chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient has red rash at site of injection. Patient advised to apply BENADRYL to the area. If rash persists see the doctor.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: Received TWINRIX, TDP, flu, pneumonia vaccine. KEFLEX.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Off label use
Clinical narrative: Patient given an Adult dose of Hep A in error.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: Fever, chills, muscle aches, shortness of breath, fatigue, headache, extreme sweating, loss of appetite.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, shortness of breath, fatigue, headache, extreme sweating, loss of appetite.
Age: 47.0
Sex: F
Vaccine: FLU3, HEPAB, PPV
Symptoms: Body temperature increased, Joint range of motion decreased, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: 2 days T - up to 102.8. Pain could not lift arm. Local swelling with increasing margins. Rx TYLENOL, BENADRYL, day 3 - KEFLEX.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia
Clinical narrative: This spontaneous report as from a consumer via social media who obtained the information from a third source launched a campaign against the HPV vaccine and released the video shown at last week's briefing, who reported that a 20 years old female on an unknown date was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date not reported). The patient stated that her parents never told about the adverse events that could occur after receiving GARDASIL. The patient reported that before receiving GARDASIL, she played soccer and softball. On an unknown date, after receiving GARDASIL she "could not walk". At the time of the report, the patient's outcome was unknown. It was stated that it was not a coincidence that the patient could not walk. Upon internal review "could not walk" was considered to be disabling. This is one of several reports received from the same source. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site rash, Injection site warmth
Clinical narrative: Reaction to ZOSTAVAX vaccination. Pt states "Bothered on Sunday, rash by Monday - big and hot, about the size of a silver dollar at injection site on back of arm, 2" above elbow."
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Syncope
Clinical narrative: This spontaneous report as from an other via social media who obtained the information from a campaign against the HPV vaccine and released a video, who reported that a 20 year old female patient prior to receiving GARDASIL was healthy, vibrant and fun-loving. It was reported that the patient's physician gave her all the right reasons to receive GARDASOL. On an unknown date, was vaccinated with a dose of GARDASIL (dose and route not reported). Prior to receiving GARDASIL there was no mention of GARDASIL side effects. On an unspecified date, the patient began fainting and days later was found dead in bed. It was reported that it was no coincidence that the patient died after receiving GARDASIL. This is one of several reports received from the same source. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt was asymptomatic day of injection, but site became red and sore the following evening. It formed a raised rash about 5" in diameter which was itchy and warm. She called her PCP on Monday and was instructed to apply cold compresses which gave some relief and improvement.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Pt was asymptomatic day of injection but woke up next day with a sore arm which was red, swollen and warm to the touch. The reaction was central to injection site and about the size of baseball I instructed him to apply cold compresses and contact PCP if it worsen or does not improve.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as from a consumer via social media who obtained the information from a third party, who reported that a female patient of an unknown age, on an unknown date was vaccinated with a dose of GARDASIL (dose, lot number, expiration date and route not reported). The patient stated that she was newlywed and always wanted to become a mom. On an unknown date, the patient was diagnosed with premature ovarian failure. At the time of the report, the patient's outcome was unknown. The patient stated that because she received GARDASIL there was one less mom in the world. The patient reported that premature ovarian failure was not a coincidence. This is one of several reports received from the same source.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis reactive, Biopsy muscle, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram
Clinical narrative: Acutely: fever, reactive arthritis/joint pain chronic following injection developed muscle fatigability, muscle spasms, fasciculations and since then asymmetric muscle atrophy, extensive neurologic workup/testing since 2011 has led to diagnosis of CDIP and we are attributing it to the flu vaccine.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Muscle atrophy, Muscle contractions involuntary, Muscle spasms, Neurological examination abnormal
Clinical narrative: Acutely: fever, reactive arthritis/joint pain chronic following injection developed muscle fatigability, muscle spasms, fasciculations and since then asymmetric muscle atrophy, extensive neurologic workup/testing since 2011 has led to diagnosis of CDIP and we are attributing it to the flu vaccine.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Acutely: fever, reactive arthritis/joint pain chronic following injection developed muscle fatigability, muscle spasms, fasciculations and since then asymmetric muscle atrophy, extensive neurologic workup/testing since 2011 has led to diagnosis of CDIP and we are attributing it to the flu vaccine.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Contusion, Fatigue, Muscular weakness, Pain in extremity, Ultrasound Doppler normal
Clinical narrative: This consumer report (initial receipt 12-Nov-2013) concerns a 24 year old female patient with a medical history of diabetes. Concomitant medications include NOVOLOG and LEVEMIR. On 17-Sep-2013, the patient received an unspecified flu vaccine (manufacturer and batch number not specified) and GARDASIL (batch number not specified). On an unspecified date, after her first dose of GARDASIL the patient developed muscle weakness, bad left arm pain, fatigue, leg pain and bruising. The patient only had one dose of GARDASIL and it was unknown whether the patient will continue to get the rest of the doses in the series. The patient went to the physician. A Doppler test was negative. No treatment was provided. Outcome was reported as not recovered.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Atrial fibrillation, Ventricular extrasystoles
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a 66 year old female patient. On 03-OCT-2013, the patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown) (lot #, expiration date, dose, frequency and route not reported) and a dose of PNEUMOVAX23 (lot #, expiration date, dose, frequency and route not reported) in a local physicians office and a dose of ZOSTAVAX, lot # J005720, expiration date 13-AUG-2014 (dose, frequency and route not reported) in their pharmacy on the same day. The patient had a history of an unspecified heart condition and she was prone to PVCs (premature ventricular contractions). No allergies were reported. On 03-OCT-2013, the same day she received the vaccines, she was admitted to an unknown hospital for premature ventricular contractions or atrial fibrillation. The patient recovered at an unknown date and was discharged from the hospital. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, FLUX, PPV, VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Ventricular extrasystoles
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a 66 year old female patient. On 03-OCT-2013, the patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown) (lot #, expiration date, dose, frequency and route not reported) and a dose of PNEUMOVAX23 (lot #, expiration date, dose, frequency and route not reported) in a local physicians office and a dose of ZOSTAVAX, lot # J005720, expiration date 13-AUG-2014 (dose, frequency and route not reported) in their pharmacy on the same day. The patient had a history of an unspecified heart condition and she was prone to PVCs (premature ventricular contractions). No allergies were reported. On 03-OCT-2013, the same day she received the vaccines, she was admitted to an unknown hospital for premature ventricular contractions or atrial fibrillation. The patient recovered at an unknown date and was discharged from the hospital. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging, Ophthalmoplegia
Clinical narrative: Vertigo, nausea, dizziness, blurry vision, INO (internuclear ophthomoplegia).
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Vertigo, Vision blurred
Clinical narrative: Vertigo, nausea, dizziness, blurry vision, INO (internuclear ophthomoplegia).
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Headache, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: EXTREMELY BLOOD SHOT EYES, EXTREMELY SORE THROAT, CONGESTED CHEST AND COUGH, CHILLS, HEADACHE. SYMPTOMS LASTED 8HR - 24 HRS.  TOOK BENADRYL AND IBRUPROFEN.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: EXTREMELY BLOOD SHOT EYES, EXTREMELY SORE THROAT, CONGESTED CHEST AND COUGH, CHILLS, HEADACHE. SYMPTOMS LASTED 8HR - 24 HRS.  TOOK BENADRYL AND IBRUPROFEN.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Lump under the skin at injection site, diameter of tennis ball, red, swollen, hot, itchy and very sore.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Lump under the skin at injection site, diameter of tennis ball, red, swollen, hot, itchy and very sore.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ocular hyperaemia, Skin warm, Swelling face, Urticaria
Clinical narrative: Mother called on 11/04/2013 to report that child woke up next am after shots with large red whelps all over body, very hot to touch, face and eyes swollen and red, no fever.  Health unit has requested parent provide a copy of medical notes from office visit to MD.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Pruritus, Rash generalised
Clinical narrative: Broke out in a generalized rash...with itching.  Beginning in left armpit.  The shot was given in the right arm.
Age: 56.0
Sex: M
Vaccine: MEN
Symptoms: Cellulitis, Erythema
Clinical narrative: Cellulitis - arm turned red.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Blood test, Chills, Colitis ulcerative, Computerised tomogram
Clinical narrative: Chills, fevers (would fluctuate between the two), vomiting, terrible stomach pains (like a knife was being pushed into my stomach over and over again). Was forced to go into the hospital for a 2-night stay. Got a little better after that but then a week later ended up in the hospital again and this time for different symptoms: vomiting, uncontrollable diarrhea, fevers, chills. Was diagnosed with Ulcerative Colitis.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Chills, fevers (would fluctuate between the two), vomiting, terrible stomach pains (like a knife was being pushed into my stomach over and over again). Was forced to go into the hospital for a 2-night stay. Got a little better after that but then a week later ended up in the hospital again and this time for different symptoms: vomiting, uncontrollable diarrhea, fevers, chills. Was diagnosed with Ulcerative Colitis.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Borrelia test negative, Extraocular muscle paresis, Facial paresis, VIIth nerve paralysis
Clinical narrative: Right side of face weakness, mouth and eyes - Bell's Palsy diagnosed.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Rash
Clinical narrative: Muscle aches, bump on arm.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Dyspnoea, Erythema, Fatigue, Headache
Clinical narrative: Provider's notes: (Patient was having follow-up appt for dyspnea; so after those notes, she writes)  Additional information:  After OV yesterday, she slept most of the day, felt overpowering fatigue. Had frontal HA and took Tylenol.  Had soreness in both arms from the vaccines yesterday.  This morning noted swelling and redness in right arm so made appt. POC: Ice affected area three times a day for 20 minutes.  Go to ER if worsens over the weekend. I talked with patient after the OV.  She said onset was soon after the injections  she had gone straight home & became very fatigued went to bed.  Took 2 Tylenol ES for HA at 5:30PM & 10:30PM, otherwise slept most of the late afternoon, evening, & through the night.  Had one watery stool in the morning (day after shots).  Still feels fatigued but not as much. 11/26/13 at 4:27  I called patient & she said she is feeling back to normal.   Right arm still some tenderness but no welt as before.  Was feeling much better by Sunday evening.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersomnia, Local swelling, Pain in extremity, Tenderness, Urticaria
Clinical narrative: Provider's notes: (Patient was having follow-up appt for dyspnea; so after those notes, she writes)  Additional information:  After OV yesterday, she slept most of the day, felt overpowering fatigue. Had frontal HA and took Tylenol.  Had soreness in both arms from the vaccines yesterday.  This morning noted swelling and redness in right arm so made appt. POC: Ice affected area three times a day for 20 minutes.  Go to ER if worsens over the weekend. I talked with patient after the OV.  She said onset was soon after the injections  she had gone straight home & became very fatigued went to bed.  Took 2 Tylenol ES for HA at 5:30PM & 10:30PM, otherwise slept most of the late afternoon, evening, & through the night.  Had one watery stool in the morning (day after shots).  Still feels fatigued but not as much. 11/26/13 at 4:27  I called patient & she said she is feeling back to normal.   Right arm still some tenderness but no welt as before.  Was feeling much better by Sunday evening.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain in extremity, X-ray normal
Clinical narrative: Patient reports that pain started immediately after receiving injection  and has worsened each day.  No injection site pain or redness, just pain from top of shoulder down to elbow.  Pt has taken over the counter ibuprofen and reports that pain is affecting her sleep. Patient presented to the ER on 11/26/13 (19 days post injection) and MD did X-ray. She reports that the doctor told her that he "couldn't be sure it was 100% related to the flu shot".  Pt. received a cortisone injection in the hip and Rx for Lortab.
Age: 33.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chest discomfort, Feeling hot
Clinical narrative: Shortly after received vaccinations, complaint of extreme heat to upper toroso and tightness in chest.  Laid client down and O2 via mask.  Ct recovered and declined seeking further medical evaluation by PMD.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered
Clinical narrative: Patient was given vaccine that was expired.
Age: 1.01
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MM, VARCEL
Symptoms: Injection site discolouration, Injection site rash, Injection site swelling
Clinical narrative: Mom noticed his legs changing color about 1500 today, she states that his lower legs were purple and the underneath tips of toes were purple, along with swelling, the discoloration lasted about 1 hour and resolved.  Now he has a rash to his upper and lower legs.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Miosis, Pallor
Clinical narrative: Pt pale, pinpoint Pupils.NO SOB, in no acute distress.to RTC in 1 week for FU C PCP NP. Vs @ 1345 HR 126 Resp. 36 Repeated @ 1400. HR 130 RR 36 Temp 98 F SPO2 96% !410: Pt Dc home ED precautions and home care Instructions given. Parent V/U agree plan of care.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling hot, Heart rate increased, Malaise, Nausea
Clinical narrative: Starting not feeling well. Felt very warm, thick saliva (kind that you get right before going to throw up). Nauseous, did not vomit but dry heaved. Lightheaded. Fever. Fast heart beat.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Retching
Clinical narrative: Starting not feeling well. Felt very warm, thick saliva (kind that you get right before going to throw up). Nauseous, did not vomit but dry heaved. Lightheaded. Fever. Fast heart beat.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Injection site reaction, Pain, Paraesthesia
Clinical narrative: The zoster vaccine was administered on 10/30/2013.  On November 25th, the patient reported to a pharmacist on duty that she was experiencing pain and inquired if this was a normal side effect.  On November 26th, I spoke with the patient and she reported that a few days after getting the shot she was feeling what she described as "shocks" in that arm.  She mentioned that it started more near her shoulder, traveling towards her elbow.  She reports that it is not a constant pain, just intermittent "shocks".  She reports that it has gotten better over time and that she is currently experiencing it 1-2 times per day and more towards her elbow.  She also reports that she is having trouble with both arms with putting her jacket on.  Since the vaccine she had been her physician and did not mention the "shock" pains and only mentioned the problems with both arms putting on a jacket.  I spoke with the physician to report the symptoms the patient reported to us.  I also recommended patient call the office to discuss with her MD.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Headache, Pruritus
Clinical narrative: Headache, itching, redness size of egg with little blisters...so started taking my Valtrex...1000mg the 20th and 500 mg everyday for 5 days.
Age: 46.0
Sex: F
Vaccine: FLUN4
Symptoms: Chills, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose, fever, chils, cold symptoms.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Dtap site rash, fever, pain, and hot to touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: The patient developed cellulitis on her arm.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Came to clinic just for flu vaccination, after receiving vaccine patient fainted while walking out to car, dad caught patient. Pt sweaty and light headed for about 10 mins, gave juice and crackers. Vitals stable. Felt better after 10 min, no additional tx needed.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bedridden, Myalgia, Pyrexia
Clinical narrative: Over the course of 24 hours developed fever, muscle pain and weakness that resulted in her being bedridden. Lasted 24 hours.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram head, Confusional state, Dysphagia, Dysphonia
Clinical narrative: One day after flu shot; confusion, tremors, weakness (L) side of face, (L) arm and hand, and (L) leg. Also dysphonia, dysphagia, problems with gait. All persistent even today. I had 2 ER visits and one to urgent care. Extensive workup including CT and MRI to rule out other causes.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Facial paresis, Gait disturbance, Laboratory test, Muscular weakness
Clinical narrative: One day after flu shot; confusion, tremors, weakness (L) side of face, (L) arm and hand, and (L) leg. Also dysphonia, dysphagia, problems with gait. All persistent even today. I had 2 ER visits and one to urgent care. Extensive workup including CT and MRI to rule out other causes.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Tremor
Clinical narrative: One day after flu shot; confusion, tremors, weakness (L) side of face, (L) arm and hand, and (L) leg. Also dysphonia, dysphagia, problems with gait. All persistent even today. I had 2 ER visits and one to urgent care. Extensive workup including CT and MRI to rule out other causes.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Pt came back with inflamed, red injection site spanning 8-10". Pt also complained of fever for 2 days.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Within 4 hrs patient went to ER with swelling of throat and difficulty breathing ER treated with BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Pt. briefly had a fainting spell for 2-3 seconds regained consciousness immediately and is doing fine now.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: About 1 week after receiving MMR vaccine, developed "measles type rash" and fever. Resolved with no treatment.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Passed out.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Anal pruritus, Eye irritation, Eye pruritus, Headache, Lip exfoliation
Clinical narrative: Itching burning red eyes, sensitive to light and sound, headache same to next day. Red unraised different size blotches and rash second to third day. Tingly gnawing itchy feeling under skin including vaginal and peri-rectal area. Sores and sloughing of mouth mucosa and lips, day 4 - 9. NIGHTQUIL on day 1 - 7. BENADRYL day 3 - 7. CLARITIN and PEPCID day 6. DIFLUCAN, ATARAX, miconazole. Prednisone, K-LOR, pantoprazole from day 7 until presently.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Oral mucosal exfoliation, Paraesthesia, Photophobia, Pruritus
Clinical narrative: Itching burning red eyes, sensitive to light and sound, headache same to next day. Red unraised different size blotches and rash second to third day. Tingly gnawing itchy feeling under skin including vaginal and peri-rectal area. Sores and sloughing of mouth mucosa and lips, day 4 - 9. NIGHTQUIL on day 1 - 7. BENADRYL day 3 - 7. CLARITIN and PEPCID day 6. DIFLUCAN, ATARAX, miconazole. Prednisone, K-LOR, pantoprazole from day 7 until presently.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash macular, Stevens-Johnson syndrome, Stomatitis, Vulvovaginal pruritus
Clinical narrative: Itching burning red eyes, sensitive to light and sound, headache same to next day. Red unraised different size blotches and rash second to third day. Tingly gnawing itchy feeling under skin including vaginal and peri-rectal area. Sores and sloughing of mouth mucosa and lips, day 4 - 9. NIGHTQUIL on day 1 - 7. BENADRYL day 3 - 7. CLARITIN and PEPCID day 6. DIFLUCAN, ATARAX, miconazole. Prednisone, K-LOR, pantoprazole from day 7 until presently.
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Death, Vaccination complication
Clinical narrative: Patient's husband indicated she had reaction from vaccine and passed away. Do not have specific details.
Age: 63.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 63 year old patient. Pertinent medical history and drug allergies/reactions were not reported. On 08-NOV-2013, the patient was inadvertently administered a dose of VARIVAX (lot number, dose and route were not reported) instead of the intended ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test positive, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On 31-OCT-2013 the patient was vaccinated with VARIVAX, subcutaneous. Dose, dose number, lot number and frequency were not reported. Later the day (31-OCT-2013), the results of the patient's antibody titer were received by the physician assistant. The patient was already positive for varicella immunity according to the titer results. (The titer was drawn "a few days earlier: on an unspecified date.) No known adverse effects. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose and route not reported). On an unknown date the patient experienced heavy rash that lasted for two weeks. It was unknown if patient sought medical attention. The outcome of heavy rash was reported as recovering/resolving. Additional information is not expected.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male patient of unknown age regarding himself without drug reactions/allergies. The patient's medical history included shingles (no other pertinent medical history). On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant therapies included Nexium, Restasis, Metoprolol, and Klor-Con, aspirin (manufacturer unknown and Furosemide (manufacturer unknown). It was reported that the patient received ZOSTAVAX after previously having shingles and developed another case of shingles on an unspecified date approximately one month after he received ZOSTAVAX. The patient treated with acyclovir and lidocaine patches. There were no lab diagnostics studies performed. At the time of reporting, the patient was not recovered. The patient sought medical attention by office visit. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event, Ultrasound antenatal screen
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.), a Pregnancy Registry product, concerning a 16 year old female patient with migraine and allergic rhinitis and no drug reactions or allergies, who on 16-SEP-2011 was vaccinated with a dose of GARDASIL (Lot # 0298AA EXP 21-JUN-2013) intramuscularly. Concomitant therapy included HAVRIX and albuterol. The nurse reported that the patient received a blood and urine test on 13-SEP-2011 which showed that she was pregnant. She was brought by her mother (who did not know she was pregnant) into the physician's office on 16-SEP-2011 to receive GARDASIL. It was later found on chart review that the patient was pregnant when receiving GARDASIL. Patient's last menstrual period was on 06-AUG-2011 and her estimated delivery date on 12-MAY-2012. No known adverse effects were reported. Follow up information has been received via initial questionnaire concerning the 16 year old female patient with no previous pregnancies, asthma, and a history of tonsillectomy, adenoidectomy and tube insertion in ears, who on 28-SEP-2011 (previously reported as 16-SEP-2011) was vaccinated with her first dose of GARDASIL. The Family Practice reported that on 26-AUG-2010 an ultrasound was performed as a patient request and confirmed positive human chorionic gonadotropin (hCG). The patient was notified. Patient's last menstrual period was on 05-AUG-2011 (previously reported as 12-MAY-2011). Follow up information has been received: the outcome of the pregnancy remains pending. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product packaging quantity issue
Clinical narrative: This spontaneous report has been received from a pharmacist concerning to an unspecified patient of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the unspecified patients were vaccinated with ZOSTAVAX, lot # J001698, expiration date 08-MA-2014, (dose and route not reported). The diluent lot# was reported as J006364, expiration date August 2015. Concomitant medication was not reported. The reporter stated that dose of ZOSTAVAX have been measuring a volume of less than 0.65ml, a PQC filed for diluent underfill. No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: This spontaneous report was received from a physician via representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose, LOT # unknown). Physician had cell phone photo of patient's injections site reaction post dose two of GARDASIL. Patient developed a quarter inch diameter hypopigmentation at the injections site, unspecified which arm. Patient received no other vaccines on that day. This occurred over the summer of 2013. On an unspecified date, the patient came into office to seek medical attention. Patient had recovered. Since then patient received a third dose of GARDASIL, with no adverse effects reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 73 year old male patient with high blood pressure and no drug reactions or allergies. On 08-NOV-2013, the patient was vaccinated with a dose of ZOSTAV AX (Lot # J007301; expiration date 20-SEP-2014) (dose and route not reported). The pharmacist reported that a patient who received ZOSTAVAX developed a weeping rash. On 16-NOV-2013, the patient started taking "Valcyclovir" as treatment. The outcome of the patient was unknown. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an approximately 50 year old male patient with shingles. There were no drug reactions or allergies. On 30-OCT-2013, the patient was vaccinated with ZOSTAVAC vial 19400 PFU lot # H022152 exp date 18-MAR-2014, 0.65 ml, subcutaneous for routine vaccination. There was no concomitant medication. In 2013, the patient experienced rash at an unspecified site of his body. On 11-NOV-2013, the patient sought for medical attention at the physician's office and was prescribed Valtrex as treatment for the rash. The outcome of rash was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Crying, Fall, Pyrexia, Weight bearing difficulty
Clinical narrative: On 9/30/13 the patient received influenza trivalent vaccine and HIB vaccine. Taken home, took a nap and awoke crying. When attempting to crawl, pt could not put weight on left arm or left knee. When attempting to sit would fall over. Low grade fever that night. On 10/1/13 was able to put more weight on (L) hand and (L) leg. Has slowly improved. As of 11/4/13 almost back to normal.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Generalized maculopapular rash.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pneumonia, Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: High Fever over 105 for three days Pneumonia Diagnosis Rapid Breathing Vomiting
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt has hives on chest and arms c/o pruritis.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 43 year old male patient with asthma and without any drug reactions/allergies. The pharmacist reported that the patient was in the hospital for an unspecified simple surgical procedure, and before hospital discharge on 18-NOV-2013, the patient was administered PNEUMOVAX23 lot # J010654, "25 Micrograms", intramuscular in the right arm. Concomitant medication included unspecified inhalers for asthma. The patient returned to the hospital on 21-NOV-2013 with cellulitis on the right upper extremity, redness and swelling at the site of PNEUMOVAX23 injection and fever. The patient was admitted to the hospital and is currently being treated with Vancomycin (manufacturer unknown). Unspecified blood cultures were performed. Result were not provided. The outcome of cellulitis of the right upper extremity, redness and swelling at the site of PNEUMOVAX23 injection and fever were reported as not recovered/not resolved. No reporter causality provided. The pharmacist requested that a lot check for this PNEUMOVAX23, lot # J010654, expiry date 17-OCT-2014. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. The reporter stated that on an unknown date, the patient was inadvertently administered with a dose of LIQUID PEDVAXHIB (dose, strength, route and site of administration not reported). No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood creatine phosphokinase, Borrelia test, Full blood count, Metabolic function test
Clinical narrative: Pt. presented with ongoing pain in shoulders, back, and legs. Pt was afebrile, pain was more profound in right deltoid area. Pt was treated with prednisone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Red blood cell sedimentation rate, Rheumatoid factor, Vitamin D
Clinical narrative: Pt. presented with ongoing pain in shoulders, back, and legs. Pt was afebrile, pain was more profound in right deltoid area. Pt was treated with prednisone.
Age: 68.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Injection site erythema, Injection site pruritus, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an approximately 68 year old female patient with hypercholesterolemia, hypertension, hypothyroidism, vaccination and pre-diabetes. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown). Concomitant therapies included LIPITOR, unspecified thyroid supplement and unspecified medication for hypertension. On an unknown date the patient developed an erythema and pruritis at the injection site on her left arm. The reaction measured 3 cm. in diameter. On 14-NOV-2013 the patient developed rash on the left side of her neck and was evaluated in the office. The nurse practitioner noted that the erythema at the injection site had resolved and the patient had developed several groups of vesicular lesions on the left side of her neck. There were no lab diagnostics studies performed. The patient was prescribed valacyclovir (manufacturer unknown). The outcome of several groups of vesicular lesions, rash on the left side of her neck and pruritis at the injection site was reported as recovering. The outcome of erythema at the injection site was reported as recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product packaging quantity issue, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The medical history of the patient was unknown. It was reported that on an unknown date, the pharmacist had used two partial sterile diluents (lot # J010232, expiry date was 31-OCT-2015) vials to equal 0.65 ml in order to reconstitute one ZOSTAVAX (lot number and expiry date not provided). The concomitant medications were not reported. No adverse events were reported. Product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 62 year old female patient. The patient had received an unspecified flu shot on 24-OCT-2013, with no adverse effects. On 18-NOV-2013, the patient was vaccinated with ZOSTAVAX (vial 19400 PFU) lot # J011212 and expiry date 29-AUG-2014, 0.65 ml, via subcutaneous route. After receiving the dose, on an unknown date in November 2013 the patient developed an injection site reaction that was red, about 2 inches in diameter and was swollen and hard on the inside. The patient has received no treatment, but that the symptoms were lessening in severity. The patient had sought medical attention by pharmacy visit. The outcome of events was reported as recovering/resolving. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash
Clinical narrative: This spontaneous report was received from a 62 year old female consumer refers to herself. The patient's current condition included arthritis in hip. The patient had no drug allergies. On 14-NOV-2013 the patient was vaccinated with ZOSTAVAX, one dose injection in the upper right arm (dose, LOT # unknown). There was no concomitant medication. On 14-NOV-2013, after receiving ZOSTAVAX the patient developed a red, oval shaped rash that was slightly raised and hurts. The patient was treated with ALEVE. The patient didn't seek medical attention. There was no lab performed. The outcome of the events was reported as recovering at report time. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Nervous system disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was a friend of pharmacist's neighbour. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, frequency, route of administration and reason for use where not reported) after which the patient experienced an unspecified neurological issue. The outcome of an unspecified neurological issue is unknown. The relatedness between unspecified neurological issue and ZOSTAVAX was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 26 year old female patient. On an unspecified date in January 2012 the patient may have been vaccinated with GARDASIL (date, route, dose and lot number unknown) dose 2. No other suspect therapy or concomitant medication was reported. On an unspecified date in January 2012 the patient may have received a second dose of GARDASIL after she turned 26 years of age. No adverse effects reported. No patient contact details available. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via Publicist representative refers to an 81 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX vial dose and route unspecified, lot # J000492 and expiry date 19-JAN-2014, in the right arm. The patient experienced a swollen right arm from her shoulder to the wrist after receiving the vaccine. Pharmacist stated this was the same arm that patient received the injection. Patient saw her physician who recommended BENADRYL. Pharmacist reported that the patient stated this settled down two weeks later. The outcome of a swollen right arm from her shoulder to the wrist after receiving the vaccine was reported as recovered/resolved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia oral, Neck pain, Toothache
Clinical narrative: This spontaneous report as received from a health care worker refers to a 17 year old female patient. The patient was allergic to amoxicillin. The patient had no other pertinent medical history. On 01-APR-2013, the patient was vaccinated with GARDASIL dose 1 (Lot # H020002). On 17-JUL-2013, the patient was vaccinated with GARDASIL dose 2 (Lot # H017698). No adverse events were reported with dose 1 and 2. On 21-NOV-2013 the patient was vaccinated with GARDASIL dose 3 (Lot # J009788). The patient was not on any concomitant medications. On 21-NOV-2013, the patient felt dizzy about 5 minutes following the vaccination and the patient was kept at the office for duration of 15 minutes. The patient reproted that on 21-NOV-2013, she developed headache on the left side and neck pain on the left side (same side as GARDASIL vaccination) after the patient left the office. On 22-NOV-2013 when the patient woke up, she experienced numbness of lower lip and teeth pain (teeth hurt). The patient sought medical attention. No treatment was rendered for the event. No lab tests were performed. The outcome of neck pain on the left side (same side as GARDASIL vaccination), teeth pain and numbness of lower lip was reproted as not resolved. The outcome of headache was unknown. The outcome of patient felt dizzy was reported as resolved on 21-NOV-2013. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J010447, exp. date: 22-APR-2014, single dose, subcutaneous (site, strength not reported). On 05-NOV-2013 the patient experienced a lump, about two inches wide and was sore, after receiving ZOSTAVAX. The patient only called pharmacist, no treatment was given for adverse event. The outcome of events was not reported. The relatedness between ZOSTAVAX and events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 2 patients of unknown demographics. On 16-NOV-2013, M-M-R II of batch H018950, lot 1483AA and expiration date 18-NOV-2014 went through an unsupported temperature excursion. On 19-NOV-2013 the 2 patients were vaccinated with this lot of M-M-R II. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received via a company representative from a pharmacist refers to a patient of unknown age and gender with no reported medical history. On 31-OCT-2013 (reported as 2 weeks ago) the patient was vaccinated with ZOSTAVAX (route, dose and lot number unknown). No other suspect therapy or concomitant medication was reported. On an unspecified date in November 2013 (reported as since been diagnosed, on an unspecified date) the patient experienced active shingles. The unspecified patient returned to the pharmacy on an unspecified date to fill a prescription for an unspecified cream that was prescribed by an unspecified healthcare provider to help with itching from shingles. The outcome of active shingles is unknown. The reporters relatedness of active shingles to ZOSTAVAX is unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Malaise, Muscle swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a 67 year old male consumer refers to himself. Patient had drug reaction/allergy to sulfa based antibiotic. The patient's medical history included stroke(dates not provided). Approximately in August 2013 (reported as about 3 months ago) the patient was vaccinated with pneumococcal vaccine, polyvalent (manufacturer unknown) one dose, injection (lot# not reported)) (dose, strength, route and site of administration not reported). Concomitant therapies included PLAVIX and FLOMAX. Approximately in August 2013 (reported as about 3 months ago) the patient developed pain his arm and the muscle over his shoulder was swollen and the patient stated he did not feel like himself and he felt crummy. No treatment for events was given. No lab test performed. Approximately in September 2013 (reported as about 2 months ago) the patient recovered from the events. The relatedness between pneumococcal vaccine, polyvalent (manufacturer unknown) and the events was not reported. The patient sought medical attention via phone call to physician. This is one the two reports from the same reporter and patient (Same patient link # 1311USA006205). Additional information is not expected.
Age: 1.05
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product label confusion, Rash morbilliform, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 month old patient. On 29-OCT-2013 the patient was   vaccinated with PROQUAD (also reported as MMRV) (of lot and expiry date J007862, 28-DEC-2014). Other suspect therapies included VARIVAX (Merck) (of lot and expiry date J003230, 15-MAR-2015) administered on same day. The patient was ordered to receive M-M-R II, but actually received PROQUAD on that day. The reporter stated that the healthcare worker who administered PROQUAD instead of the MMR reported that she confused the two products. The nurse stated that the cartons and the labels did look very similar and it would be helpful if the labels were of a different color. The nurse stated that the patient was brought to the clinic on 07-NOV-2013 with a measles-like rash, and the patient was seen by physician assistant. The physician assistant informed that besides the measles-like rash, the child was playful and a-febrile. The nurse informed that the rash was distributed on her chest, arms, and groin. The patient had not recovered from the event at the time of report. The report also had a comment that Varicella Zoster Virus Identification Program (VZVIP) was not offered because the rash did not resemble varicella, and this scenario did not fit the criteria for VZVIP. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # H018510, expiry date 15-JAN-2014) (route and dosing regimen unknown) one time. On an unknown date approximately in 2013 the patient experienced a varicella-zoster like reaction on the forearm, and the reaction was a raised bump about the size of a golf ball. The patient was treated with ACYCLOVIR (manufacturer unknown). The outcome of the event was unknown. The relatedness of the event to the therapy with ZOSTAVAX was unknown. Additional information has been requested.