chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness, warmth, swelling at injection site; fever of 101 degrees F.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RVX
Symptoms: Abnormal faeces, Barium double contrast, Blood test, Faeces discoloured, Hypersomnia
Clinical narrative: On 04/15/2013, patient vomited shortly after breastfeeding at 8 pm in the evening. She proceeded to vomit after her 3 feedings during the night and early morning. She was very lethargic and slept constantly, only waking to nurse, which she would then vomit up and go back to sleep again. Her father and I took her in to walk-in clinic. She was seen by Dr. who diagnosed her with a UTI. She could not keep down even a teaspoon of fluid and after no wet diapers and one diaper that contained a small amount of foul smelling, black, tarry stool, we proceeded to the ER. She was diagnosed with an intussusception and was transported via ambulance to another hospital. The night of 04/16/13, she underwent an air and contrast enema to reduce the intussusception. She was then placed on the surgical floor of the hospital for monitoring throughout the night and the next day until she could eat without vomiting and had a bowel movement. She was discharged on 4/17/2013.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RVX
Symptoms: Intussusception, Lethargy, Melaena, Occult blood, Ultrasound scan
Clinical narrative: On 04/15/2013, patient vomited shortly after breastfeeding at 8 pm in the evening. She proceeded to vomit after her 3 feedings during the night and early morning. She was very lethargic and slept constantly, only waking to nurse, which she would then vomit up and go back to sleep again. Her father and I took her in to walk-in clinic. She was seen by Dr. who diagnosed her with a UTI. She could not keep down even a teaspoon of fluid and after no wet diapers and one diaper that contained a small amount of foul smelling, black, tarry stool, we proceeded to the ER. She was diagnosed with an intussusception and was transported via ambulance to another hospital. The night of 04/16/13, she underwent an air and contrast enema to reduce the intussusception. She was then placed on the surgical floor of the hospital for monitoring throughout the night and the next day until she could eat without vomiting and had a bowel movement. She was discharged on 4/17/2013.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RVX
Symptoms: Urinary tract infection, Vomiting, X-ray
Clinical narrative: On 04/15/2013, patient vomited shortly after breastfeeding at 8 pm in the evening. She proceeded to vomit after her 3 feedings during the night and early morning. She was very lethargic and slept constantly, only waking to nurse, which she would then vomit up and go back to sleep again. Her father and I took her in to walk-in clinic. She was seen by Dr. who diagnosed her with a UTI. She could not keep down even a teaspoon of fluid and after no wet diapers and one diaper that contained a small amount of foul smelling, black, tarry stool, we proceeded to the ER. She was diagnosed with an intussusception and was transported via ambulance to another hospital. The night of 04/16/13, she underwent an air and contrast enema to reduce the intussusception. She was then placed on the surgical floor of the hospital for monitoring throughout the night and the next day until she could eat without vomiting and had a bowel movement. She was discharged on 4/17/2013.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and mild swelling of upper left arm in the triceps location. No pain mentioned.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, puffy and sore. Rx - BACTRIM DS, BACTROBAN and cold compress.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt. arm injection site small yellowish bruise. Redness and swelling noted approximately 5 inches below injection site on the inferior surface of the upper arm and towards the axilla, area hot to touch. Pt. treated with KEFLEX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Eye swelling, Wheezing
Clinical narrative: 5-10 min after IM (L) eye started swell after rubbing eye and developed a cough. Eye swelling increased and cough continue with a soft wheeze. Treatment: albuterol aerosol, PO steroid.
Age: 1.2
Sex: M
Vaccine: HIBV
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Culture urine negative, Electroencephalogram abnormal
Clinical narrative: Seizure-like activity followed by fever with T max 103.4 within 48 hours following vaccine administration.
Age: 1.2
Sex: M
Vaccine: HIBV
Symptoms: Nuclear magnetic resonance imaging brain normal, Pyrexia, Seizure like phenomena
Clinical narrative: Seizure-like activity followed by fever with T max 103.4 within 48 hours following vaccine administration.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia, Vaccination site warmth
Clinical narrative: Red area around vaccination site, seems to be getting larger. Also seems to be warm to touch. Patient says she feels feverish.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per telephone call - patient reported that area of injection on the upper arm has  a raised red area - now approximately size of a "softball" - initially after the injection. Pt. noted a red-raised area approx size of a small egg, but area continued to increase in size for the past 2 days. Reports now the area is approx size of a softball. Client encouraged to follow-up with primary Dr. and return call to clinic to report. Dr's recommendation - follow-up call to client for recommendation - client reported primary Dr encouraged use of CLARITIN during the day as well as use of probiotics. MD also encourage use of BENADRYL at night. Primary Dr. also suggested a titer to be drawn rather than receiving follow-up dose of Varicella. Pt. seen in clinic on 5/16/13 for follow-up Hepatitis B dose #2. Pt. reported redness, raised area resolved with use of CLARITIN and BENADRYL.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: Per telephone from client- reporting developing a rash. Described as red raised area approximately size of a "pencil eraser". Rash located on back, stomach, arms and legs.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Redness, itching, irritation spreading approximately 2-3 inches beyond site of injection. Treated with cephalexin and prednisone.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Day 6: 5-29-13 30 mm induration at site of immunization. 40 mm redness at site of immunization. Symptoms improving last 24 hours per patient. Patient reassured.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Headache, Hyperhidrosis, Nausea
Clinical narrative: Per phone call from father - patient developed symptoms of abdominal cramping, nausea, sweating and headache approximately 12 hours after taking 3rd dose of oral typhoid - ordering physician contacted. Instructions obtained from ordering physician to follow-up with father and instruct father not to administer the last dose of oral typhoid. That patient to maintain food and beverage precautions while on this trip. Also follow-up typhoid vaccine if needed in the future for international travel should be injectable. Encourage to offer fluids as needed and increase diet as tolerated. Also encourage to follow-up with primary Dr. if persist aware to call clinic if questions.
Age: 1.03
Sex: M
Vaccine: DTAP
Symptoms: Full blood count, Metabolic function test, Skin discolouration, Staring
Clinical narrative: Possible seizures 2 times with staring, color changes.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Erythema, Induration
Clinical narrative: 48 hr large red, indurated area with central bulla 6"x7".
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Rash to both legs.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Dyskinesia, Posture abnormal
Clinical narrative: Head would drop, eyes open, would stick tongue in and out repetitively. Had a cluster of 6 such episodes. Highest temp 99 no complete LOC, recovered immediately. Another single episode on day 2.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site on left deltoid. Advised patient to put cold compressions on site and to take ibuprofen and to return to clinic if worsen or no progress.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Pt. states she developed redness and swelling to injection site and muscle aches also c/o itching to injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (L) lateral thigh with slight induration, erythema 10 x 15 cm.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Patient was seen on 5/15/13 for a well child exam. He was given the vaccines listed below. Shortly after receiving the PEDIARIX he developed a local reaction with redness. He was seen again 2 days later with extensive swelling, erythema and tenderness in the entire upper thigh.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large area of erythema/mild induration at/around injection site (L) shoulder.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Insomnia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Shot was given 5/20/13 at 11:30AM at Dr. office evening of 5/20/13 left arm began to hurt and continued to hurt really bad unable to lift arm unable to sleep unable to move it at all pain was so bad went to ER. 5/21/13 at 2:00AM had ultrasounds and X-rays given pain meds severe pain entire arm shoulder and neck.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan, Vaccination complication, X-ray
Clinical narrative: Shot was given 5/20/13 at 11:30AM at Dr. office evening of 5/20/13 left arm began to hurt and continued to hurt really bad unable to lift arm unable to sleep unable to move it at all pain was so bad went to ER. 5/21/13 at 2:00AM had ultrasounds and X-rays given pain meds severe pain entire arm shoulder and neck.
Age: 1.13
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Swollen, redness, fever x 3D 100-101. Rt arm. Patient was seen at Urgent Care and treated with oral prednisolone and oral antibiotic.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Mother called 5-22 to report reaction. Approx 5cm diameter area of redness on (L) arm between elbow and shoulder. Afebrile. Asymptomatic otherwise.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Grand mal convulsion
Clinical narrative: ER visit 5/22/13 19:39. Generalized clonic-tonic seizure lasting 4 minutes. (Last seizure activity was August 2012), spontaneous resolution of seizure. Pt. active, happy upon arrival to ER. T 98.1 P 140 R-36 BP 141/100. History to seizures since fall down steps age 2 yrs.
Age: 1.92
Sex: M
Vaccine: DTAP
Symptoms: Excessive eye blinking, Fall
Clinical narrative: Pt. had episode of eyes fluttering (15-20s) and fell backwards onto his bottom. Pt. evaluated at hospital and received ATIVAN. Pt. transferred to Hospital and admitted for observation by neurology department. Pt is currently in process of being worked up for seizure disorder.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Noticed 2 days after vaccine her (R) arm was red swollen and warm, approximately 4" circle of redness. No fever - no other symptoms. Felt like swelling was beyond the 4" circle of redness. A bruise appeared.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Swelling
Clinical narrative: Pt. stated 8 hrs. after shot it swelled and was red 3 in. in diameter 48 hrs. Later hurt all the way to elbow took Aspirin felt better then was itching for 4 days.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash. No treatment.
Age: 53.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Asthenia, Musculoskeletal pain, Tremor
Clinical narrative: Received Smallpox left shoulder 03Sep2011. Received 2nd Anthrax left shoulder 06Oct2011. Still having tremors in left arm and hand. Still having weakness. Still having shoulder pain. Started pt. on left shoulder. Still weakness.
Age: 53.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Loss of consciousness, Muscular weakness, Tremor
Clinical narrative: Received Smallpox left shoulder 03Sep2011. Received 2nd Anthrax left shoulder 06Oct2011. Still having tremors in left arm and hand. Still having weakness. Still having shoulder pain. Started pt. on left shoulder. Still weakness.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Hallucination, visual, Loss of consciousness, Memory impairment, Rash
Clinical narrative: Case number PHEH2013US009533 is an initial spontaneous report received from a nurse on 26 Apr 2013 and a follow up report from the physician received on 21 May 2013. This report refers to a 28-year-old female patient. Her medical history included exposure to bat. It was reported that she was not immunized to any rabies vaccine prior to RABAVERT. Concomitant drugs included VYVANSE XR for attention deficit disorder and LAMICTAL as a mood stabilizer. She was vaccinated with first, second and third doses of RABAVERT (batch number: 517011A) on 11 Apr 2013 at left deltoid, on 14 Apr 2013 and on 15 Apr 2013 at right deltoid respectively. Reporting nurse stated that the patient came for the fourth dose and developed rash (on unspecified date). Hence the fourth dose was not given. It was reported that she did not know where the rash was located. She was the patient advocate employee and did not know the details other than rash and the clinicians decided not to give the RABAVERT and she believes that the clinician was going to resume the series with IMOVAX once the rash resolves. Her physician reported that after third dose of RABAVERT, she felt "spacey or blacking out". It was also reported that she had periods of time which she could not remember and had visual hallucinations. The outcome of the event rash was not reported. The outcome of other events was reported as recovered. The causality and seriousness of events were not reported. Follow up report from the physician received on 21 May 2013: Medical history, concomitant drugs and events (visual hallucinations, spacey or blacking out and she could not remember) were added. The information related to RABAVERT (batch number, vaccinations dates, dose and site of vaccination) and patient details were updated.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Crying, Mobility decreased, Neck pain, Pain
Clinical narrative: Seenin ER yesterday for severe pain and swelling. Pain moving across neck and collar bone (right arm). Pt stated given IV. BENADRYL and pain meds. Seen in our office 6/1/13 pt in agony crying. Cries with touch, decreased movement. Treatment hydrocodone/APAP 5/500mg x3 days, then 2 tab x3 days, then 1 tab x3 days.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Seenin ER yesterday for severe pain and swelling. Pain moving across neck and collar bone (right arm). Pt stated given IV. BENADRYL and pain meds. Seen in our office 6/1/13 pt in agony crying. Cries with touch, decreased movement. Treatment hydrocodone/APAP 5/500mg x3 days, then 2 tab x3 days, then 1 tab x3 days.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper arm from axilla to just below bicep had red, raised areas. Upper arm swollen in areas and hot to touch. Pt reports area is extremely sore. Pt given Rx for AUGMENTIN x 7 days, ice and BENADRYL.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rt arm redness, swelling and pain at pneumo injection site to include axilla area and below injection site midway down upper arm. Hot to touch - painful. Symptoms noted 24 hours after injection. BENADRYL, ice, BIAXIN.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Oedema peripheral
Clinical narrative: Rt arm redness, swelling and pain at pneumo injection site to include axilla area and below injection site midway down upper arm. Hot to touch - painful. Symptoms noted 24 hours after injection. BENADRYL, ice, BIAXIN.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR
Symptoms: Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: Mom reports vomiting and diarrhea starting 5/22/13 - 5/31/13. Fever and rash starting 5/31/13 and evaluated at medical center and was told a reaction to MMR and started on steroid x 4 days BID. Mom states rash resolving today: 6/3/13.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Blood glucose normal, Condition aggravated, Syncope
Clinical narrative: After receiving yellow fever vaccine within a few minutes pt. fainted and collapsed. While sitting on the chair she fainted and collapsed again. Paramedic came and took her BP and glucose level (71). Her guardian insisted that she go to ER to have her checked out.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Site where KINRIX is given developed redness and has gotten slightly bigger. Measures 2 inch x 1 inch on (L) upper thigh. No obvious bruising and/or swelling/induration noted at site.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) upper arm with a 3cm area with mild erythema 2-3 days. (L) upper arm with a 3cm area with redness and induration 2-3 days.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Thurs night 1st dose. Sat night 2nd dose. Today, Mon 6/3/13 - sore throat, body aches.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus generalised
Clinical narrative: Redness, swollen, itching at injection site. Scalp and ears itching, general itching. No rash.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Headache, Injection site erythema, Respiratory disorder
Clinical narrative: Dizzy within couple hours of vaccine. Next day headache, respiratory problems, cold sweats, red around injection site. Went to doctor on 2nd day after vaccine. Better now but still a little dizzy. As reported by husband on 6/3/13.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt states that she felt a burning sensation around her left eye and up on the left side (which was the same feeling she had when she had shingles in the past). Also, swelling and rednss and itchy around injection site (which was a rxn I told her may occur).
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria
Clinical narrative: 1 week after vaccination, patient noticed a hive-like reaction, 1/2 inch under injection site. Doctor prescribed antibiotics but could not tell if reaction to vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia, Rash
Clinical narrative: One-sided rash and muscle aches (neck side) about 3 days after vaccination. Had injection-site redness that subsided. Other adverse events are non-injection site events. Still achy, but rash improving. No typical allergic rxn presentation.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: 4-26-13 had a temp of 100.9 in office during vaccines. Pt. was on children's TYLENOL and children's MOTRIN as needed. Later that day fever increased.  Temp went up last night to 103, was 103 this morning when waking up, TYLENOL given this morning. Runny nose yes, slight, clear. No nasal congestion. No coughing. No poor appetite, eating well and drinking well. No sleeping poorly, sleeping well.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, Pain, Rash, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist (who was also the one of the two patients) via company representative refers to 2 patints of unknown age and gender. Approximately on an unknown date in May 2013, the patients were vaccinated with a dose of ZOSTAVAX (lot # J000853, expiry date was 23-APR-2014, route and dose were not reported) that had been accidentally left in the refrigerator for a week. The reporter had had enquired about this and was told that it was OK to use this vaccine during the next three months. Approximately on an unknown date in May 2013, (reported as the week of 12-MAY-2013, 3 days after vaccination), the patients broke out in large, painful hives, broke out with rash and welts. One of the patient who was a pharmacy technician had described the pain as being similar to a bee sting. No medical attention was sought. No treatment was provided for the event painful hives. The outcome of all the reported events was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 20-year-old female patient (reported as 'in her 20s'). Patient had a history of being immunocompromised. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date and route not reported) in the arm. No concomitant medications were reported. On an unknown date the patient developed swelling the size of a tennis ball on her arm after receiving a dose of PNEUMOVAX23. The patient's reaction was diagnosed as a cellulitis and was treated with an unspecified antibiotic. The outcome of cellulitis was reported as recovering/resolving. Patient sought medical attention for the event. It was unspecified whether laboratory studies were performed. Causality was not reported. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 3 months and 29 days old male patient. On 21-MAY-2013 the patient was inadvertently vaccinated with a dose of ROTATEQ (dose, route and lot # unknown). No adverse effects 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 registered nurse refers to a patient of unknown age and gender. On 24-MAY-2013, the patient was who was schedule to receive VARIVAX (Merck), was inadvertently vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported), subcutaneously. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient who was younger than 50 years old. "About a year ago", in approximately May 2012 the patient was vaccinated subcutaneously with ZOSTAVAX (0.65 ml, lot # not reported). It was reported that the patient developed a rash in approximately May 2012. The patient stated that the rash at the injection site was transient and resolved on its own. There was no treatment given for the event. No lab diagnostics studies were performed. The pharmacist did state that the patient did not see a physician concerning rash. The patient sought medical attention to pharmacy. VZV packet declined. Additional information is not available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Malaise, Pain in extremity
Clinical narrative: This spontaneous report as received from a 65 year old female registered nurse refers to herself. The patient received the first standard dose of PNEUMOVAX23 (Lot# and route not reported) vaccination 10 years ago in approximately May 2003. On 22-MAY-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (Lot# and route not reported). After receiving her second dose of PNEUMOVAX23 on 22-MAY-2013 the patient experienced significant arm pain. "It was hard but had no bruise". The patient also experienced a general feeling of malaise after vaccination. These symptoms lasted for a period of 48 hours before full recovery. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 62 year old female patient with no drug reactions or allergies. Patient medical history was none. On 22-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021459, expiry date was 30-APR-2014) 0.65 milliliter (ml), subcutaneously. Concomitant therapies included pravastatin sodium. On 24-MAY-2013, the patient presented with a localized reaction at the injection site that was red, raised, swollen and warm to the touch. The patient stated that the affected area did not itch. Laboratory test performed was none. The patient sought medical attention (was seen at the physician office on 24-MAY-2013). The patient was treated with ice and over the counter cortisone. The outcome of localized reaction at the injection site that was red, raised, swollen and warm to the touch was reported as not recovered/not resolved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a female patient of unknown age. On 14-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (route not reported) when she was 37 and a half wekks pregnant. The patient became pregnant with LMP of 17-AUG-2012 and EDD of 24-MAY-2013. The pregnancy outcome was outcome pending. No adverse effect was reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 63-year-old female patient. Current conditions included chronic bronchitis/asthma, GERD (Gastro oesophageal reflux disease), hypothyroidism, fibromyalgia and allergy to sulfa drugs. On 22-MAY-2013 the patient was vaccinated with a dose of 0.5 milliliter (ml) (reported as standard dose) PNEUMOVAX23 (lot# H017759, expiration date 04-JUL-2014), subcutaneously (reported as standard route) in the arm. Concomitant medications included unspecified medications for chronic bronchitis/asthma, GERD (Gastro oesophageal reflux disease), hypothyroidism and fibromyalgia. On 22-MAY-2013, the patient experienced extreme swelling and pain the evening after receiving her vaccination with PNEUMOVAX23. During her office visit the patient presented with swelling that was 8 inches across the injection site and 4 inches along the length of the arm. ROCEPHIN was given as a treatment. The outcome of the event was reported as recovering/resolving. It was unspecified whether lab diagnostic studies were performed. Causality was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 66 year old female patient with no drug reactions or allergies. Patient's medical history was none. On 20-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H019999, expiry date was 02-FEB-2014) 0.65 milliliter (ml), subcutaneously. Concomitant therapies included LIPITOR, losartan potassium and VESICARE. On 23-MAY-2013, the patient experienced localized reaction at the injection site that was red, raised, swollen, warm to the touch and was itchy and was seen at the physicians office. Laboratory tests performed was none. The patient sought medical attention (was seen at the physician's office). The events were treated with ice and over the counter cortisone. The outcome of localized reaction at the injection site that was red, raised, swollen, warm to the touch and was itchy was unknown. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old female infant. On an unknown date the 9 week old female infant was vaccinated with a dose of pediatric VAQTA 25/0.5 U/ML. Lot # was unspecified. No adverse effect reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial report was received on 22 May 2013 from a consumer who is also the patient which involved a case of misuse (expired vaccine administered). A 45-year-old male patient had received on 05 March 2013 an intramuscular left deltoid injection of TENIVAC, lot number U3870DA expiration 15 February 2013 (This is a valid lot number for DECAVAC) and immediately, experienced pain at injection site which has progressed down the arm, into the hand and across the front and back of shoulders. According to the reporter, the pain is interfering with sleep and he can not raise his arm above head. The patient's outcome was not recovered. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Swelling
Clinical narrative: Initial report was received on 22 May 2013 from a consumer who is also the patient which involved a case of misuse (expired vaccine administered). A 45-year-old male patient had received on 05 March 2013 an intramuscular left deltoid injection of TENIVAC, lot number U3870DA expiration 15 February 2013 (This is a valid lot number for DECAVAC) and immediately, experienced pain at injection site which has progressed down the arm, into the hand and across the front and back of shoulders. According to the reporter, the pain is interfering with sleep and he can not raise his arm above head. The patient's outcome was not recovered. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Expired drug administered, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Initial report was received on 22 May 2013 from a consumer who is also the patient which involved a case of misuse (expired vaccine administered). A 45-year-old male patient had received on 05 March 2013 an intramuscular left deltoid injection of TENIVAC, lot number U3870DA expiration 15 February 2013 (This is a valid lot number for DECAVAC) and immediately, experienced pain at injection site which has progressed down the arm, into the hand and across the front and back of shoulders. According to the reporter, the pain is interfering with sleep and he can not raise his arm above head. The patient's outcome was not recovered. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Initial report was received on 22 May 2013 from a consumer who is also the patient which involved a case of misuse (expired vaccine administered). A 45-year-old male patient had received on 05 March 2013 an intramuscular left deltoid injection of TENIVAC, lot number U3870DA expiration 15 February 2013 (This is a valid lot number for DECAVAC) and immediately, experienced pain at injection site which has progressed down the arm, into the hand and across the front and back of shoulders. According to the reporter, the pain is interfering with sleep and he can not raise his arm above head. The patient's outcome was not recovered. Documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Rash
Clinical narrative: Received shingle shot on a Wednesday. On Sunday notice puffy, pimples and redness on right side on head, above ear, it burned and had shooting pains in head. Called dr on Monday - prescribed acyclovir 800 mg (5 times day for 10 days).
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Acne, Burning sensation, Erythema, Headache, Pain
Clinical narrative: Received shingle shot on a Wednesday. On Sunday notice puffy, pimples and redness on right side on head, above ear, it burned and had shooting pains in head. Called dr on Monday - prescribed acyclovir 800 mg (5 times day for 10 days).
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Received shingle shot on a Wednesday. On Sunday notice puffy, pimples and redness on right side on head, above ear, it burned and had shooting pains in head. Called dr on Monday - prescribed acyclovir 800 mg (5 times day for 10 days).
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Headache, Herpes zoster, Pain
Clinical narrative: Received shingle shot on a Wednesday. On Sunday notice puffy, pimples and redness on right side on head, above ear, it burned and had shooting pains in head. Called dr on Monday - prescribed acyclovir 800 mg (5 times day for 10 days).
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Injury, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report s received from a nurse via a company representative refers to a 19 year old female patient. No information regarding the patient's medical history was provided. On 15-MAY-2013 the patient was vaccinated with dose 2 of GARDASIL. No concomitant medication was reported. Within less than a minute after the vaccination, the patient fainted while sitting on the examination table, fell forward and broke her jaw, broke a tooth and had to be stitched because of chin laceration (doctor visit). The patient did not have any problems after she received the first dose (date unspecified). No outcome was reported. No causality assessment was provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Jaw fracture, Laceration, Syncope, Tooth injury
Clinical narrative: This spontaneous report s received from a nurse via a company representative refers to a 19 year old female patient. No information regarding the patient's medical history was provided. On 15-MAY-2013 the patient was vaccinated with dose 2 of GARDASIL. No concomitant medication was reported. Within less than a minute after the vaccination, the patient fainted while sitting on the examination table, fell forward and broke her jaw, broke a tooth and had to be stitched because of chin laceration (doctor visit). The patient did not have any problems after she received the first dose (date unspecified). No outcome was reported. No causality assessment was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Mood altered, Ovarian disorder, Polymenorrhoea, Ultrasound antenatal screen
Clinical narrative: Shortened periods, ovarian degeneration, uterine fibroids, extreme mood changes.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine leiomyoma
Clinical narrative: Shortened periods, ovarian degeneration, uterine fibroids, extreme mood changes.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Electroencephalogram normal, Foaming at mouth, Grunting, Hypotonia, Lumbar puncture normal
Clinical narrative: About 48 hours after 2 month imms. patient developed grunting, turned limp, foaming at mouth, and unresponsiveness that lasted approximately 2 hours. Admitted underwent sepsis work up which was negative. EEG normal and normal MRI. Recovered without intervention. No fever documented at or around event.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging normal, Unresponsive to stimuli
Clinical narrative: About 48 hours after 2 month imms. patient developed grunting, turned limp, foaming at mouth, and unresponsiveness that lasted approximately 2 hours. Admitted underwent sepsis work up which was negative. EEG normal and normal MRI. Recovered without intervention. No fever documented at or around event.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 24 May 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL on 08 June 2012, 31 July 2012 and 01 October 2012 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 07 April 2013, approximately 6 months after the last dose. On 23 April 2013, the subject developed a cough and paroxysmal cough on 01 May 2013 with a whoop. The subject also experienced post-tussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 06 May 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 07 May 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 21 May 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 24 May 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL on 08 June 2012, 31 July 2012 and 01 October 2012 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 07 April 2013, approximately 6 months after the last dose. On 23 April 2013, the subject developed a cough and paroxysmal cough on 01 May 2013 with a whoop. The subject also experienced post-tussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 06 May 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 07 May 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 21 May 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required per protocol. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Angina pectoris, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 26-year-old male subject was found to have other and unspecified angina pectoris 1 day after receiving the following vaccines on 26 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included an abnormal ECG on 27 February 2013 and an abnormal echocardiogram on 05 March 2013. Treatments were not reported. Past medical history included palpitations/pounding heart with exercise, chest pain, abnormal ECG (electrocardiogram), shortness of breath, asthma (include exercise induced) and headaches. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV, RV5
Symptoms: Bordetella test positive, Cough, Hand-foot-and-mouth disease, Polymerase chain reaction, Pyrexia
Clinical narrative: Initial report was received from a healthcare professional on 23 May 2013. A 14-month-old male patient had received a dose 3 injection in the left thigh of DAPTACEL, lot number C4006AA and an oral dose 3 ROTATEQ, Merck, lot number 0033AA on 20 August 2012. The patient also received a dose three injection in the right thigh of ACT-HIB, lot number H153-1 (corresponding Sanofi Pasteur Inc. lot number UH62AA). On 09 May 2013, the patient presented with hand, foot and mouth disease and was treated with BENADRYL and MAALOX. He returned to the doctor's office on 17 May 2013 with a tight cough and fever and was treated with prednisolone, a ZPACK and nebulizer with albuterol. He presented again on 20 May 2013 with no improvement. Nasal swab was obtained and was positive for Pertussis DNA. Treatment continued with the nebulizer and ZPACK for a 10 day course total. The patient was at home with family and other contacts were not sick. It was unknown if vaccinations were complete for the family. No other cases were known in the family. The patient received previous doses of DAPTACEL; lot number U3327AB on 16 April 2012 and C4006AA on 18 June 2012, 2 previous doses of ACT-HIB; lot number UH258AA on 14 May 2012 and UH485AA on 06 August 2012 and 2 previous doses of ROTATEQ; lot number 0920AA on 16 April 2012 and 18 June 2012. The patient had no illness at the time of vaccination or past medical history. Outcome was not recovered. Documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Abscess, Cellulitis, Disturbance in attention, Erythema, Injection site pain
Clinical narrative: Initial information was received from a healthcare professional on 23 May 2013. A 40-year-old male patient had received a dose 1 intramuscular injection in the left arm of ADACEL, lot number C4328AA on 23 April 2013 at 10:00 AM. On 28 April 2013 (also reported as 2 days post-vaccination), the patient experienced severe pain the left arm (upper arm). The pain in the arm became worse and worse so that he could not focus on anything else and was unable to sleep. The patient went to the emergency room twice. Treatment included acetaminophen-hydrocodone, TORADOL and VALIUM. He was admitted to the hospital from 29 April 2013 to 01 May 2013. He had an MRI and was started on IV ANCEF. At some point he developed some swelling and redness described as 4cm in size. This resolved and the patient had pain which he described as 1/2 of 1 on a scale of 10 and some tenderness with palpation of the arm. Some faint redness on the back of the arm came today after he applied heat to the area. Of note is that his symptom was pain, which was severe, and involved the entire upper arm and he felt pain into the shoulder. He had no rash or redness at the site of injection, he had no swelling initially and no numbness or weakness. Diagnosis was pain after injection and was presumed to be associated with the vaccine. Discharge diagnosis was myalgia and myositis, unspecified; cellulitis and abscess of unspecified sites. Treatment included CELEBREX, TRAMADOL, KEFLEX and DILAUDID. The patient had no illness at the time of vaccination, no adverse events to prior vaccines and no past medical history. The patient had allergies (not specified). Outcome was reported as recovered. Documents held by sender: Medical Records.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Insomnia, Musculoskeletal pain, Myalgia, Myositis, Nuclear magnetic resonance imaging
Clinical narrative: Initial information was received from a healthcare professional on 23 May 2013. A 40-year-old male patient had received a dose 1 intramuscular injection in the left arm of ADACEL, lot number C4328AA on 23 April 2013 at 10:00 AM. On 28 April 2013 (also reported as 2 days post-vaccination), the patient experienced severe pain the left arm (upper arm). The pain in the arm became worse and worse so that he could not focus on anything else and was unable to sleep. The patient went to the emergency room twice. Treatment included acetaminophen-hydrocodone, TORADOL and VALIUM. He was admitted to the hospital from 29 April 2013 to 01 May 2013. He had an MRI and was started on IV ANCEF. At some point he developed some swelling and redness described as 4cm in size. This resolved and the patient had pain which he described as 1/2 of 1 on a scale of 10 and some tenderness with palpation of the arm. Some faint redness on the back of the arm came today after he applied heat to the area. Of note is that his symptom was pain, which was severe, and involved the entire upper arm and he felt pain into the shoulder. He had no rash or redness at the site of injection, he had no swelling initially and no numbness or weakness. Diagnosis was pain after injection and was presumed to be associated with the vaccine. Discharge diagnosis was myalgia and myositis, unspecified; cellulitis and abscess of unspecified sites. Treatment included CELEBREX, TRAMADOL, KEFLEX and DILAUDID. The patient had no illness at the time of vaccination, no adverse events to prior vaccines and no past medical history. The patient had allergies (not specified). Outcome was reported as recovered. Documents held by sender: Medical Records.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling, Tenderness, X-ray
Clinical narrative: Initial information was received from a healthcare professional on 23 May 2013. A 40-year-old male patient had received a dose 1 intramuscular injection in the left arm of ADACEL, lot number C4328AA on 23 April 2013 at 10:00 AM. On 28 April 2013 (also reported as 2 days post-vaccination), the patient experienced severe pain the left arm (upper arm). The pain in the arm became worse and worse so that he could not focus on anything else and was unable to sleep. The patient went to the emergency room twice. Treatment included acetaminophen-hydrocodone, TORADOL and VALIUM. He was admitted to the hospital from 29 April 2013 to 01 May 2013. He had an MRI and was started on IV ANCEF. At some point he developed some swelling and redness described as 4cm in size. This resolved and the patient had pain which he described as 1/2 of 1 on a scale of 10 and some tenderness with palpation of the arm. Some faint redness on the back of the arm came today after he applied heat to the area. Of note is that his symptom was pain, which was severe, and involved the entire upper arm and he felt pain into the shoulder. He had no rash or redness at the site of injection, he had no swelling initially and no numbness or weakness. Diagnosis was pain after injection and was presumed to be associated with the vaccine. Discharge diagnosis was myalgia and myositis, unspecified; cellulitis and abscess of unspecified sites. Treatment included CELEBREX, TRAMADOL, KEFLEX and DILAUDID. The patient had no illness at the time of vaccination, no adverse events to prior vaccines and no past medical history. The patient had allergies (not specified). Outcome was reported as recovered. Documents held by sender: Medical Records.