chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Insomnia, Nausea, Photopsia
Clinical narrative: Pt had HPV vaccine 4pm yesterday. G-mom reports at dinner (6ish) pt c/o nausea and did not eat. Pt went to bed at midnight could not sleep started having headaches, dizziness and seeing flashes. Gmom set with pt until she fell asleep. Woke up today states she feels better "no nausea or dizziness just a small headache".
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 12-MAY-2014, the patient was vaccinated with the first dose of GARDASIL 0.5 ml/once intramuscular (Lot No. was not reported). Then, on 20-MAY-2015, the patient received the second dose of GARDASIL 9 (Lot No. K026246 Expiration date: 28-JAN-2017), 0.5 ml/once intramuscular. No adverse effect was reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Balance disorder, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Client called the health dept 6/10/15. All of the history is described by the client and is as follows and states she developed GBS 1 week before thanksgiving 2011. She was diagnosed at health care center after a spinal tap was done. States her feet were numb and couldn't maintain balance and had terrible pain in her back to abdomen. She then went to hospital by ambulance. Then she was transferred to rehabilitation. She states she is still having residual effects and was forced to retire. The client states she has had several flu shots in the past and has no allergies and received the VIS statement. She states she didn't realize there is a vaccine adverse event reporting system.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Lumbar puncture abnormal
Clinical narrative: Client called the health dept 6/10/15. All of the history is described by the client and is as follows and states she developed GBS 1 week before thanksgiving 2011. She was diagnosed at health care center after a spinal tap was done. States her feet were numb and couldn't maintain balance and had terrible pain in her back to abdomen. She then went to hospital by ambulance. Then she was transferred to rehabilitation. She states she is still having residual effects and was forced to retire. The client states she has had several flu shots in the past and has no allergies and received the VIS statement. She states she didn't realize there is a vaccine adverse event reporting system.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash maculo-papular, Rash pruritic
Clinical narrative: Awoke with fever 102.7 morning after IZ's given (6-9-15). Fever persisted through 6-10-15. Patient awoke with itchy scattered macular papular rash on bilat. ankles, spread upwards to lets, posterior thighs and few on trunk on 6-10-15.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea, Pyrexia
Clinical narrative: Stomach cramping, nausea, fever.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever between 100 and 102F.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Crying, Erythema, Pyrexia, Skin discolouration, Skin mass
Clinical narrative: Golf ball sized knot under the skin. Painful to the touch, red and purple coloring around the knot. Fever and excessive crying for days following vaccination.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Golf ball sized knot under the skin. Painful to the touch, red and purple coloring around the knot. Fever and excessive crying for days following vaccination.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine
Clinical narrative: Migraine.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING AND REDNESS OF BOTH LEGS.
Age: 33.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Blister, Herpes zoster, Injection site induration, Injection site infection, Injection site pain
Clinical narrative: Woke up with a very sore arm. Later that day the injection site started swelling, itching, burning and was hard to touch. The next day there were shingle blisters and the swelling covers most of my upper arm. Went to the doctors office on 06/10/15. I was diagnosed with shingles and an infection to the site. I am on Benadryl every 6 hours, Zyrtec twice a day, Keflex 500 Mg 2 caps 2 times a day for 10 days, Bactrim 800 mg 1 cap 2 times a day for 10 days, bactroban applied topically 3 times a day for 10 days, Valtrex 1 s tabs 2 times a day for 7 days. Gabapentin 300 MG 2 tabs 3 times a day. Also watching the swelling to make sure it stops and no red streaks. If the swelling gets worse or red streaks appear I need to go straight to the ER.
Age: 33.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Woke up with a very sore arm. Later that day the injection site started swelling, itching, burning and was hard to touch. The next day there were shingle blisters and the swelling covers most of my upper arm. Went to the doctors office on 06/10/15. I was diagnosed with shingles and an infection to the site. I am on Benadryl every 6 hours, Zyrtec twice a day, Keflex 500 Mg 2 caps 2 times a day for 10 days, Bactrim 800 mg 1 cap 2 times a day for 10 days, bactroban applied topically 3 times a day for 10 days, Valtrex 1 s tabs 2 times a day for 7 days. Gabapentin 300 MG 2 tabs 3 times a day. Also watching the swelling to make sure it stops and no red streaks. If the swelling gets worse or red streaks appear I need to go straight to the ER.
Age: 33.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Woke up with a very sore arm. Later that day the injection site started swelling, itching, burning and was hard to touch. The next day there were shingle blisters and the swelling covers most of my upper arm. Went to the doctors office on 06/10/15. I was diagnosed with shingles and an infection to the site. I am on Benadryl every 6 hours, Zyrtec twice a day, Keflex 500 Mg 2 caps 2 times a day for 10 days, Bactrim 800 mg 1 cap 2 times a day for 10 days, bactroban applied topically 3 times a day for 10 days, Valtrex 1 s tabs 2 times a day for 7 days. Gabapentin 300 MG 2 tabs 3 times a day. Also watching the swelling to make sure it stops and no red streaks. If the swelling gets worse or red streaks appear I need to go straight to the ER.
Age: 33.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Blister, Herpes zoster, Injection site induration, Injection site infection, Injection site pain
Clinical narrative: Pt notified us on 06/11/2015 she developed a reaction at the injection site. She is now on antibiotics she is also having a shingles out break.
Age: 33.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Pt notified us on 06/11/2015 she developed a reaction at the injection site. She is now on antibiotics she is also having a shingles out break.
Age: 33.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Pt notified us on 06/11/2015 she developed a reaction at the injection site. She is now on antibiotics she is also having a shingles out break.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product formulation administered
Clinical narrative: Pentacel (green top was taken out of fridge and mixed with sterile dilutent).  Pentacel was not banded together. It was administerd to the patient.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Immediately after vaccination: Fever, headache, muscle weakness, fatigue. One week after vaccination: loss of appetite, explosive diarrhea, fatigue.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Immediately after vaccination: Fever, headache, muscle weakness, fatigue. One week after vaccination: loss of appetite, explosive diarrhea, fatigue.
Age: 0.88
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Incorrect product formulation administered
Clinical narrative: Pentacel (green top was taken out of fridge and mixed with sterile dilutent).  Pentacel was not banded together. It was administerd to the patient.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood bilirubin normal
Clinical narrative: Baby developed a fever and vomiting 6/7/15 PM, subsequently found to have transaminitis.  She was admitted, developed encephalopathy and brain death by 6/8/15. She was also found to have an E. coli UTI.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Brain death, Encephalopathy, Escherichia infection, Escherichia test positive, Haematocrit decreased
Clinical narrative: Baby developed a fever and vomiting 6/7/15 PM, subsequently found to have transaminitis.  She was admitted, developed encephalopathy and brain death by 6/8/15. She was also found to have an E. coli UTI.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: International normalised ratio increased, Nuclear magnetic resonance imaging brain abnormal, Platelet count increased, Prothrombin time prolonged, Pyrexia
Clinical narrative: Baby developed a fever and vomiting 6/7/15 PM, subsequently found to have transaminitis.  She was admitted, developed encephalopathy and brain death by 6/8/15. She was also found to have an E. coli UTI.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Transaminases increased, Urinary tract infection, Vomiting, White blood cell count decreased
Clinical narrative: Baby developed a fever and vomiting 6/7/15 PM, subsequently found to have transaminitis.  She was admitted, developed encephalopathy and brain death by 6/8/15. She was also found to have an E. coli UTI.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Approximately 8-10 following the vaccine, the patient exhibited signs of lightheadedness and dizziness. They were then asked to be seated while they recovered.
Age: 23.0
Sex: F
Vaccine: FLU3, HEPAB, HPV9
Symptoms: Incoherent, Unresponsive to stimuli
Clinical narrative: Pt received 3rd series of Twinrix, 1st series of HPV 9, and injectable Influenza. Pt was incoherent 3-5 minutes after receiving vaccines. Pt did not respond to verbal or painful stimuli. Adult EPI was immediately administered. Pt responded immediately after initial EPI injection while needle was still in leg.
Age: 0.39
Sex: M
Vaccine: 6VAX-F
Symptoms: Breath holding, Seizure
Clinical narrative: Seizure and pallid breath holding spells.  First ever episode was within 15 min of receiving DTaP shot.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 19-MAY-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K011492; expiration date: 22-JUN-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 16-MAY-2015 the patient ws vaccinated with an improperly stored dose of GARDASIL (lot # K006960; expiration date: 19-FEB-2017) (dose and route not provided). No adverse effects were reported.  This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: (RL) was 27cm round with redness from the top of the thigh to the knee. (LL) is 25cm round.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 18-MAY-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960; expiration date: 19-FEB-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 19-MAY-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960; expiration date: 19-FEB-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Balance disorder, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Approx 2 hours after the shot was given, employee started to feel drain. Felt buzzed. Mind would blank out and lose balance. Slight headaches. Slight nausea. Next day after sleeping, felt better but then started to feel bad again when arrived at work.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Right anteriolateral thigh pain /redness/ swelling with firmness and warmth abruptly started and progressed over 45 minutes- approx 14 cm x 16 cm with irregular borders and slightly blanchable.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor
Clinical narrative: Right anteriolateral thigh pain /redness/ swelling with firmness and warmth abruptly started and progressed over 45 minutes- approx 14 cm x 16 cm with irregular borders and slightly blanchable.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Constipation, Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: Constipation, vomiting, headache, dizziness, fever of 100F.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Body temperature increased
Clinical narrative: Temp to 102.9.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Mouth breathing, Pyrexia
Clinical narrative: Got Hepatitis A vaccine yesterday, fever began last night. Started 100.4, continues to rise today to 103.7. Breathes with mouth open like a dog. No other symptoms of note. Use cold damp towels with concerned. No NSAIDs needed.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and Hives.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site haematoma
Clinical narrative: HEMATOMA TO RT SHOULDER AREA.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: HIVES AND ITCHING.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, TD
Symptoms: Pallor, Vomiting
Clinical narrative: After vaccines were given patient started to vomit and she felt pale, recoverd in 10 min.
Age: 69.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Dyspepsia
Clinical narrative: Severe heartburn and severe right abdominal pain. It took 6 weeks for abdominal pain to completely subside. I took ranitidine, tums and ate a very bland diet.
Age: 25.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Dizziness, Nausea, Tinnitus, Vision blurred
Clinical narrative: Dizziness, blurring of vision, nausea, ringing in ears.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Pain, Pruritus
Clinical narrative: Red inflammed area at site of injection - some mild pain/itching.
Age: 3.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Patient has a sparse widespread itchy rash and  fever of 100 axillary. Patient was given Tylenol and Benadryl by his parents.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Blood test, Chills, Disturbance in attention
Clinical narrative: Headache, arm discomfort, then pain, redness and severe swelling, then got very hard. Extremely tired, joints ached. Fast heart beat, chills, extremely weak, fuzzy headed, and slurred language. Pain so bad, woke me at night. Slept alot, even during the day. Couldn't think straight or focus on anything, too tired.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Dysarthria, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: Headache, arm discomfort, then pain, redness and severe swelling, then got very hard. Extremely tired, joints ached. Fast heart beat, chills, extremely weak, fuzzy headed, and slurred language. Pain so bad, woke me at night. Slept alot, even during the day. Couldn't think straight or focus on anything, too tired.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Heart rate increased, Induration, Limb discomfort, Mental impairment, Middle insomnia
Clinical narrative: Headache, arm discomfort, then pain, redness and severe swelling, then got very hard. Extremely tired, joints ached. Fast heart beat, chills, extremely weak, fuzzy headed, and slurred language. Pain so bad, woke me at night. Slept alot, even during the day. Couldn't think straight or focus on anything, too tired.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Headache, arm discomfort, then pain, redness and severe swelling, then got very hard. Extremely tired, joints ached. Fast heart beat, chills, extremely weak, fuzzy headed, and slurred language. Pain so bad, woke me at night. Slept alot, even during the day. Couldn't think straight or focus on anything, too tired.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain
Clinical narrative: Very Strong shoulder pain.  Nothing alleviated it.  Lasted for about 1 week although pain lessened after about 4 days.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Electroencephalogram, Seizure
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative referring to a 14 year old male patient. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 1 vial (lot #, expiration date, route of administration and frequency were not reported). Concomitant medications were not reported. On an unknown date, two weeks after the vaccination with GARDASIL, the patient experienced a convulsive seizure. On an unspecified date the patient sought medical attention and was seen in office visit, no treatment was given for the adverse event but the patient underwent an Electroencephalogram (EEG) (results were not provided). It was also reported that the event did not cause hospitalization. At the time of the report, the outcome of seizure was unknown, and the relatedness of GARDASIL with seizure was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Received vaccine 5/16/15. Next day experienced redness, itching, swelling. Resolved after 2 days. Then on 5/29 began to swell, become hot and cause arm pain. Tx with XYZAL for allergic response. Tx cellulitis with BACTRIM. Pt then went out of town.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Received vaccine 5/16/15. Next day experienced redness, itching, swelling. Resolved after 2 days. Then on 5/29 began to swell, become hot and cause arm pain. Tx with XYZAL for allergic response. Tx cellulitis with BACTRIM. Pt then went out of town.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Has rash on injection site. Tenderness with warm sensation.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Tdap and MENACTRA administered IM in (R) deltoid. Area swollen/red with induration. Length of swelling 18 cm x 17 cm. Instructed by provider to use Ibuprofen for pain w/ cold compresses.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Lower back pain beginning morning of 06/11/15.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Arthralgia, Fatigue, Hot flush, Injection site pain
Clinical narrative: Major joint pain fingers, toes, etc. Could not eat eggs or chicken based food. IBS. Fatigue. Hot flashes. Pain from injection site up arm to back of head. Heart palpitations/nausea.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Irritable bowel syndrome, Nausea, Palpitations
Clinical narrative: Major joint pain fingers, toes, etc. Could not eat eggs or chicken based food. IBS. Fatigue. Hot flashes. Pain from injection site up arm to back of head. Heart palpitations/nausea.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pruritus, Skin warm
Clinical narrative: Raised red area at vaccination site (Rt deltoid) 3" x 5". Itchy and warm.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site. See in local ER and diagnosed with cellulitis and prescribed oral antibiotics.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Fall, Gait disturbance, Hypotonia, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 18 year old female patient with no pertinent medical history/drug allergies or drug reactions reported. On 20-MAY-2015, the patient was vaccinated with first dose of GARDASIL 0.5 ml (lot# K011562, expiration date: 08-APR-2017) intramuscular in the right arm and the first dose of VAQTA 0.5 ml (lot # K018181, expiration date: 04-JUN-2017) in the left arm. There was no concomitant therapy reported. On the same date, within seconds of completed the dose of GARDASIL, the patient who was sitting on the exam table fell backwards and hit the wall, the patient experienced gait disturbance reported as "the patient was limp at first", tremor reported as "began shaking", musculoskeletal stiffness reported as "became stiff with her arms extended and cross" pallor reported as "turned pale in color". The nurse stated that the patient's oxygen saturation was 99% and that her blood pressure and pulse were normal (results were not provided). The patient stated that she felt better but a little dizzy and nauseated and vomited before left the office. The patient's mother stated that after the patient went home, she took a short nap and woke up ate dinner and felt fine. No treatment was given to the patient and no laboratory test was performed. The nurse stated that an unspecified physician said that the patient would not finish the GARDASIL, due this reaction, but did not specify if she would administer VAQTA to the patient again. The outcome of pallor, nausea, vomiting, dizziness, fall, musculoskeletal stiffness, gait disturbance and tremor was reported as recovered/resolved on the same date. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea, Pallor, Tremor, Vomiting
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 18 year old female patient with no pertinent medical history/drug allergies or drug reactions reported. On 20-MAY-2015, the patient was vaccinated with first dose of GARDASIL 0.5 ml (lot# K011562, expiration date: 08-APR-2017) intramuscular in the right arm and the first dose of VAQTA 0.5 ml (lot # K018181, expiration date: 04-JUN-2017) in the left arm. There was no concomitant therapy reported. On the same date, within seconds of completed the dose of GARDASIL, the patient who was sitting on the exam table fell backwards and hit the wall, the patient experienced gait disturbance reported as "the patient was limp at first", tremor reported as "began shaking", musculoskeletal stiffness reported as "became stiff with her arms extended and cross" pallor reported as "turned pale in color". The nurse stated that the patient's oxygen saturation was 99% and that her blood pressure and pulse were normal (results were not provided). The patient stated that she felt better but a little dizzy and nauseated and vomited before left the office. The patient's mother stated that after the patient went home, she took a short nap and woke up ate dinner and felt fine. No treatment was given to the patient and no laboratory test was performed. The nurse stated that an unspecified physician said that the patient would not finish the GARDASIL, due this reaction, but did not specify if she would administer VAQTA to the patient again. The outcome of pallor, nausea, vomiting, dizziness, fall, musculoskeletal stiffness, gait disturbance and tremor was reported as recovered/resolved on the same date. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown gender and age. No concurrent condition or medical history was reported. On 02-JUN-2015 the patient was vaccinated with an improperly stored dose of VARIVAX (L00454: Exp date 06-JAN-2017) (Concentration, dose # and route of administration were not reported). No adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX and quadrivalent (route, anatomical location, dose, lot# and expiration date were not reported). There was not concomitant therapy reported. No adverse effects reported. The reporter did not have the lot numbers for VARIVAX (Merck) at the time of this report. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL (dose, route, lot number and expiry date were not reported). No adverse effects reported or product quality complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ oral (dose, lot number and expiry date were not reported). No adverse effects reported or product quality complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 08-JUN-2015 the patient was vaccinated with a properly stored dose of PNEUMOVAX 23 (lot # J011045, expiration date: 15-MAY-2015, route and dose were unknown) that had expired. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 20-MAY-2015 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for RECOMBIVAX HB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 years old male patient. The patient's medical history and concurrent conditions were not reported. 29-MAY-2015, the patient was vaccinated with GARDASIL 9 be default (dose, frequency and lot number were not reported) at the age of 16. No adverse effects were reported. The patient's concomitant therapies were not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 20-MAY-2015 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for RECOMBIVAX HB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (oral solution, strength, lot#, expiration date and dose were unknown) orally. The temperature excursion ROTATEQ was supported with in-house stability date. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 27-MAY-2015 the patient was vaccinated with a dose of improperly stored VAQTA (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for VAQTA was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 28-MAY-2015 the patient was vaccinated with a dose of improperly stored VAQTA (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for VAQTA was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 22-MAY-2015 the patient was vaccinated with a dose of improperly stored GARDASIL (strength, lot#, dosage, frequency and route unspecified) (incorrect product storage). The temperature excursion for GARDASIL was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a nurse practitioner via a field representative referring to her daughter, who was currently 11 years old. Medical history and drug allergy were not reported. On an unknown date the patient was vaccinated with her first dose of GARDASIL, 1 vial. (dose and strength were not reported, lot # was reported as HOZO90L and expiration date was reported as 05-JUL-2015) intramuscularly in the deltoid in the right arm by the nurse practitioner reporter. The patient simultaneously received 2 other vaccines in her left arm, diptheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). The next day her entire right arm swelled all the way down to her right hand. There was no reaction in her left arm. The patient was treated with an unspecified dosage of BENADRYL. The swelling subsided in three days. No lab tests were performed. The patient was not going to receive any more vaccines in the GARDASIL series. The patient did not seek medical attention. At the time of reporting, the causality was not reported. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant (M.A.) referring to a 64 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J012660, expiration date 10-JAN-2015; dose and route not reported). No adverse effects had been observed or reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 29-MAY-2015 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for RECOMBIVAX HB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event reported. This is one of several reports received from the same reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (R) lateral thigh swelling, redness, pain after immunizations.
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a male patient of unknown age. On 31-MAR-2015, the patient's mother was inadvertently vaccinated with her first dose of GARDASIL (lot # K009482, expiration date 06-MAR-2017, dose 0.5 ml, intramuscular, administration in the left deltoid instead of TDAP (wrong drug administered). Concomitant therapies included iron (unspecified), minerals (unspecified), TDAP and erythromycin. The patient's mother became pregnant with Last Menstrual Period (LMP) of 10-SEP-2014 and Estimated Delivery Date (EDD) of 23-JUN-2015. On an unknown date in 2015, the patient experienced tight nuchal cord. Outcome of tight nuchal cord was unknown. In June 2015, at 37 to 38 weeks, the patient was delivered as a stillbirth/fetal death. The patient and his mother did not experience complications during the delivery. The patient's length was 19 (unit not provided) and weight was 6lb and 9oz. Head circumference was not measured. Apgar score was 0 and 1 and 5 minutes. The relationship of the events and GARDASIL was not reported. Upon internal review, stillbirth/fetal death at 37-38 weeks from LMP was considered to be an event of medically significant. This case was linked to the patient's mother case (MARRS# 1504USA001103). Additional information is not expected as all follow up attempts have been obtained.
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Apgar score low, Foetal exposure during pregnancy, Stillbirth, Umbilical cord around neck
Clinical narrative: Information has been received from a registered nurse referring to a male patient of unknown age. On 31-MAR-2015, the patient's mother was inadvertently vaccinated with her first dose of GARDASIL (lot # K009482, expiration date 06-MAR-2017, dose 0.5 ml, intramuscular, administration in the left deltoid instead of TDAP (wrong drug administered). Concomitant therapies included iron (unspecified), minerals (unspecified), TDAP and erythromycin. The patient's mother became pregnant with Last Menstrual Period (LMP) of 10-SEP-2014 and Estimated Delivery Date (EDD) of 23-JUN-2015. On an unknown date in 2015, the patient experienced tight nuchal cord. Outcome of tight nuchal cord was unknown. In June 2015, at 37 to 38 weeks, the patient was delivered as a stillbirth/fetal death. The patient and his mother did not experience complications during the delivery. The patient's length was 19 (unit not provided) and weight was 6lb and 9oz. Head circumference was not measured. Apgar score was 0 and 1 and 5 minutes. The relationship of the events and GARDASIL was not reported. Upon internal review, stillbirth/fetal death at 37-38 weeks from LMP was considered to be an event of medically significant. This case was linked to the patient's mother case (MARRS# 1504USA001103). Additional information is not expected as all follow up attempts have been obtained.
Age: 55.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 55 year old male patient. On 22-MAY-2015 the patient was vaccinated with his first dose of VARIVAX (Merck) (lot # K010337, expiration date:22-JUL-2016, route, strength and dose were unknown). On 27-MAY-2015, the patient developed little bumps all over his body that were painful, itchy and fluid filled. On 05-JUN-2015, the patient's rash was worse and he went to the emergency room on the day. The patient was not admitted to the hospital and he filled a prescription for naproxen on 06-JUN-2-15. The pharmacist did not know if the naproxen prescription that was filled by the patient was for the treatment of the patient's rash. The outcome of rash was reported as not recovered/not resolved. The relationship of the adverse event and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 55 year old male patient. On 22-MAY-2015 the patient was vaccinated with his first dose of VARIVAX (Merck) (lot # K010337, expiration date:22-JUL-2016, route, strength and dose were unknown). On 27-MAY-2015, the patient developed little bumps all over his body that were painful, itchy and fluid filled. On 05-JUN-2015, the patient's rash was worse and he went to the emergency room on the day. The patient was not admitted to the hospital and he filled a prescription for naproxen on 06-JUN-2-15. The pharmacist did not know if the naproxen prescription that was filled by the patient was for the treatment of the patient's rash. The outcome of rash was reported as not recovered/not resolved. The relationship of the adverse event and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Dyspnoea, Influenza, Mycobacterium tuberculosis complex test positive, Pain in extremity, Paraesthesia
Clinical narrative: Tingling in my hands. Soreness at vaccine site. The soreness spread to lower arm and shoulder, within 2 weeks full blown flu symptoms, followed by difficulty breathing....
Age: 58.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Tingling in my hands. Soreness at vaccine site. The soreness spread to lower arm and shoulder, within 2 weeks full blown flu symptoms, followed by difficulty breathing....
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Hypoaesthesia, Nausea, Neck pain, Pain in extremity
Clinical narrative: Fever, severe local pain extending upwards into left neck and down left arm into wrist and hand, hand numbness, nausea & vomiting - Not resolved yet (6/12/2015).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, severe local pain extending upwards into left neck and down left arm into wrist and hand, hand numbness, nausea & vomiting - Not resolved yet (6/12/2015).
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Impaired work ability, Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Severe shoulder pain that started quickly, thought it was a dislocated shoulder.  Pain intensified to a 9/10 and could not move arm.  No noticeable swelling or redness at shot site.  Next day still severe pain, rash that changed frequently over entire body from neck down.  Could not move arm.  Could not contact doctor for help, left message, office closed.  Did not call emergency line but should have.  Day 3 pain 7/10, rash continued to change, opposite hand showed some swelling.  Still not noticeable swelling or redness at the shot site (left arm).  Finally able to see doctor 4:30 PM on 6/4/2015.  Prescribed Methylprednisolone 4 mg dospack 21's which I started taking at 6:00 PM.  Almost immediate relief of pain and rash that continued to improve over time.  By 6/6/2015 almost all pain and rash gone.  Continued taking Methylprednisolone as prescribed.  6/8/15 - today still some pain in upper left arm.  Feels like a pulled muscle.  Concerned about the continuing side effects. I missed a week of work due to the pain, rash, and inability to move my left arm.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Peripheral swelling, Rash generalised
Clinical narrative: Severe shoulder pain that started quickly, thought it was a dislocated shoulder.  Pain intensified to a 9/10 and could not move arm.  No noticeable swelling or redness at shot site.  Next day still severe pain, rash that changed frequently over entire body from neck down.  Could not move arm.  Could not contact doctor for help, left message, office closed.  Did not call emergency line but should have.  Day 3 pain 7/10, rash continued to change, opposite hand showed some swelling.  Still not noticeable swelling or redness at the shot site (left arm).  Finally able to see doctor 4:30 PM on 6/4/2015.  Prescribed Methylprednisolone 4 mg dospack 21's which I started taking at 6:00 PM.  Almost immediate relief of pain and rash that continued to improve over time.  By 6/6/2015 almost all pain and rash gone.  Continued taking Methylprednisolone as prescribed.  6/8/15 - today still some pain in upper left arm.  Feels like a pulled muscle.  Concerned about the continuing side effects. I missed a week of work due to the pain, rash, and inability to move my left arm.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Nausea, Pain in extremity, Pruritus, Rash, Swelling
Clinical narrative: Severe shoulder pain that started quickly, thought it was a dislocated shoulder.  Pain intensified to a 9/10 and could not move arm.  No noticeable swelling or redness at shot site.  Next day still severe pain, rash that changed frequently over entire body from neck down.  Could not move arm.  Could not contact doctor for help, left message, office closed.  Did not call emergency line but should have.  Day 3 pain 7/10, rash continued to change, opposite hand showed some swelling.  Still not noticeable swelling or redness at the shot site (left arm).  Finally able to see doctor 4:30 PM on 6/4/2015.  Prescribed Methylprednisolone 4 mg dospack 21's which I started taking at 6:00 PM.  Almost immediate relief of pain and rash that continued to improve over time.  By 6/6/2015 almost all pain and rash gone.  Continued taking Methylprednisolone as prescribed.  6/8/15 - today still some pain in upper left arm.  Feels like a pulled muscle.  Concerned about the continuing side effects. I missed a week of work due to the pain, rash, and inability to move my left arm.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Activities of daily living impaired, Chills, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe shoulder pain that started quickly, thought it was a dislocated shoulder.  Pain intensified to a 9/10 and could not move arm.  No noticeable swelling or redness at shot site.  Next day still severe pain, rash that changed frequently over entire body from neck down.  Could not move arm.  Could not contact doctor for help, left message, office closed.  Did not call emergency line but should have.  Day 3 pain 7/10, rash continued to change, opposite hand showed some swelling.  Still not noticeable swelling or redness at the shot site (left arm).  Finally able to see doctor 4:30 PM on 6/4/2015.  Prescribed Methylprednisolone 4 mg dospack 21's which I started taking at 6:00 PM.  Almost immediate relief of pain and rash that continued to improve over time.  By 6/6/2015 almost all pain and rash gone.  Continued taking Methylprednisolone as prescribed.  6/8/15 - today still some pain in upper left arm.  Feels like a pulled muscle.  Concerned about the continuing side effects. I missed a week of work due to the pain, rash, and inability to move my left arm.
Age: 54.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Pain, Rash generalised
Clinical narrative: Severe shoulder pain that started quickly, thought it was a dislocated shoulder.  Pain intensified to a 9/10 and could not move arm.  No noticeable swelling or redness at shot site.  Next day still severe pain, rash that changed frequently over entire body from neck down.  Could not move arm.  Could not contact doctor for help, left message, office closed.  Did not call emergency line but should have.  Day 3 pain 7/10, rash continued to change, opposite hand showed some swelling.  Still not noticeable swelling or redness at the shot site (left arm).  Finally able to see doctor 4:30 PM on 6/4/2015.  Prescribed Methylprednisolone 4 mg dospack 21's which I started taking at 6:00 PM.  Almost immediate relief of pain and rash that continued to improve over time.  By 6/6/2015 almost all pain and rash gone.  Continued taking Methylprednisolone as prescribed.  6/8/15 - today still some pain in upper left arm.  Feels like a pulled muscle.  Concerned about the continuing side effects. I missed a week of work due to the pain, rash, and inability to move my left arm.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid red, swollen, warm to touch, temp 99.1. Went to urgent care for evaluation and to r/o cellulitis. ARNP stated symptoms were delayed reaction to vaccine. Applied ice and took Aleve and symptoms resolved in 2-3 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood test, Dyskinesia, Foaming at mouth, Muscle rigidity, Poor quality sleep
Clinical narrative: AFEBRILE SEIZURE, UNUSUAL MOVEMENTS; RESTLESS NIGHT; WENT TO ER ON 6-11-15 FOR LEG RIGIDNESS, MOUTH FOAMING, DIFFICULTY WAKING UP.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure, Somnolence
Clinical narrative: AFEBRILE SEIZURE, UNUSUAL MOVEMENTS; RESTLESS NIGHT; WENT TO ER ON 6-11-15 FOR LEG RIGIDNESS, MOUTH FOAMING, DIFFICULTY WAKING UP.