chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Acute respiratory failure, Bradycardia, Continuous positive airway pressure, Cyanosis, Infantile apnoea
Clinical narrative: Patient had apneic event, was intubated, and transferred to hospital. Per note from RT on 2/18 at 1913. - "1230 this afternoon transport team arrived to transport patient to hospital for PDA ligation. Patient was stable at this time on 5cm 21% bubble CPAP. When transport team removed Patient from CPAP and placed on transport CPAP with Ram canula Sats dropped and baby did not tolerate change. NIPPV mode was also attempted on transport ventilator with no success. Baby was bagged with Neo tee by transport team with no improvement of sats in the teens. MRSOPA was utilized and then switched to self inflating Ambu bag with peep valve with PIP35 and Peep 7 and SpO2 maintaining in 20-30s. Two attempts were then made by NNP with successful intubation on 2nd try with 3.0 ETT at 7.5 cm at gums, Lg leak observed. Lg amt of Blood visualized in airway before any attempts were made at intubation. CXR obtained and showed complete white out. Baby was then placed on APV CMV mode on transport ventilator with no improvement in sats and little to no volumes. PC CMV was then tried and no Vt observed with Sats in the teens. Baby then placed on Flow Interupter by transport team. CBG obtained with PH 6.7 PCO2 >130. 1 unit of PRBC and 1 unit FFP started due to suspected pulmonary hemorrhage. On Flow Interupter pressures gradually increased with final settings MAWP 22, 10 HZ. Life flight was called and asked to switch plans from ground transport to flight. SpO2 finally reached high 80s and 90s briefly. Life flight arrived and while preparing for transition to transport isolette a repeat CXR was obtained and still showing complete whiteout. ABG obtained Ph 7.44 PCO2 34. SpO2s began to decline again and decision made to keep baby here on Oscillator and try to stabilize. SpO2s in low 30s again. Baby placed on 3100 A oscillator and MAWP gradually increased from 16-22 over period of time with Delta P eventually topping out at 44 with 10 HZ. Sats still in 20s and 30s and very poor chest wiggle. Nitric ordered by Dr. and 2nd RT began preparing Nitric to be placed on baby. Dr. decided to reintubate with larger tube due to large leak, poor chest wiggle and poor saturations. Dr. had sucessful intubation at 1620 with one attempt. 3.5 ETT taped at 8cm at gums. Very small leak heard. Repeat CXR shows good placement. Placed back on 3100 A with MAWP 22 Delta P 40 and 8 HZ with 100% FiO2 and sats began to climb to 60s and 70s. Nitric Oxide started at 1635 at 20 ppm and sats steadily improving to 80s and low 90s."
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Neonatal hypoxia, Unresponsive to stimuli
Clinical narrative: Patient had apneic event, was intubated, and transferred to hospital. Per note from RT on 2/18 at 1913. - "1230 this afternoon transport team arrived to transport patient to hospital for PDA ligation. Patient was stable at this time on 5cm 21% bubble CPAP. When transport team removed Patient from CPAP and placed on transport CPAP with Ram canula Sats dropped and baby did not tolerate change. NIPPV mode was also attempted on transport ventilator with no success. Baby was bagged with Neo tee by transport team with no improvement of sats in the teens. MRSOPA was utilized and then switched to self inflating Ambu bag with peep valve with PIP35 and Peep 7 and SpO2 maintaining in 20-30s. Two attempts were then made by NNP with successful intubation on 2nd try with 3.0 ETT at 7.5 cm at gums, Lg leak observed. Lg amt of Blood visualized in airway before any attempts were made at intubation. CXR obtained and showed complete white out. Baby was then placed on APV CMV mode on transport ventilator with no improvement in sats and little to no volumes. PC CMV was then tried and no Vt observed with Sats in the teens. Baby then placed on Flow Interupter by transport team. CBG obtained with PH 6.7 PCO2 >130. 1 unit of PRBC and 1 unit FFP started due to suspected pulmonary hemorrhage. On Flow Interupter pressures gradually increased with final settings MAWP 22, 10 HZ. Life flight was called and asked to switch plans from ground transport to flight. SpO2 finally reached high 80s and 90s briefly. Life flight arrived and while preparing for transition to transport isolette a repeat CXR was obtained and still showing complete whiteout. ABG obtained Ph 7.44 PCO2 34. SpO2s began to decline again and decision made to keep baby here on Oscillator and try to stabilize. SpO2s in low 30s again. Baby placed on 3100 A oscillator and MAWP gradually increased from 16-22 over period of time with Delta P eventually topping out at 44 with 10 HZ. Sats still in 20s and 30s and very poor chest wiggle. Nitric ordered by Dr. and 2nd RT began preparing Nitric to be placed on baby. Dr. decided to reintubate with larger tube due to large leak, poor chest wiggle and poor saturations. Dr. had sucessful intubation at 1620 with one attempt. 3.5 ETT taped at 8cm at gums. Very small leak heard. Repeat CXR shows good placement. Placed back on 3100 A with MAWP 22 Delta P 40 and 8 HZ with 100% FiO2 and sats began to climb to 60s and 70s. Nitric Oxide started at 1635 at 20 ppm and sats steadily improving to 80s and low 90s."
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoeic attack, Dyspnoea, Heart rate decreased, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: Patient had apneic event, was intubated, and transferred to hospital. Per note from RT on 2/18 at 1913. - "1230 this afternoon transport team arrived to transport patient to hospital for PDA ligation. Patient was stable at this time on 5cm 21% bubble CPAP. When transport team removed Patient from CPAP and placed on transport CPAP with Ram canula Sats dropped and baby did not tolerate change. NIPPV mode was also attempted on transport ventilator with no success. Baby was bagged with Neo tee by transport team with no improvement of sats in the teens. MRSOPA was utilized and then switched to self inflating Ambu bag with peep valve with PIP35 and Peep 7 and SpO2 maintaining in 20-30s. Two attempts were then made by NNP with successful intubation on 2nd try with 3.0 ETT at 7.5 cm at gums, Lg leak observed. Lg amt of Blood visualized in airway before any attempts were made at intubation. CXR obtained and showed complete white out. Baby was then placed on APV CMV mode on transport ventilator with no improvement in sats and little to no volumes. PC CMV was then tried and no Vt observed with Sats in the teens. Baby then placed on Flow Interupter by transport team. CBG obtained with PH 6.7 PCO2 >130. 1 unit of PRBC and 1 unit FFP started due to suspected pulmonary hemorrhage. On Flow Interupter pressures gradually increased with final settings MAWP 22, 10 HZ. Life flight was called and asked to switch plans from ground transport to flight. SpO2 finally reached high 80s and 90s briefly. Life flight arrived and while preparing for transition to transport isolette a repeat CXR was obtained and still showing complete whiteout. ABG obtained Ph 7.44 PCO2 34. SpO2s began to decline again and decision made to keep baby here on Oscillator and try to stabilize. SpO2s in low 30s again. Baby placed on 3100 A oscillator and MAWP gradually increased from 16-22 over period of time with Delta P eventually topping out at 44 with 10 HZ. Sats still in 20s and 30s and very poor chest wiggle. Nitric ordered by Dr. and 2nd RT began preparing Nitric to be placed on baby. Dr. decided to reintubate with larger tube due to large leak, poor chest wiggle and poor saturations. Dr. had sucessful intubation at 1620 with one attempt. 3.5 ETT taped at 8cm at gums. Very small leak heard. Repeat CXR shows good placement. Placed back on 3100 A with MAWP 22 Delta P 40 and 8 HZ with 100% FiO2 and sats began to climb to 60s and 70s. Nitric Oxide started at 1635 at 20 ppm and sats steadily improving to 80s and low 90s."
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, HIBV, DTAPHEPBIP, HIBV, PNC13
Symptoms: Pallor, Sleep apnoea syndrome
Clinical narrative: Patient had apneic event, was intubated, and transferred to hospital. Per note from RT on 2/18 at 1913. - "1230 this afternoon transport team arrived to transport patient to hospital for PDA ligation. Patient was stable at this time on 5cm 21% bubble CPAP. When transport team removed Patient from CPAP and placed on transport CPAP with Ram canula Sats dropped and baby did not tolerate change. NIPPV mode was also attempted on transport ventilator with no success. Baby was bagged with Neo tee by transport team with no improvement of sats in the teens. MRSOPA was utilized and then switched to self inflating Ambu bag with peep valve with PIP35 and Peep 7 and SpO2 maintaining in 20-30s. Two attempts were then made by NNP with successful intubation on 2nd try with 3.0 ETT at 7.5 cm at gums, Lg leak observed. Lg amt of Blood visualized in airway before any attempts were made at intubation. CXR obtained and showed complete white out. Baby was then placed on APV CMV mode on transport ventilator with no improvement in sats and little to no volumes. PC CMV was then tried and no Vt observed with Sats in the teens. Baby then placed on Flow Interupter by transport team. CBG obtained with PH 6.7 PCO2 >130. 1 unit of PRBC and 1 unit FFP started due to suspected pulmonary hemorrhage. On Flow Interupter pressures gradually increased with final settings MAWP 22, 10 HZ. Life flight was called and asked to switch plans from ground transport to flight. SpO2 finally reached high 80s and 90s briefly. Life flight arrived and while preparing for transition to transport isolette a repeat CXR was obtained and still showing complete whiteout. ABG obtained Ph 7.44 PCO2 34. SpO2s began to decline again and decision made to keep baby here on Oscillator and try to stabilize. SpO2s in low 30s again. Baby placed on 3100 A oscillator and MAWP gradually increased from 16-22 over period of time with Delta P eventually topping out at 44 with 10 HZ. Sats still in 20s and 30s and very poor chest wiggle. Nitric ordered by Dr. and 2nd RT began preparing Nitric to be placed on baby. Dr. decided to reintubate with larger tube due to large leak, poor chest wiggle and poor saturations. Dr. had sucessful intubation at 1620 with one attempt. 3.5 ETT taped at 8cm at gums. Very small leak heard. Repeat CXR shows good placement. Placed back on 3100 A with MAWP 22 Delta P 40 and 8 HZ with 100% FiO2 and sats began to climb to 60s and 70s. Nitric Oxide started at 1635 at 20 ppm and sats steadily improving to 80s and low 90s."
Age: 2.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse refers to a 2 years old patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On 10-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 days before she turned 2 years old(administered to patient of inappropriate age). No adverse effects. The outcome of product administered to patient of inappropriate age and no adverse event were unknown.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Muscle fatigue, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 6th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced shivering, muscle fatigue, influenza-like symptoms and nausea. On an unknown date, the outcome of the shivering, muscle fatigue, influenza-like symptoms and nausea were recovering/resolving. It was unknown if the reporter considered the shivering, muscle fatigue, influenza-like symptoms and nausea to be related to SHINGRIX. Additional details were reported as follows: The patient experienced Shivering, muscle fatigue, flu like symptoms, slight nausea after receiving SHINGRIX. The patient experienced pretty much everything adverse events except headache. The patient reported he feels a little better in morning of the reporting date. The patient was inquiring about the duration of the time the side effects he reported yesterday might last. As per the Package Insert (PI), advised the caller the side effects could last 3 to 5 days, on average around 2 to 3 days. The patient also inquired if he would had a similar reaction to the 2nd vaccine and he was advised that he most likely would had a similar reaction. The patient did not think the follow up would be necessary.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Scar, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, swelling arm, scar and welts. On an unknown date, the outcome of the fever, swelling arm, scar and welts were unknown. It was unknown if the reporter considered the fever, swelling arm, scar and welts to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX shot about 5 months ago and had a really bad reaction, fever and arm swelled up with a welt like a baseball and actually left a scar on arm. The patient was kind of nervous to get the next shot. The patient asked what would happen if the patient did not receive the 2nd dose.
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This case was reported by a consumer and described the occurrence of hair loss in a male patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 2nd dose of SHINGRIX. On 15th December 2018, 7 days after receiving SHINGRIX, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved. It was unknown if the reporter considered the hair loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The week after SHINGRIX vaccination, the patient noticed significant hair loss. This was never an issue for the patient in the past. The patient's hair had always grown very fast and rarely noticed any hair fall. This could be purely coincidental and the vaccine was a protein derivative, but it was a condition none the less. The patient realized this was likely entirely coincidental, but he had always been exceptionally healthy.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Mastication disorder, Nausea, Neuralgia, Odynophagia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (For 1st dose, refer case US2019GSK029971). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, nausea, pain, nerve pain, swallowing painful, chewing difficulty and speech disorder. On an unknown date, the outcome of the fever, headache, nausea, pain, nerve pain, swallowing painful, chewing difficulty and speech disorder were unknown. It was unknown if the reporter considered the fever, headache, nausea, pain, nerve pain, swallowing painful, chewing difficulty and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced high fever, severe headache, nausea, and severe aches and pains like the ones experienced with the flu. A few weeks later, the patient had nerve pain in maxilla (upper jaw bone) so severe that she could barely swallow without pain and had pain severe enough to prevent her from speaking or chewing food. The reporter asked if this nerve pain could be a side effect of the booster SHINGRIX (2nd dose).
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Speech disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (For 1st dose, refer case US2019GSK029971). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, nausea, pain, nerve pain, swallowing painful, chewing difficulty and speech disorder. On an unknown date, the outcome of the fever, headache, nausea, pain, nerve pain, swallowing painful, chewing difficulty and speech disorder were unknown. It was unknown if the reporter considered the fever, headache, nausea, pain, nerve pain, swallowing painful, chewing difficulty and speech disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced high fever, severe headache, nausea, and severe aches and pains like the ones experienced with the flu. A few weeks later, the patient had nerve pain in maxilla (upper jaw bone) so severe that she could barely swallow without pain and had pain severe enough to prevent her from speaking or chewing food. The reporter asked if this nerve pain could be a side effect of the booster SHINGRIX (2nd dose).
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter agreed to follow up from GlaxoSmithKline.
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received TWINRIX ADULT (batch number 95KG9, expiry date 29th October 2020) for prophylaxis. On 13th January 2019, the patient received the 1st dose of TWINRIX ADULT. On 13th January 2019, less than a day after receiving TWINRIX ADULT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to TWINRIX ADULT. Additional details were provided as follows: The patient received TWINRIX ADULT in the right deltoid. In the evening after vaccination, the patient experienced arm pain in her entire right arm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of maculopapular rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On 11th February 2019, unknown after receiving SHINGRIX, the patient experienced maculopapular rash. The patient was treated with antihistamine. On an unknown date, the outcome of the maculopapular rash was unknown. It was unknown if the reporter considered the maculopapular rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by physician for herself. The age at vaccination was not reported. The batch number and expiry date of SHINGRIX were not reported. On the day of reporting, the patient experienced a maculopapular rash that was crossing the mid-line all over her body from the neck down with no itching, but she does take an antihistamine. The patient declined to complete safety report and stated that her pharmacist would call in to report the adverse event. The reporter declined to provide address.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itching both hands in a 89-year-old male patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced itching both hands. On an unknown date, the outcome of the itching both hands was not recovered/not resolved. It was unknown if the reporter considered the itching both hands to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid. The patient indicated that several days after receiving the SHINGRIX vaccine, he developed itching on the palms of both of his hands. This progressed to itching of both calves, predominately his left calf. The patient also had itching above his elbows, again predominantly was left elbow. The itching occurred every day. It would go away and return the next day. The reporter consented to follow up. This case has been linked to case US2019025968, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 9th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX in left arm. The reporter stated that the patient came into the healthcare professional's (HCP) office on 12th February 2019 with redness and tenderness in left arm. The patient required to visit emergency room (ER).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Gait inability, Joint swelling, Pain, Pharyngeal swelling
Clinical narrative: On the next day my joints (especially Knees) swelled up and I could not walk by afternoon, my rheumatologist prescribed prednisone 20mg and by saturday I had  relief of pain. Swelling remained until sunday. I continued to take the prednisone 20mg daily and on Sunday night my tongue, esophagus and neck swelled so much I could not swallow but my breathing was not impaired. I took benedryl 50mg, zantac 300mg. By Monday afternoon the swelling was gone. I notified both the IM doc and my rheumatologist and am continuing on prednisone.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Swollen tongue
Clinical narrative: On the next day my joints (especially Knees) swelled up and I could not walk by afternoon, my rheumatologist prescribed prednisone 20mg and by saturday I had  relief of pain. Swelling remained until sunday. I continued to take the prednisone 20mg daily and on Sunday night my tongue, esophagus and neck swelled so much I could not swallow but my breathing was not impaired. I took benedryl 50mg, zantac 300mg. By Monday afternoon the swelling was gone. I notified both the IM doc and my rheumatologist and am continuing on prednisone.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Conjunctivitis, Eye discharge, Eye irritation, Eye pain, Eye pruritus
Clinical narrative: I began feeling an itchy irritades right eye symptoms over the weekend but I didn't give much attention to it. By the following Monday after the vaccine I had woken up with a red itchy right eye, I thought I had just cought a case of pink eye which I had twice before in my life so I kept the area clean and suspecting it would clear up within a day or two as it normally had done in the past. It wasn't until after two days after that the condition was only worsening, now my eye was red and swollen, itchy and painful barely able to open and oozing yellow greenish puss, when I finally decided something was worse than any infection I had ever gotten. To avoid infecting anyone else I reamined locked in my room avoiding all contact even with my own husband and son. I scheduled a doctor's visit with Dr.  over video to avoid further contamination, since the infection and condition of my eye was very clearly visible. Dr. agreed that I had a severe Conjuctivitis condition developed on my right eye and immediately prescribed: Polymyxim B- trimethoprim ophthalmic 10000 units 1mg to  drop in eye for 7-10 days every 3 hours. I followed his medical instructions exactly and it took over 7 days for the swelling and redness and pus gradually disappear. After almost 2 weeks of finishing the medication my right eye remained smaller than the left which can be seen in my forward facing pictures.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Ocular hyperaemia, Purulent discharge
Clinical narrative: I began feeling an itchy irritades right eye symptoms over the weekend but I didn't give much attention to it. By the following Monday after the vaccine I had woken up with a red itchy right eye, I thought I had just cought a case of pink eye which I had twice before in my life so I kept the area clean and suspecting it would clear up within a day or two as it normally had done in the past. It wasn't until after two days after that the condition was only worsening, now my eye was red and swollen, itchy and painful barely able to open and oozing yellow greenish puss, when I finally decided something was worse than any infection I had ever gotten. To avoid infecting anyone else I reamined locked in my room avoiding all contact even with my own husband and son. I scheduled a doctor's visit with Dr.  over video to avoid further contamination, since the infection and condition of my eye was very clearly visible. Dr. agreed that I had a severe Conjuctivitis condition developed on my right eye and immediately prescribed: Polymyxim B- trimethoprim ophthalmic 10000 units 1mg to  drop in eye for 7-10 days every 3 hours. I followed his medical instructions exactly and it took over 7 days for the swelling and redness and pus gradually disappear. After almost 2 weeks of finishing the medication my right eye remained smaller than the left which can be seen in my forward facing pictures.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Influenza like illness, Injection site pain, Malaise, Musculoskeletal pain
Clinical narrative: Starting the evening of the shot the pt starting to feel ill the next day and until 2/20/19 the patient felt like she had the flu and could not leave the house with pain on tops of her hands and feet and pain in shoulders. Blisters also developed about 2/18 and are starting to go away now. She is feel better today.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Starting the evening of the shot the pt starting to feel ill the next day and until 2/20/19 the patient felt like she had the flu and could not leave the house with pain on tops of her hands and feet and pain in shoulders. Blisters also developed about 2/18 and are starting to go away now. She is feel better today.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Blister, Injection site pain, Malaise
Clinical narrative: Starting the evening of the shot the pt starting to feel ill the next day and until 2/20/19 the patient felt like she had the flu and could not leave the house with pain on tops of her hands and feet and pain in shoulders. Blisters also developed about 2/18 and are starting to go away now. She is feel better today.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood test normal, Computerised tomogram normal, Erythema, Headache, Intervertebral disc degeneration
Clinical narrative: Started with pain, redness, lump under the skin on 2/05/19. Did not go away until 02/08/19. On 02/08/19 I started with a new symptom of a stiff neck. On 02/09/19, I still had the stiff neck and then a headache that eventually sent me to the ER twice that weekend. I went to Hospital twice for the headache pain. Today is 02/20/19 and I still have an unexplained headache. I've had a CT Scan and MRI's of my head and neck. My doctor is sending me for a spinal tap to make sure I don't have a CSF leak. Still have an unexplained headache which is very intense.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Mass, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Pain
Clinical narrative: Started with pain, redness, lump under the skin on 2/05/19. Did not go away until 02/08/19. On 02/08/19 I started with a new symptom of a stiff neck. On 02/09/19, I still had the stiff neck and then a headache that eventually sent me to the ER twice that weekend. I went to Hospital twice for the headache pain. Today is 02/20/19 and I still have an unexplained headache. I've had a CT Scan and MRI's of my head and neck. My doctor is sending me for a spinal tap to make sure I don't have a CSF leak. Still have an unexplained headache which is very intense.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Urine analysis normal
Clinical narrative: Started with pain, redness, lump under the skin on 2/05/19. Did not go away until 02/08/19. On 02/08/19 I started with a new symptom of a stiff neck. On 02/09/19, I still had the stiff neck and then a headache that eventually sent me to the ER twice that weekend. I went to Hospital twice for the headache pain. Today is 02/20/19 and I still have an unexplained headache. I've had a CT Scan and MRI's of my head and neck. My doctor is sending me for a spinal tap to make sure I don't have a CSF leak. Still have an unexplained headache which is very intense.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Feeling abnormal, Full blood count, Headache, Injection site cellulitis
Clinical narrative: Per narrative complaint from patient, her arm was very sore the afternoon of injection. Next morning patient wrote that she felt horrible and was running a temperature of 99-101, all limbs were weak and her head was throbbing and her eyes were sensitive. Patient states in complaint that she could do nothing on Saturday except lay under blankets and use the restroom. On day 3 after injection patient writes that her arm had a pinching feeling and the back of her was getting stiff and she still felt bad. She then reported to local ER at Hospital. She reports that it was at that time she noticed the redness and swelling at the injection site and that she could not turn her neck at that time. She had labs drawn at Hospital and was diagnosed by ER physician with Cellulitis of the left shoulder and upper arm. ER report notes that there is a 5cm area of erythema to left mid bicep and only a small amount of swelling and ttp to injection site at left deltoid. Patient was given discharge instructions to use TYLENOL or MOTRIN PRN for fever according to label instructions.  And she was prescribed Doxycycline for 10 days as well as a MEDROL DOSEPAK to be taken as per package instructions. At time of patient filing written complaint with the Immunization Clinic patient reported that her arm was still sore.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Metabolic function test
Clinical narrative: Per narrative complaint from patient, her arm was very sore the afternoon of injection. Next morning patient wrote that she felt horrible and was running a temperature of 99-101, all limbs were weak and her head was throbbing and her eyes were sensitive. Patient states in complaint that she could do nothing on Saturday except lay under blankets and use the restroom. On day 3 after injection patient writes that her arm had a pinching feeling and the back of her was getting stiff and she still felt bad. She then reported to local ER at Hospital. She reports that it was at that time she noticed the redness and swelling at the injection site and that she could not turn her neck at that time. She had labs drawn at Hospital and was diagnosed by ER physician with Cellulitis of the left shoulder and upper arm. ER report notes that there is a 5cm area of erythema to left mid bicep and only a small amount of swelling and ttp to injection site at left deltoid. Patient was given discharge instructions to use TYLENOL or MOTRIN PRN for fever according to label instructions.  And she was prescribed Doxycycline for 10 days as well as a MEDROL DOSEPAK to be taken as per package instructions. At time of patient filing written complaint with the Immunization Clinic patient reported that her arm was still sore.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Photophobia
Clinical narrative: Per narrative complaint from patient, her arm was very sore the afternoon of injection. Next morning patient wrote that she felt horrible and was running a temperature of 99-101, all limbs were weak and her head was throbbing and her eyes were sensitive. Patient states in complaint that she could do nothing on Saturday except lay under blankets and use the restroom. On day 3 after injection patient writes that her arm had a pinching feeling and the back of her was getting stiff and she still felt bad. She then reported to local ER at Hospital. She reports that it was at that time she noticed the redness and swelling at the injection site and that she could not turn her neck at that time. She had labs drawn at Hospital and was diagnosed by ER physician with Cellulitis of the left shoulder and upper arm. ER report notes that there is a 5cm area of erythema to left mid bicep and only a small amount of swelling and ttp to injection site at left deltoid. Patient was given discharge instructions to use TYLENOL or MOTRIN PRN for fever according to label instructions.  And she was prescribed Doxycycline for 10 days as well as a MEDROL DOSEPAK to be taken as per package instructions. At time of patient filing written complaint with the Immunization Clinic patient reported that her arm was still sore.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Discomfort, Joint range of motion decreased
Clinical narrative: AFTER FEW DAYS, FELT DISCOMFORT, ESPECIALLY WITH ANY APPLIED PRESSURE TO ARM. OVER NEXT 30-45 DAYS, EXPERIENCED SOME LOSS IN RANGE OF MOTION. IN LAST 2 WEEKS, PAIN PROGRESSED AND RANGE OF MOTION DECREASED MORE. WAS SEEN AND DIAGNOSED WITH BURSITIS. GIVEN A COURSE OF STEROID BLAST AND PAIN MEDICATION. WILL FOLLOW UP WITH DOCTOR PENDING RESULTS.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills, headache, back ache, tiredness. The fever and chills lasted about 12 hours, the headache, backache and tiredness lasted 36 hours and were relieved with Ibuprofen.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric/Adolescent Hep A (HAVRIX) dose given. Adult dose should have been given. Pt to return to health dept. in 1-2 mths to receive a 2nd dose of Pediatric/Adolescent Hep A (HAVRIX) to complete the series. Pt. will not be charged for this visit. Pt. verbalizes understanding & will make appt.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects known at this time.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Patient was at the pharmacy. She received both a SHINGRIX (left deltoid) and a FLUZONE in the right shoulder. She was evaluated on 2-18-19 for increasing pain. She has had decreased ROM and pain since the injection on 9-25-18.
Age: 1.08
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash macular, Urticaria
Clinical narrative: Mother states on day 4 following the vaccines patient developed "welts/skin blotches/ hives all over his body" not aware of any fever or chills at that time. The parents did not seek any medical treatment, and this lasted for 3-4 days. Patient recovered from this episode.
Sex: U
Vaccine: HPVX
Symptoms: No adverse event
Clinical narrative: Information has been received from the authors in a published literature article. This case concerns to 14 adult patients (10 males and 4 females). The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unspecified date, 4 unspecified patients were vaccinated with GARDASIL (dose, frequency, route, lot# and expiration date were not provided), and 10 unspecified patients were vaccinated with GARDASIL 9 (dose, frequency, route, lot# and expiration date were not provided), for recurrent respiratory papillomatosis (RRP). Two unspecified patients, received the first dose of GARDASIL but had not complete the series. There were no reported side effects due to vaccination. A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 2 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 11-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were not reported) at an unspecified location out of state, for prophylaxis (wrong product administered). No adverse effect reported.
Sex: M
Vaccine: MMR
Symptoms: Product use in unapproved indication
Clinical narrative: This literature marketed report has been received from the authors of a published literature article and refers to a healthy 10-year-old boy presented with verrucae on both hands and his right elbow. Several rounds of debulking followed by cryotherapy were initially attempted. Because of unsatisfactory improvement after 13 months, topical salicylic acid and imiquimod were trialed for three months but failed. On an unknown date, the patient and his parents elected for a single intralesional injection of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, lot # and expiration date were not reported) into the two largest warts on his hand. The patient was previously vaccinated against measles, mumps, and rubella (MMR) but not Human Papilloma Virus (HPV). Four weeks after the single treatment, the injected warts demonstrated involution. Four months later, all treated warts as well as untreated warts demonstrated complete involution without recurrence.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: This spontaneous report was received from the physician via Pfizer refers to a female patient of unknown age. The patient's medical history included prevnar 13 injection in 2015. The patient's concurrent conditions and concomitant therapy was not reported. On 12-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 in the left deltoid (dosing details, route, lot # and expiration date were not reported) for prophylaxis. On 12-JUN-2018, the patient experienced cellulitis post injection (cellulitis) and on an unknown date in 2018, the patient experienced significant swelling at the injection site (injection site swelling). The patient was prescribed with bactrim DS 800/160mg every 12 hours as a treatment for the events, but it did not respond. On 16-JUN-2018, patient was hospitalized, and the patient's discharge date was unknown. The patient's sought medical attention. Outcome of cellulitis was reported as recovered completely and outcome of injection site swelling was unknown. The reporter considered cellulitis to be related to PNEUMOVAX 23 and the causality assessment for the event injection site swelling was not reported. Upon internal review the event of "cellulitis" was determined to be medically significant.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling hot, Injected limb mobility decreased
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (around 15 to 16 years of age). Previously administered products included ZOSTAVAX (received around September 2017). On 9th February 2019, the patient received the 1st dose of SHINGRIX. On 9th February 2019, 4 hrs after receiving SHINGRIX, the patient experienced injection site swelling, shivering, feeling hot, pain in arm and malaise. On 10th February 2019, the patient experienced activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy. In February 2019, the patient experienced limbs stiffness. On an unknown date, the outcome of the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy were recovering/resolving and the outcome of the limbs stiffness was unknown. It was unknown if the reporter considered the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased, loss of energy and limbs stiffness to be related to SHINGRIX. Additional details were provided as follows: The patient never received chicken pox vaccine. On Friday around 2 pm, the patient received 1st dose of SHINGRIX on an unknown arm as recommended by physician. Six hours after receiving SHINGRIX, the patient experienced Shivering, feeling feverish and malaise. One day after receiving SHINGRIX, the patient was unable to perform normal functions (basically lay on the couch all day and evening) all day, experienced muscle weakness which led slow response to move legs to walk, extreme fatigue, extreme malaise, Pain (unable to lift injected arm above shoulder level as it was very painful to try to lift it) and no energy. The appetite of patient was normal. On 11th February 2019, the patient's condition was pretty much back to normal, injected arm still stiff, minimal pain raising arm fully up (which was unable to do yesterday). The patient asked are adverse events more pronounced or serious to response to 2nd shot or attenuated. Clarification raised to clarify discrepancy about GSK receipt date.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Malaise, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (around 15 to 16 years of age). Previously administered products included ZOSTAVAX (received around September 2017). On 9th February 2019, the patient received the 1st dose of SHINGRIX. On 9th February 2019, 4 hrs after receiving SHINGRIX, the patient experienced injection site swelling, shivering, feeling hot, pain in arm and malaise. On 10th February 2019, the patient experienced activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy. In February 2019, the patient experienced limbs stiffness. On an unknown date, the outcome of the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased and loss of energy were recovering/resolving and the outcome of the limbs stiffness was unknown. It was unknown if the reporter considered the injection site swelling, shivering, feeling hot, pain in arm, malaise, activities of daily living impaired, muscle weakness, slow response to stimuli, fatigue, injected limb mobility decreased, loss of energy and limbs stiffness to be related to SHINGRIX. Additional details were provided as follows: The patient never received chicken pox vaccine. On Friday around 2 pm, the patient received 1st dose of SHINGRIX on an unknown arm as recommended by physician. Six hours after receiving SHINGRIX, the patient experienced Shivering, feeling feverish and malaise. One day after receiving SHINGRIX, the patient was unable to perform normal functions (basically lay on the couch all day and evening) all day, experienced muscle weakness which led slow response to move legs to walk, extreme fatigue, extreme malaise, Pain (unable to lift injected arm above shoulder level as it was very painful to try to lift it) and no energy. The appetite of patient was normal. On 11th February 2019, the patient's condition was pretty much back to normal, injected arm still stiff, minimal pain raising arm fully up (which was unable to do yesterday). The patient asked are adverse events more pronounced or serious to response to 2nd shot or attenuated. Clarification raised to clarify discrepancy about GSK receipt date.