arm was red, hot, swollen and painful. She was "put on something for 203 weeks". Grandmother and patient did not known the name of the medication. Patient grandmother reports this was confirmed by urgent care via a "test", though she does not know which one nor which provider was seen. Recommended that parents of patient contact provider and get clearance for second VAR; then update public health. No vaccinations given today. 11/4/2015 Mother called r/t July reaction to varicella. States daughter had swelling that started same day as vaccination but got bigger and more painful a few days later. No fever but hot, painful and swollen, and "skin had bumps under swelling" 4 x 6 inches at the largest. Treated daughter with TYLENOL and BENADRYL by self. Took daughter to urgent care plus 4-5 days post vaccination and was told she had a "staff infection". No testing was done. UC told mom to tell us to use the "orange cleaner" instead of alcohol swabs. Daughter was put on antibiotic (she can't remember name) and 2-3 days later started resolving. Mom states she needs 2nd dose for school. Child has no healthcare provide. Referred to pediatricians to establish care, to discuss enrolling in an insurance plan. I advised mom I'd file a VAERS, copy to her. Called employee at school and left message to offer a conditional attendance form until ascertained what kind of a reaction this was.
Age: 43.0
Sex: M
Vaccine: RAB
Symptoms: Blood pressure increased, Coronary artery disease, Headache, Hypertensive crisis
Clinical narrative: I was bitten by a bat on 7/29/2015 and received my first RABAVERT injection on that dates. Shortly after receiving the injection, my blood pressure began to spike. I received my second injection on 8/1/2015 and pressures climbed higher leading to headaches and when my blood pressure rose into the hypertensive crisis range, I was hospitalized until my BP were stabilized. My blood pressure returned to its' normal range about a week and a half after receiving my final injection on 8/12/2015. I have a very small right coronary artery and resulting mild hypertension (treated) which may have contributed to the reaction.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Aggression, Crying, Depression, Pyrexia
Clinical narrative: Uncontrollable Crying; Depression; Aggression and Physical Outbursts; Fever 105; Lasted for 2 weeks.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Cognitive disorder, Dyskinesia, Influenza A virus test negative, Influenza virus test negative
Clinical narrative: Fever 105; Pale Skin; Chills; Rocking Back and forth; Staring off into Space; Shaking of hands and body; cognitively "not with it"; Vomiting.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pallor, Pyrexia, Staring, Streptococcus test negative, Tremor
Clinical narrative: Fever 105; Pale Skin; Chills; Rocking Back and forth; Staring off into Space; Shaking of hands and body; cognitively "not with it"; Vomiting.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Fever 105; Pale Skin; Chills; Rocking Back and forth; Staring off into Space; Shaking of hands and body; cognitively "not with it"; Vomiting.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Allergy to animal, Asthma, Wheezing
Clinical narrative: Wheezing.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Erythema, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, pain, hives, redness, weakness in arm, warm to touch, and dizziness.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm, Urticaria
Clinical narrative: Swelling, pain, hives, redness, weakness in arm, warm to touch, and dizziness.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Immediately after receiving Gardasil pain. Within the first hour pain and redness increased, also a headache started. Four hours after receiving the vaccine severe pain. Raised red bumped from shoulder to elbow. Severe headache. Nausea. Dizziness. Still on going side effects as of 11/22/2015. Which include, severe pain in site of the vaccine. Off and on swelling and heat. Headaches that were not present prior to the vaccine. Unusual tiredness. Weakness in left arm where vaccine was given.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Muscular weakness, Nausea, Pain, Peripheral swelling
Clinical narrative: Immediately after receiving Gardasil pain. Within the first hour pain and redness increased, also a headache started. Four hours after receiving the vaccine severe pain. Raised red bumped from shoulder to elbow. Severe headache. Nausea. Dizziness. Still on going side effects as of 11/22/2015. Which include, severe pain in site of the vaccine. Off and on swelling and heat. Headaches that were not present prior to the vaccine. Unusual tiredness. Weakness in left arm where vaccine was given.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Vaccination site pain
Clinical narrative: Immediately after receiving Gardasil pain. Within the first hour pain and redness increased, also a headache started. Four hours after receiving the vaccine severe pain. Raised red bumped from shoulder to elbow. Severe headache. Nausea. Dizziness. Still on going side effects as of 11/22/2015. Which include, severe pain in site of the vaccine. Off and on swelling and heat. Headaches that were not present prior to the vaccine. Unusual tiredness. Weakness in left arm where vaccine was given.
Age: 1.02
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Fever over 101 for 3 days. Rash developed on stomach on 11/21/2015.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Epistaxis, Headache, Influenza virus test, Oropharyngeal pain
Clinical narrative: Severe body aches and pains, slowly progressed to headache, sinus pressure, lungs hurting, sore throat, cough and culminated in bleeding of nose with green/black phlegm from nose and lungs.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paranasal sinus discomfort, Productive cough, Pulmonary pain, Sputum discoloured
Clinical narrative: Severe body aches and pains, slowly progressed to headache, sinus pressure, lungs hurting, sore throat, cough and culminated in bleeding of nose with green/black phlegm from nose and lungs.