chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPVX, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness swelling, localized to upper R arm only.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Blisters, pruritis, urticaria on palms of hands. Primarily on right hand, scant on left hand. Pt reports self treating with cortisone cream with minimal relief. Will continue to monitor and assess. Instructed pt to f/u with PCP if the condition does not resolve or gets worse.
Age: 86.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Patient claimed she has pain and discomfort at the site of injection.
Age: 37.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, TYP, YF
Symptoms: Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: Client called and notified me of events below 3-2-15 Client states went to ER 12 days after receiving vaccines for "vertigo and vomiting." States ER Doctor diagnosed her with "vestibular neuritis." States he told her it was probably caused by "either the vaccines or exposure to the Herpes virus from her husband's cold sores" was hospitalized x 2days.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Dizziness, Heart rate increased
Clinical narrative: TIGHTNESS IN CHEST, DIZZINESS, FAST HEARTBEAT.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Paraesthesia oral, Pruritus, Syncope, Vomiting
Clinical narrative: Syncopal episode, dizziness, vomited, tingling to tongue, itching.
Age: 1.04
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Abasia, Abnormal behaviour, Lethargy, Pain, Pain in extremity
Clinical narrative: Patient was in extreme pain, he couldn't walk and had a high fever became really lethargic and stopped talking or interacting. He never spoke again till he was about 3 1/2 and his speech development was slow.
Age: 1.04
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Speech disorder developmental
Clinical narrative: Patient was in extreme pain, he couldn't walk and had a high fever became really lethargic and stopped talking or interacting. He never spoke again till he was about 3 1/2 and his speech development was slow.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Asthenia, Depressed level of consciousness, Hyperhidrosis, Pallor, Seizure
Clinical narrative: While baby was sleeping, his body became extremely hot. I woke him up to give him some Tylenol and he began to start convulsing and sweating profusely. I took all of his clothes off and wiped him down with a cool paper towel while he was still convulsing and then he had a bowel movement and stopped convulsing. Then, he became very week, faint, and pale. He also was not alert for about 5 minutes. I then called 911.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Skin warm, Syncope
Clinical narrative: While baby was sleeping, his body became extremely hot. I woke him up to give him some Tylenol and he began to start convulsing and sweating profusely. I took all of his clothes off and wiped him down with a cool paper towel while he was still convulsing and then he had a bowel movement and stopped convulsing. Then, he became very week, faint, and pale. He also was not alert for about 5 minutes. I then called 911.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, X-ray normal
Clinical narrative: Pain in shoulder noted 10/07/14 and decreased range of motion noted 10/09/2014 along with severe pain.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Reports body/joints aches, fatigue. Resolved without treatments.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dizziness, Urticaria, Vomiting
Clinical narrative: Dizziness, vomiting, urticaria.
Age: 42.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, hives following flu shot.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Fever 100.5 degree F-101. Achy joints the next day (knees, hips, shoulders).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Extended local reaction to flu shot in left deltoid. Itching, erythema, pain, swelling extending into shoulder.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain developed distal to injection site, began within several hours of the injection. Got progressively worse, by Friday she could not move her arm enough, secondary to pain, to dress herself. Slight improvement but still with abduction and extension Lt deltoid.
Age: 58.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain developed distal to injection site, began within several hours of the injection. Got progressively worse, by Friday she could not move her arm enough, secondary to pain, to dress herself. Slight improvement but still with abduction and extension Lt deltoid.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Immediate reaction at site of injection of flu shot in Lt. deltoid. Redness and itching.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Eye movement disorder, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3 1/2" wide 2" length  swollen, redness, tenderness at injection site Lt leg turned gray and eyes rolled back into head per dad after shots. Mom has "weird" reactions when receiving anything.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: (L) deltoid with redness, warmth and c/o itching.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Sore shoulder and arm with movement.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Patient complained of severe muscle aches in both arms in which vaccines were administered. Received FLUVIRIN. Received PNEUMOVAX.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Red reaction in left arm 100mm long and 110mm wide.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Pain in extremity
Clinical narrative: After vaccines had arm pain and dizziness, felt tired. Experiencing bilateral arm pain, dizziness and tiredness after returning to office 2-2.5 hrs post visit.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients of unknown age and gender. Medical history and concurrent condition of the patients were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ, orally (lot#, expiry date, dose unspecified), that was stored improperly. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Culture throat, Pallor, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient first developed spots to the right side of her face on 02/21/2015 sometime in the afternoon. Patient boarded a flight.  When patient arrived home rash began to spread from cheek to rest of body, entire body was covered except palms and soles of feet. Mom reports by 2/22/2015 patient was covered with rash. Patient also had slight runny nose and low grade fever. Patient came to our office on 2/24/2015 reporting rash was not as bad as it had been two days ago. Patient presented in office with rash to body from head to toe zero rash to palms or soles of feet. Rash to arms and legs redder, flat, blanching.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rhinorrhoea
Clinical narrative: Patient first developed spots to the right side of her face on 02/21/2015 sometime in the afternoon. Patient boarded a flight.  When patient arrived home rash began to spread from cheek to rest of body, entire body was covered except palms and soles of feet. Mom reports by 2/22/2015 patient was covered with rash. Patient also had slight runny nose and low grade fever. Patient came to our office on 2/24/2015 reporting rash was not as bad as it had been two days ago. Patient presented in office with rash to body from head to toe zero rash to palms or soles of feet. Rash to arms and legs redder, flat, blanching.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Redness down arm, swelling, pain in arm, itchiness.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Breast pain, Chills, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Inability to move my left arm AT ALL. Frozen in place with arm across my stomach.  Continuous excruciating throbbing pain in shoulder, radiating down to elbow, shoulder blade, breast area, and up neck.  Uncontrollable shivering, nausea, horrible headache, I'm pretty sure low grade fever (but I didn't have a thermometer so can't be positive).  All this lasted from 2/24/15 at 11:00am until around Thursday morning after taking 2 Aleve every 4 hours.  Went back to Dr. on 2/26/15 @ 2:40 pm where she was able to release my arm to my side, but thats all the movement I got.  Then it was frozen to my side.  Dr. gave me RX for 600mg Ibruprofen, to be taken every 6 hours with Tylenol inbetween.  By 3/3/15 still could not move my arm, shoulder, so started physical therapy.  Will continue with PT for now.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Pyrexia
Clinical narrative: Inability to move my left arm AT ALL. Frozen in place with arm across my stomach.  Continuous excruciating throbbing pain in shoulder, radiating down to elbow, shoulder blade, breast area, and up neck.  Uncontrollable shivering, nausea, horrible headache, I'm pretty sure low grade fever (but I didn't have a thermometer so can't be positive).  All this lasted from 2/24/15 at 11:00am until around Thursday morning after taking 2 Aleve every 4 hours.  Went back to Dr. on 2/26/15 @ 2:40 pm where she was able to release my arm to my side, but thats all the movement I got.  Then it was frozen to my side.  Dr. gave me RX for 600mg Ibruprofen, to be taken every 6 hours with Tylenol inbetween.  By 3/3/15 still could not move my arm, shoulder, so started physical therapy.  Will continue with PT for now.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster Diagnosis at pediatrician in a one dose varicella vaccine recipient on 12/11/2014. Unilateral in one dermatome. Lasted less than 4 weeks. No antiviral treatment. Also had loose stool. Given amoxicillin. Rash in palm of hand to right forearm.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Rheumatoid arthritis
Clinical narrative: Patients daughter explained her father had a Prevnar 13 vaccine in June, then a blood transfusion that he had a reaction to in July, then possible reaction in October to Fluvirin lot 1413101 exp Jun 15 -that lead him to have severe attack of RA.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: Patient got localized rash (looking like hives).   Very swollen thigh around area of injection.  Entire leg above knee is red.  Still ongoing 3 days later.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Blood glucose increased, Body temperature increased, Diplopia, Hyperhidrosis, Oxygen saturation decreased
Clinical narrative: Blood sugar over 200, Temp 100.4, Double vision, Sweating for 2 days after shot, pulse ox dropped to 82.
Age: 1.88
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Malaise, Oropharyngeal pain, Photophobia, Pyrexia
Clinical narrative: She seemed off since being exposed. Kept her at home and away from others while she got better. She was a text book study. Pink eye, fever, sore throat, photophobia, rash... The rash showed up about a week later. Severe photophobia. Her fever got up to 105 for only 30 minutes and then went down after we gave her a bath to bring the fever down and gave her homeopathic remedy to bring it down. It did. We almost went to the hospital but called again and they said as long as it was going down and she was functioning, eating and drinking, just to keep an eye on her. It took a few weeks to get over. Gave her homeopathic remedy Euphrasia 30x and it helped alleive the pain of photophobia during that time. Then homeopathic remedy Belladonna 30x for the high fever, which she responded to very quickly any time her fever came on. And to get the rash to go away Sulphuricum Acidicum homeopathic remedy 30x. She wasn't itchy.
Age: 1.88
Sex: F
Vaccine: MMR
Symptoms: Rash, Secondary transmission
Clinical narrative: She seemed off since being exposed. Kept her at home and away from others while she got better. She was a text book study. Pink eye, fever, sore throat, photophobia, rash... The rash showed up about a week later. Severe photophobia. Her fever got up to 105 for only 30 minutes and then went down after we gave her a bath to bring the fever down and gave her homeopathic remedy to bring it down. It did. We almost went to the hospital but called again and they said as long as it was going down and she was functioning, eating and drinking, just to keep an eye on her. It took a few weeks to get over. Gave her homeopathic remedy Euphrasia 30x and it helped alleive the pain of photophobia during that time. Then homeopathic remedy Belladonna 30x for the high fever, which she responded to very quickly any time her fever came on. And to get the rash to go away Sulphuricum Acidicum homeopathic remedy 30x. She wasn't itchy.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Back pain, Feeling abnormal, Injection site pruritus, Rhinorrhoea
Clinical narrative: Unusual feeling. Back pain. Hair loss. Runny nose. Itching in area of shot.
Age: 18.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Patient admitted to Nurse she might be pregnant. Pt had #3 HPV; #2 MCV4 & Flu IM.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Lethargy
Clinical narrative: Mom states patient was lethargic for 1 1/2 days after receiving HPV#2. Also lethargic for 5 hours after 1st dose on 8/12/14. He required no treatment and we didn't hear about the reaction until mom called recently to explain why she was cancelling the appointment for HPV #3.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: The patient experienced a non allergic rash around the injection site. She reported this event to myself (immunizing pharmacist) on 3/4/15.  She did not seek medical attention.  The rash was discribed as burning, red, and not itchy.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Dry skin, Rash, Rash erythematous
Clinical narrative: Rash developed base of the back of the neck and upper part of the back, it looked like a sunburn. There was a mild amount of red pimple like spots on the abdomen. Took patient in 02/09/2015, at 6:00 PM. Saw doctor who diagnosed it as dry skin. On 02/11/2015 the rash had progressed covering all the back, torso, abdomen and also spread to arms and legs. Took patient in 02/11/2015, first thought it was a newborn rash, then ruled that out as patient was too old, then thought it may be viral then said could be eczema. On 2/09/15 and 2/11/15 both doctors ruled out antibiotics that were started on 2/6/15 as a reason for the rash. It was gone about a week later, approx 2/17/15.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Influenza like illness, Malaise, Overdose, Wheezing
Clinical narrative: This case was reported by a consumer and described the occurrence of cough in a 69-year-old male patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for asthma and VENTOLIN Hfa inhaler for asthma, wheezing and wheezing. Concurrent medical conditions included COPD from asthma. On an unknown date, the patient received Influenza vaccine at an unknown dose and ADVAIR Diskus (inhaled) at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the patient started VENTOLIN Hfa (inhaled) at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine, ADVAIR Diskus and VENTOLIN Hfa, the patient experienced cough, overdose, sickness and wheezing. The dose of ADVAIR Diskus was increased. The dose of VENTOLIN Hfa was increased. On an unknown date, the outcome of the cough, sickness and wheezing were recovering/resolving and the outcome of the overdose was not recovered/not resolved. The reporter considered the cough, sickness and wheezing to be unrelated to Influenza vaccine and ADVAIR Diskus. It was unknown if the reporter considered the cough, overdose, sickness and wheezing to be related to VENTOLIN Hfa. A patient who has been on unknown doses of ADVAIR and VENTOLIN for a long time has been taking a little more of both ADVAIR and VENTOLIN than usual/as prescribed because he has been sick. Even though he got his flu shot the patient's wife said it was something like the flu not the actual flu. He has been coughing and wheezing more than normal. He is now doing a bit better and not coughing as much.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect product storage
Clinical narrative: This pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, an unkonwn time after receiving BOOSTRIX, the patient experienced vaccine exposure during pregnancy and incorrect storage of drug. On an unknown date, the outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown. A BOOSTRIX vaccine that was stored below 32 degrees F was administered to a pregnant patient. RN had no further information. She will call back with more info on the patient. All that was given was recorded.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Breath sounds, Bronchitis, Dyspnoea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 55-year-old male patient who received Flu vaccine. Co-suspect products included ADVAIR Diskus inhalation powder (batch number 3ZP4760, expiry date unknown) for chronic obstructive pulmonary disease. The patient's past medical history included pneumonia (born with pneumonia). Concurrent medical conditions included hypertension (has had it for 5-10 years) and anemia (since he was a little boy). Concomitant products included Albuterol, ipratropium and trazodone. In October 2014, the patient received Flu vaccine. In 2013, the patient started ADVAIR Diskus (inhaled) 1 puff(s) (see dose text). On an unknown date, the dose was changed to an unknown dose and frequency. In October 2014, an unknown time after receiving Flu vaccine and ADVAIR Diskus, the patient experienced breath sounds. On 29th October 2014, the patient experienced fever, bronchitis and difficulty breathing. ADVAIR Diskus was continued with no change. On an unknown date, the outcome of the fever, bronchitis, difficulty breathing and breath sounds were unknown. The reporter considered the fever, bronchitis, difficulty breathing and breath sounds to be unlikely related to Flu vaccine and ADVAIR Diskus. Additional information: the caller reports that her partner has taken ADVAIR Diskus for about a year and a half. She reports that he takes one puff twice a day of the ADVAIR Diskus. The caller reports that her partner received a flu shot last week on Wednesday or Tuesday of last week. She reports that he started to develop a fever on 29 October 2014. He also had bronchitis like symptoms since then. She reports that he has had difficulty breathing and has been making gurgling sounds since then. She reports that her partner usually gets bronchitis about this time every year. She also reports that they are going to the doctor right now to see what is wrong with him.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Injection site nodule, Injection site pain, Injection site reaction
Clinical narrative: Initial reactoin of bluish color around injection site that went away after a few days; "knotted" feeling with soreness around injection site that has gotten worse.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash, Rash erythematous, Skin discolouration
Clinical narrative: "Pink discoloration of skin from crotch up to belly button with red scattered spots from waist up to chest." Doctor visit made 02/13/15 P.M. Doctor felt it was a normal reaction and possibly related to having a fever before having the shots. Parent was advised by physician to continue to get vaccinations according to recommendations.
Age: 0.62
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pyrexia, Rash, Urticaria, Vomiting
Clinical narrative: Given Quad flu vaccine at 10:25, had LG fever 99.8 (temporal temp) no other symptoms. MOC called at 2:44 pm to report rash, later during the night started vomiting and diarrhea. Rash/hives have persisted. BENADRYL prn given.
Sex: M
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age referring to himself. The patient's medical history included chronic headaches. On 11-FEB-2015, the patient was vaccinated with the 1st dose of GARDASIL (lot # not reported). The patient stated that after receiving the shot of GARDASIL his headache worsened. He referred it as constant pulsating in his head. He described feeling his heart in his head ever since getting GARDASIL. The patient tried calling physician's office. The outcome of headache was unknown. Additional information is not expected, because the patient did not wish to provide information.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 24-OCT-2014, the patient was vaccinated inadvertently with expired dose of PNEUMOVAX23 (lot number, dose, frequency and route unspecified) (expired product administered). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with PNEUMOVAX23 was not reported. Product quality issue was not involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-SEP-2014 the patient was vaccinated with the second dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Armpit on side of injection/vaccine itching since administration on 2/8.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: C/o (L) thigh pain. Redness and swelling appeared 3-4-15 afternoon.
Age: 1.79
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-SEP-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2-15 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Large red warm area on left arm itching, swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender who on unknown date in 2015 was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # J012679, expiration date 21-JAN-2015) intramuscular (dose and site of administration were not reported). No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a 48 years old female consumer as part of marketing research study reporting on herself. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) (route, dose, lot# and expiration date were not reported). On an unknown date the patient experienced malaise reported as "usually got sick". The outcome of the malaise was unknown. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MEN
Symptoms: Unevaluable event
Clinical narrative: No adverse event per pt.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Visual field defect
Clinical narrative: MENACTRA was given 3-2-15. Developed headache, dizziness, and "blind spot" in his vision on 3-4-15. Spoke with DOH, unsure if related.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 5-10 minutes after receiving 2 vaccines, pt developed an erythematous, blanching rash on his trunk and legs that he said itched somewhat. No respiratory symptoms; itching improved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Pt had a 2-5 minute tonic/clonic seizure right after DTaP, IPV, MMR, VARIVAX.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Fatigue, Feeling hot, Hypoaesthesia
Clinical narrative: 1 min post vaccine mild dizziness returned to office 2-2.5 hrs post vaccines feels tired and warm. (L) arm feels numb with no pain, (R) arm is fine.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Vomiting x2 the day vaccine was administered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Peripheral swelling
Clinical narrative: Arm Swelling, blisters on injection site.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm red swollen 4 x 3 cm
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Tenderness
Clinical narrative: Left arm soft tissue lump, mild tenderness.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Asymptomatic rash for 1 day mostly on trunk.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reaction within hours of given immunization to right upper thigh - redness and warmth at site of injections.
Age: 84.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: Redness and itchiness on the site of injection, small vesicular rash resembling zoster rash on and around the site of infection.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. In approximately December 2014 reported as about two months ago, the patient was vaccinated with a dose of ZOSTAVAX. On an unknown date, the patient was diagnosed with herpes zoster. The outcome of herpes zoster was unknown. Relatedness between the therapy with ZOSTAVAX and the herpes zoster was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL intramuscular (dose and lot # were not reported). On an unknown date the patient experienced postural orthostatic tachycardia syndrome after receiving GARDASIL. The outcome of this event was reported as recovered/resolved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 2 month old male patient. Patient's concurrent conditions, concomitant medication and medical history were not provided. On 02-MAR-2015 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (injection, lot#, strength, dose, route and expiry date were not provided) (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant via field representative refers to a 13 year old male patient. The patient's pertinent medical history was not reported. Approximately in August 2013 (reported as about one year ago) the patient was vaccinated with PROQUAD (Merck) (Dose/Frequency: one shot, Therapy Route: subcutaneous injection) accidentally "in an off-label use". Concomitant medications were not reported. The reporter felt this was off-label because she stated the product information states that MMR and VARIVAX (Merck) should have been received separately by the patient rather than a dose of PROQUAD (Merck) instead. No adverse effects were reported. There was no product confusion involved, there was no product quality complaint (PQC). 04-MAR-2015: This is a corrected report. The event of 'received a dose of PROQUAD accidentally in an off-label use" was changed to '13 year old received a dose of PROQUAD' and mapped to the preferred term of drug administered to patient of inappropriate age (previous mapped to off label use). The reporter felt there was off-label use (described above). However, this is not considered off label use. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Peripheral swelling
Clinical narrative: Redness and swelling to left arm below injection site. Patient reports it started on 2/26/14. Also complains of itching. Red, raised area to left arm. Measures 7 cm long x 14.5 cm wide. Warm to touch. Swelling under left arm - onset 3/3/15. Pt reports tenderness to arm and under arm. Treatment = cool compress as needed, moisturizer.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Redness and swelling to left arm below injection site. Patient reports it started on 2/26/14. Also complains of itching. Red, raised area to left arm. Measures 7 cm long x 14.5 cm wide. Warm to touch. Swelling under left arm - onset 3/3/15. Pt reports tenderness to arm and under arm. Treatment = cool compress as needed, moisturizer.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL intramuscular (dose and lot # were not reported). On an unknown date the patient experienced postural orthostatic tachycardia syndrome after receiving GARDASIL. The outcome of this event was reported as recovered/resolved. This is ine of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a pharmacist referring to a 63 year old female patient. Concurrent condition and medical history were not reported. The patient had no drug reactions or allergies. On 03-FEB-2105 the patient was vaccinated with a dose of ZOSTAVAX (strength 19400 PFU) (lot no. K016325, expiration date 24-DEC-2015, dose and route were unknown) (reported as routine administration). Concomitant therapies were not reported. On 04-FEB-2015, the patient experienced tingling down her arm and hand. No treatment was given for the adverse event. No lab diagnostic studies were performed. The patient did not seek for medical attention. There was no significant disability of hospitalization. The outcome of the event was reported as recovered/resolved on an unknown date in February 2015. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Presented to clinic approx 3 hrs after vaccine administration with hives to face and torso. Examined by physician given 7/5mL of BENADRYL in office. Instructions for follow up given to the mother.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical Nurse refers to unspecified number of patients of unknown demographics. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Vaccination site swelling
Clinical narrative: (L) arm area of vaccine was swollen, swelling went down, but left side hurts when he sleeps on it. Did not have similar reaction w/ the previous GARDASIL vaccine. No tenderness.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 14-OCT-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.21
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Rash similar to chicken pox all over child body.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients of unknown age and gender. Medical history and concurrent condition of the patients were not reported. On an unknown date the patients were vaccinated with a dose of PNEUMOVAX 23 (lot#, expiry date, dose, route unspecified), that was stored improperly. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient was given vaccine on 2/26/15. Pt. called us on 2/27/15 in evening stating she had "itchy" small rash around injection site. Patient asked if she could take BENADRYL, I stated it was okay to take, and we would let her MD know.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Information has been received from a 68 year old male patient referring to himself. The patient had no pertinent medical history or drug reactions/allergies. Between 15 to 18 years ago, on an unknown date, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (manufacture unknown) (lot#, strength, dose, route and expiry date were not provided). Concomitant therapies included LIPITOR. The patient experienced a mild reaction to the unspecified pneumococcal vaccine (manufacture unknown). The patient reported that he experienced redness, warmth around the injection site, and swelling within six hours of administration of the pneumococcal vaccine (manufacture unknown). Within the next two days the adverse effects dissipated and he recovered on an unknown date. The patient didn't seek for medical attention. No treatment was given for the adverse events. No lab diagnostics study was performed. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Hypersensitivity, Injection site erythema, Irritability, Pyrexia, Rash
Clinical narrative: The patient is a 6 month old, dependent who was referred to the agency, Immunization Healthcare Brand (IHB) by Dr for vaccine causality assessment of a rash following receipt of her 4 month vaccinations. According to the infant's mother the patient received her 2 month old vaccinations (PEDIARIX, PEDVAXHIB, PREVNAR 13 and ROTARIX) on 10/9/14 without adverse event. The infant received her 4 month vaccinations (PEDIARIX-left thigh, PEDVAXHIB -right thigh, PREVNAR 13-right thigh, and ROTARIX) on 12/17/14 at 1100. On 12/18/14 at 0400 the infant was noted to have a fever (103.0). The mother called the Nurse Advice Line (NAL) and treated the infant with a dose of TYLENOL. Later that evening (at 1800) the mother noted that the infant had "little red bumps/blotches" at each vaccination site and that the site was red and "felt warm". Over the next 12-96 hours the rash began to spread upward to the groin and downward toward the knee bilaterally. The mother took the infant to a ER on 12/20/14 and was told that the child was having an allergic reaction-no treatment was prescribed. Over the next week the rash slowly resolved. The infant was slightly fussy but continued to eat normally-without vomiting or diarrhea, sleep without difficulty, wet the normal amount of diapers and was consolable. On 2/25/15 the mother brought the patient to Clinic for her 6 month old check-up: her vaccinations were deferred due to "urticaria following 4 month vaccines".
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash erythematous, Rash macular, Urticaria, Vaccination site reaction, Vaccination site warmth
Clinical narrative: The patient is a 6 month old, dependent who was referred to the agency, Immunization Healthcare Brand (IHB) by Dr for vaccine causality assessment of a rash following receipt of her 4 month vaccinations. According to the infant's mother the patient received her 2 month old vaccinations (PEDIARIX, PEDVAXHIB, PREVNAR 13 and ROTARIX) on 10/9/14 without adverse event. The infant received her 4 month vaccinations (PEDIARIX-left thigh, PEDVAXHIB -right thigh, PREVNAR 13-right thigh, and ROTARIX) on 12/17/14 at 1100. On 12/18/14 at 0400 the infant was noted to have a fever (103.0). The mother called the Nurse Advice Line (NAL) and treated the infant with a dose of TYLENOL. Later that evening (at 1800) the mother noted that the infant had "little red bumps/blotches" at each vaccination site and that the site was red and "felt warm". Over the next 12-96 hours the rash began to spread upward to the groin and downward toward the knee bilaterally. The mother took the infant to a ER on 12/20/14 and was told that the child was having an allergic reaction-no treatment was prescribed. Over the next week the rash slowly resolved. The infant was slightly fussy but continued to eat normally-without vomiting or diarrhea, sleep without difficulty, wet the normal amount of diapers and was consolable. On 2/25/15 the mother brought the patient to Clinic for her 6 month old check-up: her vaccinations were deferred due to "urticaria following 4 month vaccines".
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to multiple unspecified patients of unknown age and gender. Medical history and concurrent condition of the patients were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (lot#, expiry date, dose, route unspecified), that was stored improperly. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lip swelling
Clinical narrative: Swelling of lips. PO BENADRYL given.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical nurse refers to unspecified number of patients of unknown demographics. Patiens concurrent and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis
Clinical narrative: Information has been received from an unspecified reporter, as part of a marketing research program, referring to a 42 years old female patient. On an unknown date the patient was vaccinated with a dose of pneumococcal vaccine (manufacture unknown) (strength, lot#, dosage and route unspecified). On an unknown date the patient reported that she caught a very bad case of acute bronchitis. The outcome of acute bronchitis was unknown. The causality between the event and pneumococcal vaccine (manufacture unknown) was unknown. The seriousness of the event was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical Nurse refers to unspecified number of patients of unknown demographics. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Since 01-JAN-2015, improperly stored VARIVAX (Merck) (lot#, expiration date, dose, frequency and route were unknown) were administered to multiple unspecified patients. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Pain, Rash, Rash generalised
Clinical narrative: Information has been received from a female patient of unknown age concerning herself. On 07-JAN-2015, the patient was vaccinated with her first and only dose of VARIVAX (Merck) (strength not reported, 1 dose, injection). On 21-JAN-2015, 14 days after receiving VARIVAX (Merck), the patient developed spots all over her body, including the injection site, with the largest spots on her face. Patient also said that she felt a full body ache. There was valacyclovir hydrochloride given as treatment for the adverse events. The patient went to see unspecified health care professional (HCP) for medical attention. The patients said most of the spots had crusted over. Outcome of the full body ache was unknown. Causality between the adverse events and VARIVAX (Merck) was unknown. Additional information is not expected since no contact information provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed practical nurse refers to unspecified number of patients of unknown demographics. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-SEP-2014 the patient was vaccinated with the first dose of PROQUAD (Merck), lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Irritability, Measles post vaccine, Rash generalised
Clinical narrative: 3/3/15 poss reaction to vaccine no appetite-rash all over body fussy-and diarrhea.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain
Clinical narrative: 43 yo female with no PMH received seasonal influenza vaccine on 10/2/14 on right arm. Despite use of NSAIDS and supportive care by applying ice and heat, pt persistently experienced pain in the right shoulder. No further information on symptom resolution available per chart review. Arthralgia.