chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Hypersomnia, Immediate post-injection reaction, Malaise, Nervousness, Pain
Clinical narrative: Patient received a flu shot and her second GARDASIL 9. She was nervous in the immediate time period right before the shots were administered. She then said it hurt a lot. Approximately 1-2 minutes later she said, "I feel sick". She was as white as a sheet, then fainted leaning forward. I caught her and lay her down across her sister, who was seated on the exam table next to her. Her eyes rolled back, she started smacking her lips, and then had small jerking movements of all four extremities. This lasted approximately 10 seconds. She woke, complained of not being able to hear, and started crying. She calmed down after several minutes. She was lay down for 15 minutes and was given juice. She had fatigue and was subdued for the next 36 hours. She slept 11 hours that night, which is atypical, and then stayed in bed the next day until the evening.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope, Tardive dyskinesia
Clinical narrative: Patient received a flu shot and her second GARDASIL 9. She was nervous in the immediate time period right before the shots were administered. She then said it hurt a lot. Approximately 1-2 minutes later she said, "I feel sick". She was as white as a sheet, then fainted leaning forward. I caught her and lay her down across her sister, who was seated on the exam table next to her. Her eyes rolled back, she started smacking her lips, and then had small jerking movements of all four extremities. This lasted approximately 10 seconds. She woke, complained of not being able to hear, and started crying. She calmed down after several minutes. She was lay down for 15 minutes and was given juice. She had fatigue and was subdued for the next 36 hours. She slept 11 hours that night, which is atypical, and then stayed in bed the next day until the evening.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Ache in arm at injection site as well as the shoulder area. It's 3 1/2 weeks later and the shoulder pain is deep and severe. Arm movement is compromised.
Age: 21.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Unevaluable event
Clinical narrative: No adverse effects.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016482786) on 31-Aug-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced allergy to vaccine (allergies: influenza virus vaccines). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Drug hypersensitivity
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016482786) on 31-Aug-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced allergy to vaccine (allergies: influenza virus vaccines). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Cyanosis, Dizziness, Fatigue, Headache
Clinical narrative: Initial unsolicited report received from a physician on 03 Nov 2016. This case involves an 11-year-old female patient who was vaccinated with a dose of MENACTRA (batch number, expiration date, site, dose not reported) via intramuscular route on 17 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify), Illness at time of vaccination and concomitant medications were not provided. On 17 Oct 2016, immediately following the vaccination, the patient's lips tuned blue, patient was lightheaded, had nausea and syncope. On an unspecified date, post vaccination, the patient had nausea, headache, abdominal pain, fatigue and dizziness. Patient required doctor or ER visit three times. Lab data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the event syncope (for two hours). The patient's was not recovered from other events (reported as symptoms persisted since vaccine). Upon internal review, the company decided to consider the event serious because of important medical lips turned blue. List of documents held by sender: none. Sender's Comments: This case concerns a 11 year old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and immediately after vaccination her lips turned blue. Time to onset is compatible with the role of vaccination. Her symptoms have persisted since the vaccination. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, medical history, concomitant medication and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: Initial unsolicited report received from a physician on 03 Nov 2016. This case involves an 11-year-old female patient who was vaccinated with a dose of MENACTRA (batch number, expiration date, site, dose not reported) via intramuscular route on 17 Oct 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify), Illness at time of vaccination and concomitant medications were not provided. On 17 Oct 2016, immediately following the vaccination, the patient's lips tuned blue, patient was lightheaded, had nausea and syncope. On an unspecified date, post vaccination, the patient had nausea, headache, abdominal pain, fatigue and dizziness. Patient required doctor or ER visit three times. Lab data and corrective treatment was not reported. On an unspecified date, the patient was recovered from the event syncope (for two hours). The patient's was not recovered from other events (reported as symptoms persisted since vaccine). Upon internal review, the company decided to consider the event serious because of important medical lips turned blue. List of documents held by sender: none. Sender's Comments: This case concerns a 11 year old female patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and immediately after vaccination her lips turned blue. Time to onset is compatible with the role of vaccination. Her symptoms have persisted since the vaccination. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, medical history, concomitant medication and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Patient received the PNEUMOVAX 23 vaccine on 11-11-16 and returned to the pharmacy on 11-13-16 to pick up an antibiotic because she had a red inflamed area on her left/inner upper arm with red streaks leading away from the area. She claims that she discovered it the morning of 11-13-16 and went to the MD because she was concerned. The red area was located about 4 inches away from where she received the IM injection. The patient stated that the MD was not sure if the red area was related to the vaccine. The patient is now taking antibiotics (doxycycline 100mg) for 7 days to treat.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling and redness.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Extreme pain on injection and post injection.  Loss of range of motion to right arm, persistent dull pain at rest and with movement of shoulder.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Brain scan abnormal, Headache, Optic neuritis, Sinus pain, Visual field tests abnormal
Clinical narrative: Severe headache on the side and back of my right eye. Took sinus medication thinking it was sinus pain.Then in continue to worsen with issues with sight in the right eye. Now having same pain in the left eye.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Visual impairment
Clinical narrative: Severe headache on the side and back of my right eye. Took sinus medication thinking it was sinus pain.Then in continue to worsen with issues with sight in the right eye. Now having same pain in the left eye.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain-Barre Syndrome.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abasia, Guillain-Barre syndrome, Mechanical ventilation, Mobility decreased
Clinical narrative: Guillain-Barre Syndrome.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchitis, Influenza virus test, Pneumonia, X-ray
Clinical narrative: I was in the hospital for bronchitis and pneumonia.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the site.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that a few hours after receiving shot her arm started hurting really bad.  The next day it got worst so patient went to ER and followed up with PCP on 11/14/16.  Came to us on 11/14/16 saying her arm hurt and she was having trouble moving it.
Age: 49.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Erythema, Induration, Injection site nodule, Skin warm, Swelling
Clinical narrative: It was red, hot & raised at first.  As Fri, Sat & Sun continued it was getting hotter, bigger, raised & there is a HUGE knot on my right arm where I received the tetanus shot.  I also got a flu shot on my left arm. I had the same symptoms but not nearly as severe.  I had zero pain at the time of the flu shot & I felt the tetanus (but was completely tolerable).  I see that all the symptoms are expected with the tetanus & while worrisome I have a friend who is a nurse who told me it is common with the tetanus.   It is currently 5 days later.  It is still a very large bump (at least an inch high) & it is a very, very hard knot, hot & red although improved.  It was VERY painful this weekend.  I've had lots of shots & various vaccines & never had a reaction like that.  If it doesn't improve greatly over the next few days I will go back to the doctor.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Mobility decreased
Clinical narrative: Unable to raise arm above shoulder- suspect given intra-articular/intra-bursal.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injected limb mobility decreased
Clinical narrative: Possible PCV13 reaction right leg (right leg "locked up" in flexed position for 48hrs).
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth
Clinical narrative: Area below injection site reddened and warm to the touch.  Flu Shot given on 10/03/2016, Arm red and swollen on 10/04/2016.  Employee sent to clinic for evaluation and was diagnosed with an allergic reaction.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles, confirmed by 2 physicians.
Age: 75.0
Sex: F
Vaccine: FLUC4
Symptoms: Medication error, No adverse event
Clinical narrative: Provided another influenza vaccine, no adverse symptoms or treatments provided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, and swelling to entire right upper arm.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Fatigue, Injection site erythema, Pyrexia
Clinical narrative: Patient reports that within a couple hours of her PCV13 injection she became dizzy, weak, fatigued and she developed a fever. She also reports injection site was red. She states that she felt weak and fatigued for a week after injection.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Gait disturbance, Irritability, Peripheral swelling
Clinical narrative: Irritability, left leg swollen, did not want to walk due to pain. Gave ibuprofen, distracted him with cold pack. An hour later, gave TYLENOL. Symptoms gone by next morning.
Age: 61.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling at the site of injection of the Herpes zoster vaccine on the left arm. Area of redness and swelling measured ~5 inches. Swelling and redness stabilized by 2 days post vaccines. No fever or other signs of systemic illness.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching.
Age: 13.0
Sex: M
Vaccine: MEN, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt received PROQUAD at age 13 no reaction.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme soreness in injection site of annual flu shot. More severe than any previous vaccine I've received in the past. Though it lessened after 3 days, overall soreness has continued for 14 days. Limited mobility in arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Shoulder where vaccination given sore; can't raise that arm above my head, pain when I try to lift it in other positions.
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed spontaneous abortion. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure before pregnancy. The outcome of spontaneous abortion was unknown. The outcome(s) of the additional event(s) included vaccine exposure before pregnancy (unknown). The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. The investigator considered that there was a reasonable possibility that the spontaneous abortion may have been caused by Flu seasonal TIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a pregnant female of unspecified age who vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) before pregnancy. The patient was a part of study to evaluate the fetal risk and relative safety of the seasonal influenza vaccine overall and secondarily season by season from 2010-2014 using data from the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), a research program developed specifically to evaluate medications and vaccines used by pregnant women. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 2010 and 2011, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided) between LMP-DOC (in this study, LMP-DOC is defined as exposure between 1st day of last menstrual period and estimated date of conception. Vaccine year started from August 1st of each year). On an unspecified date, an unknown period after vaccination exposure, the patient had spontaneous abortion (in this study, spontaneous abortion was defined as spontaneous pregnancy loss at less than 20 gestational weeks). Treatment was unknown. The authors did not comment on the relationship between spontaneous abortion and unspecified seasonal influenza vaccine. The authors concluded that "Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine." This is 1 of the 5 valid cases from the same literature article.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Patient came back to pharmacy nearly 2 weeks after injection and still had significant bruising and redness at injection site.  No other pain reported.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Epstein-Barr virus test positive, Rash generalised, Urticaria
Clinical narrative: Whole body hives/rash about 12 hours after flu shot. 2 EDs visits for BENADRYL SOLU MEDROL. Place on 10 days worth of SOLU MEDROL and SINGULAR per PCP.
Sex: U
Vaccine: FLU4
Symptoms: Influenza like illness, Malaise, Pyrexia, Streptococcus test negative
Clinical narrative: Mom stated child got very sick. Had fever of 100.3 with TYLENOL and MOTRIN. Had flu-like symptoms within 1 to 2 hrs of administration of vaccine-Saw MD next morning- did strep screen neg-.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Pt developed a red rash with slight swelling on her arm. Extending from injection site and continuing down to bend of elbow.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Abasia, Balance disorder, Cerebellar ataxia, Neurological examination
Clinical narrative: Patient was given varicella vaccine 3 days prior. Came in with complain of off balance. He was able to walk but tilts to side, sits down and seems off balance. MD consulted with neuro and agrees with diagnosis of cerebellar ataxia due to varicella vaccination. To monitor home. No treatment needed.
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Red, swollen, painful welt from shoulder to elbow. Tx: BENADRYL and cold compress
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Severe pain in my arm and it wont let me get no sleep sometimes arm gets weak and bruising hasn't gone away.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Bruising at site 1/2 inch wide round.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Urticaria
Clinical narrative: Patient indicates receiving vaccine (flu) at around 3pm on 11/2, at about 10pm she developed hives all over body and dizziness, symptoms lasted 2 hrs. Was taken to emergency department for observation. No medications prescribed. Has had flu vaccine in previous years with no adverse results.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 60-year-old female patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 20th June 2017). On 26th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 26th September 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovering/resolving. It was unknown if the reporter considered the injection site tenderness to be related to FLUARIX QUADIRVALENT. Additional details were provided as follows: The patient received a dose of FLUARIX QUADRIVALENT in her left arm and experienced injection site tenderness when laying on it, soreness was 2 inches below shoulder that hurt when she raised her arm. No additional information was provided.
Sex: U
Vaccine: FLU4
Symptoms: Laceration, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of laceration of hand in a adult patient who received FLULAVAL QUADRIVALENT (batch number 9N2X7, expiry date April 2017). On an unknown date, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced laceration of hand and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of hand was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the laceration of hand to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by an Office Manager. This case was associated with product complaint. The age at vaccination was not reported. The caller stated that unnamed doctor cut hand while preparing vaccination. The caller declined to provide doctor's name. Doctor injured self while preparing vaccine. No patient involved. No event date available. The caller requested not to receive safety report mailing and related quality complaint. The reporter stated 1 broken vial discovered. Cracked vial was discovered prior to preparation. Caller reported original package was not damage. No damage noted to blister tray but evidence of leakage noted. The glass pieces were available for return with damaged vial. The product was stored separately from its original packaging. No product still present in vial. No needle used. The extended crack was noted at base of vial. Reporter stated that other person opened the product box. The person administering vaccine was experienced doctor of medicine. The product was purchased from GlaxoSmithKline directly. No administration and no patient involved. The product was available for return. The Credit Request Template was complete to arrange credit.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient was elderly in nursing home but developed a high fever after shot was administered. She had numerous preexisting conditions prior to shot, but I was told by staff she developed, for sure, a high fever and was sent to local hospital a few days after it was given.
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of anaphylaxis in a 37-year-old female patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date June 2017). Previously administered products included Flu vaccine with an associated reaction of adverse reaction (for tolerance to previous dose of Flu vaccine, refer case US2016GSK167847). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, 10 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant), allergic reaction, hives, pruritus and shortness of breath. The patient was treated with BENADRYL. On an unknown date, the outcome of the anaphylaxis, allergic reaction, hives, pruritus and shortness of breath were recovered/resolved. The reporter considered the anaphylaxis, allergic reaction, hives, pruritus and shortness of breath to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient's age at vaccination was not reported. The events were resolved after administration of BENADRYL. The patient did not require hospital visit. The reporter did not know if it was actually anaphylaxis or just an allergic reaction. This was 2nd of 5 cases reported by the same reporter. This case was linked to US2016GSK167847, as reported by the same patient.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site abscess, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot, hard at injection site. Patient used Tylenol, Benadryl and ice packs with no relief.  Redness seems to be spreading.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia
Clinical narrative: Patient report haveing joint pain in her Knees and hips that developed 2 days after receiving her FLUZONE HD and PREVNAR 13 vaccination on 9/14/16. She is still having joint pain that has only slightly improved.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Client developed very sore red arm and itchy hives on legs.
Age: 80.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Arthralgia
Clinical narrative: Patient reports joint pain in his Knees, hips and ankles that started 2 days after he received his FLUZONE HD and PREVNAR 13 vaccination. At this time he is still having joint pain and it has only slightly improved.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Musculoskeletal stiffness, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Immediately after patient received the HPV vaccine (her last vaccine on this date), she stated she felt dizzy, began to lean forward, then this nurse assisted her to lean back on the exam table.  She then quickly had tightening of her upper extremities and lower extremities, which lasted several seconds, then she had a brief period of unresponsiveness for approx. 40-60 seconds.  She then slowly regained her alertness, and was monitored for almost one hour in the clinic before leaving the Pedi. PCC, in stable condition, accompanied by Mom and younger sibling.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain, Sleep disorder
Clinical narrative: Vaccine was given very high on my right arm/shoulder on 9/28/16. What I thought was standard soreness from a flu shot turned into daily chronic pain, limited mobility, worsen symptoms at night when sleeping. From 9/28/16 until 10/12/16, applied moist heat 2-4 times per day with 2000-3000 mg of TYLENOL for pain. October 12 was seen at the same urgent care clinic. Was prescribed diclofenac 75 mg to take 2x day in addition to hydrocodone-acetaminophen 5-325 for the pain. Refilled the diclofenac again on 11/5/16. Continued chronic pain and lack of sleep. Reported to clinic management. Seeing a shoulder specialist on 11/16/16.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 80 mm x 50 mm redness, swelling at site.  Plans to use over-the-counter medications and ICE to area as needed and return to Occupational Health if increased symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Muscle fatigue, Myalgia, Rash, Vaccination complication
Clinical narrative: I received the shingles vaccine at a local pharmacy on October 24th. There was no local reaction to the vaccine. On 11/6/16 I developed a rash and muscle aches/fatigue. Over the next days the rash progressed to a blistered painful area (on my right trunk only). I went to my physician who confirmed it was most likely a vaccine reaction. My fatigue and muscle pain have been present 5 days now and is helped only somewhat by NSAIDs. The rash is painful but no new lesions have developed.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Tremor
Clinical narrative: Received High dose Flu Shot and second Pneumonia shot(both in one arm). 10 hours later, woke up with massive headache and when stood, body trembled violently. Took 1k mg's of TYLENOL and went back to bed. Arm was swollen from shot site to elbow, extremely hot and red. Stayed in bed next day, went to doctor following day. Doctor said nothing to do but take TYLENOL and BENADRYL and go back to pharmacist to let them known and make report.
Age: 82.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chest X-ray, Dizziness, Dry mouth, Dysgeusia, Electrocardiogram normal
Clinical narrative: Pt. received a subcutaneous ZOSTAVAX injection on 11-1-16 at approximately 11:40 am, and a regular Flu injection (his request) in the other arm at the Health Department. As soon as he left the room he complained of feeling dizzy, and having a "funny taste", dry mouth and "numbness to my lips", and a slight headache. He was immediately sat down and his blood pressure was checked with a reading of 120/100. He denied having any SOB chest discomfort, nausea, vomiting, or itchiness of the throat, palms or soles of feet. He never lost consciousness and was answering questions the Health Department staff and EMT were asking him. Ambulance was called at 11:44 am with arrival of 11:49; they rechecked his blood pressure 140/86 and assessed him. They administered an Adult EPI-PEN, started oxygen and transported him to the local hospital for observation and treatment. At approximately 2:25pm patient called to report he had been dismissed and was going home. He stated the hospital ran and EKG-normal, chest x-ray and gave him IV's. He stated he still has some tingling of his lips (and in the legs that started upon his arrival to the hospital) and a slight headache but was feeling better. He stated his blood pressure at the hospital was 134/95. 11-2-16 Called patient for follow up at 4:40pm, he reported "my head still feels a little stuffy, and I still have a little tingling of the lips but it's getting better all the time. I've been outside all day." He denied any issues with the site of the injections. He asked if he should keep his dental appointment, I advised him to contact the hospital for a record of his treatment, his dentist and his provider to let them know what had occurred, as they may choose to cancel this appointment. 11-4-16 Patient attended our Health Fair and stated he was much better. At approximately 1:30 pm he returned to the health department to leave his medication list and reported he had been to his dental appointment at 9:00am today and had the same issues at the office (mouth numbness etc. ...) as he did on 11-1-16. He stated he and the dentist thinks he is allergic to Latex.
Age: 82.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Headache, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Pt. received a subcutaneous ZOSTAVAX injection on 11-1-16 at approximately 11:40 am, and a regular Flu injection (his request) in the other arm at the Health Department. As soon as he left the room he complained of feeling dizzy, and having a "funny taste", dry mouth and "numbness to my lips", and a slight headache. He was immediately sat down and his blood pressure was checked with a reading of 120/100. He denied having any SOB chest discomfort, nausea, vomiting, or itchiness of the throat, palms or soles of feet. He never lost consciousness and was answering questions the Health Department staff and EMT were asking him. Ambulance was called at 11:44 am with arrival of 11:49; they rechecked his blood pressure 140/86 and assessed him. They administered an Adult EPI-PEN, started oxygen and transported him to the local hospital for observation and treatment. At approximately 2:25pm patient called to report he had been dismissed and was going home. He stated the hospital ran and EKG-normal, chest x-ray and gave him IV's. He stated he still has some tingling of his lips (and in the legs that started upon his arrival to the hospital) and a slight headache but was feeling better. He stated his blood pressure at the hospital was 134/95. 11-2-16 Called patient for follow up at 4:40pm, he reported "my head still feels a little stuffy, and I still have a little tingling of the lips but it's getting better all the time. I've been outside all day." He denied any issues with the site of the injections. He asked if he should keep his dental appointment, I advised him to contact the hospital for a record of his treatment, his dentist and his provider to let them know what had occurred, as they may choose to cancel this appointment. 11-4-16 Patient attended our Health Fair and stated he was much better. At approximately 1:30 pm he returned to the health department to leave his medication list and reported he had been to his dental appointment at 9:00am today and had the same issues at the office (mouth numbness etc. ...) as he did on 11-1-16. He stated he and the dentist thinks he is allergic to Latex.
Age: 89.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Cellulitis, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pronounced pain 5h after vaccine, followed by increased pain and severe swelling of arm over next 24h. Patient went to ER diagnosed with cellulitis in the arm and admitted to hospital I.V. antibiotics administered during 1 day stay. Patient had to return for outpatient I.V. antibiotics additional 7 days.
Age: 89.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: Pronounced pain 5h after vaccine, followed by increased pain and severe swelling of arm over next 24h. Patient went to ER diagnosed with cellulitis in the arm and admitted to hospital I.V. antibiotics administered during 1 day stay. Patient had to return for outpatient I.V. antibiotics additional 7 days.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None. Patient administered vaccine that was outside her age group. *No reaction as of today 11/7/16.
Age: 82.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient). A 82-year-old female patient received PREVNAR 13, NDC number 00005-1971-02, intramuscular in left arm on 13Oct2016 13:15 at 1 ml one shot, for immunisation. Medical history included atrial fibrillation from 1975 and ongoing, cerebrovascular accident in 15Feb2004, thyroidectomy in 1970, clostridium difficile infection in Jul2015, hysterectomy in 1971, shoulder operation in Feb2015, rotator cuff syndrome, joint dislocation, depression, thrombosis. The patient had no illness at vaccination time. Concomitant medication included FLUZONE administered on 13Oct2016 intramuscular in the right arm, citalopram for at least 4 years and ongoing for depression, levothyroxine from 1970 and ongoing for thyroidectomy, warfarin sodium from 15Feb2004 and ongoing for blood clot, DILTIAZEM CD ongoing for atrial fibrillation, and probiotics nos from Jul2015 and ongoing for Clostridium difficile. The patient previously took pneumococcal vaccine ten years ago, and Fluzone in 2015. The patient experienced very limited movement of the left arm, pain inside the arm/ if she extends the arm it is painful between the shoulder and elbow, and if the patient holds her arm up to her shoulder it is uncomfortable in Oct2016 after vaccination. The patient experienced soreness at injection site on 14Oct2016. The outcome of the events experienced very limited movement of the left arm, pain inside the arm/ if she extends the arm it is painful between the shoulder and elbow and if the patient holds her arm up to her shoulder it is uncomfortable was not recovered. The outcome of the event soreness at injection site was recovered on unspecified date.  The patient underwent lab tests and procedures which included clostridium test positive on Jul2015.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13 single dose and FLU VACCINE VII, both in the same arm via an unspecified route of administration, on an unspecified date for immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced extreme redness and swelling on an unspecified date with outcome of unknown. It was noted that it was more prevalent when injecting the influenza vaccine and pneumococcal 13-val conj vac (dipht crm197 protein) in the same arm.
Age: 68.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Bronchitis
Clinical narrative: This is a spontaneous report from a contactable female consumer reporting for herself. This female patient of unknown age and race/ethnicity received on an unspecified date PREVNAR 13 at 0.5 ml single dose for immunization. Concomitant medications and medical history were not reported. On an unspecified date, the patient had a bronchial infection. Outcome was not reported.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported for two patients. This is the second of the 2 patients. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration in the arm on an unspecified date at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced significant swelling in the arm from injection site in the upper deltoid down toward the elbow. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016526195 same reporter/ drug/ AE, different patient.
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported the same event for 3 patients. This is the 3rd of three reports. A patient of unspecified age, race and gender received PREVNAR 13 (NDC number 0005197102, Lot Number: M98915, Expire Date: Sep2017), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history was not reported. Concomitant medication included AFLURIA (NDC number 3333201601, Lot Number: WT58708, Expire Date: 30Jun2017) via an unspecified route of administration on an unspecified date for immunisation. The patient experienced increased redness at the injection site of the Prevnar 13 on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016527789 Same reporter/different patient, same product, same event; US-PFIZER INC-2016527786 Same reporter/different patient, same product, same event.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Gait disturbance, Headache
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) on 03 Nov 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in left deltoid on 01 Nov 2016. Reporter denied illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as brain aneurysm 1988 and 2003. Concomitant medications were not reported. On 01 Nov 2016, same day following the vaccination, the patient had developed headache, weakness, difficulty walking (felt "totally week" and could "hardly walk") and blotchy appearance to skin. On an unknown date, the patient went to hospital for evaluation. Patient required emergency room or doctor visit. It was reported that ED physician could not determine cause of symptoms and patient was discharged to home. The patient previously vaccinated with FLUZONE HD in 2015. The patient's laboratory data included Blood work, urinalysis and CT scan of head, results were normal. The patient's corrective treatment was not reported. On 01 Nov 2016, the patient recovered from blotchy appearance (duration 6-8 hours). On 03 Nov 2016, the patient recovering from other events (outcome was also reported as unknown). List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Urine analysis normal
Clinical narrative: Initial unsolicited report received from a consumer (patient's husband) on 03 Nov 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in left deltoid on 01 Nov 2016. Reporter denied illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as brain aneurysm 1988 and 2003. Concomitant medications were not reported. On 01 Nov 2016, same day following the vaccination, the patient had developed headache, weakness, difficulty walking (felt "totally week" and could "hardly walk") and blotchy appearance to skin. On an unknown date, the patient went to hospital for evaluation. Patient required emergency room or doctor visit. It was reported that ED physician could not determine cause of symptoms and patient was discharged to home. The patient previously vaccinated with FLUZONE HD in 2015. The patient's laboratory data included Blood work, urinalysis and CT scan of head, results were normal. The patient's corrective treatment was not reported. On 01 Nov 2016, the patient recovered from blotchy appearance (duration 6-8 hours). On 03 Nov 2016, the patient recovering from other events (outcome was also reported as unknown). List of documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Arthritis
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016224273 ) on 07 November 2016. This case involves an 81-years-old female patient who was vaccinated with INFLUENZA VACCINE (dose, dose in series, route and site of administration, batch number and expiry date not reported) on an unspecified date three weeks ago. The patient's medical history was not reported. The patient's concomitant medications included XELJANZ 5 mg tablets. On an unspecified date, after vaccination (reported as three weeks ago), the patient suffered arthritis flare up. Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a 81 year old female patient who had an arthritis flare up three weeks after receiving a FLU Shot. However details regarding medical history, concurrent conditions, patient immune status at the time of vaccination and other etiologies would be helpful to further assess this case. Based on the available information, the role of vaccine cannot be assessed.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Patient presented for Urgent Care hives/allergic reaction from Flu vaccine on 11-2-16.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling, Tinea capitis
Clinical narrative: Patient experienced reactions upon receiving flu vaccination. Reported swelling and tingling several days after vaccination.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Cyst, Erythema
Clinical narrative: Localized redness, cellulitis. Of notes, pt is mentally handicapped. Pt picked and band aid causing a cyst. This cellulitis may have been from self-inflicted cut or the vaccine.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Noted redness at site of injection 9x12 cm. Ice as needed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site pain, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: Received shot for over 65 yo on Oct. 19 around noon. A couple of hours later about an inch below injection site arm itched, swelled and burned. It spread down my arm toward my forearm at 5pm I returned to show to med staff it was oval shaped hot sore swollen area to the other side of my elbow. The next morning I returned to our occupational health department and had it looked at again. The size the swelling had increased and was spreading around the inside of my arm the PA drew with marker on my arm to see if the swelling would continue to grow. It overlapped the boundaries the next morning but wasn't quite as hot as before. I assumed it was getting better. It remained swollen over the next week or so but gradually went away. The third day after the shot. Saturday October 22, 2016 I started to feel like I was coming down with a virus or a cold. My throat was sore, my ears itched and I felt congested. By Sunday morning I was too sick to do anything but sleep. My head and chest were completely congested and I had a fever 101. I felt like someone was sitting on my chest. I couldn't cough anything up but found breathing more difficult than usual. This lasted Sunday, Monday, and Tuesday. The fever went down so I went back to work Wednesday October 26. The coughing and nose blowing began and I still have it today, November 9, 2016. It could have been something I picked up before the flu shot but it is very unusual for me to get sick. I have had egg sized swelling in the past with flu shots but never any swelling as large as this. I have never become ill after receiving a flu shot. I have gotten them every year (27) since I have been employed here. I have gotten the over 65 shot for the past four years without reaction. That's my story.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pruritus, Pyrexia, Respiratory tract congestion
Clinical narrative: Received shot for over 65 yo on Oct. 19 around noon. A couple of hours later about an inch below injection site arm itched, swelled and burned. It spread down my arm toward my forearm at 5pm I returned to show to med staff it was oval shaped hot sore swollen area to the other side of my elbow. The next morning I returned to our occupational health department and had it looked at again. The size the swelling had increased and was spreading around the inside of my arm the PA drew with marker on my arm to see if the swelling would continue to grow. It overlapped the boundaries the next morning but wasn't quite as hot as before. I assumed it was getting better. It remained swollen over the next week or so but gradually went away. The third day after the shot. Saturday October 22, 2016 I started to feel like I was coming down with a virus or a cold. My throat was sore, my ears itched and I felt congested. By Sunday morning I was too sick to do anything but sleep. My head and chest were completely congested and I had a fever 101. I felt like someone was sitting on my chest. I couldn't cough anything up but found breathing more difficult than usual. This lasted Sunday, Monday, and Tuesday. The fever went down so I went back to work Wednesday October 26. The coughing and nose blowing began and I still have it today, November 9, 2016. It could have been something I picked up before the flu shot but it is very unusual for me to get sick. I have had egg sized swelling in the past with flu shots but never any swelling as large as this. I have never become ill after receiving a flu shot. I have gotten them every year (27) since I have been employed here. I have gotten the over 65 shot for the past four years without reaction. That's my story.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Syringe issue
Clinical narrative: MA went to administer vaccine on LA. Injected vaccine and plunger wouldn't plunge. Pushed x 2 Pt. cried in pain stated L shoulder hurt. Vaccine removed gotten rid of. Area examined by physician. No erythema. Ice pack applied. New flu administered on R. arm w/no complications.