chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: PATIENT DEVELOPED REDNESS AND SWELLING FACE ONLY, WITH ITCHING, NO SOB.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased eye contact, Electrocardiogram normal, Hypotonia, Mental status changes
Clinical narrative: Altered mental status 15-30 seconds seemed "limp" not making eye contact.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear pain, Fatigue, Hypoacusis, Immediate post-injection reaction
Clinical narrative: Right after the Influenza shot she developed head congestion nasal  discharge initially clear and then green and earache on left and right with tinnitis and less hearing with sore throat now cough. On the night of the 10/24/2012 there was emesis and on 10/25 only felt nauseated, no fever or chills, though feet were cold, plus fatigue but no myalgias. Patient self treatment herself with Ibuprofen and Vit. C, OTC. The night of 10/24 pt went to the emergency department and was treated with Augmentin after 1st dose -- she threw up. They also gave her Percocet with the treatment. Then got seen my MD to follow up emergency department visit, that same day/morning. MD gave her Percocet and Cefaclor for her Otitis Media and was told to call the office if she continues to be sick in one week.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Otitis media, Peripheral coldness, Rhinorrhoea
Clinical narrative: Right after the Influenza shot she developed head congestion nasal  discharge initially clear and then green and earache on left and right with tinnitis and less hearing with sore throat now cough. On the night of the 10/24/2012 there was emesis and on 10/25 only felt nauseated, no fever or chills, though feet were cold, plus fatigue but no myalgias. Patient self treatment herself with Ibuprofen and Vit. C, OTC. The night of 10/24 pt went to the emergency department and was treated with Augmentin after 1st dose -- she threw up. They also gave her Percocet with the treatment. Then got seen my MD to follow up emergency department visit, that same day/morning. MD gave her Percocet and Cefaclor for her Otitis Media and was told to call the office if she continues to be sick in one week.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Upper respiratory tract congestion, Vomiting
Clinical narrative: Right after the Influenza shot she developed head congestion nasal  discharge initially clear and then green and earache on left and right with tinnitis and less hearing with sore throat now cough. On the night of the 10/24/2012 there was emesis and on 10/25 only felt nauseated, no fever or chills, though feet were cold, plus fatigue but no myalgias. Patient self treatment herself with Ibuprofen and Vit. C, OTC. The night of 10/24 pt went to the emergency department and was treated with Augmentin after 1st dose -- she threw up. They also gave her Percocet with the treatment. Then got seen my MD to follow up emergency department visit, that same day/morning. MD gave her Percocet and Cefaclor for her Otitis Media and was told to call the office if she continues to be sick in one week.
Age: 50.0
Sex: M
Vaccine: VARCEL
Symptoms: Liver function test normal, Rash generalised, Rash pruritic, Rash vesicular, White blood cell count normal
Clinical narrative: Generalized pruritic vesicular rash.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: At the site where the vaccine was administered, my four-year-old son developed a very red and raised/swollen circle around the injection site, about two inches in length across. The injection site also felt hard underneath the skin when I pushed on it with my finger and the skin felt chapped at that location as well. The injection site bled a bit after the shot was administered so I don't know if the reaction was due to that or if it was a reaction to the vaccine. My son had no other symptoms, however (no fever or sluggishness, rash, or anything else).
Age: 4.0
Sex: M
Vaccine: DTAP, FLUX, IPV, MMR, VARCEL
Symptoms: Skin fissures
Clinical narrative: At the site where the vaccine was administered, my four-year-old son developed a very red and raised/swollen circle around the injection site, about two inches in length across. The injection site also felt hard underneath the skin when I pushed on it with my finger and the skin felt chapped at that location as well. The injection site bled a bit after the shot was administered so I don't know if the reaction was due to that or if it was a reaction to the vaccine. My son had no other symptoms, however (no fever or sluggishness, rash, or anything else).
Age: 11.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Wrong drug administered
Clinical narrative: None. Administered DTaP instead of Tdap.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Sensory disturbance
Clinical narrative: Patient here to get Flu shot, shot given, patient felt fine. Patient checking out and said he didn't feel a thing. I was documenting immunization and a thump was heard, went to see and patient was surrounded by doctors. Patient taken back to room, where examined by doctors.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: About 20 vesicular lesions on right upper back, shoulder and anterior neck chicken pox.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching, & warmth at the injection site, starting day after injection.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Decreased appetite, Erythema, Extensive swelling of vaccinated limb
Clinical narrative: Fever, chills, myalgias, headache, nausea, anorexia, diaphoresis, weakness; arm pain, erythema, swelling extensively at injection site 16 x 20 cm - sx's onset approx 12 hrs after injection, with peak at x 60 hrs & resolution of sx's (except for arm pain, extensive swelling) by about 100 hrs.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Pain in extremity
Clinical narrative: Fever, chills, myalgias, headache, nausea, anorexia, diaphoresis, weakness; arm pain, erythema, swelling extensively at injection site 16 x 20 cm - sx's onset approx 12 hrs after injection, with peak at x 60 hrs & resolution of sx's (except for arm pain, extensive swelling) by about 100 hrs.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, chills, myalgias, headache, nausea, anorexia, diaphoresis, weakness; arm pain, erythema, swelling extensively at injection site 16 x 20 cm - sx's onset approx 12 hrs after injection, with peak at x 60 hrs & resolution of sx's (except for arm pain, extensive swelling) by about 100 hrs.
Age: 0.36
Sex: F
Vaccine: DTAP, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: DTaP accidentally administered x2 on same day on 1/12/13. Patient with fever 101 on 1/12/13 - 1/13/13.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site exfoliation, Nodule
Clinical narrative: Developed cellulitis in right arm. Large knot, red with streaks. Temp 100 F. ER physician gave client IM ROCEPHIN x2. Client now OK. Skin peeling around injection site.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient given an IM flu shot on 1-9-13. Patient's arm has been painful & swollen since the evening of 1-9-13. She saw her doctor on 1-11-13 & was given cefadroxil in case of secondary infection pharmacy will follow up with patient next week.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Patient complained of upper arm swelling Sat. 5pm & then said improved Sunday 9am.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient reported on 1/7/13 that his right deltoid muscle was very sore making it hard to use for 1st week after flu vaccine was given. Deltoid still hurts but is improving - almost normal now per pt.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blister
Clinical narrative: 4 or 5 blisters ranging from 3 mm to 1 cm on the right leg.
Sex: F
Vaccine: HPV4
Symptoms: Live birth, Maternal exposure before pregnancy
Clinical narrative: Information has been received from a pharmacist for GARDASIL, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with dose 1 0.5 ml GARDASIL (lot # was unknown) 15 months ago in October 2010 and dose 2 12 months ago in January 2011. No concomitant medications were reported. Subsequently, 3 months after the second dose the patient became pregnant with an LMP of April 2012. It was reported that the patient delivered a healthy baby with no complications at an unspecified hospital on an unspecified date recently. The patient sought unspecified medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye swelling, Headache, Nausea, Ocular hyperaemia
Clinical narrative: Headache, nausea, hacking cough, hives, swollen, red and puffy eyes until mid-day on 1/12/2013.  Called Dr. morning of 01/11/2013 due to symptoms; Dr. was not convinced symptoms were related to flu vaccine, yet symptoms suddenly appeared after vaccination and stopped shortly after receiving vaccine.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Headache, nausea, hacking cough, hives, swollen, red and puffy eyes until mid-day on 1/12/2013.  Called Dr. morning of 01/11/2013 due to symptoms; Dr. was not convinced symptoms were related to flu vaccine, yet symptoms suddenly appeared after vaccination and stopped shortly after receiving vaccine.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Severe headache, dizziness, fatigue.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: None.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Unresponsive to stimuli
Clinical narrative: None.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: PT REPORTED A LARGE BUMP AT VAX SITE WITH REDNESS AND SOME RED BUMPS FURTHER DOWN ARM. PT SAW DERMATOLOGIST AND RECD RXS FOR TAC AND CLINDA TOPICAL SOLN.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Extreme nausea, followed by violent vomiting. Continue to vomit every hour. Consuming water when I could to ease the bile. I got an email off to my MD asking him to prescribe a anti nausea suppository to help me. Dr. phoned in Promethegan. I started the medication on 1/11/2013 @ 2 pm. It worked. I took the medication every 4 hours, for a total of 4 doses. I phoned the pharmacy on 1/11/13, sharing my story. The Pharmacist was off that day. I left my name and number and asked they share what I experienced. Also, I noticed I had a rash on my chest and abdomen, prior to starting the suppository.
Age: 60.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Asthenia, Influenza like illness, Pyrexia
Clinical narrative: High fever, flu like symptoms, weakness for 2 days.  Treated with rocephin IM and oral azithromycin.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Feeling cold, Injection site reaction, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Slight dizziness.  Arm very painful.  Expected this due to implications on info sheet.  About 5:30 pm very cold.  Took Motrin about 6:30 and went to bed.  Next day feeling better, but arm still very painful.  Dizziness gone.  About 08:00 PM noticed arm swollen and red splotches under shot and down to elbow on the underside of arm.  Shoulder sore.  Took Motrin again and went to bed.  Better on Sunday.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Slight dizziness.  Arm very painful.  Expected this due to implications on info sheet.  About 5:30 pm very cold.  Took Motrin about 6:30 and went to bed.  Next day feeling better, but arm still very painful.  Dizziness gone.  About 08:00 PM noticed arm swollen and red splotches under shot and down to elbow on the underside of arm.  Shoulder sore.  Took Motrin again and went to bed.  Better on Sunday.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Throat tightness
Clinical narrative: According to patient's husband who came in to fill a prescription for an oral antiemetic, patient was having severe HA, nausea, chills, and her "throat began to tighten".
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Non-local hives, which cleared after several hours.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram head normal, Dyskinesia, Emotional distress, Fatigue
Clinical narrative: Day after flu vaccine, at 7:20PM, my child had what seemed to resemble a seizure. While my child was sitting in my lap, she threw her head back and her whole body became rigid.  Her eyes rolled back.  She was unable to control her body or respond to me for aprox 60 secs.  When she came out of it, she was tired and upset.  911 called.  I transported child to ER.  ER Dr ordered blood work and CT Scan. Both normal. Released at 4AM on Jan 12th. No meds given.  Instructed to monitor child and follow up with pediatrician on Monday, Jan 14, 2013.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Gaze palsy, Muscle rigidity, Posture abnormal, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Day after flu vaccine, at 7:20PM, my child had what seemed to resemble a seizure. While my child was sitting in my lap, she threw her head back and her whole body became rigid.  Her eyes rolled back.  She was unable to control her body or respond to me for aprox 60 secs.  When she came out of it, she was tired and upset.  911 called.  I transported child to ER.  ER Dr ordered blood work and CT Scan. Both normal. Released at 4AM on Jan 12th. No meds given.  Instructed to monitor child and follow up with pediatrician on Monday, Jan 14, 2013.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Cold sweat, Feeling of body temperature change, Headache, Heart rate increased
Clinical narrative: Headache, fever, leading to severe aches, headache, fever of 101 degrees, hot and cold flashes, clamminess, racing heartbeat by 7:00 AM 1/13/13. As of 1/14/13 at 5:00 PM headache and hot flash and chills continue.
Age: 34.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, fever, leading to severe aches, headache, fever of 101 degrees, hot and cold flashes, clamminess, racing heartbeat by 7:00 AM 1/13/13. As of 1/14/13 at 5:00 PM headache and hot flash and chills continue.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site exfoliation, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Injection site and then 3/4 of left upper arm painful and swollen within a couple of hours. Awakened early the next morning, feeling ill. 1.5cm patch of skin had sloughed, 3cm ring about site red and edematous, upper arm swollen from just above elbow to just below deltoid.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Injection site and then 3/4 of left upper arm painful and swollen within a couple of hours. Awakened early the next morning, feeling ill. 1.5cm patch of skin had sloughed, 3cm ring about site red and edematous, upper arm swollen from just above elbow to just below deltoid.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Flu-like illness with fever, malaise, rhinorrhea that didn't resolve for 5 days.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives for 3 days so far. Come and go.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Lots of pain after flu shot upper left arm, radiating up to neck and down arm to hand.  Bruising about 1 1/2" across.  Very tender upper arm 1 week later, sleep problems due to pain. Using NSAIDS, Tylenol, ice and heat.  Had a pneumonia shot on upper right arm same time with no pain at all.
Age: 11.0
Sex: M
Vaccine: MMR, PPV, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 years old male patient without pertinent medical history, with allergy to: minoxidil, nifedipine, morphine, codeine, clindamycin, isradipine, clonidine and to an unspecified vaccine, who on 03-JAN-2013, was vaccinated in the right lateral thigh with a dose of PNEUMOVAX 23 (dose was not reported) (lot number reported as H016295, expiration date: 02-NOV-2013). On the same date, the patient also vaccinated with MMR II (dose, indication and lot number were not reported) and (Merck) VARIVAX (dose, indication and lot number were not reported). Concomitant vaccines included Tdap (dose, indication and lot number were not reported). The registered nurse reported that on 05-JAN-2013, the patient was seen in the emergency room of the hospital with a 104.7 F fever and red, warm, raised and swollen rash at the PNEUMOVAX 23 injection site that was 5.5 centimeters in diameter: no shortness of breath was noted. The patient sought medical attention. On the same date, the patient was admitted to the hospital. The patient was administered acetaminophen and on 06-JAN-2013 his fever was down to 100.6F. On 08-JAN-2013, the patient was discharged from the hospital. At the time of the report, the patient was recovering from the adverse events. The relatedness for the adverse events was unknown for MMR II, (Merck) VARIVAX and PNEUMOVAX 23. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Developed swelling of left upper arm and right foot with 24 hrs of immunization. Seen in ER. No fever or respiratory symptoms. Treated with diphenhydramine. Resolved within 24-48 hours.
Age: 57.0
Sex: U
Vaccine: TDAP
Symptoms: Chills, Dizziness, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Patient reports fever, chills, redness & pain to injection site, and slight dizziness. Treated with BENADRYL, ibuprofen, warm compress.
Age: 37.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Erythematous, edematous left upper arm with tenderness and warmth, painful. Pt experienced high fever. Treatment with ibuprofen 800mg, prednisone, clindamycin.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Pain
Clinical narrative: Redness / induration / pain x 3 days - left deltoid possible cellulitis also -> Treated with antibiotic & pain relievers.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 years old female patient who on 15-AUG-2012 was vaccinated with dose 1 GARDASIL injection, intramuscularly (dose, and lot number not provided). It was reported that the patient also received doses of GARDASIL on 25-OCT-2012 and on 04-JAN-2013 respectively (dose, route and lot number not reported). No adverse effect reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Anxiety, Conversion disorder, Facial pain, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Immediately following administration of Tdap Lt deltoid pt experienced hysteria, Lt facial numbness, sharp pain Lt shoulder to face, anxiety & shakiness. VS remain stable - pt given BENADRYL all sxs ceased over the next 5-10 min.
Age: 56.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal pain, Tremor
Clinical narrative: Immediately following administration of Tdap Lt deltoid pt experienced hysteria, Lt facial numbness, sharp pain Lt shoulder to face, anxiety & shakiness. VS remain stable - pt given BENADRYL all sxs ceased over the next 5-10 min.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Wrong technique in drug usage process
Clinical narrative: Administered HIB with diluent (sterile H2O) instead of provided liquid.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Wrong technique in drug usage process
Clinical narrative: Administered HIB with diluent instead of provided solution.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itch around the injection site.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Presyncope, Visual impairment
Clinical narrative: Vagal response - dizziness, trouble seeing, nausea, called EMT's after pt sat for several mins. was ok and walked out without help & was cleared by EMT's.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Day 1-2 after injection local rx red warm to touch. Rx faded. 1/13/13 injection site red warm to touch again, pt feeling fatigued. 1/14/13 - Rx improved, less fatigue, injection site redness fading.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule, Skin warm
Clinical narrative: Arm hot & has a knot about the size of 1 inch in diameter.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Dyspnoea, Erythema, Feeling of body temperature change
Clinical narrative: Shortness of breath, nauseated, 103 degrees temp, dizzy, looked like: "posturing of all joints", severe headache. DK reddened face, hurt all over. Some confusion, hot/cold started about 1 hr after vaccination & increased until severe by AM.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Posturing
Clinical narrative: Shortness of breath, nauseated, 103 degrees temp, dizzy, looked like: "posturing of all joints", severe headache. DK reddened face, hurt all over. Some confusion, hot/cold started about 1 hr after vaccination & increased until severe by AM.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Nausea, sweating, paleness, dizzy, weak.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Dizziness, Malaise, Vision blurred
Clinical narrative: The patient received an intramuscular dose of prefilled FLUZONE at around 3:45 PM. She waited about minutes while her brother received his dose. She appeared fine and left. A few minutes later she reported feeling unwell with dizziness, unable to walk and cloudy eyes. The EMT was called and she was seen by them. They left about 15 mins later with the patient walking.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever 101 degrees F from 3AM (1-9-13) to 3 PM (1-9-13) weakness - resolved after 48 hours.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient (gender and age unknown). On 06-NOV-2012, the patient was vaccinated with GARDASIL (lot number not provided), 0.5 ml, intramuscular. On 08-JAN-2013, the patient received GARDASIL (lot # 667165/1167Z; expiration date on 08-DEC-2012), 0.5 ml, intramuscular. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of the patient received an expired dose of GARDASIL was unknown. Patient received an expired dose of GARDASIL was not related to GARDASIL. Additional information ahs been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown gender and age who on 24-MAY-21012 was vaccinated with dose 1 GARDASIL injection (dose, route and lot number not provided). It was reported that the patient also received dose of GARDASIL on 03-AUG-2012 and on 10-OCT-2012. No adverse effect reported. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Headache, Lymphadenopathy
Clinical narrative: This spontaneous report was received from a consumer refers to her son, 21 years old male patient. On unknown date, the patient was vaccinated with GARDASIL (lot number, dose and route not provided) as HPV vaccination. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced headaches and swollen glands. No treatment information was reported. Blood work was done three weeks ago (results not provided). The patient sought medical attention. The outcome of headache and swollen glands was reported as not recovered. The relatedness for headache and swollen glands was unknown for GARDASIL. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Cough, Influenza like illness, Oropharyngeal pain, Respiratory tract congestion, Sneezing
Clinical narrative: Flu-like symptoms: chest congestion, cough, sneezing, sore throat.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 18 years old female patient who in sometime in May 2012 was vaccinated with her first dose of GARDASIL 0.5 ml, injection, intramuscularly on left arm (lot number not provided) and the second dose of GARDASIL (dose, route and lot number was not provided) was administered on 09-JAN-2013. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old male patient with walnut allergy. The nurse reported that the patient received series dose of live (Merck) VARIVAX (Lot# not reported), 1st dose on 23-FEB-2009, and 2nd dose on 27-FEB-2012. Concomitant medications included: EPIPEN for walnut allergy. On 03-JAN-2013 the patient contracted the chicken pox. Nurse reported that "the rash started on the patient's buttocks and was spreading throughout his body." The patient visited office for medical attention. BENADRYL and calamine lotion were given for treatment. At the time of this report the patient had not recovered from chicken pox. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of live (Merck) VARIVAX (lot # reported as 1040Z, exp date 11-AUG-2012), subcutaneously on 09-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. She reported that the patient was seen to receive a dose of live ZOSTAVAX today 09-JAN-2013, but instead received live (Merck) VARIVAX, which had expired. No adverse effects reported. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 87 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated SC with single dose of live ZOSTAVAX (lot # reported as H01049, exp. 05-SEP-2013) into her left arm on 28-DEC-2012. Concomitant therapy including unspecified eye drops. On 30-DEC-2012 the patient experienced redness and soreness at injection site, 3 days after onset of therapy and soreness at injection site. The patient came to pharmacy for medical attention. The patient had self-treated with TYLENOL. The outcome of redness and soreness at injection site was reported as recovering/resolving. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information has been received from a pharmacist concerning a male patient with an unspecified age, pertinent medical history or drug reactions / allergies. Approximately in December 2012, the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX23 (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 28-DEC-2012, the patient experienced swelling and redness at the injection site after the administration of PNEUMOVAX23. This was also the patient's second dose of PNEUMOVAX23 within a year to year period. The patient was unaware of his vaccination history prior to receiving the second dose of PNEUMOVAX23: The patient was advised to apply cold compresses and ice. There was not lab diagnostics test performed. On 04-JAN-2013, the patient recovered, within 1 week all swelling and redness had disappeared. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to unknown number of patients who on an unspecified dates may have received a dose of PNEUMOVAX23 (dose, route and lot number not reported) that was stored above the proper temperature range. No other co-suspects were reported. No concomitant medications were reported. The unknown number of patients were not experiencing any known symptoms. Patients' outcome were unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site joint pain
Clinical narrative: This spontaneous report as received from a of unknown age consumer refers to herself, ho on 10-JAN-2013, was vaccinated with a dose of PNEUMOVAX23 (dose and lot number were not reported). NO other co-suspects were reported. No concomitant medications were reported. The consumer reported that during the injection of PNEUMOVAX23 that she moved from the needle piercing her skin. From the sudden shift, the patient was experiencing pain in her right shoulder. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients (unspecified number) of unknown age, who were vaccinated with a dose of live (Merck) VARIVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient could have received doses of live (Merck) VARIVAX that were improperly stored. The nurse reported that her practice had "dormitory-style" freezer and when new thermometer was placed in, temperature reading was around 10-15 F. The nurse reported that could not tell how long live (Merck) VARIVAX might had been exposed to 10- 15 F. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Diabetes mellitus, Erythema, Feeling hot, Flushing
Clinical narrative: This spontaneous report as received from a physician refers to a 67 years old male patient with diabetes, hypertension, hyperlipidemia, vitamin B12 deficiency, depression and no drug reactions/allergies. On 04-JAN-2013, the patient was vaccinated IM with a booster dose of PNEUMOVAX23 (lot # H013399, Exp. Date: 07-MAR-2014). No other co-suspects were reported. Concomitant medications included metformin XR, hydrochlorothiazide (+) lisinopril. JANUVIA, LIPITOR, glipizide, vitamin B12, PROTONIX and amitriptyline hydrochloride. On 04-JAN-2013, the patient became flushed and warm 5-10 minutes after receiving "a booster dose" of PNEUMOVAX23,. The physician stated that patient was visibly red in the face, arms, hands and chest and the patient reported he felt hot and had a headache. The physician mentioned these symptoms subsided within 20 minutes and mentioned the patient had fasted for 14 hours prior to receiving PNEUMOVAX23 for unspecified blood work testing and was diabetic. The physician also mentioned the patient received a first dose of PNEUMOVAX23 on an unspecified date in October 1998. The patient was given water for the events. No lab diagnostics studies were performed. At the time of the report, the patient was recovering from the evens. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Skin warm
Clinical narrative: This spontaneous report as received from a physician refers to a 67 years old male patient with diabetes, hypertension, hyperlipidemia, vitamin B12 deficiency, depression and no drug reactions/allergies. On 04-JAN-2013, the patient was vaccinated IM with a booster dose of PNEUMOVAX23 (lot # H013399, Exp. Date: 07-MAR-2014). No other co-suspects were reported. Concomitant medications included metformin XR, hydrochlorothiazide (+) lisinopril. JANUVIA, LIPITOR, glipizide, vitamin B12, PROTONIX and amitriptyline hydrochloride. On 04-JAN-2013, the patient became flushed and warm 5-10 minutes after receiving "a booster dose" of PNEUMOVAX23,. The physician stated that patient was visibly red in the face, arms, hands and chest and the patient reported he felt hot and had a headache. The physician mentioned these symptoms subsided within 20 minutes and mentioned the patient had fasted for 14 hours prior to receiving PNEUMOVAX23 for unspecified blood work testing and was diabetic. The physician also mentioned the patient received a first dose of PNEUMOVAX23 on an unspecified date in October 1998. The patient was given water for the events. No lab diagnostics studies were performed. At the time of the report, the patient was recovering from the evens. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was inadvertently vaccinated SC with a 0.5 ml dose of live (Merck) VARIVAX (lot # 669645/0033AA) on 04-JAN-2013 that had expired on 18-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Endotracheal intubation, Irritability, Mental status changes, Respiratory failure
Clinical narrative: This spontaneous report as received from a physician refers to a 12 months old male patient who on 29-AUG-2012 was vaccinated in the right thigh with a one vial dose of M-M-R II (lot number 1570AA, expiration date: October 2013) and VARIVAX (Merck) (lot number 1145AA, expiration date: July 2013) on the left thigh. No concomitant medications were reported.. The patient was very cranky after the shot. Then when the patient was taken to home. The patietn expeirienced several very severe adverse experiences on 29-AUG-2012. These adverse experienced were vomiting, hiving seizures, having an alered mental state and respiration failure. The patient's mother called 911 and the patient was taken in an ambulance to the hospital for an unspecified about of time until the patient was transferred to other hospital. The patient sought medical attention and was treated for adverse events, he was incubated while he was at this hospital. At the time of the repot, the patient had not recovered from adverse events. He was currently stable and he was removed from incubation. The patient was still at the hospital. The relatedness for the adverse events was unknown for M-M-R II and VARIVAX (Merck). The adverse events were considered as life-threatening and disabling. Follow up information received with aware date of 11-SEP-2012. The patient's current conditions included torticollis for which he was scheduled for physical therapy and a very mild growth motor delay. The patient was vaccinated with M-M-R II and VARIVAX (Merck) subcutaneously. The patient was treated with DIASTAT rectal gel for the event of seizures. The patient was discharged form the hospital on 31-AUG-2012 (also reported as 2 or 3 days after admission) but she has not yet seen him in the office. It was unknown if the patient has started on any anti-seizure medications but the patient wsa noted to follow up with the neurologist. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 12 months old male patient who on 29-AUG-2012 was vaccinated in the right thigh with a one vial dose of M-M-R II (lot number 1570AA, expiration date: October 2013) and VARIVAX (Merck) (lot number 1145AA, expiration date: July 2013) on the left thigh. No concomitant medications were reported.. The patient was very cranky after the shot. Then when the patient was taken to home. The patietn expeirienced several very severe adverse experiences on 29-AUG-2012. These adverse experienced were vomiting, hiving seizures, having an alered mental state and respiration failure. The patient's mother called 911 and the patient was taken in an ambulance to the hospital for an unspecified about of time until the patient was transferred to other hospital. The patient sought medical attention and was treated for adverse events, he was incubated while he was at this hospital. At the time of the repot, the patient had not recovered from adverse events. He was currently stable and he was removed from incubation. The patient was still at the hospital. The relatedness for the adverse events was unknown for M-M-R II and VARIVAX (Merck). The adverse events were considered as life-threatening and disabling. Follow up information received with aware date of 11-SEP-2012. The patient's current conditions included torticollis for which he was scheduled for physical therapy and a very mild growth motor delay. The patient was vaccinated with M-M-R II and VARIVAX (Merck) subcutaneously. The patient was treated with DIASTAT rectal gel for the event of seizures. The patient was discharged form the hospital on 31-AUG-2012 (also reported as 2 or 3 days after admission) but she has not yet seen him in the office. It was unknown if the patient has started on any anti-seizure medications but the patient wsa noted to follow up with the neurologist. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal mass, Abnormal behaviour, Apnoeic attack, Autopsy, Cardiac arrest
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 24-MAY-2012, a 0.5 year old male with otitis media and cough and with no known relevant medical history was vaccinated orally with a third dose of ROTATEQ (Lot # 669571/1474AA). Suspect therapy included a third dose of PEDVAXHIB (Lot # reported as UH416AB) vaccinated intramuscularly in his right leg. Concomitant therapy included PREVNAR (Lot # F65442) vaccinated intramuscularly in his left leg and PEDIARIX (Lot # AC21B305CA) intramuscularly in his right leg. Other concomitant therapy included amoxicillin. On 28-MAY-2012 the patient began having diarrhea. On 29-MAY-2012, the patient was a little fussy in the morning, his mom gave gripe water and baby ORAGEL. The patient's babysitter called his dad in the afternoon saying that the patient was not himself. When the dad picked him up he said the child was "out of it". Went to grandfather's house and called EMS. On EMS arrival patient had pulse in the 140's and RR in the 30's, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed. X-ray performed, it showed no focal pulmonary consolidation. Multiple prominent air filled bowel loops. No free air. Resuscitation was unsuccessful and the patient passed away. Upon attempt at a rectal temperature, bloody stool was noted in the diaper. There was also palpable mass in the abdomen. The medical examiner confirmed the presence of intussusception on the autopsy. The original reporting source was not provided. The VAERS ID # is 456644-1. Lot number UH416AB is an invalid lot number for PEDVAXHIB. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Diarrhoea, Haematochezia, Intussusception, Irritability
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 24-MAY-2012, a 0.5 year old male with otitis media and cough and with no known relevant medical history was vaccinated orally with a third dose of ROTATEQ (Lot # 669571/1474AA). Suspect therapy included a third dose of PEDVAXHIB (Lot # reported as UH416AB) vaccinated intramuscularly in his right leg. Concomitant therapy included PREVNAR (Lot # F65442) vaccinated intramuscularly in his left leg and PEDIARIX (Lot # AC21B305CA) intramuscularly in his right leg. Other concomitant therapy included amoxicillin. On 28-MAY-2012 the patient began having diarrhea. On 29-MAY-2012, the patient was a little fussy in the morning, his mom gave gripe water and baby ORAGEL. The patient's babysitter called his dad in the afternoon saying that the patient was not himself. When the dad picked him up he said the child was "out of it". Went to grandfather's house and called EMS. On EMS arrival patient had pulse in the 140's and RR in the 30's, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed. X-ray performed, it showed no focal pulmonary consolidation. Multiple prominent air filled bowel loops. No free air. Resuscitation was unsuccessful and the patient passed away. Upon attempt at a rectal temperature, bloody stool was noted in the diaper. There was also palpable mass in the abdomen. The medical examiner confirmed the presence of intussusception on the autopsy. The original reporting source was not provided. The VAERS ID # is 456644-1. Lot number UH416AB is an invalid lot number for PEDVAXHIB. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mechanical ventilation, Resuscitation, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 24-MAY-2012, a 0.5 year old male with otitis media and cough and with no known relevant medical history was vaccinated orally with a third dose of ROTATEQ (Lot # 669571/1474AA). Suspect therapy included a third dose of PEDVAXHIB (Lot # reported as UH416AB) vaccinated intramuscularly in his right leg. Concomitant therapy included PREVNAR (Lot # F65442) vaccinated intramuscularly in his left leg and PEDIARIX (Lot # AC21B305CA) intramuscularly in his right leg. Other concomitant therapy included amoxicillin. On 28-MAY-2012 the patient began having diarrhea. On 29-MAY-2012, the patient was a little fussy in the morning, his mom gave gripe water and baby ORAGEL. The patient's babysitter called his dad in the afternoon saying that the patient was not himself. When the dad picked him up he said the child was "out of it". Went to grandfather's house and called EMS. On EMS arrival patient had pulse in the 140's and RR in the 30's, by the time patient arrived at the ED patient was apneic and asystolic with bag valve mask ventilation being performed. X-ray performed, it showed no focal pulmonary consolidation. Multiple prominent air filled bowel loops. No free air. Resuscitation was unsuccessful and the patient passed away. Upon attempt at a rectal temperature, bloody stool was noted in the diaper. There was also palpable mass in the abdomen. The medical examiner confirmed the presence of intussusception on the autopsy. The original reporting source was not provided. The VAERS ID # is 456644-1. Lot number UH416AB is an invalid lot number for PEDVAXHIB. No further information is available.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal pain, Neck pain
Clinical narrative: Immediately after receiving vaccine, this employee had pain which radiated to the shoulder and neck regions.  She continued to work until the arm was numb, felt heavy, and had a sharp needle like pain in the hands. Symptoms did not improve despite ibuprofen.  She was seen at a local ED and then referred to her primary care doctor.  The primary care doctor referred patient to a neurologist and neurophysiologist.  He treated the patient with gabapentin and prednisone.  MRI and EMG performed, but I did not learn results. At this time, pain is improved.   Patient missed 3 months of work.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Sensation of heaviness
Clinical narrative: Immediately after receiving vaccine, this employee had pain which radiated to the shoulder and neck regions.  She continued to work until the arm was numb, felt heavy, and had a sharp needle like pain in the hands. Symptoms did not improve despite ibuprofen.  She was seen at a local ED and then referred to her primary care doctor.  The primary care doctor referred patient to a neurologist and neurophysiologist.  He treated the patient with gabapentin and prednisone.  MRI and EMG performed, but I did not learn results. At this time, pain is improved.   Patient missed 3 months of work.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Chest discomfort, Dyspnoea, Flushing, Heart rate increased
Clinical narrative: Pt.'s face began to get flush & heart rate increased with SOB. Lasted about 10 minutes, gave 50mg of BENADRYL P.O. monitored for 2 hrs with provider on site.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Dyspnoea, Flushing, Heart rate increased
Clinical narrative: Pt.'s face began to get flush & heart rate increased with SOB. Lasted about 10 minutes, gave 50mg of BENADRYL P.O. monitored for 2 hrs with provider on site.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient with itching, treat with BENADRYL 50mg every 6 hours. The patient only take one dose.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Myelitis transverse, Pain, Paralysis
Clinical narrative: This spontaneous report was received from a consumer concerning his approximately 84 year old father in-law with no drug reactions/allergies. The medical history of the patient included 2 replacements of valves in his heart and a pacemaker. On 18-JUN-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were 672608/1715AA and 02-FEB-2013 respectively) (dose and route unspecified). Concomitant medication included COUMADIN. On 15-DEC-2012, the patient experienced transverse myelitis. Approximately on 26-DEC-2012 (for the last 2 weeks), he experienced extreme pain and is now paralyzed from the waist down. He was admitted to the Medical Center since 01-JAN-2013. He was treated with an unspecified medication to boost his blood pressure. On an unknown date, computerized tomography scans with dye and unspecified blood test were performed. The outcomes of all the events were reported as not resolved. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.