chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Sensation of heaviness, Tendon pain, Vaccination complication
Clinical narrative: This spontaneous report as received from a field employee, an acquaintance with the patient. The report refers to a 74 year old female patient with drug reactions/allergies for Beta Blockers. The patient received her first pneumonia vaccination (manufacturer unknown) at age 64 years of age (assumed in 2003). On 13-SEP-2013 at 12PM the patient was vaccinated with PNEUMOVAX 23 (dosing information and route are unknown). Concomitant therapies included WARFARIN and Calcium Channel Blocker. The field employee reported that the patient told her she had received a PNEUMOVAX 23 injection and afterward her arm was very sore and painful. The patient told her she felt "lousy" and had to stay in bed for three days. Follow up information was received from the patient. The patient reported that she developed a "total knock down reaction" to PNEUMOVAX 23 injection. She stated that later that evening, on 13-SEP-2013, her arm had begun to feel very heavy. The patient then stated that by that afternoon the arm had developed intense pain from the injection site and spread into her tendons. The patient attempted to treat the pain with TYLENOL with was unsuccessful. The patient then stated that by that night the pain was so intense it became hard to sleep, and afterward she also developed ice-cold sweats and nausea. The patient explained that the entire reaction occurred over a 4 day period with 1.5 days of intense pain, and the remaining time with lingering pain in her tendons and forearm. The patient present status was reported as recovering/resolving. No reporter causality provided. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Injection site erythema.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Dyspnoea, Hypopnoea, Lung disorder, Painful respiration
Clinical narrative: Information had been received from a female who reported that her sister was injected with PNEUMOVAX23 by her physician on 10-JAN-2013 during a physical exam. It was immediately after her well physical that the patient had begun her "own respiratory nightmare". The patient began wheezing and having trouble breathing the very weekend following her pneumonia vaccination. She had several emergency room visits and was then hospitalized for over a week. Following discharge, the patient was sent to rehabilitation for another week. When the patient finally got back to her independent apartment, she continued to have the same breathing and wheezing issues. Thinking it was possibly being exacerbated by secondhand smoke, the patient's sister moved her to a nursing rehabilitation center. At the time the patient first became ill, she never even thought of the vaccination. Patient was taken off of the vitamin D that her physician had ordered thinking she may be allergic to it. The patient's sister noted that they never thought it could have been related to the pneumonia vaccine. At this time, the patient battles her breathing issues every day. The reporter who also had events with PNEUMOVAX23 (see MARRS# 1309USA014552 stated she woke up with a real feeling of constriction in the lower part of her lungs. She realized that she was no longer normally breathing from the diaphragm, but only from her upper chest. It was a very shallow and difficult breathing pattern. When she tried to take deep breaths to the diaphragm, she could make the air go there, but it hurt. This was the exact breathing pattern that her sister had begun to use. Deep breathing was hard for her sister. Her sister simply had not recovered with all the best medical attention she had been able to access. It was reported that the patient had lost her freedom and all her wordly possessions at 61 years of age. This time last year that patient was doing well and had no breathing issues. Now she was on multiple nebulizer treatments a day and nothing stops the wheeze. The patient was now confined to a wheelchair. On 30-AUG-2013, patient saw her physician who had been working with her since the hospitalization. Physician scheduled a scope of the patient's bronchial tubes in an effort to find out what was wrong. The patient began to use a breathing pattern that included taking deep breaths to the diaphragm because deep breathing was hard for her. The patient's sister reported that she knew PNEUMOVAX23 caused her illness and knew that her sister had the exact same thing happen to her. The patient's sister also noted she was doubtful the patient would ever be okay again as she was already handicapped from a car wreck at the age of 18. Wheezing, trouble breathing, and shallow breathing were considered to be disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory disorder, Wheelchair user, Wheezing
Clinical narrative: Information had been received from a female who reported that her sister was injected with PNEUMOVAX23 by her physician on 10-JAN-2013 during a physical exam. It was immediately after her well physical that the patient had begun her "own respiratory nightmare". The patient began wheezing and having trouble breathing the very weekend following her pneumonia vaccination. She had several emergency room visits and was then hospitalized for over a week. Following discharge, the patient was sent to rehabilitation for another week. When the patient finally got back to her independent apartment, she continued to have the same breathing and wheezing issues. Thinking it was possibly being exacerbated by secondhand smoke, the patient's sister moved her to a nursing rehabilitation center. At the time the patient first became ill, she never even thought of the vaccination. Patient was taken off of the vitamin D that her physician had ordered thinking she may be allergic to it. The patient's sister noted that they never thought it could have been related to the pneumonia vaccine. At this time, the patient battles her breathing issues every day. The reporter who also had events with PNEUMOVAX23 (see MARRS# 1309USA014552 stated she woke up with a real feeling of constriction in the lower part of her lungs. She realized that she was no longer normally breathing from the diaphragm, but only from her upper chest. It was a very shallow and difficult breathing pattern. When she tried to take deep breaths to the diaphragm, she could make the air go there, but it hurt. This was the exact breathing pattern that her sister had begun to use. Deep breathing was hard for her sister. Her sister simply had not recovered with all the best medical attention she had been able to access. It was reported that the patient had lost her freedom and all her wordly possessions at 61 years of age. This time last year that patient was doing well and had no breathing issues. Now she was on multiple nebulizer treatments a day and nothing stops the wheeze. The patient was now confined to a wheelchair. On 30-AUG-2013, patient saw her physician who had been working with her since the hospitalization. Physician scheduled a scope of the patient's bronchial tubes in an effort to find out what was wrong. The patient began to use a breathing pattern that included taking deep breaths to the diaphragm because deep breathing was hard for her. The patient's sister reported that she knew PNEUMOVAX23 caused her illness and knew that her sister had the exact same thing happen to her. The patient's sister also noted she was doubtful the patient would ever be okay again as she was already handicapped from a car wreck at the age of 18. Wheezing, trouble breathing, and shallow breathing were considered to be disabling. This is one of several reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Injection site discolouration, Mouth haemorrhage
Clinical narrative: Pt said the site of the injection is big, navy blue and purple in color, and pt was bleeding out of her nose and mouth and unable to stop. Called ambulance and went to hospital. They told her no vaccines while on COUMADIN and checks pt Q Monday.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Headache, Mobility decreased, Myalgia
Clinical narrative: Rigors, chills, arthralgias, myalgias, headache, nausea, low grade fevers to 101.1 F.  Incapacitated for 36 hours.  Could not get out of bed.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pyrexia
Clinical narrative: Rigors, chills, arthralgias, myalgias, headache, nausea, low grade fevers to 101.1 F.  Incapacitated for 36 hours.  Could not get out of bed.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Headache, Influenza like illness, Mass, Pain
Clinical narrative: Flu-like symptoms flushed, warm, body aches, headache, and a swollen mass on right ankle bone.  All symptoms resolved by 1PM the next day except the ankle mass.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Flu-like symptoms flushed, warm, body aches, headache, and a swollen mass on right ankle bone.  All symptoms resolved by 1PM the next day except the ankle mass.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives under and around bra line, took Benadryl.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hyperaesthesia, Injection site pain, Oropharyngeal pain
Clinical narrative: Patient complained of severe pain to bicep area; radiated to front shoulder. Pain level 3/10. No fever noted, but did experience chills, fatigue. No swelling to arm, but sensitive to touch to area. Patient complained of sore throat. Patient states she took advil by Sat 09/28/2013 all symptoms subsided.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Patient's left arm is very hot to the touch, red and swollen with induration measuring 11 cm laterally across and 7 cm distally down her arm.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Disturbance in attention, Fatigue, Headache
Clinical narrative: Patient complains of headache, lack of concentration, fatigue. Patient denies any fever. Patient stated she took OTC Tylenol after a long while she stated she felt slightly better.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Oedema mouth, Pruritus, Urticaria
Clinical narrative: Soft palate swelling, itching of hands, hives, unable to sleep.
Age: 50.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Hypoaesthesia oral, Injection site reaction, Rash erythematous, Somnolence
Clinical narrative: Dizzy, feeling like head was swimming. Sudden sleepiness-like I hadn't slept in 24 or more hours--felt like I could just go right to sleep if I closed my eyes. Numb lips--like they had been novacained. Round, red rash--about 3 inch diameter at injection site that evening.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in shoulder and arm. Can't lift arm up or out. Can't lay on right side.  Use heat, took Tylenol.  Can't lift grocery bag or other similar things unless I use other hand.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Disturbance in attention, Fatigue, Headache, Injection site reaction
Clinical narrative: Patient complains of severe fatigue, loss of strength to injection site. Arm was heavy. Inability to focus. Patient stated she left home early due to severe fatigue. Patient complains of pressure to head on following day. Patient states fatigued. Patiend denied fever. Extremely fatigued for a few days.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Sensation of heaviness
Clinical narrative: Patient complains of severe fatigue, loss of strength to injection site. Arm was heavy. Inability to focus. Patient stated she left home early due to severe fatigue. Patient complains of pressure to head on following day. Patient states fatigued. Patiend denied fever. Extremely fatigued for a few days.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Muscle twitching, Neurological examination, Sensation of heaviness, Skin warm
Clinical narrative: Muscle twitches in arms and legs, hot heavy sensation in arms and legs, diarrhea.
Age: 1.09
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Chest X-ray normal, Full blood count normal, Grand mal convulsion, Metabolic function test normal, Pyrexia
Clinical narrative: Generalized tonic clonic seizure not associated with fever on 9/26/13. Had another generalized tonic clonic self-resolving seizure 9/30/13 associated with a fever.
Age: 1.09
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: Generalized tonic clonic seizure not associated with fever on 9/26/13. Had another generalized tonic clonic self-resolving seizure 9/30/13 associated with a fever.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Woke up with swelling and redness in right arm around shot area, pain and fever and called the doctor and went in the office on 09/24/2013 around 1:00 PM and the Doctor prescribed diphenhydrAMINE Tablet which did no good so on Friday 09/27/2013 I ended up in the ER.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain, Pain, Photophobia
Clinical narrative: Worst headache I've ever had, exacerbated by bright lights.  Also with significant neck pain on movement and general body aches.  Almost like meningitis - if it had lasted any longer I would've gone to the ER.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Neck pain
Clinical narrative: Severe left sided neck pain.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Dehydration, Granulocyte count increased, Injection site swelling, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Pt. reports swelling of Right upper arm, extending around and up to shoulder and stiff neck with onset 2hr after injection.  Pt. reports nausea and vomiting for last 24 hr, unable to hold liquids. In clinic today, L and R arm both 26.5cm circumfrence at base of bicep, no observable erythema. Limited range of motion of arm to about 10 degree abduction, able to move fingers, flex and extend forearm. Pt. dehydrated, anti-nausea medications prescribed, IV attempted-unable to access vein.  Pt. recommended to ER for hydration and follow up visit at clinic Sat. early AM.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Nausea, Urine analysis normal, Vomiting, White blood cell count increased
Clinical narrative: Pt. reports swelling of Right upper arm, extending around and up to shoulder and stiff neck with onset 2hr after injection.  Pt. reports nausea and vomiting for last 24 hr, unable to hold liquids. In clinic today, L and R arm both 26.5cm circumfrence at base of bicep, no observable erythema. Limited range of motion of arm to about 10 degree abduction, able to move fingers, flex and extend forearm. Pt. dehydrated, anti-nausea medications prescribed, IV attempted-unable to access vein.  Pt. recommended to ER for hydration and follow up visit at clinic Sat. early AM.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red spot at place of vaccination and itchy with some mild swelling.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Headache, nausea, fever, dizziness, congestion, sore throat, diarrhea.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Headache, nausea, fever, dizziness, congestion, sore throat, diarrhea.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Redness and hard lump at injection site, warm.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Night sweats, Pain, Pyrexia
Clinical narrative: Body aches, High-grade fever of 101.7, Chills, Nightsweats; Treatment with Ibuprofen.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 01-OCT-2013 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # 0491AE, EXP date 15-SEP-2013, dose and route was not reported). No adverse effects were reported. It was unknown if patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 24-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # 0217AE; expiry date: 22-AUG-2013). No adverse effect. The outcome of event was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On an unknown date the patient might received vaccinated with VARIVAX (lot number, dose, route, strength and injection site were not reported). On an unspecified date the patient had developed a fever and "now" (on an unknown date in 2013) the patient had a "rash". The action taken was not reported. The outcome was reported as not recovered/not resolved. The patient had an office visit for medical attention. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a currently 22 year old non-pregnant female patient. On 14-NOV-1997 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 18-DEC-1997 and the third dose was administered on 22-MAY-1998 (also reported as 22-MAY-1997). The reporter stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. This is one of 10 reports from the same source. (1309USA005675, 1309USA007825, 1309USA007826, 1309USA007827, 1309USA007828, 1309USA007829, 1309USA007830, 1309USA007831, 1309USA007831, 1309USA007833). Additional information has been requested.
Age: 0.78
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 3 month old (at the time of second vaccination) and currently 21 year old non-pregnant patient. On 09-JUL-1992 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 10-SEP-1992 and the third dose was administered on 08-MAR-1993. The reported stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. The is one of 10 reports from the same source. (1309USA005675, 1309USA007825, 1309USA007826, 1309USA007827, 1309USA007828, 1309USA007829, 1309USA00730, 1309USA007831, 1309USA007833). Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: This spontaneous report as received from a 32 year old male patient refers to himself with hypertriglyceridemia. The patient had no drug reactions/allergies. On 23-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# unspecified) (route, dose location unspecified). Concomitant therapies included with fenofibrate (dosage and manufacturer unknown), CRESTOR (dose and manufacturer unknown), amlodipine (dosage and  manufacturer unknown). On 23-SEP-2013, the patient reported that he experienced severe pain, soreness, tenderness and limitation of movement in the arm after he received the PNEUMOVAX23 vaccine. The patient did not seek medical attention. No lab diagnostics studies were performed. No treatment was given for the events. At the time of report, the outcome of the events was not recovered. Additional information is not expected.
Age: 0.74
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old (at the time of second vaccination) and currently 21 year old non-pregnant female patient. On 10-MAY-1992 the patient was vaccinated with the first dose of RECOMBIVAX injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 10-JUL-1992 and the third dose was administered on 08-JAN-1993. The reported stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was give for adverse event. The outcome of hepatitis B titer negative was unknown. This is one of 10 reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Condition aggravated, Depression, Nausea
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via Company Representative refers to a 12 year old female patient. The patient's medical history included anxiety. On 23-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J002641; expire on 10-DEC-2015) (dosage and route not reported). No concomitant therapy. The nurse practitioner reported to the representative that, "after the patient received their first dose in the series of GARDASIL, she experienced anxiety, depression, and nausea". The representative stated, "the patient did not discontinue the series of GARDASIL, and still planned on receiving the second dose in the future, on an unspecified date". The patient sought medical attention via office visit on 23-SEP-2013. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Local swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age who reported on herself. The patient's current medical history included asthma, gastrooesophageal reflux disease (GERD), fish allergy, primary hyperthyroid, sulfa and narcotics allergy. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number and expiration date not provided). Concomitant therapies included fluticasone propionate, ADVAIR and cetirizine hydrochloride reported as generic ZYRTEC (manufacturer unknown). The patient reported that she received a vaccine to prevent pneumonia, possibly PNEUMOVAX23. She did not recall in which arm she received the shot, but the arm blew up and was enlarging past her elbow. It lasted for more than one day. The patient was treated with BENADRYL. Lab diagnostic studies included blood work (results not provided). The patient sought medical attention via calling physician. She also recalled having an unspecified tetanus shot at a previous unspecified time where the same reaction occurred. The outcome of arm blew up and was enlarging past her elbow was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 30-SEP-2013 the patient was vaccinated with VARIVAX (lot# reported as H020587, EXP date 13-NOV-2014, route and dose not reported) which was exposed to 48F for 40.5 hours, which was unsupported. No adverse effects were reported. I was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a male consumer of an unknown age referring to himself. On 27-SEP-2012, approximately (also reported as one year ago), the patient was vaccinated with ZOSTAVAX, (lot number not reported). The patient reported that he had a reaction at the injection site from the ZOSTAVAX vaccine. He had a small patch of redness at the injection site. The outcome of he had a reaction at the injections site from the ZOSTAVAX vaccine and he had a small patch of redness at the injections site was unknown. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Wheezing
Clinical narrative: Redness swelling pain left upper arm - site of flu injection. Also increased shortness of breath, wheezing.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Nausea, Rash, Urticaria
Clinical narrative: Patient complained of nausea/vomiting at 3PM on 10/2/13, diarrhea on 10/3/13 and woke up with hives on Friday 10/4/13. Patient isn't having any trouble breathing. Advised her to take BENADRYL for rash and to call or if worsened.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient complained of nausea/vomiting at 3PM on 10/2/13, diarrhea on 10/3/13 and woke up with hives on Friday 10/4/13. Patient isn't having any trouble breathing. Advised her to take BENADRYL for rash and to call or if worsened.
Sex: U
Vaccine: HEP, HEPA, HPV4, MMR, PPV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients. On unknown dates, the patients may have received doses of VAQTA, RECOMBIVAX HB, GARDASIL, MMR II, PNEUMOVAX23 and ROTATEQ, that were exposed to unsupported temperature excursions (doses, route and lot numbers not provided). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). On an approximately 12-SEP-2013 (about a week ago), the patient was vaccinated with an expired dose of PNEUMOVAX23, 0.5 ml (route, lot number not reported, exp. Date 10-MAY-2013). No adverse effect reported. The patient's outcome was unknown. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report was received from an 85 year old female consumer referring on herself. On 2013, a few months ago she was vaccinated with ZOSTAVAX, (lot number not reported). On an unknown date, she got a case of the shingles on her left arm, shoulder, left part of her back. The shingles came and went after a few weeks but still suffers with nerve pain, still present. The patient sought medical attention and was treated with patches. The outcome of she got a case of the shingles on her left arm, shoulder, left part of her back was reported as not recovered/not resolved. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Pt complained tingling sensation at tip of her finger on the hand that vaccine was administered.
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received flu vaccine mist on 9/19/2013. Patient noted on screening form NA for possible pregnant status had positive pregnancy test on.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Respiratory disorder, Throat tightness
Clinical narrative: Pt. had difficulty breathing and throat closing around 9:00 PM. Pt went to hospital and was given Benadryl and discharged. At 5:30 AM pt now complains of respiratory illness (10/4/13).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Chest discomfort, Condition aggravated
Clinical narrative: Patient states her chest tightened at night of vaccination and progressively got worse. She required hospitalization on Tuesday for a couple of hours due to severe asthma symptoms.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Computerised tomogram, Dizziness, Eyelid oedema, Local swelling
Clinical narrative: Pt's mother reported chills and hives 30 mins after administration. Eyes swollen shut, hives, "extreme" swelling in (R) arm for 48 HR. Dizzy, vomiting sxs started 48 Hr after administration. Pt seen at ER dept and received MRI and CT scan. Pt released from hospital 10-2-13 6 AM. Event reported to Pharmacy at 1:30pm 10/4/13 by patient's mother.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging, Urticaria, Vomiting
Clinical narrative: Pt's mother reported chills and hives 30 mins after administration. Eyes swollen shut, hives, "extreme" swelling in (R) arm for 48 HR. Dizzy, vomiting sxs started 48 Hr after administration. Pt seen at ER dept and received MRI and CT scan. Pt released from hospital 10-2-13 6 AM. Event reported to Pharmacy at 1:30pm 10/4/13 by patient's mother.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Skin infection
Clinical narrative: On 10/4/13, patient came to pharmacy for antibiotic for skin infection, redness enlarging on L arm near site of injection.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest discomfort, Cough, Headache, Pyrexia
Clinical narrative: Severe headache starting 1 hr after shot, followed by cough / chest tightness, achy joints, fever lasting about 20 hrs. Pt has recovered.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Hyperhidrosis, Lethargy, Pain
Clinical narrative: Date given-Sept. 9, 2013 12:15 PM. 9:00 PM sever chills, teeth chattering shivers, 11:15 PM feverish, sweating. Sept. 10 very lethargic - could not attend usual cardio class had 4-5 naps throughout the day, body aches. I have had flu shots ever since they have been on the market and I have never before had any side effects.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Somnolence
Clinical narrative: Date given-Sept. 9, 2013 12:15 PM. 9:00 PM sever chills, teeth chattering shivers, 11:15 PM feverish, sweating. Sept. 10 very lethargic - could not attend usual cardio class had 4-5 naps throughout the day, body aches. I have had flu shots ever since they have been on the market and I have never before had any side effects.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: She had hives. MD had prescribed ATARAX and SINGULAIR.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 67 year old female consumer without drug reactions/allergies or pertinent medical history regarding herself. In February 2010, the patient was vaccinated with ZOSTAVAX, 1 time vaccine, subcutaneous for prevent shingles (lot number and expiration date not reported). There was none concomitant medication. On 18-SEP-2013, the patient has shingles, after receiving the vaccine. No lab diagnostic were performed. In September 2013, the patient sought unspecified medical attention and was treated with antivirals and pain pills. The outcome of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (lot# reported as H021941; exp. date: 11-JUL-2014) (dose and route not provided) which was exposed to 11C for 56 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from same source. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Received MENACTRA #2 and HPV #3 (GARDASIL) on 10/2/2013 1630 pm was fine after vaccination. Started with rash 10/3/2013 AM and rash progressed. Seen today 10/4/2013 in office with generalized urticaria. No joint swelling, no trouble breathing. No wheeze.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site inflammation, Injection site warmth, Pain in extremity
Clinical narrative: Around 10pm 10/2/13 pt began feeling pain/numbness in pneumo arm and injection site became hot/inflamed. Pt took "pain med." Came to pharmacy 10/3/13 at 1:30pm - RPh noted redness/inflammation in 4-5 inch area around injection site. Saw nurse practitioner at MD office who recommended she go to ER for possible cellulitis. ER MD said no cellulitis. Saw MD today and MD told her to continue w/ compresses and wrote Rx for antibiotic if needed.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Neck pain, Tenderness
Clinical narrative: Patient stated that the day after receiving the flu shot, she started experiencing stabbing pain in the back of right neck and ear and tenderness on the right side of the top of her head. She has been taking ibuprofen for the pain and was recommended by a pharmacist over the phone to take ibuprofen and CLARITIN. The tenderness went away on 10/3/13, but still feels the stabbing pain.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelids pruritus, Injection site erythema, Injection site pruritus
Clinical narrative: Patient noted itchiness then redness around injection site about 1 1/2 inch diameter on 10/1 - Also her left eyelid was itchy and uncomfortable. She showed me her arm 10/2/13 at about (1pm) the redness was almost faded and the itchiness as well.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Mobility decreased, Pain, Tenderness
Clinical narrative: Pt called on 9/19/13 to report that she had developed pain on her Rt side with swelling of Rt knee and tenderness of Rt ankle that started the evening after she received her flu shot. Pt came in to see MD on 9/23/13 with continued symptoms. Pt cont having difficulty getting out of bed due to the pain. 10/3/13 pt called with c/o cont swollen joints and pain on the Rt side. 10/3/13 pt was given Rx for prednisone x 5d.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Feeling cold, Immediate post-injection reaction, Oropharyngeal pain, Tremor
Clinical narrative: Immediately after vaccination pt reports pain in throat (no swelling), pain in throat when coughing, pt threw up, and had shakes and felt very cold did not take temperature. Pt reported to me 10/4/13.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Immediately after vaccination pt reports pain in throat (no swelling), pain in throat when coughing, pt threw up, and had shakes and felt very cold did not take temperature. Pt reported to me 10/4/13.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia
Clinical narrative: Pt developed a "red spot" on her L sclera about 1-1 1/2 hr after Fluzone quadrivalent vaccine. MD office notified - determined pt did not have to be seen - Ocular hyperemia is listed as Adverse side effect. Per MD red spot - possible broken vessel.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given a Flu mist vaccine. No adverse events noted (tried to notify pt's mother no response will send letter).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Redness near injection site two days after injection. The area is hot as well.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Dyspnoea, Oedema mouth, Pyrexia, Urticaria
Clinical narrative: Patient stated on 10/3/13 (date vaccine provided) that has asthma attack and difficulty breathing, but today (10/4) when I called to follow up, she said yesterday she had fever, swollen mouth, and hives, but feel fine today.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Redness (2" x 1 1/2 ") and warm to touch (2 3/4" x 2 1/2") - at 9 AM 10/3/13. Localized reaction.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Injection site pain, Radiculitis brachial
Clinical narrative: Vaccine given 9/11/13 - Rt deltoid. Pain, weakness onset 9/14. Seen in emergency dept. 9/23. Seen by health center 10/4 -> brachial neuritis.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7 cm red swollen area (L) deltoid around the injection site, painful, warm. ORAPRED 5 ml PO BID.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, rash, warmth from knee to groin in (R) leg (injection site) ORAPRED 5 ml PO BID.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Rash
Clinical narrative: The patient came in 2 days after receiving the vaccine and she had a rash 2 inches in diameter. She was  instructed to use Benadryl and hydrocortisone cream.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Heart rate decreased, Presyncope
Clinical narrative: Vasovagal response HR decreased 54 BPM. Pt placed in a supine position until able to determine if stable. Monitored w/ O2 Sat. Continuously monitoring in room VS taken.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site injury, Injection site irritation
Clinical narrative: Two days after patient was given Zostavax immunization on 9/20/13, patient came in today 10/2/13 with circular redness. It has dissipated some. Patient says he has bumped injection site a few times, irritating spot.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not reported) which was exposed to 11.5C for 82.5 hours an excursion that was not supported by in-house stability data. No adverse effect. This is one of several reports received from same source. Lot number H022281 is an invalid lot number for PNEUMOVAX23.  Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Pruritus generalised, Rash
Clinical narrative: Redness, rash of face and hands. "Itchy" feeling all over.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5C for 80.5 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports from the same source. Additional information is not expected.
Age: 91.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Received quadrivalent flu vaccine on 9/26/13 in (L) arm - pain in (L) arm x3 days - called doctors office told her she was having muscle spasms and to take OTC pain relievers.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) who was vaccinated with PNEUMOVAX23 which was exposed to 12C for 78.5 hours. No adverse effect reported. This is one of several reports from the same source. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria, Wheezing
Clinical narrative: Approx. 12 hrs after injection, hives, urticaria across chest, arms, hands and wheezing improved with 10mg loratadine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Dizziness, Dysarthria, Grip strength decreased, Muscle twitching
Clinical narrative: After administration of HPV in left arm patient just looked straight ahead. I asked patient if she felt light headed and she said yes. I had her lay down. She did not have any loss of consciousness. Upon laying down she stared straight ahead. Her Uncle was asked to come back to the room and Dr. was brought into the room to exam patient. I asked her to tell me her name, where she was, why she was here. She slowly answered all questions appropriately. At that time she had left arm twitching that lasted about 6-7 minutes. All vitals with in normal limits. 911 was called due to starring, delayed speech and left arm twitching that did not stop. Once ambulance arrived patient's arm twitching had stopped, she was sitting up and able to answer all questions appropriately with out and any delay. Escorted to hospital by ambulance. Called to see patient about 5 mins after HPV injection. When I entered room, patient was supine on the bed, staring with LUE shaking. She responded in a slurred voice to questions but answered correctly. No eye deviation, but appeared to be staring, ? left mouth drooling. She was able to squeeze right UE but left was weaker. Uncle in the room had never seen this prior. No recent illnesses per uncle. On phone conversation her aunt denies any previous seizure history or pseudoseizure. No new medications. Complex psych history and social situation. Reviewed last WCC. VSS as below (HR 76, O2 96%, BP as below) entire event were stable. LUE twitching continued > 6 minutes. Due to decreased LOC and continued shaking, EMS was called. On their arrival she was alert and shaking had stopped. She stated "what happened?" but then could relay events. No weakness and normal neuro exam otherwise she was tearful. Reviewed events with aunt, via phone and also EMS. DDX - pseudoseizure vs partial seizure vs stress event. Referred to ED for further care given change in LOC, via ambulance.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination normal, Partial seizures, Psychogenic seizure, Slow speech, Staring
Clinical narrative: After administration of HPV in left arm patient just looked straight ahead. I asked patient if she felt light headed and she said yes. I had her lay down. She did not have any loss of consciousness. Upon laying down she stared straight ahead. Her Uncle was asked to come back to the room and Dr. was brought into the room to exam patient. I asked her to tell me her name, where she was, why she was here. She slowly answered all questions appropriately. At that time she had left arm twitching that lasted about 6-7 minutes. All vitals with in normal limits. 911 was called due to starring, delayed speech and left arm twitching that did not stop. Once ambulance arrived patient's arm twitching had stopped, she was sitting up and able to answer all questions appropriately with out and any delay. Escorted to hospital by ambulance. Called to see patient about 5 mins after HPV injection. When I entered room, patient was supine on the bed, staring with LUE shaking. She responded in a slurred voice to questions but answered correctly. No eye deviation, but appeared to be staring, ? left mouth drooling. She was able to squeeze right UE but left was weaker. Uncle in the room had never seen this prior. No recent illnesses per uncle. On phone conversation her aunt denies any previous seizure history or pseudoseizure. No new medications. Complex psych history and social situation. Reviewed last WCC. VSS as below (HR 76, O2 96%, BP as below) entire event were stable. LUE twitching continued > 6 minutes. Due to decreased LOC and continued shaking, EMS was called. On their arrival she was alert and shaking had stopped. She stated "what happened?" but then could relay events. No weakness and normal neuro exam otherwise she was tearful. Reviewed events with aunt, via phone and also EMS. DDX - pseudoseizure vs partial seizure vs stress event. Referred to ED for further care given change in LOC, via ambulance.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Stress, Tearfulness, Tremor
Clinical narrative: After administration of HPV in left arm patient just looked straight ahead. I asked patient if she felt light headed and she said yes. I had her lay down. She did not have any loss of consciousness. Upon laying down she stared straight ahead. Her Uncle was asked to come back to the room and Dr. was brought into the room to exam patient. I asked her to tell me her name, where she was, why she was here. She slowly answered all questions appropriately. At that time she had left arm twitching that lasted about 6-7 minutes. All vitals with in normal limits. 911 was called due to starring, delayed speech and left arm twitching that did not stop. Once ambulance arrived patient's arm twitching had stopped, she was sitting up and able to answer all questions appropriately with out and any delay. Escorted to hospital by ambulance. Called to see patient about 5 mins after HPV injection. When I entered room, patient was supine on the bed, staring with LUE shaking. She responded in a slurred voice to questions but answered correctly. No eye deviation, but appeared to be staring, ? left mouth drooling. She was able to squeeze right UE but left was weaker. Uncle in the room had never seen this prior. No recent illnesses per uncle. On phone conversation her aunt denies any previous seizure history or pseudoseizure. No new medications. Complex psych history and social situation. Reviewed last WCC. VSS as below (HR 76, O2 96%, BP as below) entire event were stable. LUE twitching continued > 6 minutes. Due to decreased LOC and continued shaking, EMS was called. On their arrival she was alert and shaking had stopped. She stated "what happened?" but then could relay events. No weakness and normal neuro exam otherwise she was tearful. Reviewed events with aunt, via phone and also EMS. DDX - pseudoseizure vs partial seizure vs stress event. Referred to ED for further care given change in LOC, via ambulance.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine admin in (L) deltoid on 10/1/13. No complaints made by pt. Pt states her deltoid started hurting immediately and has worsened. Redness, swelling in most of (L) upper arm. Bad pain. Hot to touch. Radiating pain into shoulder and rest of arm. Weakness.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Vaccine admin in (L) deltoid on 10/1/13. No complaints made by pt. Pt states her deltoid started hurting immediately and has worsened. Redness, swelling in most of (L) upper arm. Bad pain. Hot to touch. Radiating pain into shoulder and rest of arm. Weakness.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5 C for 100 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5 C for 103.5 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from same source. Additional information is not expected.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Light headed, dizzy, nauseated shortly after given the vaccine. He did feel better after lying down.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 12C for 192 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports received from the same source. Additional information is not expected.