chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Patient had an injection site reaction which resulted in a shingles-like rash. It has been months since injection and she is experiencing postherpetic neuralgia at the injection site.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Severe, worsening extremity weakness.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia, Fatigue, Vision blurred
Clinical narrative: Fatigue and blurred/double vision.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Erythema, Induration, Injection site mass, Nausea
Clinical narrative: Lightheaded and slightly nauseous day of injection, lasting 2 more days. Red, itchy, indurated area x2 on right leg on 3rd day after injection, another similar area on abdomen a couple days after, then similar area on right upper back and perineum on 11/29/13 when seen in center. Other sites left dark coloring on skin. Under left deltoid injection site, pea-sized lump. No other symptoms.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Pruritus, Skin discolouration
Clinical narrative: Lightheaded and slightly nauseous day of injection, lasting 2 more days. Red, itchy, indurated area x2 on right leg on 3rd day after injection, another similar area on abdomen a couple days after, then similar area on right upper back and perineum on 11/29/13 when seen in center. Other sites left dark coloring on skin. Under left deltoid injection site, pea-sized lump. No other symptoms.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Conjunctival hyperaemia, Fatigue, Headache, Inflammation, Insomnia
Clinical narrative: Headaches, insomnia, inflammatory response, fatigue, congestion.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Mobility decreased, Musculoskeletal pain, Pain in extremity, Tenderness
Clinical narrative: 1st day arm was sorer than previous yrs. flu shot. This lasted a full week. Then subsided for a couple of days and then came back even worse than before. The pain is in my upper arm and shoulder, it is difficult to lift my arm beyond a certain point, it effected the mobility. It is sore to touch or lay on. Have seen P.A. a little over 3 weeks after injection. PA indicated there was bursitis in shoulder. 6 day course of oral steroids and told to contact if returned after completion of steroids. PA indicated they would do xray and then may need cortisone injection. Have completed steroids last week and pain has come back. Will contact dr. office on Monday, Dec. 2, 2013.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: KINRIX given in right deltoid 11/27. 11/28, dad noticed right upper arm completely swollen, red, painful itching. Giving BENADRYL 7 ml and MOTRIN 7 ml w/ no improvement. No worsening or spreading of rash since yesterday. Low grade temps, loss of appetite since vaccine 11/27. No wheezing, no mouth/lip swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Rash
Clinical narrative: KINRIX given in right deltoid 11/27. 11/28, dad noticed right upper arm completely swollen, red, painful itching. Giving BENADRYL 7 ml and MOTRIN 7 ml w/ no improvement. No worsening or spreading of rash since yesterday. Low grade temps, loss of appetite since vaccine 11/27. No wheezing, no mouth/lip swelling.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: Rec'd shot in arm, by the afternoon had flu-like symptoms - very severe according to wife. Fever, chills, aches, and sore arm. Lasted about 2 days. Full recovery.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site inflammation
Clinical narrative: Localized erythema and inflammation at injection site. No treatment required.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Two days after vaccine administered patient states numbness radiating down arm. (Including fingers).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt came in at 0915 AM on 11/29/13 to show injection site -> stated she received ZOSTAVAX on Wed (11/27/13). Area surrounding injection site red, possibly some swelling. Also stated area was painful and itchy. Denied fever. Also reported headache. Rash extended on outer arm from elbow to shoulder. Rash red, flat; darker red nearest injection site. Recommended f/u with MD. BENADRYL and TYLENOL/ADVIL PRN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt came in at 0915 AM on 11/29/13 to show injection site -> stated she received ZOSTAVAX on Wed (11/27/13). Area surrounding injection site red, possibly some swelling. Also stated area was painful and itchy. Denied fever. Also reported headache. Rash extended on outer arm from elbow to shoulder. Rash red, flat; darker red nearest injection site. Recommended f/u with MD. BENADRYL and TYLENOL/ADVIL PRN.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Syncope
Clinical narrative: Patient was very nervous/anxious. Fainted after HPV shot. Checks by Dr./Nurse. Recovered within 10 minutes. Told patient to stay in the room until feel better to leave.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Noticed: redness, swelling and warmth the next morning to the left arm - injection site (reported to MD on 11/29/13).
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Joint hyperextension, Pain, Posture abnormal, Screaming, Seizure like phenomena
Clinical narrative: 2hours screaming, twisting tongue from right side to the left uncontrollably, unable to breast feed, stiffening of legs and feet, finger fidgeting pain, knee pain, biting bottom lip repeatedly, ever since these vaccines abnormal body movements. Irritated easily, aggressive behavior, when in crying spell he is confused and cannot come to me and I cannot pick him up or pacify him in any way, everyday since August 14 2013 he is not the same. I cannot take him certain places.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Tongue paralysis
Clinical narrative: 2hours screaming, twisting tongue from right side to the left uncontrollably, unable to breast feed, stiffening of legs and feet, finger fidgeting pain, knee pain, biting bottom lip repeatedly, ever since these vaccines abnormal body movements. Irritated easily, aggressive behavior, when in crying spell he is confused and cannot come to me and I cannot pick him up or pacify him in any way, everyday since August 14 2013 he is not the same. I cannot take him certain places.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Aggression, Aphagia, Arthralgia, Compulsive lip biting, Computerised tomogram
Clinical narrative: 2hours screaming, twisting tongue from right side to the left uncontrollably, unable to breast feed, stiffening of legs and feet, finger fidgeting pain, knee pain, biting bottom lip repeatedly, ever since these vaccines abnormal body movements. Irritated easily, aggressive behavior, when in crying spell he is confused and cannot come to me and I cannot pick him up or pacify him in any way, everyday since August 14 2013 he is not the same. I cannot take him certain places.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Confusional state, Crying, Dyskinesia, Electroencephalogram, Feeding disorder neonatal
Clinical narrative: 2hours screaming, twisting tongue from right side to the left uncontrollably, unable to breast feed, stiffening of legs and feet, finger fidgeting pain, knee pain, biting bottom lip repeatedly, ever since these vaccines abnormal body movements. Irritated easily, aggressive behavior, when in crying spell he is confused and cannot come to me and I cannot pick him up or pacify him in any way, everyday since August 14 2013 he is not the same. I cannot take him certain places.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Irritability, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity, Screaming
Clinical narrative: 2hours screaming, twisting tongue from right side to the left uncontrollably, unable to breast feed, stiffening of legs and feet, finger fidgeting pain, knee pain, biting bottom lip repeatedly, ever since these vaccines abnormal body movements. Irritated easily, aggressive behavior, when in crying spell he is confused and cannot come to me and I cannot pick him up or pacify him in any way, everyday since August 14 2013 he is not the same. I cannot take him certain places.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Tongue disorder
Clinical narrative: 2hours screaming, twisting tongue from right side to the left uncontrollably, unable to breast feed, stiffening of legs and feet, finger fidgeting pain, knee pain, biting bottom lip repeatedly, ever since these vaccines abnormal body movements. Irritated easily, aggressive behavior, when in crying spell he is confused and cannot come to me and I cannot pick him up or pacify him in any way, everyday since August 14 2013 he is not the same. I cannot take him certain places.
Age: 37.0
Sex: F
Vaccine: FLU3, MMR, TDAP, FLUX, MMR, TDAP
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 37 year old female consumer regarding herself. Medical history and drug reactions/allergies were not reported. The patient stated that she had received two doses of M-M-R II in her youth and in 2011 had titer done with strong Rubella results. On 27-SEP-2013, at 38 weeks of pregnancy, the patient was inadvertently vaccinated with M-M-R II dose3, 0.5 ml (lot and route not reported). The same day was vaccinated with other suspect therapies as TDaP (lot, dose, route and indication not reported) and influenza virus vaccine (manufacturer unknown)(lot, dose and route not reported). Concomitant medication ws not reported. The patient became pregnant on an unknown date. The LMP and EDD were not known. Initial exposure to M-M-R II and influenza virus vaccine (manufacturer unknown) was at 38 weeks. On 15-OCT-13, the patient delivered an infant (unknown gender), reported as the child had no rubella symptoms or congenital defects. The patient stated that this had already been reported. No adverse effects reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3, MMR, TDAP, FLUX, MMR, TDAP
Symptoms: Delivery, Exposure during pregnancy, No adverse event, Rubella antibody positive
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 37 year old female consumer regarding herself. Medical history and drug reactions/allergies were not reported. The patient stated that she had received two doses of M-M-R II in her youth and in 2011 had titer done with strong Rubella results. On 27-SEP-2013, at 38 weeks of pregnancy, the patient was inadvertently vaccinated with M-M-R II dose3, 0.5 ml (lot and route not reported). The same day was vaccinated with other suspect therapies as TDaP (lot, dose, route and indication not reported) and influenza virus vaccine (manufacturer unknown)(lot, dose and route not reported). Concomitant medication ws not reported. The patient became pregnant on an unknown date. The LMP and EDD were not known. Initial exposure to M-M-R II and influenza virus vaccine (manufacturer unknown) was at 38 weeks. On 15-OCT-13, the patient delivered an infant (unknown gender), reported as the child had no rubella symptoms or congenital defects. The patient stated that this had already been reported. No adverse effects reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injection site pain, Injection site pruritus, Nodule
Clinical narrative: 2" by 4" red knot and severe itching/burning at injection site.  On 11/25/13 red spots, facial burning and swelling all over face that last for four days.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: 2" by 4" red knot and severe itching/burning at injection site.  On 11/25/13 red spots, facial burning and swelling all over face that last for four days.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site joint pain, Nuclear magnetic resonance imaging
Clinical narrative: During initial immunization, there was tremendous pain in the shoulder joint. About 10 days out was the height of my decreased range of motion and supraspinatus tendon function.
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Fever (up to 102 degF) for 2 - 3 days. Chickenpox-like lesions on face and trunk.
Age: 0.2
Sex: M
Vaccine: PNC13, RV1
Symptoms: Apparent life threatening event, Crying, Cyanosis, Irritability, Respiratory arrest
Clinical narrative: Patient experienced an ALTE two times in the evening.  He was observed to stop breathing for 10-15 seconds and lips were blue. Throughout the day, child had been irritable and crying. Since the episode, child has been irritable with high pitched screaming.
Age: 0.2
Sex: M
Vaccine: PNC13, RV1
Symptoms: Screaming
Clinical narrative: Patient experienced an ALTE two times in the evening.  He was observed to stop breathing for 10-15 seconds and lips were blue. Throughout the day, child had been irritable and crying. Since the episode, child has been irritable with high pitched screaming.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chills, Discomfort, Fatigue, Malaise
Clinical narrative: Sharp upper leg pain for 2 hrs then lessened. Then, 11/29/2013 PM, stomach pain, nausea & chills along with tiredness and not feeling well for more than 48 hrs. Gave Advil for pain and discomfort.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain in extremity
Clinical narrative: Sharp upper leg pain for 2 hrs then lessened. Then, 11/29/2013 PM, stomach pain, nausea & chills along with tiredness and not feeling well for more than 48 hrs. Gave Advil for pain and discomfort.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt described a shingles like rash developing on her chest.  It is not painful, but is small raised bumps.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Woke up broken out in hives on my upper torso, back, arms, and face/head with extreme itching. This is the first time I have ever had hives. I got my first flu shot ever 4 days earlier. Went to urgent care and was given a steroid shot, prescribed Hydroxyzine. Treatment is ongoing and hives have not gone away.
Age: 24.0
Sex: F
Vaccine: HPVX
Symptoms: Anxiety, Arthralgia, Blood test, Cardiac monitoring, Chest X-ray
Clinical narrative: Shortness of breath, heart palpitations, headaches, muscles aches, fatigue, muscle fasciculations, joint pain, dizziness, anxiety.
Age: 24.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Headache
Clinical narrative: Shortness of breath, heart palpitations, headaches, muscles aches, fatigue, muscle fasciculations, joint pain, dizziness, anxiety.
Age: 24.0
Sex: F
Vaccine: HPVX
Symptoms: Muscle contractions involuntary, Myalgia, Palpitations
Clinical narrative: Shortness of breath, heart palpitations, headaches, muscles aches, fatigue, muscle fasciculations, joint pain, dizziness, anxiety.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Blister, Blister rupture, Blood test normal, Erythema
Clinical narrative: Do not remember the exact onset of the redness and itchy feeling.  But my husband was at our PCP on 10/03/13.  Our doctor was not in that day but his associate saw him, did not think it was from the shingles vaccine administered on 09/23/2013.  He prescribed predisone and told my husband to return if symptoms persisted or worsened.  The med helped with the itchy feeling but rash worsened and my husband was back at our doctor on 10/29/2013. Doctor prescribed more predisone, an antihistamine, Benadryl, and ordered some blood work.  Blood work came back normal.  Doctor gave us the name of a dermatologist if symptoms worsened.  Also he did not think it was from shingles vaccine. On 11/12/2013, rash is still worsening and now a blister formed. Saw the dermatologist on 11/14/2013.  He prescribed some cream and took two biopsies, one at the blister site and one in an area of redness.  He was not sure if rash was from shingles vaccine.  Rash resembles chicken pox only blisters are larger.  Blisters do rupture and crust over. Went to have stitches removed and two more biopsies were performed (waiting for results) and blood test was ordered.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab
Clinical narrative: Do not remember the exact onset of the redness and itchy feeling.  But my husband was at our PCP on 10/03/13.  Our doctor was not in that day but his associate saw him, did not think it was from the shingles vaccine administered on 09/23/2013.  He prescribed predisone and told my husband to return if symptoms persisted or worsened.  The med helped with the itchy feeling but rash worsened and my husband was back at our doctor on 10/29/2013. Doctor prescribed more predisone, an antihistamine, Benadryl, and ordered some blood work.  Blood work came back normal.  Doctor gave us the name of a dermatologist if symptoms worsened.  Also he did not think it was from shingles vaccine. On 11/12/2013, rash is still worsening and now a blister formed. Saw the dermatologist on 11/14/2013.  He prescribed some cream and took two biopsies, one at the blister site and one in an area of redness.  He was not sure if rash was from shingles vaccine.  Rash resembles chicken pox only blisters are larger.  Blisters do rupture and crust over. Went to have stitches removed and two more biopsies were performed (waiting for results) and blood test was ordered.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Decreased appetite, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Extreme itching at sight very inflamed hot to the touch red area covering entire bicep.  Loss of appetite pain and congestion provided child with Motrin and Benadryl reported symptoms to doctor monitoring reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pain, Respiratory tract congestion
Clinical narrative: Extreme itching at sight very inflamed hot to the touch red area covering entire bicep.  Loss of appetite pain and congestion provided child with Motrin and Benadryl reported symptoms to doctor monitoring reaction.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Hypoaesthesia oral, Nausea, Rash
Clinical narrative: Approximately 10 minutes after immunization patient complainted of numb tongue.  Gave 25mg diphenhydramine solution.  15 minutes complaint of slight nausea and could pass out.  5 minutes after that slight rash on neck.  Called 911, gave another 25mg diphenhydramine solution. No change complaint of breathing issues no change in tongue numbness.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itch, red, swollen area.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac flutter, Headache, Local swelling, Nausea, Pain in extremity
Clinical narrative: Patient developed a fever of 102F within 24 hours of receiving the vaccination.  Patient had nausea, headache, fluttering heart beat, and painful and itchy swelling of the arm that vaccination was given in.  This reaction proceded for 48 hours before begining to subside.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Patient developed a fever of 102F within 24 hours of receiving the vaccination.  Patient had nausea, headache, fluttering heart beat, and painful and itchy swelling of the arm that vaccination was given in.  This reaction proceded for 48 hours before begining to subside.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Increased tendency to bruise, Injected limb mobility decreased, Injection site pain
Clinical narrative: Stiffness and pain in back on head, left shoulder. Pain, tingling, numbness down left arm and into left hand. Pain has gotten worse over the past month. Now additionally experiencing bilateral pain in the right arm with tingling and numbness. Easy bruising, brittle nails, swelling of the limbs.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling, Musculoskeletal stiffness, Onychoclasis, Pain in extremity, Paraesthesia
Clinical narrative: Stiffness and pain in back on head, left shoulder. Pain, tingling, numbness down left arm and into left hand. Pain has gotten worse over the past month. Now additionally experiencing bilateral pain in the right arm with tingling and numbness. Easy bruising, brittle nails, swelling of the limbs.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Pain
Clinical narrative: This spontaneous report was received from a physician via field representative refers to a 19 year old female patient. On an unknown date the patient was vaccinated with GARDASIL dose 1 for prevention of hpv (Human Papillomavirus). On an unknown date the patient experienced twinges and muscle spasms within a few days after receiving the first dose. The twinges had continued so that, when the patient presented for the second dose, it was withheld until the patient could be referred to a neurologist. It was noted that the spasms began in the arm in which GARDASIL had been administered, but had traveled to other, unspecified areas of the body. No treatment was received for the events, however sought medical attention (referred to specialist). The events were reported to be not recovered at the time of the report. Reporter's causality was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker and nurse refers to an unspecified number of patients of unknown demographics. Healthcare worker reports the patient may have received doses of PROQUAD that were exposed to an unspecified temperature excursion. Healthcare worker could not provide details for the temperature excursion. Nurse reported that PROQUAD and VARIVAX (Merck) went through a supported temperature excursion. No adverse effect reported. It was not reported if the patients had received the doses or not. Outcome was unknown. No PQC was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of over 65 years of age. Patient was vaccinated with ZOSTAVAX at some of other facility on November 2013 (reported as "several days ago"). Patient now had redness, pain and swelling at the injection site. Site was unspecified. Physician states that he had not seen the patient in the office yet, so unknown if client has any vesicles or rash. No treatment was taken for the events. The patient sought medical attention by calling the physician. The outcome of the events was reported as not recovered. No PQC was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea
Clinical narrative: This spontaneous report was received from a 18 year old female patient's mother. Patient had no pertinent medical history. Patient has possible sulfa antibiotic allergies. Sometime in August 2013, patient was vaccinated with GARDASIL dose 1 (intramuscular). On 25-NOV-2013 the patient received GARDASIL dose 2, intramuscularly. Concomitant therapy included ethinyl estradiol, ferrous fumarate, JUNEL FE. On 25-NOV-2013 after the patient received the second dose, she had trouble breathing. Reporter stated that the physician advised the patient to use ADVIL (unspecified dose/frequency and manufacturer), because he thought the patient was hyperventilating. The outcome of the event was not recovered. No lab diagnostics were performed. Patient sought medical attention by visiting office on 26-NOV-2013. No PQC involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Patient received vaccine 11-15-13. Called 11-18-13 to inform of redness, swelling, rash (about softball size) that started 11-16-13 in the afternoon. Swelling, redness started to subside. Suggested BENADRYL 50mg at bedtime and to contact MD if no improvement. Asked patient to call back, could not reach.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse refers to her 71 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (dosage regimen, lot # and expiry date not provided) for vaccination. On an unknown date the nurse reported that one of her friends developed shingles (reported as a while ago). The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via Novartis refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. Other suspect therapies included influenza virus vaccine (manufacturer unknown) (subcutaneous). An unspecified adverse event was reported with ZOSTAVAX injection. The outcome of the adverse event is unknown. No PQC involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Computerised tomogram normal, Convulsion, Disturbance in attention
Clinical narrative: Within 24 hours started with headache, difficulty concentrating turned into flu like symptoms over weekend in bed 3 days on Monday thought she felt better sent to school she was found in bathroom on floor unconscious. When came to she had a large lump on back of head complained of dizziness difficulty walking photosensitivity. We took her Hospital she was admitted her EEG CT Scan MRI was normal. On 12/14 discharged I told them her headache wasd no better and that she was having a hard time walking they said it was cause she had been in bed for 2 days. The next day I carried her into pediatrician office they admitted her to another Hospital was seen by a adult neurologist. He said she had definite left sided weakness and left foot drop after 2 days of testing she was getting worse they transfer her to another hospital where we remembered about her having the Gardasil Vaccine and they treated with Gammaglobulin she was d/c on 12/22 able to take steps. She relapse on 1/11 unable to walk. And this nightmare has never been normal since. Had her first known seizure in school witness by nurse and paramedic. She now has occasional seizures lost quality of life is now hospital/home bond schooled.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electroencephalogram normal, Gait disturbance, Head injury, Headache
Clinical narrative: Within 24 hours started with headache, difficulty concentrating turned into flu like symptoms over weekend in bed 3 days on Monday thought she felt better sent to school she was found in bathroom on floor unconscious. When came to she had a large lump on back of head complained of dizziness difficulty walking photosensitivity. We took her Hospital she was admitted her EEG CT Scan MRI was normal. On 12/14 discharged I told them her headache wasd no better and that she was having a hard time walking they said it was cause she had been in bed for 2 days. The next day I carried her into pediatrician office they admitted her to another Hospital was seen by a adult neurologist. He said she had definite left sided weakness and left foot drop after 2 days of testing she was getting worse they transfer her to another hospital where we remembered about her having the Gardasil Vaccine and they treated with Gammaglobulin she was d/c on 12/22 able to take steps. She relapse on 1/11 unable to walk. And this nightmare has never been normal since. Had her first known seizure in school witness by nurse and paramedic. She now has occasional seizures lost quality of life is now hospital/home bond schooled.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiparesis, Immunoglobulin therapy, Influenza like illness, Loss of consciousness, Nuclear magnetic resonance imaging normal
Clinical narrative: Within 24 hours started with headache, difficulty concentrating turned into flu like symptoms over weekend in bed 3 days on Monday thought she felt better sent to school she was found in bathroom on floor unconscious. When came to she had a large lump on back of head complained of dizziness difficulty walking photosensitivity. We took her Hospital she was admitted her EEG CT Scan MRI was normal. On 12/14 discharged I told them her headache wasd no better and that she was having a hard time walking they said it was cause she had been in bed for 2 days. The next day I carried her into pediatrician office they admitted her to another Hospital was seen by a adult neurologist. He said she had definite left sided weakness and left foot drop after 2 days of testing she was getting worse they transfer her to another hospital where we remembered about her having the Gardasil Vaccine and they treated with Gammaglobulin she was d/c on 12/22 able to take steps. She relapse on 1/11 unable to walk. And this nightmare has never been normal since. Had her first known seizure in school witness by nurse and paramedic. She now has occasional seizures lost quality of life is now hospital/home bond schooled.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Peroneal nerve palsy, Photosensitivity reaction, Quality of life decreased
Clinical narrative: Within 24 hours started with headache, difficulty concentrating turned into flu like symptoms over weekend in bed 3 days on Monday thought she felt better sent to school she was found in bathroom on floor unconscious. When came to she had a large lump on back of head complained of dizziness difficulty walking photosensitivity. We took her Hospital she was admitted her EEG CT Scan MRI was normal. On 12/14 discharged I told them her headache wasd no better and that she was having a hard time walking they said it was cause she had been in bed for 2 days. The next day I carried her into pediatrician office they admitted her to another Hospital was seen by a adult neurologist. He said she had definite left sided weakness and left foot drop after 2 days of testing she was getting worse they transfer her to another hospital where we remembered about her having the Gardasil Vaccine and they treated with Gammaglobulin she was d/c on 12/22 able to take steps. She relapse on 1/11 unable to walk. And this nightmare has never been normal since. Had her first known seizure in school witness by nurse and paramedic. She now has occasional seizures lost quality of life is now hospital/home bond schooled.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Golf ball sized swollen, red area at injection site.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Erythema, Flushing
Clinical narrative: Sudden onset of dizziness; flushing; red streaks down neck and arms lasting about 10 minutes; several more episodes during night and over next couple of days; same as first episode.
Age: 50.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Oedema mouth, Oropharyngeal pain, Pharyngeal oedema, Vomiting
Clinical narrative: Swelling of throat and mouth. Sore throat. Vomiting. Headache.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Arm soreness still persisting 2 wks later. Hurts all the time, especially at night while trying to sleep.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Myalgia, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Stuffy nose, rhinorhea, muscle pain, extreme sneezing.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: There was not a hint of anything wrong with me when I went in, but it was a terrible night!  About 2 hours (5:30ish) after I got home I started getting a sore throat and a cough.  That lasted for a couple of hours and then I started getting aches and chills (7:30ish).  The chills were very violent and my whole body shook and shook.  I was finally able to get into bed (with lots of covers piled on) about 9:00 or 9:30.  I was so miserable that my husband called Dr. at home to make sure I would live.  I was able to go to sleep, but at midnight I woke up extremely nauseated and vomited for awhile.  Finally, I started feeling better and kicked all the covers off.  This morning I woke up with a bad headache, worn out and wet.  Guess I had a fever that broke in the night.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: There was not a hint of anything wrong with me when I went in, but it was a terrible night!  About 2 hours (5:30ish) after I got home I started getting a sore throat and a cough.  That lasted for a couple of hours and then I started getting aches and chills (7:30ish).  The chills were very violent and my whole body shook and shook.  I was finally able to get into bed (with lots of covers piled on) about 9:00 or 9:30.  I was so miserable that my husband called Dr. at home to make sure I would live.  I was able to go to sleep, but at midnight I woke up extremely nauseated and vomited for awhile.  Finally, I started feeling better and kicked all the covers off.  This morning I woke up with a bad headache, worn out and wet.  Guess I had a fever that broke in the night.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: There was not a hint of anything wrong with me when I went in, but it was a terrible night!  About 2 hours (5:30ish) after I got home I started getting a sore throat and a cough.  That lasted for a couple of hours and then I started getting aches and chills (7:30ish).  The chills were very violent and my whole body shook and shook.  I was finally able to get into bed (with lots of covers piled on) about 9:00 or 9:30.  I was so miserable that my husband called Dr. at home to make sure I would live.  I was able to go to sleep, but at midnight I woke up extremely nauseated and vomited for awhile.  Finally, I started feeling better and kicked all the covers off.  This morning I woke up with a bad headache, worn out and wet.  Guess I had a fever that broke in the night.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: PATIENT COMPLAINING OF SORE ARM FROM SITE OF INJECTION RADIATING DOWN TO HER WRIST. INJECTION SITE WARM TO TOUCH. PAIN HAS CONTINUED SINCE INJECTION.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Flushing, Headache, Hyperhidrosis
Clinical narrative: Severe headache started at 10:00 PM on 11/15/2013 and lasted until 12:00 PM on 11/17/2013. Nausea started at 9:00 AM on 11/16/2013 and lasted until 8:00 PM on 11/16/2013. Projectile vomiting started at 1:00 PM on 11/16/2013 and lasted until 6:00 PM on 11/16/2013.  Emesis episodes were preceded by flushed skin and diaphoresis.  Emesis episodes were followed by chills and feelings of exhaustion. Treatment:  ice packs applied to head, neck, shoulders; Advil; sips of clear liquids; small bites of fresh apple; rinsing mouth out with water and Peroxyl mouthwash after each emesis episode; thoroughly cleaning bathroom after each emesis episode; resting in bed between each emesis episode; changing all hand towels used in between each emesis episode; laundering all towels in bleach wash; gentle walk outside in fresh air/sunshine on 11/17/2013 in afternoon; opening doors/windows on 11/17/2013 to let in fresh air/sunshine.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting, Vomiting projectile
Clinical narrative: Severe headache started at 10:00 PM on 11/15/2013 and lasted until 12:00 PM on 11/17/2013. Nausea started at 9:00 AM on 11/16/2013 and lasted until 8:00 PM on 11/16/2013. Projectile vomiting started at 1:00 PM on 11/16/2013 and lasted until 6:00 PM on 11/16/2013.  Emesis episodes were preceded by flushed skin and diaphoresis.  Emesis episodes were followed by chills and feelings of exhaustion. Treatment:  ice packs applied to head, neck, shoulders; Advil; sips of clear liquids; small bites of fresh apple; rinsing mouth out with water and Peroxyl mouthwash after each emesis episode; thoroughly cleaning bathroom after each emesis episode; resting in bed between each emesis episode; changing all hand towels used in between each emesis episode; laundering all towels in bleach wash; gentle walk outside in fresh air/sunshine on 11/17/2013 in afternoon; opening doors/windows on 11/17/2013 to let in fresh air/sunshine.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Computerised tomogram, Nuclear magnetic resonance imaging, Tinnitus, Urine analysis
Clinical narrative: Vertigo, tinnitus.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Vertigo, tinnitus.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Extreme shoulder/upper arm pain. Affects my range of motion--unable to lift arm above chest or away from my body; cannot remove shirt or put weight on arm. Sharp pain, especially bad at night. Have been taking ibuprofen, but only helps minimally. Pain has persisted for four weeks so far with little improvement.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient called me on 12/1/13 @ 4:30pm describing that she has had a possible adverse reaction from the Fluvirin Preservative Free vaccination she received on 11/17/13.  She describes the pain in the arm where she received the vaccination along the deltoid muscle where the shot was given.  She states that the pain was severe and she had trouble lifting her arm.  The pain has since subsided, but is not completely eliminated.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Injection site pain
Clinical narrative: Patient called me on 12/1/13 @ 4:30pm describing that she has had a possible adverse reaction from the Fluvirin Preservative Free vaccination she received on 11/17/13.  She describes the pain in the arm where she received the vaccination along the deltoid muscle where the shot was given.  She states that the pain was severe and she had trouble lifting her arm.  The pain has since subsided, but is not completely eliminated.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash, Urticaria
Clinical narrative: Low grade fever; rashes and hives covering entire body; loss of appetite; irritability.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. It was also reported that patient was not pregnant at the time of the report. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# were not reported). No concomitant medications were reported. The pharmacist reported that subsequently after the administration of the vaccine, couple of weeks later (dates unspecified) she went to the hospital (unspecified name and location). It was reported that she was diagnosed with a case of shingles. The outcome of shingles was unknown. The reported event shingles was considered to be serious due to hospitalization. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling
Clinical narrative: Patient had significant swelling in both arms, although greater in the right arm. She went to the hospital, was examined and was given BENADRYL and a course of oral antibiotics.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient stated that after receiving vaccine felt tingling from shoulder to hand for 30 minutes. She took 2 ALEVE and that relieved the pain. The next day she stated she had aching from shoulder down to elbow. Arm now aches only when lifting objects.
Age: 61.0
Sex: M
Vaccine: FLUC3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pt received flu shot on 11/25/13 and had pain in the arm. The pain moved up to the neck and lasted for over 3 days.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema
Clinical narrative: Patient developed anaphylactic reaction to FLULAVAL. She became red and had trouble breathing within a couple minutes of vaccination. She's had prior flu vacc. without any incidents in previous years. EPIPEN 0.3mg was administer and patient vital/physical signs normalized.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paralysis
Clinical narrative: Pt received vaccine 11-29-13 about 1030 am. About 4 pm (same day) pt had "pain" in right arm and arm felt like it was paralyzed. "Pt applied ice and took two ALEVE. About 4 am (11-30-13) pt felt "a lot better" 11-30-13 Ppt reported adverse reaction. Instructed ice and ALEVE.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Left arm edema, erythema, tenderness (all left arm) no forearm BENADRYL and cold compresses. TYLENOL or Ibuprofen for pain.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a 5 year old (reported as age 5) female patient. The patient was a 1.5 pound preemie, had past history of respiratory problems and had taken multiple steroids over her lifetime and details of her vaccination history were in a company registry. On 31-JAN-2012 the patient was vaccinated with VARIVAX (Merck) dose 2 for vaccination in the nurse's office. Dose and route were not reported. Lot number was 669271/1605Z and expiry date (reported as 1605Z). The date of first dose was not reported. From an unknown date in 2013 approximately (reported as currently), the patient had developed chicken pox, diagnosis confirmed on 18-NOV-2013. The patient ha 100 pox, itching and no fever. The outcome of events was not resolved. Medical attention was sought by visit to clinic. Nurse stated that she thought it was unique that both children had chickenpox reported one day apart that were administered in January 2012, in different facilities. Both children had small, multiples of chicken pox. No treatment was prescribed. This is 1 of 2 reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via representative refers to a male patient in his 60's (years of age). On an unknown date the patient was vaccinated with ZOSTAVAX for prevention of shingles. Dose, route, lot and expiry date were unknown. On an unknown date, after receiving vaccine, the patient developed an injection site reaction that included pain and swelling. No treatment was given. Patient had called the pharmacy to seek medical attention. One week after injection, the reaction resolved on itself. The outcome was reported as recovered/resolved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a 70 year old male patient's wife. The patient's medical history included back pain. Patient had no drug reactions/allergies. On 22-MAY-2013 the patient was vaccinated with ZOSTAVAX. There were no concomitant medications. It was reported that the patient's arm, at the injection site was red and swollen. Outcome of the events was unknown. The reporter (patient's wife) touched the ZOSTAVAX injection site on her husband's arm with her hand and developed shingles over her left eye a week or two after her husband received ZOSTAVAX (Related case # 1311USA013045). No PQC was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 27-NOV-2013 the patient was vaccinated with VARIVAX (Merck). Nurse practitioner reports that a patient was inadvertently given VARIVAX (Merck) instead of ZOSTAVAX today. The patient will be given a dose of ZOSTAVAX today. No adverse effect was reported. No other information provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: This spontaneous report was received from an office manager (certified medical assistant) refers to a nursing mother of unknown age. On 21-NOV-2013 the nursing mother was vaccinated with first dose of GARDASIL (dose, LOT # unknown). No adverse effects reported. The patient sought medical attention via office visit on an unspecified date. No treatment was given. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. Her medical history included heart disease. The patient had no drug reactions/allergies. On 22-NOV-2013 the patient was vaccinated with a 0.5ml dose of PNEUMOVAX (lot# J004196, expiry date: 06-DEC-2014) intramuscular at left arm. No concomitant medication was reported. The pharmacist reported that after the patient received PNEUMOVAX23, she developed redness at the injections site and swelling of the "entire" injected arm on 23-NOV-2013. No treatment was given for the events. No lab diagnostics studies were performed. The patient came back into the pharmacy on 23-NOV-2013 to report this reaction. At the time of report, the outcome of events was unknown. 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 public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning a patient. On 13-SEP-2013 the patient was vaccinated with improperly stored M-M-R II (H018181, exp. 05-OCT-2014), which were exposed to 53F for 12 hours (date excursion ended 22-JUL-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011615, 1311USA011616, 1311USA011617, 1311USA011618, 1311USA011619). Additional information is not expected.