chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction, Nervous system disorder
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 11 Oct 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced bad reaction: neurological system shutdown. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. Upon medical review, the case was considered as serious due to important medical event: neurological impairment. List of documents held by sender: none.; Sender's Comments: This is poorly documented case where really bad reaction- the person's neurological system shut down reported after influeza vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Hypoaesthesia, Muscle spasms, Musculoskeletal chest pain, Pelvic pain
Clinical narrative: By 2:00 P.M. Tension Headache.  By 5:00 P>M> thru 3 :00 PM next day 102 temperature.  Hands went numb.  Spine and pelvic pain.  Muscle spasms in quads and under rib pain.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Spinal pain, Tension headache
Clinical narrative: By 2:00 P.M. Tension Headache.  By 5:00 P>M> thru 3 :00 PM next day 102 temperature.  Hands went numb.  Spine and pelvic pain.  Muscle spasms in quads and under rib pain.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Bone marrow oedema, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Joint effusion
Clinical narrative: Patient has experienced pain in left shoulder x12 weeks in deltoid area, especially on flexion and extension of left shoulder. Numbness of inner side of left upper arm down to little finger reported 08/10/16.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Nerve conduction studies abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging abnormal, Pain, Ultrasound scan normal
Clinical narrative: Patient has experienced pain in left shoulder x12 weeks in deltoid area, especially on flexion and extension of left shoulder. Numbness of inner side of left upper arm down to little finger reported 08/10/16.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Red knot on right leg at site of vaccines- advised office on 9/29/2016.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Varicella
Clinical narrative: Chickenpox: widespread rash. Treated with VALTREX 1gram.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Left deltoid noted to be warm to touch, red, swollen.  Erythema extended to inner aspect of the bicep 3-4cm diameter from the injection site. Pt stated she took ibuprofen and diphenhydramine. Instructed to watch closely. 10/19/16: erythema significantly increased to >10 cm extending from deltoid covering entirety of the inner aspect of left bicep. Patient reported fever PM of 10/18/16. discomfort is significant. Advised to see PCP as soon as possible for assessment.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling, pain at injection site. Tightness in Right upper extremity. Given Medrol dose pack and Augmentin given.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Laboratory test, Skin tightness
Clinical narrative: Erythema, swelling, pain at injection site. Tightness in Right upper extremity. Given Medrol dose pack and Augmentin given.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Body temperature increased, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: Patient vomited minutes after receiving DTaP and Influenza immunizations. Patient was also suddenly pale and sweaty. Her temperature was 97.2. She sat on moms lap and color returned to normal.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Diarrhoea, Night sweats, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported similar events for 2 patients. This is the 2nd of 2 reports. A 66-year-old male patient started to receive PREVNAR 13 (Lot # M35761, Expiry date: 30May2016) at 0.5 ml, single in left deltoid on 23Sep2016 10:17 for pneumonia immunisation    Medical history included ongoing pancreatitis chronic, ongoing pain, ongoing chronic obstructive pulmonary disease, ongoing intervertebral disc degeneration, ongoing sciatica, ongoing seizure, ongoing lung adenocarcinoma, ongoing osteoarthritis, ongoing prostatic specific antigen increased. Concomitant medication included ipratropium bromide (ATROVENT) 17 ug, as needed (4 times a day) ongoing for COPD, pancreatin (CREON) 36000 units 4 time as a day by mouth for Chronic pancreatitis, glyceryl trinitrate (NITROSTAT) 0.4mg sublingual as needed for angina, morphine sulfate (MS CONTIN) one tablet twice daily as needed by mouth for chronic pain.   The patient experienced abdominal pain, night sweats, diarrhea, fever the evening of the 23Sep2016 after receiving the PREVNAR 13 injection. The outcome of the events was completely recovered on 26Sep2016: all of the patients symptoms were gone within 3 days after receiving the vaccine. There were no relevant tests. The nurse assessed there was a reasonable possibility these events were related to this suspect product.
Sex: U
Vaccine: PNC13
Symptoms: Local swelling, Mobility decreased, Pain
Clinical narrative: This is a spontaneous report obtained from a non-contactable physician. This physician reported similar events for three patients. This is the first of three reports. A patient of unspecified age, gender and race received, on an unknown date, PREVNAR 13 at 0.5 ml single dose, for immunization. Medical history and concomitant medications were not provided. On an unspecified date, the patient experienced pain and swelling locally and it was hard for the patient rose hands over the head. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2016482854. Same reporter/drug/event different patients; US-PFIZER INC-2016483159. Same reporter/drug/event different patients.
Sex: U
Vaccine: PNC13
Symptoms: Local swelling, Mobility decreased, Pain
Clinical narrative: This is a spontaneous report obtained from a non-contactable physician. This physician reported similar events for three patients.  This is the second of three reports. A patient of unspecified age, gender and race received on an unknown date PREVNAR 13 at 0.5 ml single dose, for immunization. Medical history and concomitant medications were not provided. On an unspecified date the patient experienced large local pain, swelling locally and hard time raising the hand over the head. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016483131 same reporter/drug/AE, different patient.;US-PFIZER INC-2016482854 same reporter/drug/AE, different patient.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Initial unsolicited case received from a consumer (patient mother) on 11 Oct 2016. This case involves a 4 year old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, and dose was not reported) in left thigh on 03 Oct 2016. The patient Pre-existing physician diagnosed allergies, birth defects, medical conditions were not provided, and illness at the time of vaccination and any other vaccinations within 4 weeks of vaccinations were reported as none. The patient concomitant medications were unknown. On 04 Oct 206, one day after vaccination the patient left thigh was red, hot it had a baseball size lump at the injection site with pain. The patient Required doctor visit and went to the physician on an unknown date. The patient lab tests were reported as none. The patient was taken a first dose of antibiotics prescribed by the physician. The patient recovered from the events on an unspecified date. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (Same source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. It was reported that, patient also had Influenza vaccine earlier on an unspecified date and got sick. Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient was "dick" (sick). Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported.  List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Death, Influenza
Clinical narrative: Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is linked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (same source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a first dose of FLU SHOT (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, after a week following the vaccination, the patient experienced flu (deathly ill). Patient's lab data and corrective treatment was not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a consumer on 10-Oct-2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOTS) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was reported that, the patient received pneumonia vaccination in the past. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced near lethal flu. It was a case of potential vaccination failure. It was reported that, the patient received flu shots in the past and experinced near lethal flu as an event after the vaccination. Lab data and corrective treatment were not reported. The outcome of the events was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: near lethal flu and potential vaccination failure. Documents held by sender: none.; Sender's Comments: This social media case reported by consumer on facebook patient had two flu shot and both times he got lethal flu. Time to onset is unknown, additional information regarding patient medical history , lab investigation regarding the type of virus, culture report are needed to further assess the case. Based on available information the role of vaccine cannot be assess.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling to right upper arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Aura, Headache, Migraine, Nausea
Clinical narrative: Migraine (auras, headache, nausea).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Eyelid oedema, Paraesthesia oral, Skin discolouration
Clinical narrative: Night of vaccine patient reports feeling lightheaded and her lips were tingling.  Her arm was red.  The next day her arm turned black and her eyes were swollen shut.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood test, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Chills, fever, headache, muscle pain, nausea, dizziness, vomiting, teeth chattering.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Chills, fever, headache, muscle pain, nausea, dizziness, vomiting, teeth chattering.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Mass, Peripheral swelling
Clinical narrative: Hard lump beneath the skin about the size of a fist per patient's report. Arm swollen, redness around the lump. Denies fever, difficulty breathing. Lump is still present at date of VAERS report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Tremor
Clinical narrative: Chills then severe shaking (whole body) for 1/2 hour.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchy with small bumps around the injection site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 102 fever.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Hypersomnia, Injection site erythema
Clinical narrative: This employee received the Influenza vaccine on Friday, 14 Oct at approximately 1230. Specific vaccine was FLUARIX by GSK, lot number CS979. She has never experienced adverse events from the Influenza vaccine before. She last received the injectable flu shot in 2005 and has received FLUMIST each year since that time. She reports that approximately 1445 she developed a headache on the day of vaccination. She describes it as "all over", non throbbing, mild but unrelenting. Took TYLENOL at home with no relief. Early the next morning she began having loose stools. On Saturday, day 1 post vaccine, she was very fatigued and slept most of the day, having to cancel all planned activities. At the injection site her upper arm was exquisitely painful with erythematous swelling. She took a 400mg dose of over-the-counter MOTRIN with no improvement in headache or arm pain. Bowel and headache symptoms but resolved on day 5 post vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: This employee received the Influenza vaccine on Friday, 14 Oct at approximately 1230. Specific vaccine was FLUARIX by GSK, lot number CS979. She has never experienced adverse events from the Influenza vaccine before. She last received the injectable flu shot in 2005 and has received FLUMIST each year since that time. She reports that approximately 1445 she developed a headache on the day of vaccination. She describes it as "all over", non throbbing, mild but unrelenting. Took TYLENOL at home with no relief. Early the next morning she began having loose stools. On Saturday, day 1 post vaccine, she was very fatigued and slept most of the day, having to cancel all planned activities. At the injection site her upper arm was exquisitely painful with erythematous swelling. She took a 400mg dose of over-the-counter MOTRIN with no improvement in headache or arm pain. Bowel and headache symptoms but resolved on day 5 post vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Heart rate increased, Pain, Urticaria
Clinical narrative: Fast heartbeat, dizziness, weakness, severe aches, intermittent hives (appear and disappear).
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Dysstasia, Gait disturbance, Muscle spasms, Pain
Clinical narrative: Severe muscle cramps in thighs, adductors muscles (both legs), left calf muscle, brachioradialis, and extensor muscles of arms. Cramping persisted severly for two days, which made walking difficult, climbing and descending stairs impossible, and sitting and standing extremely difficult and painful. Symptoms persisted severely for two days, and gradually improved on day three and full 100 per cent recovery took seven days.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Chills, Nausea, Peripheral swelling, Pyrexia, Tinnitus
Clinical narrative: Chills, fever (101), swollen arm, nausea, blurred vision, ringing in ears; seen at urgent care evening of 10/15 diagnosed as adverse reaction to Bexsero, treated with antinausea medication.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Vaccination complication, Vision blurred
Clinical narrative: Chills, fever (101), swollen arm, nausea, blurred vision, ringing in ears; seen at urgent care evening of 10/15 diagnosed as adverse reaction to Bexsero, treated with antinausea medication.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Tremor
Clinical narrative: After receiving 2 vaccine Menactra an Trumemba the pt sat for a few minutes and they left the exam room. Once in the hallway he passed out. Once on the ground he shakes for a 2 second an then came too within 30 seconds.  He remained in the office for 20 minutes, while his vital signs were checked by the provider.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Injection site erythema, Injection site swelling, Loss of control of legs
Clinical narrative: Pt became very warm and began to sweat. Vision became blurry, lasted ~ 5min. Knees buckled and pt collapsed on floor. Erythema and swelling to the area of injection (~2/3 of upper left arm). Warm unable to bend or lie on the arm, lasted several hours into the evening. Nausea, but not vomiting. Lightheadedness. Consumed fluids to help manage once nausea resolved.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Skin warm, Syncope, Vision blurred
Clinical narrative: Pt became very warm and began to sweat. Vision became blurry, lasted ~ 5min. Knees buckled and pt collapsed on floor. Erythema and swelling to the area of injection (~2/3 of upper left arm). Warm unable to bend or lie on the arm, lasted several hours into the evening. Nausea, but not vomiting. Lightheadedness. Consumed fluids to help manage once nausea resolved.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Peripheral swelling, Pruritus
Clinical narrative: Swollen and itchy hands, difficult to make a fist, hands feel tight. Patient took Ibuprofen and saw some improvement overnight. Hands still show some swelling roughly 20 hours post vaccination.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Significant pain, swelling, itching at site of PNEUMOVAX injection.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pain
Clinical narrative: Patient complained of severe aches all over body after getting vaccine. No fever or nausea. Patient was very ill all through Saturday night but felt fine on Sunday.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist via Pfizer sales representative. An elderly female (over 65) patient of an unspecified ethnicity received PREVNAR 13 intramuscular at single dose at deltoid muscle sometime in 2016 (in the past month before this report, not specified if Sep or Oct2016) for pneumonia pneumococcal immunization. The patient medical history was not reported. Concomitant medication included influenza vaccine (INFLUENZA, Flu shot) on the same day in 2016. The patient experienced cellulitis on the arm where the PREVNAR 13 was administered in 2016 with outcome unknown. She was treated with Clinamycin. The patient stated she would not get the product again. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old white female patient received PREVNAR 13 (lot M79320, NDC number 00005197102, Expiry Date Aug2017) at 0.5ml single dose via intramuscular route for prevention of pneumonia on 05Oct2016. Medical history was unknown. The patient received unknown concomitant medications. On 08Oct2016 the patient experienced a Rash like a band across the arm, 3 inch wide at the injection site more to the size of the Band Aid. The patient described the rash as pink in color and a little itchy but not painful. The outcome was not recovered. The nurse did not think the rash was related to the vaccine. Sender's Comments: The reported event might be compatible with the known adverse event profile of PREVNAR 13; a causal relationship therefore cannot be excluded.
Age: 83.0
Sex: U
Vaccine: PNC13
Symptoms: Chills, Fatigue
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for her/him self.  An 83-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose in Oct2016 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, pretty tired on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia, Rash generalised
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist.   A female patient of an unspecified age received a single dose of  PREVNAR 13 on an unknown date for immunization. The patient medical history and concomitant medications were not reported. On an unknown date the patient experienced rash on the body, fever and ache, which were described as follows:  a day after vaccination, the patient got fever and ache and a week later, she developed some rash (not into face or arm or leg) for about 4 days. Pharmacist didn't think that the rash was due to pneumococcal 13-val conj vaccination, because it appeared a week later. The final outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient is still having pain 1 month later on the front of the arm and on back of arm in a horseshoe pattern but not pain at injection site. Advised patient to call MD.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Mobility decreased, Myalgia
Clinical narrative: Severe muscle pain and limited arm movement with discomfort.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, mild swelling, induration, some pain and pruritus around shot site, worsened some on day 2 of reaction.  Area affected limited to 15-16 cm area on right arm at injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Oral mucosal blistering, Pneumonia, Pyrexia
Clinical narrative: Received vaccines MMRV, HepA 8/1.  presented to ER 8/3 with fever, dx with blister in mouth and pneumonia.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Left arm swollen, redness radiating down almost to elbow.  Reports pruritis.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Nausea
Clinical narrative: Vaccine administered pt stated "that's it?" pt then stood up to let sister sit down for her shot. Pt then lost consciousness and fell to the ground hitting his head on the way. Pt regained consciousness about 15 seconds after the initial fall. Pt appeared pale and c/o head pain and nausea. Pt did not know what happened and it took about 3 minutes before he regained his bearing. Incident reported to RN and physician. Pt advised to go to ED via bls transport parent refused. Patient advised to sit and be watched for awhile to ensure no more side effects. Parent refused.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Pallor
Clinical narrative: Vaccine administered pt stated "that's it?" pt then stood up to let sister sit down for her shot. Pt then lost consciousness and fell to the ground hitting his head on the way. Pt regained consciousness about 15 seconds after the initial fall. Pt appeared pale and c/o head pain and nausea. Pt did not know what happened and it took about 3 minutes before he regained his bearing. Incident reported to RN and physician. Pt advised to go to ED via bls transport parent refused. Patient advised to sit and be watched for awhile to ensure no more side effects. Parent refused.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Deep vein thrombosis, Peripheral swelling, Pulmonary embolism
Clinical narrative: Arm swelling started shortly after flu vaccine given.  Patient was then diagnosed with R brachial DVT and pulmonary embolism after presenting to ER 13 October 2016.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received FLUZONE injection on 10/17/16. Patient return to office on 10/19/16 with a 5 by 3 in swelling and redness in his left deltoid. The same arm the injection was given in.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased
Clinical narrative: Pt developed temp 106 after flu injection requiring ER visit.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Red swollen injection site. Approx 6x6 cm. Fever of 101 (may also have a viral illness and has abd. pain).
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Flushing, Pruritus, Rash erythematous
Clinical narrative: Complains of severe bodily itching and fine reddened rash with flushing and mild chest tightness. No wheezing or stridor. No c/o throat swelling. Given 50mg BENADRYL IM and evaluated by Medical Provider. Sent home w/co-worker and RX for PO BENADRYL and PEPCID.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Pt received FLUZONE HD on 9-30-16 and said her arm was swollen for 2 wks after. She is now fine.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm was swollen, red, and stinging, with a red stripe down her arm (reported by patient). At visit on 10/18/16: left upper arm is tender to palpation, near axilla. Resolving barely noticeable erythema from mid biceps to proximal forearm. Circumference is 39 cm and equal to right arm.
Age: 1.17
Sex: M
Vaccine: FLU4
Symptoms: Erythema multiforme, Hypersensitivity, Urticaria
Clinical narrative: Allergy, urticaria erythema multiforme.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills/101 degree fever/aches/pains for one day following vaccination.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient is experiencing worsening arm pain in the arm she received the vaccine. Especially at night making it hard to sleep. Patient said she will be contacting her PCP.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: C/O fine rash inside (L) upper arm, chest over sternum, legs, and chin started 6-12 hours after flu shot. Very itchy.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized reaction to LD - red, warm. Swollen - bruise noted. Encouraged to use BENADRYL.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient experience a burning sensation from injection site (left deltoid) all the way down to inner elbow. Arm turned red and warm.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Redness on upper arm.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Sore throat, low grade fever, chills, coughing, body aches, flu sxs (no appetite, tiredness, headache).
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, low grade fever, chills, coughing, body aches, flu sxs (no appetite, tiredness, headache).
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Left axillary lymphadenopathy x 1 day with unchanged symptoms. No treatment. Will continue to monitor.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Eye swelling, Feeling abnormal
Clinical narrative: Swelling and redness of both eyes. Went away in the morning. Wheezing and tightness of chest and shortness of breath. Took two doses of sulbutanol puffs every six hours for three times. Had sleep disturbance, body ache, felt uneasy and weak.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Ocular hyperaemia, Pain, Sleep disorder, Wheezing
Clinical narrative: Swelling and redness of both eyes. Went away in the morning. Wheezing and tightness of chest and shortness of breath. Took two doses of sulbutanol puffs every six hours for three times. Had sleep disturbance, body ache, felt uneasy and weak.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Patient began experiencing throat/tongue swelling.  1 mL Benadryl given IM.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient woke up with a red inflamed arm where the Pneumovax immunization was injected.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV4, MENB, MNQ
Symptoms: Myoclonic epilepsy, Postictal state, Presyncope
Clinical narrative: Vasovagal response, short myoclonic seizure lasting 2 seconds, post ictal for roughly 2 minutes.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator referring to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 03-OCT-2016, the patients were vaccinated with improperly stored doses of PROQUAD lot # L046509 and expiration date of 17-MAY-2017 (strength, dose and route of administration were not provided). No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Local swelling, Mobility decreased, Pain
Clinical narrative: This is a spontaneous report from a non-contactable physician. This physician reported a similar event for three patients. This is the third of three reports. A patient of unspecified age, gender and race received, on an unknown date, PREVNAR 13 at 0.5 ml single dose, for immunisation. Medical history and concomitant medications were not provided. On an unspecified date, the patient experienced painful large local,  swelling locally and it was hard for the patient raising hands over the head. Clinical outcome of the events was unknown at time of this report. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2016483131 same reporter/drug/event different patients; US-PFIZER INC-2016483159 same reporter/drug/event different patients.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Fatigue, Inflammation, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: The day after pt was vaccinated she began to have flu like symptoms, body aches, tiredness, and arm stiffness. The arm became inflamed and was warm to the touch. Pt went to Md and was diagnosed with Cellulitis and given Keflex.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Skin warm
Clinical narrative: The day after pt was vaccinated she began to have flu like symptoms, body aches, tiredness, and arm stiffness. The arm became inflamed and was warm to the touch. Pt went to Md and was diagnosed with Cellulitis and given Keflex.
Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient received immunization after confirming he never had any severe reactions previously.  Patient ended up fainting minutes after receiving the immunization, but became conscious soon after. He then stated he had this happen before some years back.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Hot to touch and golf ball sized red circle at injection site.  Has not sought treatment or taken anything for it.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Facial hives.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Erythema, Eye movement disorder, Immediate post-injection reaction, Tension
Clinical narrative: Vasovagal event with possible seizure. Pt felt faint immediately following Hep A vaccination (after previously tolerating Typhoid vaccination). Instead of just passing out, her entire body became tense and she grabbed my arms, her face turned red, eyes rolled back. No visible convulsions or nystagmus, and pt came to after 15 seconds. No loss of bladder or bowel control or post ictal state, but not typical vasovagal reaction, possible mild seizure. Pt recovered 100% by end of visit, was able to return to work. Vitals stable throughout, no fever.
Age: 1.25
Sex: M
Vaccine: DTAPH, FLUX, MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Scattered hives, fever. Gave Benadryl and Tylenol.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Called to check on patient. No redness or pain at injection site. No signs or symptoms for allergic reaction.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy.
Age: 27.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: Bell's Palsy.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Dyskinesia, Fatigue, Hallucination, Lethargy
Clinical narrative: My daughter started to become very lethargic, very tired, and started to spike a fever. It proceeded to get much worse, with little or no relief from Children's Tylenol. She was hallucinating, crying out, shaking, and stated her tongue was itchy and couldn't stop moving her mouth at one point. The fever reached 103.8 and I considered taking her to the emergency room, but kept trying fluids, cold compresses, and Tylenol throughout the night Saturday and into the early hours of Sunday the 16th.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Tongue pruritus, Tremor
Clinical narrative: My daughter started to become very lethargic, very tired, and started to spike a fever. It proceeded to get much worse, with little or no relief from Children's Tylenol. She was hallucinating, crying out, shaking, and stated her tongue was itchy and couldn't stop moving her mouth at one point. The fever reached 103.8 and I considered taking her to the emergency room, but kept trying fluids, cold compresses, and Tylenol throughout the night Saturday and into the early hours of Sunday the 16th.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Laboratory test, Nausea
Clinical narrative: Nausea and dizziness. Persisted overnight and went to emergency room at major hospital to rule out stroke or heart attack.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: Sore Arm.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Headache, chills, sweats, body aches, fever 102 that lasted 24 hrs-ibuprofen alternated with Tylenol.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: FEVER, SWOLLEN ARM, MUSCLE SORENESS.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode w/out resulting injury.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Pain and swelling of lymph nodes in right arm pit. Swelling and pain at injection sight (right arm).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Road traffic accident
Clinical narrative: Patient called approximately 2 hours post injection to complain of soreness, swelling and itching at injection site. Called Tuesday (day after) complaining that there was now 2 holes in her arm and the redness and itching was extending down to her elbow. Pharmacist on duty advised patient to visit physician or clinic to diagnose. On her way to clinic, patient was involved in a motor vehicle accident being struck by an intoxicated driver. I followed up with the hospital to resolve vaccine issue, they had no record of complaint due to vaccination.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: CELLULITIS
Age: 75.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 101 x 2 days and arm soreness.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 102 degrees/chills started around 6pm. Physician called 7pm-pt was told to take extra strength Tylenol every 4 hours.  Temp 100 degrees next morning. Fever gone by evening of the next morning.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site mass, Injection site rash
Clinical narrative: LUMP AND RASH AROUND IMMUNIZATION SITE. RASH WAS 3"X3" WITH RAISED WHITE CIRCLES FORMING WITHIN PERIMETER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain, Pruritus, Swelling
Clinical narrative: Redness, stinging, itchiness, swelling, pain. Golf ball sized lump after 2 days.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Injection site redness, swelling, heat. Knot located around arm and traveled down arm closer to tricep area. Reaction started the night of the injection and was still present 24hours after injection. Pharmacist recommended patient to take APAP or NSAID over the counter and to apply cool compress.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Pt came to pharmacy on 10/19 (today) with a pink inflamed baseball size mark on arm. Pt said did not start right away. Pt said had red lines going towards heart--but none now. Pt did was not feverish, did not experience swelling elsewhere, not run down or dizzy. Pt said it was getting better.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling abnormal, Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Area around vaccine is warm, hard, and red. Area is about 3 inches wide all around. Chills and not feeling right as well.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt stated right arm sore starting eve of flu shot 9/28/2016. We recoreded shot being given in left arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Small round red rash (approx 1.5" in diameter") at injection site.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Decreased appetite, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: PATIENT COMPLAINED OF FEVER, NAUSEA, VOMITING AND DIARRHEA WHICH CONTINUED UNTIL FOLLOWING MORNING. AS OF 530 PM 10/19/2016 SHE STILL EXPERIENCED NAUSEA AND COULD NOT EAT MUCH.
Age: 0.75
Sex: F
Vaccine: DTP, HEP, IPV, PPV
Symptoms: Crying, Decreased appetite, Insomnia, Irritability, Pain
Clinical narrative: After being given an overdose of vaccines my daughter has had the following symptoms: paleness, fever, vomiting, loss of appetite, crankiness, sleeplessness, pain that is inconsolable and sinus congestion.
Age: 0.75
Sex: F
Vaccine: DTP, HEP, IPV, PPV
Symptoms: Pallor, Pyrexia, Sinus congestion, Vomiting
Clinical narrative: After being given an overdose of vaccines my daughter has had the following symptoms: paleness, fever, vomiting, loss of appetite, crankiness, sleeplessness, pain that is inconsolable and sinus congestion.
Age: 78.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Patient indicated he had rash around his abdominal and legs.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to pharmacy with redness, swelling, warmth, and tenderness at injection site.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: CELLULITIS.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood glucose decreased, Condition aggravated, Diabetes mellitus, Hypoglycaemia
Clinical narrative: Patient got extremely low blood sugars on the night of getting both a PREVNAR 13 and FLUZONE HD shot. But they are also diabetic and on insulin. They were taking variable dosing of insulin. After reviewing with the patient's friend, I suggested that the hypoglycemia episode was most likely due to insulin problems or not eating enough food.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Local swelling, Pruritus
Clinical narrative: Per patient area not painful but swollen and slightly hard to the touch. On 10/18/16 was reported itchy prior to bedtime.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Pruritus
Clinical narrative: At 1142, RN was made aware that patient was complaining of itching. RN went to patient and completed visual assessment. Patient states she had mild itching on her arms. Patient states no difficulty breathing. Patient relayed that she has had itching following flu vaccines in the past, as well (not relayed prior to receiving vaccine today). RN made "Medical Management of Adverse Reaction in Adult Standing Order" available for guidance, if needed. Epi Pen present in clinic, if needed. 1145 - Patient voluntarily took 25 mg of her personal Benadryl. States no difficulty breathing. 1148 - Patient voluntarily took 2 puffs of her personal Symbicort - stated some mild chest tightness. Patient states immediately resolved following medication. 1153 - Patient states no difficulty breathing. Patient states itching is still mild. Patient and co-workers state she has had similar symptoms after receiving flu vaccine in the past (not relayed prior to receiving vaccine today). 1157 - Patient states no difficulty breathing. Patient states itching has improved. Patient states mild dizziness. 1204 - Patient states she is feeling better and feels OK to go back to work. 1210 - Patient left the building with two co-workers. Patient assessed to look visually improved from beginning of situation.  Patient instructed to call 911 if any worsening of symptoms. Patient verbalized understanding.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: Left upper arm below injection site with ecchymosis without erythema, painful, 4X5 inch. no Lower arm numbness or tingling.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest pain, Joint swelling, Lymphadenopathy, Mobility decreased
Clinical narrative: On 9/26/2016 went to clinic for the 3rd shot in the series of hep B. Starting getting shoulder pain around 2:00 pm. Then it proceeded into my back in the shoulder blade area. Tuesday 9/27/2016 my chest was hurting, felt like a pulled muscle. Wednesday 9/28/2016 when I woke up my left wrist and left ankle was all swollen up. Could barely move them but my chest was better. Went to urgent care on 9/30/2016 where the dr on duty told me that he thought he was a reaction to the shot I gotten and just to wait a couple of days till my body absorbed the shot. Woke up on 10/3/2016 with my face swollen especially on the left side. My work sent to clinic where the dr on duty there said he had no clue what it was from and recommended me to go see my dentist. On 9/4/2016 went to my doctor and after looking and feeling my face decided it was a possible reaction to the shot. My glands in my cheek were all swollen. Dr prescribed me a anti-inflammatory to help with the swelling. My left side was more swollen than the right side. The swelling started going down on 10/6/2016 and by 10/10/2016 the swelling was completely gone.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal pain, Swelling face, Vaccination complication
Clinical narrative: On 9/26/2016 went to clinic for the 3rd shot in the series of hep B. Starting getting shoulder pain around 2:00 pm. Then it proceeded into my back in the shoulder blade area. Tuesday 9/27/2016 my chest was hurting, felt like a pulled muscle. Wednesday 9/28/2016 when I woke up my left wrist and left ankle was all swollen up. Could barely move them but my chest was better. Went to urgent care on 9/30/2016 where the dr on duty told me that he thought he was a reaction to the shot I gotten and just to wait a couple of days till my body absorbed the shot. Woke up on 10/3/2016 with my face swollen especially on the left side. My work sent to clinic where the dr on duty there said he had no clue what it was from and recommended me to go see my dentist. On 9/4/2016 went to my doctor and after looking and feeling my face decided it was a possible reaction to the shot. My glands in my cheek were all swollen. Dr prescribed me a anti-inflammatory to help with the swelling. My left side was more swollen than the right side. The swelling started going down on 10/6/2016 and by 10/10/2016 the swelling was completely gone.