chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Bowel movement irregularity, Crying, Decreased appetite, Diarrhoea, Ear infection
Clinical narrative: There was a large lump at the injection site for several days (small lump still palpable on 10/16/2018) with significant soreness. She refused to crawl or walk for a couple days and would stop moving and cry when she would try to crawl or walk. She showed general drowsiness, reduced appetite, and irritability in comparison to her normal demeanor. She developed a fever on 10/14/2018 which peaked at 101.4* and dissipated without medication within 24 hours. She had some irregular bowel movement on 10/14-16/2018 (some solid and some liquid poop in same diaper). She would not sleep alone or laying flat on 10/14/2018 and 10/15/2018. She was refusing portions of her bottles and food 10/13/2018-10/17/2018.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Irritability, Mobility decreased, Pain, Pyrexia
Clinical narrative: There was a large lump at the injection site for several days (small lump still palpable on 10/16/2018) with significant soreness. She refused to crawl or walk for a couple days and would stop moving and cry when she would try to crawl or walk. She showed general drowsiness, reduced appetite, and irritability in comparison to her normal demeanor. She developed a fever on 10/14/2018 which peaked at 101.4* and dissipated without medication within 24 hours. She had some irregular bowel movement on 10/14-16/2018 (some solid and some liquid poop in same diaper). She would not sleep alone or laying flat on 10/14/2018 and 10/15/2018. She was refusing portions of her bottles and food 10/13/2018-10/17/2018.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Somnolence
Clinical narrative: There was a large lump at the injection site for several days (small lump still palpable on 10/16/2018) with significant soreness. She refused to crawl or walk for a couple days and would stop moving and cry when she would try to crawl or walk. She showed general drowsiness, reduced appetite, and irritability in comparison to her normal demeanor. She developed a fever on 10/14/2018 which peaked at 101.4* and dissipated without medication within 24 hours. She had some irregular bowel movement on 10/14-16/2018 (some solid and some liquid poop in same diaper). She would not sleep alone or laying flat on 10/14/2018 and 10/15/2018. She was refusing portions of her bottles and food 10/13/2018-10/17/2018.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, erythema at injection site. Tx included TYLENOL.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: Moderate to strong muscle soreness and tenderness to the touch around injection site, redness and slight swelling below injection site, dull headache, cold chills, felt lethargic, mostly noticeable upon waking the following morning. Took TYLENOL the following night, felt much better the next morning. The side effects were much stronger than I expected. I am in good health, normal weight range, walk on treadmill approximately 15-20 miles per week, nonsmoker, had chickenpox in early teens. Even though I still have some soreness and redness, I indicated that I recovered.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy
Clinical narrative: Moderate to strong muscle soreness and tenderness to the touch around injection site, redness and slight swelling below injection site, dull headache, cold chills, felt lethargic, mostly noticeable upon waking the following morning. Took TYLENOL the following night, felt much better the next morning. The side effects were much stronger than I expected. I am in good health, normal weight range, walk on treadmill approximately 15-20 miles per week, nonsmoker, had chickenpox in early teens. Even though I still have some soreness and redness, I indicated that I recovered.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Pain and soreness in the shoulder that received the vaccine starting the next day, and pain continuing for 12 days. Patient was seen by primary MD who said it was likely an injury to ligament in shoulder. Patient received cortisone injection from MD office today, 11-06-18.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash, Rubber sensitivity
Clinical narrative: Pt allergic to Latex, used latex bandaid after administration --- realized this after placing bandaid on patient. Removed Bandaid personally, cleaned area with alcohol swab. Had patient stay in waiting area for 15 min after Adverse event and gave a BENADRYL 25mg. Rash started to dissipate soon after and patient stated she was fine.
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient given influenza vaccine on 10/8/2018 after already having a dose this season on 9/24/2018.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Arm reported was swollen and warm to the touch on 11/5 after vaccine. Patient came into pharmacy to report. Pt reported are was felling much better and looked visibly ok at the time of reporting.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pt with fever to 104+ Saturday 11/3 PM. Had several episodes of vomiting and feeling like whole body hurt. Seen in office Sun 11/4, abd exam reassuring and did give ZOFRAN for nausea. PR on Monday 11/5 is that pt remains afebrile and doing better. Not sure if related to vaccine since reaction within hours or unrelated viral process.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, PPV, TDAP
Symptoms: Wrong product administered
Clinical narrative: PPSV 23 given instead of HPV 9. NO adverse reactions as per discussion with guardian on 11/6/18.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: CDC stated that there might be a possible increase reaction at injection site. PCP stated there was no concern.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain
Clinical narrative: Patient states felt fine after immunization having mild discomfort on first day- she states then on 11/5/18 in afternoon she started getting jabbing pains in site where shot was given (she said felt like needle poking her). She said this pain came every 30 minutes. She states no fever, rash, itching, swelling, or redness. She took TYLENOL and used ice pack which helped minimally. She came in to report this to pharmacy on 11-6-18 and said the pain is still there but now just dull pain. We examined her arm and no sign of redness, rash or inflammation or bruising. She states no fever or itching. We told her to continue with ice and TYLENOL and if pain continues to call MD to get examined. We told her we would report this to VAERS website and will follow up and check on her in next day.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reported feeling feverish and chills 1 hour following flu immunization. Patient denied rash, hives, tightness in throat or trouble breathing. RN monitored vitals and completed a physical assessment. RN suggested patient remain in the area if she wanted to, or said she could go back to her work area. Contact physician if symptoms persist.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient reported swelling the size of half a softball, with redness that measured 4in in diameter per her eye. She was instructed to start on BENADRYL on the evening of 11/5/18, and follow up with her primary care clinic if symptoms had not improved/resolved by the morning. Upon follow up on 11/6/18 at 2:00 PM, she stated that her redness had gone down somewhat, but the swelling had remained. She had already followed up with her primary care physician and was going to continue BENADRYL and go to see her doctor if needed and instructed by the office.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong patient received product
Clinical narrative: Client received Dtap/IPV instead of Tdap, client was here with her sister who was to get Dtap/IPV.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase normal, Blood creatinine normal, Blood electrolytes normal, Blood gases normal, C-reactive protein normal
Clinical narrative: Patient noted normal soreness for 2 days following vaccine but discomfort remained. Clinician noted soreness in upper outer part of her arm and upon examination on 10/24/2018, there was tenderness to upper lateral aspect of upper left arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Liver function test normal, Red blood cell sedimentation rate normal
Clinical narrative: Patient noted normal soreness for 2 days following vaccine but discomfort remained. Clinician noted soreness in upper outer part of her arm and upon examination on 10/24/2018, there was tenderness to upper lateral aspect of upper left arm.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives all over body started day after influenza vaccination.
Age: 1.75
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient suffered from body-wide hives within 1-2 hours of vaccination; hives resolved on their own.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect reported; however, gave a duplicate dose of vaccination, patient previously received in 2015.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives all over back and chest then spread to arms and neck.
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient reported feeling lightheaded 15 minutes post flu immunization. RN evaluated patient, suggested he lie down, provided ice pack to the back of neck, provided fluids. Patient remained in the clinic area for 45 minutes. After 45 minutes, patient reported feeling well and agreed to continue with fluids and will eat lunch. RN advised he return to the clinic area if symptoms return.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Muscle twitching, Musculoskeletal stiffness, Neck pain
Clinical narrative: About a week after immunization started having severe lower back pain, from central spine radiating out to both sides. Followed by a stiff and sore neck. Could not lay on left side muscles would jump. She is just now starting to feel better.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Computerised tomogram normal, Flank pain, Influenza virus test negative, Pyrexia
Clinical narrative: One hour after patient received TDAP patient experienced chills. Patient stated she took a nap an woke up and had a 103 fever, vomiting, and left flank pain. Patient was evaluated at emergency room and was treated with ZOFRAN intravenous. Patient had lab work done, CAT scan, and flu test. CAT scan reported by patient as normal- flu negative.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: One hour after patient received TDAP patient experienced chills. Patient stated she took a nap an woke up and had a 103 fever, vomiting, and left flank pain. Patient was evaluated at emergency room and was treated with ZOFRAN intravenous. Patient had lab work done, CAT scan, and flu test. CAT scan reported by patient as normal- flu negative.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: Flu-like symptoms, etc. All over body aching. Weak, light headed, headache. Slept for one and half days from fatigue and left-arm burning and raised redness where shot was given.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Flu-like symptoms, etc. All over body aching. Weak, light headed, headache. Slept for one and half days from fatigue and left-arm burning and raised redness where shot was given.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction to FLUBLOK given to 17 year old. Pt was 37 weeks and 3 days on day of administration with EDD of 11/5/2018.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Disorientation, Dizziness, Fall, Vomiting
Clinical narrative: 2 minutes post flu immunization patient reported light headedness, clammy skin, and fell to the floor.  Patient was unaware of surroundings for approximately 2 minutes. RN monitored vital signs, raised his legs, provided juice and animal crackers. Called 911 after 30 minutes. EMS arrived and took over.  Patient vomited after EMS picked him up and transferred him to the gurney. Patient's wife was notified.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Immediate post-injection reaction, Migraine
Clinical narrative: Patient described the adverse reaction as starting immediately, symptoms included: Nausea, Vomiting, Diarrhea, GI cramping, Migraine, Dizziness.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Patient described the adverse reaction as starting immediately, symptoms included: Nausea, Vomiting, Diarrhea, GI cramping, Migraine, Dizziness.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient reported that 4-5 hours after vaccination she had a swollen arm in the area of the vaccine and redness and pain, she also reported a fever.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Blood electrolytes normal, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: The adverse effects started the next day after the vaccine.  Started having extreme fatigue.  10 days after the vaccine started having fasciculations of major muscle groups-   Upper and lower extremities primarily. Upper and lower extremities felt very heavy.  Started having sensory changes in hands and feet.  Numbness in hands and feet that would come and go.  Hot/cold sensation in left foot. The above fasciculations and sensory changes were bilateral.  Tightness in throat and dizziness.  Some difficulty breathing.  Difficulty sleeping.  The numbness in the hands and feet have improved, however I continue to have the same symptoms as stated above to date.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Insomnia, Limb discomfort, Muscle contractions involuntary, Neurological examination normal
Clinical narrative: The adverse effects started the next day after the vaccine.  Started having extreme fatigue.  10 days after the vaccine started having fasciculations of major muscle groups-   Upper and lower extremities primarily. Upper and lower extremities felt very heavy.  Started having sensory changes in hands and feet.  Numbness in hands and feet that would come and go.  Hot/cold sensation in left foot. The above fasciculations and sensory changes were bilateral.  Tightness in throat and dizziness.  Some difficulty breathing.  Difficulty sleeping.  The numbness in the hands and feet have improved, however I continue to have the same symptoms as stated above to date.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral coldness, Sensory disturbance, Throat tightness
Clinical narrative: The adverse effects started the next day after the vaccine.  Started having extreme fatigue.  10 days after the vaccine started having fasciculations of major muscle groups-   Upper and lower extremities primarily. Upper and lower extremities felt very heavy.  Started having sensory changes in hands and feet.  Numbness in hands and feet that would come and go.  Hot/cold sensation in left foot. The above fasciculations and sensory changes were bilateral.  Tightness in throat and dizziness.  Some difficulty breathing.  Difficulty sleeping.  The numbness in the hands and feet have improved, however I continue to have the same symptoms as stated above to date.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Eye pain, Headache, Lethargy, Pyrexia, Vomiting
Clinical narrative: Woke up with a High fever of 102.8 on same day vaccine was administered at approximately 11pm. Patient was very lethargic and complained of severe headache and eye pain. Fever got worse at 5 am the next day. About 104 degrees. Continued lethargy all day and fevers, headache and vomiting.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Constipation, Diarrhoea, Drooling, Incomplete course of vaccination
Clinical narrative: When returning for next "set" of vaccines, mother, refuses further ROTATEQ, as she believes he had a reaction to the first one. She reports tongue swelling, drooling, and severe abdominal pain with constipation for "a few" days, which then became diarrhea. She denies seeking medical attention for the baby at that time.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Swollen tongue
Clinical narrative: When returning for next "set" of vaccines, mother, refuses further ROTATEQ, as she believes he had a reaction to the first one. She reports tongue swelling, drooling, and severe abdominal pain with constipation for "a few" days, which then became diarrhea. She denies seeking medical attention for the baby at that time.
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK administered to a 14 year old. No adverse reaction.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: Raised bumps along hairline 10/18 with fatigue, headache, joint pain, stiff neck intermittent fatigue/headache/joint pain/stiff neck/low grade fever through 10/31. 10/31-spiked fever to 102, mouth sores, petechiae on back. Intermittent symptoms continue. Fever up and down, joint pain ongoing, etc. 11/5 chills, fever, sore throat, intermittent chest discomfort with breaths periodically, continued joint pain, neck stiffness, fever, sore throat, etc.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Musculoskeletal stiffness, Oropharyngeal pain, Petechiae, Pyrexia, Rash
Clinical narrative: Raised bumps along hairline 10/18 with fatigue, headache, joint pain, stiff neck intermittent fatigue/headache/joint pain/stiff neck/low grade fever through 10/31. 10/31-spiked fever to 102, mouth sores, petechiae on back. Intermittent symptoms continue. Fever up and down, joint pain ongoing, etc. 11/5 chills, fever, sore throat, intermittent chest discomfort with breaths periodically, continued joint pain, neck stiffness, fever, sore throat, etc.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Stomatitis
Clinical narrative: Raised bumps along hairline 10/18 with fatigue, headache, joint pain, stiff neck intermittent fatigue/headache/joint pain/stiff neck/low grade fever through 10/31. 10/31-spiked fever to 102, mouth sores, petechiae on back. Intermittent symptoms continue. Fever up and down, joint pain ongoing, etc. 11/5 chills, fever, sore throat, intermittent chest discomfort with breaths periodically, continued joint pain, neck stiffness, fever, sore throat, etc.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Discomfort, Pyrexia
Clinical narrative: Patient reported the day after getting the vaccine that he experienced general discomfort, chills and fever (up to 105 degrees) overnight the night following having been vaccinated. He said there were no noticeable reactions on his arm at the site of the vaccination. He said he took TYLENOL to reduce the fever and it seemed to be resolved.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, Neuropathy peripheral, Pain
Clinical narrative: Developed severe neuropathy in right arm, face, right torso area, right upper thigh, both hands within a few hours of receiving the vaccine. Still have arm neuropathy in upper right arm, upper thigh, right side of face  and left hand. I have burning and nerve shooting pain on the surface of my skin. (The same thing happened in 2015 after I received the flu shot -- I did not get the shot in 2016 or 2017 but my employer is now requiring the vaccine so I got it this year). When it happened in 2015, the neurologist I was seeing then said the only thing I can do is double my gabapentin 3 times a day so that is what I am doing this time as well.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymph node palpable, Rash papular, Urticaria
Clinical narrative: 24 hours after taking the vaccine, I experienced firm and tender lymph nodes (behind both ears). Approximately 24-48 hours later, my neck and ears developed a bumpy rash. The rash turned into hives on both ears. Taking ZYRTEC 10mg bid x 24 hours, no resolution to symptoms yet.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Per mother, 10-27-18 child  had redness, warmth to touch and hardness to left thigh at injection site. Hardness started at 2 inches and progressively got worse, up to 4 inches. Went to ER on 10-29-18.  Given one dose of Rocephin 1 gram and Augmentin 750 mg bid x 7 days for left leg cellulitis. Noticed improvement on 10-30-18. Seen in clinic 10-31-18 for follow up. Markedly improved.
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concomitant medications and laboratory data were unknown. On an unknown date on "Friday", the patient was vaccinated with PNEUMOVAX 23 (Dosing details, route of administration, lot # and expiry date were unknown) for prophylaxis. On an unknown date in October 2018, the patient experienced numbness in his "pinkie" and ring finger and at the time of the report, a little bit in his middle finger (hypoaesthesia). The patient had not consulted a physician concerning the numbness. At the time of the report, the event was ongoing. Causality assessment was not provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed vocational nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown dates, the patient was vaccinated with the three dose series GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown). The nurse reported the third dose was administered too soon clarified as two months after the second dose was administered. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. In 2015, the patient was treated by a physician at a clinic for herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Pertussis
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a infant male patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown. It was unknown if the reporter considered the whooping cough to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The reporter's grandson got a flu shot when he was about 11 months and had some stuff sounded like a whooping cough. The reporter did not get any suggest from physicians as far as medication. The physician suggested to just eat right, exercise and feed kids healthy foods.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: This case was reported by a consumer and described the occurrence of seizure in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included seizure (well controlled with Divalproex). Concurrent medical conditions included speech impairment nos (non-verbal) and alzheimer's disease (had for 10 years). On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX the patient experienced seizure again. The reporter stated that the patient was not verbal and therefore he could not know the other side effects experienced by her. The reporter was hesitated to vaccinate the patient with the 2nd dose of SHINGRIX. The reporter provided his contact details and stated that he could be reached on those contact details for this discussion.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody, Full blood count, Joint swelling, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Joint swelling serum sickness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Serum sickness
Clinical narrative: Joint swelling serum sickness.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Gave a pediatric dose of Hep A to an adult. NO ADVERSE REACTION.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Hypoacusis, Hypoaesthesia, Loss of consciousness, Mobility decreased, Muscle spasticity
Clinical narrative: WITHIN 2 MINUTES AFTER THE ADMINISTRATION OF ALL VACCINES:BOTH OF HER HANDS BECAME SPASTIC-SHE WAS UNABLE TO MOVE THEM, SHE BEGAN HAVING GENERALIZED NUMBNESS AND TINGLING. HER HEARING CHANGED AS WELL AS HER VISION BECAME BLURRY . SHE ATTEMPTED TO CLOSE EYES AND PASS OUT. SHE WAS ABEL TO BE AROUSED BY CALLING HER NAME.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: WITHIN 2 MINUTES AFTER THE ADMINISTRATION OF ALL VACCINES:BOTH OF HER HANDS BECAME SPASTIC-SHE WAS UNABLE TO MOVE THEM, SHE BEGAN HAVING GENERALIZED NUMBNESS AND TINGLING. HER HEARING CHANGED AS WELL AS HER VISION BECAME BLURRY . SHE ATTEMPTED TO CLOSE EYES AND PASS OUT. SHE WAS ABEL TO BE AROUSED BY CALLING HER NAME.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Within 2 hours of injection, developed pain in shoulder, shoulder blade and neck. Within 48 hours of injection, could not use arm. Severe pain in shoulder, shoulder blade area, neck and down arm to wrist. Could not move arm- described as 'frozen'. This level of pain and dysfunction lasted two days and since, pain is less in wrist to elbow. Some improvement in function of arm but still pain in deltoid and bicep of arm. Not totally functional 4 days later. Encouraged patient to seek medical evaluation.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Choking sensation, Dyspnoea, Nausea, Wheezing
Clinical narrative: WHEEZING, FEELING OF CHOKING, AND DIFFICULTY BREATHING, SEVERE NAUSEA.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome
Clinical narrative: Patient is having tendinopathy of the supraspinatus tendon in her left arm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Vaccine was given on 10/21/2018, the patient had flu shots before but first time for the high dose. The sister came 11/05/18 to pick up prescription and told us that they have to bring the patient to the ER on 10/23/2018 at day time. I called the patient and verified what reactions she had and she said she had hives all over her body. She's not aware that she had taken anything after the shot that she's allergic to. She have a new prescription Bupropion that was picked up 10/15 but she said she didn't start that medication yet. At the time of the flu shot she also picked up CLARINEX because of her sinus problem.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: The vaccine shot was given a little high in the left shoulder but not high enough to involve the bursa joint capsule. There was no frozen joint type of event. The needle did not cause severe initial pain or bleeding. I do not believe the syringe was drawn back to see if it was in a blood vessel. Later that day and the following day there was the usual mild soreness at the injection site. This soon went away. About two weeks later there was severe pain about 10 centimeters below the injection site. The pain was intermittent and migratory in the upper and lower left arm. The migratory pain was dependent on arm position and would leave one area to go to another. There was no palpable mass or heat or discoloration. No weakness except due to the pain. No tenderness to touch nor fever. Pain is severe and debilitating. Pain continues at a severe level.
Age: 26.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: After administering the MENACTRA shot, the second of two shots given, the patient fainted and had a brief convulsion lasting 10 seconds. He then recovered. I monitored the patient, had him lower his head between his legs. Once he was stabilized, I got him cold wet rags and ice for his neck and wrist in an attempt to cool him, gave him a glass of water for hydration and stayed with him until he felt strong enough to depart. I called him 3 hours later to check on his status which was very good. He did not know the name of his new medical provider who he has yet to meet. Therefore, at present I do not have their contact information, waiting on the patient to provide this. At that time, I will call the provider and provide them with these details.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Autopsy, Death, Loss of consciousness
Clinical narrative: Patient was found unconscious the morning of 10/12 in the crib. Declared dead shortly after. Autopsy pending.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased, Swelling
Clinical narrative: Significant local swelling of arm from shoulder to hand. Swelling now resolving and patient able to use arm again.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states it started 11/5/2018 she had arm pain and her arm is swollen and has trouble lifting her arm. She states she doesn't understand why because the shot was pain free and was given in the middle of the deltoid muscle where it is supposed to be. She was curious to know if it was a side effect of allergic reaction and was going to her MD 11/6/2018 and would check back in with me.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Arm from injection to elbow swelled, turned red immediately after shot. Within one day swelling and redness spread to almost the entire arm. I went to see doctor on day 3 thinking I had cellulitis. He gave me an antibiotic prescription if problem persisted. By day 4 problem had resolved sufficiently and was mostly gone by day 5.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient had a flu shot on Friday. During the weekend caregiver complaining of increased redness, pain and swelling to injection site. Area tender, with erythema and induration present. Antibiotics were prescribed.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Per patient, cant lift arm up, forward or behind her. Says it is in constant pain. Had a dr appointment today and they did X-ray, gave a cortisone shot and recommends physical therapy.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient came in complaining of a bruise along the entire upper arm. Did not have signs or symptoms of continuing bleeding and claims the bruising has started to recede.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: Patient stated that her lips were tingling and her face flushed immediately following administration.  Diphenhydramine was given by mouth and she was monitored. No other symptoms occurred.
Age: 54.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Dysphagia, Endotracheal intubation, Gait inability, Lumbar puncture, Muscular weakness
Clinical narrative: Pt has had progressive weakness in hands, feet - resulting in inability to walk, control arms, to swallow, speak clearly. Breathing affected. Pt has been intubated at Hospital due to imminent respiratory failure.
Age: 54.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Respiration abnormal, Respiratory failure, Speech disorder
Clinical narrative: Pt has had progressive weakness in hands, feet - resulting in inability to walk, control arms, to swallow, speak clearly. Breathing affected. Pt has been intubated at Hospital due to imminent respiratory failure.
Age: 54.0
Sex: M
Vaccine: UNK, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt has had progressive weakness in hands, feet - resulting in inability to walk, control arms, to swallow, speak clearly. Breathing affected. Pt has been intubated at Hospital due to imminent respiratory failure.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Immunization was completed at an offsite clinic on 10/15/18. Patient called and spoke to the store manager the morning of 11/5 to inform us that he was still experiencing shoulder pain and that he was going to make a Drs. appoint. During this call the patient mentioned that he felt that the injection was given too high in the arm and that he suspects it hit his bursa. This has not been confirmed by a medical professional.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Diverticulitis, Injection site pustule, Lymphadenopathy, Pericardial effusion
Clinical narrative: Patient received her flu shot and in the week following the shot, she developed a pimple where the shot had been administered and a swollen lymph node in her armpit. A week later she went to the ER for unrelated abdominal pains which turned out to be diverticulitis, but while she was in the ER they discovered she had pericardial effusion/pericarditis. She believed she could have contracted a viral infection from the flu shot to which we reminded her that the virus in these vaccines is inactivated.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Pericarditis
Clinical narrative: Patient received her flu shot and in the week following the shot, she developed a pimple where the shot had been administered and a swollen lymph node in her armpit. A week later she went to the ER for unrelated abdominal pains which turned out to be diverticulitis, but while she was in the ER they discovered she had pericardial effusion/pericarditis. She believed she could have contracted a viral infection from the flu shot to which we reminded her that the virus in these vaccines is inactivated.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Pt called and reported her arm is very red and swollen and it hurts to move. We referred her to a doctor to have her arm evaluated.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Myalgia, Pyrexia
Clinical narrative: Fever, upset stomach, muscle aches. Fever and muscle aches diminished after about 6 hours.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pain
Clinical narrative: Patient states blistering on arm approximately 1 inch long and raised about 1/2 inch. She reports no fever, slight achiness throughout the day.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability
Clinical narrative: Extremely irritable the evening and following day of vaccines; seemed to improve 2 days after receiving vaccines.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site induration, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain/soreness, burning, swelling and harness on site of injection that became larger on second day: patient experiencing chills and fever: tingling on the whole arm: still feeling sick as of this moment.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Pain/soreness, burning, swelling and harness on site of injection that became larger on second day: patient experiencing chills and fever: tingling on the whole arm: still feeling sick as of this moment.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient came into store and reported soreness/pain with difficulty moving left arm in full range of motion; 3 weeks after shot was given Patient said she has soreness the following day after injection which was the peak pain/soreness but it slowly started to disappear but is still present 3 weeks later.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: High temperature, General pain. Patient said could not stand upright because of pain. General feeling of un-wellness and fatigue.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Infantile spitting up, Respiratory arrest, Resuscitation
Clinical narrative: Child seemed to spit up more after so the night before attempted to schedule every 3hrs 4ounces water 2 scoops of infant Enfamil (yellow) and 8:06 am woke to child obviously stopped breathing, performed CPR till fire dept. arrived to take over and ambulance arrived then rush her to the hospital. Coroner case.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patient reported running a fever of 102 degrees. Her arm was red and swollen from the site of injection all the way down to her elbow. She reported pain and itching in the area.
Age: 43.0
Sex: U
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized hives and itchiness.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction yet. Concerned that patient was given KINRIX, not appropriate for a 4 month old.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Disturbance in attention, Incoherent, Mental status changes, Pyrexia
Clinical narrative: ALTERED MENTAL STATUS: after flu shot yesterday; received flu shot at 12:30pm; when they got home (approx 1 hour after flu shot) he went to his room mother noticed his whole body looked tense; no LOC; still responsive to parents but seemed incoherent; kept moving around wouldn't keep still; seemed uncomfortable wasn't speaking correctly saying "playgwound" instead of "playground"; increased crying yesterday therapist was with them at 3pm said he looked "off"; could not focus ; couldn't play a game; hard time getting his attention yesterday; went to school this AM ; mom had to pick him up b/c he wouldn't stop crying ; Mental status improving today after waking up from nap; eye contact getting better. No fever yesterday; +fever today Tm 100.9. Seen in clinic today and was back to baseline; no treatment needed.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Speech disorder, Tension
Clinical narrative: ALTERED MENTAL STATUS: after flu shot yesterday; received flu shot at 12:30pm; when they got home (approx 1 hour after flu shot) he went to his room mother noticed his whole body looked tense; no LOC; still responsive to parents but seemed incoherent; kept moving around wouldn't keep still; seemed uncomfortable wasn't speaking correctly saying "playgwound" instead of "playground"; increased crying yesterday therapist was with them at 3pm said he looked "off"; could not focus ; couldn't play a game; hard time getting his attention yesterday; went to school this AM ; mom had to pick him up b/c he wouldn't stop crying ; Mental status improving today after waking up from nap; eye contact getting better. No fever yesterday; +fever today Tm 100.9. Seen in clinic today and was back to baseline; no treatment needed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: PATIENT GOT THE FLUZONE HD VACCINE AND COMPLAINED OF ITCHING AND REDNESS AT THE SITE OF INJECTION. SHE SAID SHE HAD A BIG WELT, BIG BALL LIKE AROUND THE SITE OF THE INJECTION. SHE DID NOT HAVE ANY PAIN AT THE SITE. THE ITCHING DECREASED OVER THE NEXT FEW DAYS AND THE REDNESS LESSENED ALSO. PATIENT HAD NO OTHER REACTIONS. PT DID NOT TAKE ANY MEDICATIONS FOR REACTION.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Sensation of foreign body, Swelling
Clinical narrative: Allergic reaction with swelling and "lump-like" feeling in throat alleviated with 2 doses of 50mg diphenhydramine.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: When patient came in for her second dose of the series, she said that about a week or two after her first dose she developed hives all over her body. She said it was definitely delayed to when she received the shot but didn't remember changing anything else that would have caused it. She said that she notified the nurse at her facility about it and they gave her steroids and it went away. She was told by several health care providers to continue and get the second dose so she did so willingly.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Disorientation, Dizziness, Erythema, Headache, Hyperhidrosis
Clinical narrative: Patient complained of her left arm being red and swollen and in a lot of pain. Pt got vaccines on 11/2 and reactions started around noon on Saturday 11/3. Patient complained of severe headache also and said she was profusely sweating. She stated that initially she was dizzy, nauseated and disoriented. She called the pharmacy for consultation on 11/5. Patient has been using cold packs, and TYLENOL for headache and pain. I advised her to take BENADRYL for the swelling. I have been following up with the patient since yesterday. Today she is feeling better, her head still hurts but not as much. Her arm is still pink. She is still taking BENADRYL and TYLENOL. Patient has had the flu vaccine in the past with no adverse reaction. Her biggest complaint was a severe headache and arm pain and swelling.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complained of her left arm being red and swollen and in a lot of pain. Pt got vaccines on 11/2 and reactions started around noon on Saturday 11/3. Patient complained of severe headache also and said she was profusely sweating. She stated that initially she was dizzy, nauseated and disoriented. She called the pharmacy for consultation on 11/5. Patient has been using cold packs, and TYLENOL for headache and pain. I advised her to take BENADRYL for the swelling. I have been following up with the patient since yesterday. Today she is feeling better, her head still hurts but not as much. Her arm is still pink. She is still taking BENADRYL and TYLENOL. Patient has had the flu vaccine in the past with no adverse reaction. Her biggest complaint was a severe headache and arm pain and swelling.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness, tiredness the day after flu shot, recovered a couple days after.