chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown patient (age and gender was not reported) who received only the diluent portion of ACTHIB, but not the Lypholized Powder portion of ACTHIB of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to inappropriate reconstitution technique. It was reported the patient only received diluent portion of ACTHIB (lot number of diluent: UU6110AA Expiry date: 21-Jan-2020) but not the powder portion of ACTHIB (Lot number of powder: UI945AA, Expiry date 01-Dec-2018). It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: She reports that her arm became itchy, swollen, red, and hot from around the injection site down to her elbow within a day of receiving the injection, peaking at around 3-5 days after the dose, lasting about 10 days. It was painful enough at the peak to interfere with her daily activities. She took BENADRYL because she believed it might be an allergic reaction and to reduce the itching.  This helped a little, but not very much. As of now, she reports that the injection site is still itchy, red, and tender.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: She reports that her arm became itchy, swollen, red, and hot from around the injection site down to her elbow within a day of receiving the injection, peaking at around 3-5 days after the dose, lasting about 10 days. It was painful enough at the peak to interfere with her daily activities. She took BENADRYL because she believed it might be an allergic reaction and to reduce the itching.  This helped a little, but not very much. As of now, she reports that the injection site is still itchy, red, and tender.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves a two months old male patient who was vaccinated with a 0.5 ml dose of PENTACEL lot number Liquid: expiry date: -U6138AB; expiry date: 30-Jun-2020 and powder: Lot U1952AB and expiry date 30-Jun-2020.; Carton: Lot U1952ABA and expiry date: 30-Jun-2020 in the right thigh on 15-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR administered in the left thigh and ROTATEQ via oral route for Immunisation. It was a case of an actual medication error due to inappropriate reconstitution technique. It was reported that the patient was administered the Liquid DTAP-IPV portion and didn't give/mix it with the Lypholized Powder ActHIB portion. It was not reported whether the patient experienced any adverse effects following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 24 months old patient of an unknown gender who received ActHib portion of PENTACEL without the diluent of the DTap/IPV (lot number, expiry date, dose, dose in series, route and site of administration not reported) on 12-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. Caller stated that one of the nurses gave the ACTHIB portion of PENTACEL and did not give the IPV portion of it. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Dyspnoea, Headache, Injection site pain, Neck pain
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 75 years old female patient who experienced issue with breathing as well. She finds she is very easily SOB with conversations, pain in left shoulder, unsteady on feet with HA, pain down left arm and neck pain, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, concomitant medication and family history were not provided. It was reported that on an unknown date, one month ago, the patient received a 0.5ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious issue with breathing as well. She finds she is very easily SOB with conversations with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious pain in left shoulder with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious unsteady on feet with HA with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious pain down left arm with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious neck pain with unknown latency following the administration of INFLUENZA VACCINE. The patient had no chest pain, does not hurt to take deep breath. Lab data was not provided. Final diagnosis was neck pain, pain down left arm, unsteady on feet with HA, pain in left shoulder and issue with breathing as well. She finds she is very easily SOB with conversations. The patient was treated with PREDNISONE taper. The patient outcome is reported as Recovering / Resolving for pain in left shoulder, as Recovering / Resolving for pain down left arm, as Recovering / Resolving for unsteady on feet with HA, as Recovering / Resolving for issue with breathing as well. She finds she is very easily SOB with conversations and as Recovering / Resolving for neck pain. Reported about 80 percent improvement in symptoms. List of documents held by sender- none.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 75 years old female patient who experienced issue with breathing as well. She finds she is very easily SOB with conversations, pain in left shoulder, unsteady on feet with HA, pain down left arm and neck pain, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, concomitant medication and family history were not provided. It was reported that on an unknown date, one month ago, the patient received a 0.5ml dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious issue with breathing as well. She finds she is very easily SOB with conversations with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious pain in left shoulder with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious unsteady on feet with HA with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious pain down left arm with unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, the patient developed a non-serious neck pain with unknown latency following the administration of INFLUENZA VACCINE. The patient had no chest pain, does not hurt to take deep breath. Lab data was not provided. Final diagnosis was neck pain, pain down left arm, unsteady on feet with HA, pain in left shoulder and issue with breathing as well. She finds she is very easily SOB with conversations. The patient was treated with PREDNISONE taper. The patient outcome is reported as Recovering / Resolving for pain in left shoulder, as Recovering / Resolving for pain down left arm, as Recovering / Resolving for unsteady on feet with HA, as Recovering / Resolving for issue with breathing as well. She finds she is very easily SOB with conversations and as Recovering / Resolving for neck pain. Reported about 80 percent improvement in symptoms. List of documents held by sender- none.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: Patient complained of experiencing severe vomitting, darrhea, headache, nausea, aches and pains, dizziness and dehydration. All symptoms began on tuesday night (night of vaccination). Patient went to the hospital and was treated for dehydration and was released.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: Patient complained of experiencing severe vomitting, darrhea, headache, nausea, aches and pains, dizziness and dehydration. All symptoms began on tuesday night (night of vaccination). Patient went to the hospital and was treated for dehydration and was released.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Malaise
Clinical narrative: Pt called next am and  complained of severe dizziness. I discussed with patient about purchasing OTC meclizine. She did so and in speaking with her later in the day she was doing much better. I spoke again with her on 12/24 and she said she was "almost well".
Age: 33.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Vaccination administered instead of AFLURIA (flu vaccine), no side effects reported yet.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: The patient complained that she had fever and chills the night of the administration on 12/19/18. She stated she felt "ill" all of Wednesday 12/20/2018 and could not get out of bed. The following day she was fine on 12/21/18. She has had no further complaints/problems. The patient stated she had trouble with the first dose in the series as well. She had stated she felt very poorly the next day after immunization and also had a red like rash lower on the left arm than where the injection site was on her first dose. She stated she did not have the rash with the second dose.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Sepsis, Vaccination complication
Clinical narrative: Daughter stated that she had to take her mother to the ER 4 hours after receiving the injection. She was admitted to the hospital for sepsis. According to the daughter the doctor said that the vaccine contributed to the onset of sepsis.
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: PATIENT FAINTED AFTER GETTING VACCINE. SHE WAS THE SECOND MEMBER OF HER FAMILY OF 3 GETTING SHOTS  IN THE PHARMACY. SHE WAS CONCIOUS AND ALERT BUT SITTING ON FLOOR AFTER THE RPh WAS ALERTED. REMAINED CONSIOUS AND ALERT WHILE I TOOK HER B/P WHICH WAS 97/87. CALLED 911 AND WAITED WITH PT AND FAMILY UNTIL THEY ARRIVED. SPOKE TO MOM BY PHONE 5PM. SHE WAS DISCHARGED BY PARAMEDICS WITH DIAGNOSIS VASOVAGAL SYNCOPE.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Gait disturbance, Hyperhidrosis, Peripheral swelling
Clinical narrative: Patient experienced swollen red arm for about 24 hours....dizziness for about 3 to 4 days, not to point of fainting...sweating per Dr. office but not from patient...imbalance gait...saw doctor about 12/10/2018...patient is feeling much better.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hypersomnia, Influenza, Injected limb mobility decreased
Clinical narrative: Patient reported these symptoms to pharmacist (myself) on 12/19/18. He stated that he had left arm pain the night he received the vaccine. Patient stated he could not lift his arm and his pain level was about an 8-10 on a scale from 1-10. Saturday morning (12/15/18) patient stated he felt "okay" then had strong flu symptoms, joint pain, and fatigue. He slept most of Saturday and then Sunday (12/16/18) he started to fell better again. On Monday (12/17/18) he noticed red bumps on his neck and applied cortisone cream. As of 12/19/18 he was feeling better just had the red bumps on his neck.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Patient reported these symptoms to pharmacist (myself) on 12/19/18. He stated that he had left arm pain the night he received the vaccine. Patient stated he could not lift his arm and his pain level was about an 8-10 on a scale from 1-10. Saturday morning (12/15/18) patient stated he felt "okay" then had strong flu symptoms, joint pain, and fatigue. He slept most of Saturday and then Sunday (12/16/18) he started to fell better again. On Monday (12/17/18) he noticed red bumps on his neck and applied cortisone cream. As of 12/19/18 he was feeling better just had the red bumps on his neck.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Pts mom came in and showed me picture of childs arm. Arm looked red and enflamed in the area of shot. I explained to mom to keep it iced down and take tylenol. If it got worse or more painful to see dr.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Fatigue, Flatulence, Headache
Clinical narrative: Very red and swollen at injection site, hurts and also itches. Upset stomach, gas, stomach pain, muscle pain in sides and back, general body ache, headache, and feeling very tired
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Very red and swollen at injection site, hurts and also itches. Upset stomach, gas, stomach pain, muscle pain in sides and back, general body ache, headache, and feeling very tired
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Very red and swollen at injection site, hurts and also itches. Upset stomach, gas, stomach pain, muscle pain in sides and back, general body ache, headache, and feeling very tired
Age: 26.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erysipelas, Injection site reaction
Clinical narrative: Erysipelas - left upper arm below injection site. Began as a few spots 12/21/18, worsened 12/22/18.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: I have never before in my life had pain or disability in the left shoulder. The pharmacist jabbed the needle into the top of my left shoulder into my rotor cuff muscle. Within 30 minutes I began to  experience acute continuous pain in the shoulder, which became frozen. Two weeks later my left shoulder still hurt acutely and continuously and I had very limited range of motion. I phoned the pharmacy to complain and I was treated dismissively. I saw Dr. on 11/8/2018 and 12/3/2018. Today, 12/25/2018, I experience a stab of acute pain maybe once an hour; at night I experience a low-level ache; and I have regained about 50% of my range of motion in my left shoulder. NDC#: 58160082311 Brand and Generic Indicator: B Drug Name: SHINGRIX Drug Strength: 50 MCG/0.5 I am absolutely disgusted that a pharmacist doesn't know how to correctly give a shot, and thinks that it's OK to jab a needle into the top of the shoulder into the rotor cuff muscle. The needle obviously damaged my rotor cuff muscle and the vaccine was probably dispensed into the bursa fluid of the shoulder to cause instant acute bursitis. I am never getting another drug store vaccination.  Pharmacy corporate HQ needs to order an in-house teaching session on how to correctly give a shot.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Periarthritis, Product administered at inappropriate site
Clinical narrative: I have never before in my life had pain or disability in the left shoulder. The pharmacist jabbed the needle into the top of my left shoulder into my rotor cuff muscle. Within 30 minutes I began to  experience acute continuous pain in the shoulder, which became frozen. Two weeks later my left shoulder still hurt acutely and continuously and I had very limited range of motion. I phoned the pharmacy to complain and I was treated dismissively. I saw Dr. on 11/8/2018 and 12/3/2018. Today, 12/25/2018, I experience a stab of acute pain maybe once an hour; at night I experience a low-level ache; and I have regained about 50% of my range of motion in my left shoulder. NDC#: 58160082311 Brand and Generic Indicator: B Drug Name: SHINGRIX Drug Strength: 50 MCG/0.5 I am absolutely disgusted that a pharmacist doesn't know how to correctly give a shot, and thinks that it's OK to jab a needle into the top of the shoulder into the rotor cuff muscle. The needle obviously damaged my rotor cuff muscle and the vaccine was probably dispensed into the bursa fluid of the shoulder to cause instant acute bursitis. I am never getting another drug store vaccination.  Pharmacy corporate HQ needs to order an in-house teaching session on how to correctly give a shot.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rotator cuff syndrome
Clinical narrative: I have never before in my life had pain or disability in the left shoulder. The pharmacist jabbed the needle into the top of my left shoulder into my rotor cuff muscle. Within 30 minutes I began to  experience acute continuous pain in the shoulder, which became frozen. Two weeks later my left shoulder still hurt acutely and continuously and I had very limited range of motion. I phoned the pharmacy to complain and I was treated dismissively. I saw Dr. on 11/8/2018 and 12/3/2018. Today, 12/25/2018, I experience a stab of acute pain maybe once an hour; at night I experience a low-level ache; and I have regained about 50% of my range of motion in my left shoulder. NDC#: 58160082311 Brand and Generic Indicator: B Drug Name: SHINGRIX Drug Strength: 50 MCG/0.5 I am absolutely disgusted that a pharmacist doesn't know how to correctly give a shot, and thinks that it's OK to jab a needle into the top of the shoulder into the rotor cuff muscle. The needle obviously damaged my rotor cuff muscle and the vaccine was probably dispensed into the bursa fluid of the shoulder to cause instant acute bursitis. I am never getting another drug store vaccination.  Pharmacy corporate HQ needs to order an in-house teaching session on how to correctly give a shot.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: Shivers and body aches. Soreness at site of vaccination.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain at site immediately after vaccine, pain with movement. Two days later redness and swelling developed at site and approximately 5 cm surrounding site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Muscle ache, headache, chills, pain at site of injection.
Age: 71.0
Sex: F
Vaccine: DT
Symptoms: Asthenia, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Weakness, fever, Swelling and redness in the area of the injection with itching . All this happened the day after the vaccine until now and all still there.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Headache, Mobility decreased, Pain, Pain in extremity
Clinical narrative: One-half hour after receiving my 2nd Zoster (SHINGRIX) injection, I experienced: intense pain throughout my entire body #9 on a 10 point scale - much more severe than I've ever had with severe flu - #4 on a 10 point scale, a severe headache - as bad as my worst migraine - #9.5 on a 10 point scale, I was unable to move, lay on, lift even a glass of water and/or reach out more than 25 degrees from the side of my body. I was either very hot or very cold but never ran a fever. The only thing I consumed for 3 days was flat Seven-Up. It took 24 hrs to consume 12 ounces, I was, and still am, experiencing intense pain when trying to pull on underwear or slacks, when raising my right arm to put on a pull-over sweater, and when rotating my right arm like when wiping after urinating. While the intense pain in my whole body and severe headache settled down in 24 hours but did not completely go away, my right arm continues to experience intense pain in the situations explained above. I'm very concerned since my injection was on November 7, 2018 and my right arm is still in the same amount of pain to date, December 25, 2018.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight bearing difficulty
Clinical narrative: One-half hour after receiving my 2nd Zoster (SHINGRIX) injection, I experienced: intense pain throughout my entire body #9 on a 10 point scale - much more severe than I've ever had with severe flu - #4 on a 10 point scale, a severe headache - as bad as my worst migraine - #9.5 on a 10 point scale, I was unable to move, lay on, lift even a glass of water and/or reach out more than 25 degrees from the side of my body. I was either very hot or very cold but never ran a fever. The only thing I consumed for 3 days was flat Seven-Up. It took 24 hrs to consume 12 ounces, I was, and still am, experiencing intense pain when trying to pull on underwear or slacks, when raising my right arm to put on a pull-over sweater, and when rotating my right arm like when wiping after urinating. While the intense pain in my whole body and severe headache settled down in 24 hours but did not completely go away, my right arm continues to experience intense pain in the situations explained above. I'm very concerned since my injection was on November 7, 2018 and my right arm is still in the same amount of pain to date, December 25, 2018.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Balance disorder, Dizziness, Fall, Feeling abnormal, Loss of consciousness
Clinical narrative: This report was identified from a form obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 710085). This spontaneous report as received from a physician refers to a 12 year old male patient. On 28-AUG-2017 at 15:30,  the patient was vaccinated with GARDASIL 9 lot # n010497 dose 1, intramuscular in the right arm for prophylaxis. On 28-AUG-2017, approximately 5 minutes after receiving the vaccine, the patient tried to stand up, his mother noticed that he looked unsteady, he started to fall and his mother caught him. He had a few seconds of twitching, and seemed to pass out. He was conscious after a few seconds. He seemed dazed, but was responsive and oriented. Vital signs were normal. The patient had some juice, crackers and water, and was monitored in clinic for 20 more minutes, then he felt fine. The outcome of loss of consciousness, fall, muscle twitching, feeling abnormal and balance disorder was reported as recovered/resolved. Causality relationship between the events and GARDASIL 9 was not reported. Follow-up information was received from the physician on 20-DEC-2018. The patient's age was reported as 13 years. The patient had no illness at the time of vaccination. The patient had no pre-existing physician diagnosed allergies, birth defects and medical conditions. Vaccination administration information was updated. Within 5 minutes after receiving GARDASIL 9, the patient stood up, felt lightheaded. The patient had also experienced syncope. On 28-AUG-2017, the event syncope, Muscle twitching and Dizziness recovered. The events syncope and Muscle twitching lasted less than one minute. The event dizziness lasted 2-3 minutes. Causality of the events was not reported. Upon internal review, the event syncope was determined to be medically significant.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle twitching, Syncope
Clinical narrative: This report was identified from a form obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 710085). This spontaneous report as received from a physician refers to a 12 year old male patient. On 28-AUG-2017 at 15:30,  the patient was vaccinated with GARDASIL 9 lot # n010497 dose 1, intramuscular in the right arm for prophylaxis. On 28-AUG-2017, approximately 5 minutes after receiving the vaccine, the patient tried to stand up, his mother noticed that he looked unsteady, he started to fall and his mother caught him. He had a few seconds of twitching, and seemed to pass out. He was conscious after a few seconds. He seemed dazed, but was responsive and oriented. Vital signs were normal. The patient had some juice, crackers and water, and was monitored in clinic for 20 more minutes, then he felt fine. The outcome of loss of consciousness, fall, muscle twitching, feeling abnormal and balance disorder was reported as recovered/resolved. Causality relationship between the events and GARDASIL 9 was not reported. Follow-up information was received from the physician on 20-DEC-2018. The patient's age was reported as 13 years. The patient had no illness at the time of vaccination. The patient had no pre-existing physician diagnosed allergies, birth defects and medical conditions. Vaccination administration information was updated. Within 5 minutes after receiving GARDASIL 9, the patient stood up, felt lightheaded. The patient had also experienced syncope. On 28-AUG-2017, the event syncope, Muscle twitching and Dizziness recovered. The events syncope and Muscle twitching lasted less than one minute. The event dizziness lasted 2-3 minutes. Causality of the events was not reported. Upon internal review, the event syncope was determined to be medically significant.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Muscular weakness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency # 712530). This spontaneous report was received from a regulatory authority and refers to a 11 year old non-pregnant female patient. The patient had no concurrent conditions or medical history. On 29-OCT-2016, the patient was vaccinated with GARDASIL 9 (lot # L037554) intramuscularly in the left arm for prophylaxis. Other medications and prior vaccinations were not reported. On 01-NOV-2016, the patient experienced bilateral leg weakness and general fatigue onset 3 days after vaccine was administered. The outcome of fatigue and muscular weakness was reported as resolved. Causality assessment was not reported. Follow-up information was received from a healthcare professional on 05-NOV-2018. Details regarding vaccination were provided. The patient had no allergies to medications, food or other products. The patient did not take any prescriptions, over-the-counter medications, dietary supplements or herbal remedies at the time of vaccination. The patient had no other illnesses at the time of the vaccination and up to one month prior. The patient had no long-standing or chronic health conditions.
Age: 79.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Blood sodium decreased
Clinical narrative: In past 2 weeks since the vaccination, I felt weak and dizzy, did not feel like eating and just wanted to go to bed to sleep. I also felt very cold. I fall down a few times in the bathroom, each time I no longer had the strength to get up on my own. I was unable to stand up. My wife and daughter told me I was responding slower than  normal. I was admitted to the Medical Center on 2/26/2018. I was told the blood test showed extremely low sodium level in my blood. Intravenous infusion of sodium chloride was applied to my blood stream. I gradually regain my strength and was discharged on 3/1/2018 at 4:30 PM.
Age: 79.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Asthenia, Blood sodium decreased, Decreased appetite, Dizziness, Dysstasia
Clinical narrative: In past 2 weeks since the vaccination, I felt weak and dizzy, did not feel like eating and just wanted to go to bed to sleep. I also felt very cold. I fall down a few times in the bathroom, each time I no longer had the strength to get up on my own. I was unable to stand up. My wife and daughter told me I was responding slower than  normal. I was admitted to the Medical Center on 2/26/2018. I was told the blood test showed extremely low sodium level in my blood. Intravenous infusion of sodium chloride was applied to my blood stream. I gradually regain my strength and was discharged on 3/1/2018 at 4:30 PM.
Age: 79.0
Sex: M
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Fall, Feeling cold, Slow response to stimuli, Somnolence
Clinical narrative: In past 2 weeks since the vaccination, I felt weak and dizzy, did not feel like eating and just wanted to go to bed to sleep. I also felt very cold. I fall down a few times in the bathroom, each time I no longer had the strength to get up on my own. I was unable to stand up. My wife and daughter told me I was responding slower than  normal. I was admitted to the Medical Center on 2/26/2018. I was told the blood test showed extremely low sodium level in my blood. Intravenous infusion of sodium chloride was applied to my blood stream. I gradually regain my strength and was discharged on 3/1/2018 at 4:30 PM.
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Face injury, Fall, Feeling cold, Hyperhidrosis, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of immunocompromised in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and BOOSTRIX, the patient experienced immunocompromised (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the immunocompromised was unknown. It was unknown if the reporter considered the immunocompromised to be related to SHINGRIX and BOOSTRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a SHINGRIX and BOOSTRIX vaccine resulting in hospitalization due to being immunocompromised.
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a consumer and described the occurrence of immunocompromised in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and BOOSTRIX, the patient experienced immunocompromised (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the immunocompromised was unknown. It was unknown if the reporter considered the immunocompromised to be related to SHINGRIX and BOOSTRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a SHINGRIX and BOOSTRIX vaccine resulting in hospitalization due to being immunocompromised.
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Immunodeficiency
Clinical narrative: This case was reported by a consumer and described the occurrence of immunocompromised in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose and BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX and BOOSTRIX, the patient experienced immunocompromised (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the immunocompromised was unknown. It was unknown if the reporter considered the immunocompromised to be related to SHINGRIX and BOOSTRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a SHINGRIX and BOOSTRIX vaccine resulting in hospitalization due to being immunocompromised.
Age: 45.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: This is another patient who is a 45-year-old male with a left arm a site reaction. No fever no chills. 1/10 pain. Worse when touch. Noticed this approximately 3 days after injection. He has never had any drainage from it. Denies fever or chills. Ultrasound left arm. Incision and debridement of abscess cavity. Cultures obtained. Irrigated and packed with gauze.
Age: 45.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Abscess, Culture, Debridement, Fungal test, Gram stain negative
Clinical narrative: This is another patient who is a 45-year-old male with a left arm a site reaction. No fever no chills. 1/10 pain. Worse when touch. Noticed this approximately 3 days after injection. He has never had any drainage from it. Denies fever or chills. Ultrasound left arm. Incision and debridement of abscess cavity. Cultures obtained. Irrigated and packed with gauze.
Age: 45.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Injection site pain, Mycobacterium test negative, Ultrasound scan, Wound treatment
Clinical narrative: This is another patient who is a 45-year-old male with a left arm a site reaction. No fever no chills. 1/10 pain. Worse when touch. Noticed this approximately 3 days after injection. He has never had any drainage from it. Denies fever or chills. Ultrasound left arm. Incision and debridement of abscess cavity. Cultures obtained. Irrigated and packed with gauze.
Age: 36.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Patient states he had a hepatitis A injection in the right upper extremity on 10/3/18. At the site of injection, the area on the proximal right arm on the skin overlying the deltoid muscle, he noticed erythema. States also that the area has drained intermittently. Reports the drainage was yellow/green pus last week. Denies any improvement in the lesion. Denies ever having a reaction like this before. Rates pain 1/10. Denies fever, sweats, chills. Ultrasound Rt. arm. I&D. Obtained cultures. Irrigated copiously and packed with gauze.
Age: 36.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Culture, Fungal test, Incisional drainage, Injection site discharge, Injection site erythema
Clinical narrative: Patient states he had a hepatitis A injection in the right upper extremity on 10/3/18. At the site of injection, the area on the proximal right arm on the skin overlying the deltoid muscle, he noticed erythema. States also that the area has drained intermittently. Reports the drainage was yellow/green pus last week. Denies any improvement in the lesion. Denies ever having a reaction like this before. Rates pain 1/10. Denies fever, sweats, chills. Ultrasound Rt. arm. I&D. Obtained cultures. Irrigated copiously and packed with gauze.
Age: 36.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Injection site pustule, Mycobacterium test, Ultrasound scan, Wound treatment
Clinical narrative: Patient states he had a hepatitis A injection in the right upper extremity on 10/3/18. At the site of injection, the area on the proximal right arm on the skin overlying the deltoid muscle, he noticed erythema. States also that the area has drained intermittently. Reports the drainage was yellow/green pus last week. Denies any improvement in the lesion. Denies ever having a reaction like this before. Rates pain 1/10. Denies fever, sweats, chills. Ultrasound Rt. arm. I&D. Obtained cultures. Irrigated copiously and packed with gauze.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Patient states she received hepatitis A injection in her right upper extremity on 10/3/18. Patient states the site where she was injected on the skin overlying her right deltoid muscle has become erythematous and painful. Rates pain 7/10. States pain is worse with palpation. Denies drainage, fever, sweats, chills, nausea, vomiting. Denies ever having reaction like this before. Incision and Debridement of abscess cavity with cultures, then packed with gauze.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Candida test, Culture, Fungal test, Gram stain, Incisional drainage
Clinical narrative: Patient states she received hepatitis A injection in her right upper extremity on 10/3/18. Patient states the site where she was injected on the skin overlying her right deltoid muscle has become erythematous and painful. Rates pain 7/10. States pain is worse with palpation. Denies drainage, fever, sweats, chills, nausea, vomiting. Denies ever having reaction like this before. Incision and Debridement of abscess cavity with cultures, then packed with gauze.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mycobacterium test
Clinical narrative: Patient states she received hepatitis A injection in her right upper extremity on 10/3/18. Patient states the site where she was injected on the skin overlying her right deltoid muscle has become erythematous and painful. Rates pain 7/10. States pain is worse with palpation. Denies drainage, fever, sweats, chills, nausea, vomiting. Denies ever having reaction like this before. Incision and Debridement of abscess cavity with cultures, then packed with gauze.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Abscess, Culture, Debridement, Fungal test, Injection site erythema
Clinical narrative: Patient states she received hepatitis A injection in her right upper extremity on 10/3/18. Patient states the site where she was injected on the skin overlying her right deltoid muscle has become erythematous and painful. Rates pain 7/10. States pain is worse with palpation. Denies drainage, fever, sweats, chills, nausea, vomiting. Denies ever having reaction like this before. Incision and Debridement of abscess cavity with cultures, then packed with gauze.
Age: 37.0
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site pain, Mycobacterium test, Wound treatment
Clinical narrative: Patient states she received hepatitis A injection in her right upper extremity on 10/3/18. Patient states the site where she was injected on the skin overlying her right deltoid muscle has become erythematous and painful. Rates pain 7/10. States pain is worse with palpation. Denies drainage, fever, sweats, chills, nausea, vomiting. Denies ever having reaction like this before. Incision and Debridement of abscess cavity with cultures, then packed with gauze.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Feeling abnormal, Fluid retention, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from an unspecified reporter via a vendor, this information was from website, concerning a 67-year-old-male-patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was a former bodybuilder. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) intramuscular injection for prophylaxis (dose, strength, lot # and expiration date were not provided). On 19-DEC-2018 (reported as on Wednesday), the patient captioned a photo of himself and stated that he went in for a pneumonia shot and landed up here with fluid in his bicep on an unknown date, the patient also reported that he was hospitalized after the vaccine went wrong, and he experienced serious adverse event. Additionally, the patient received an unspecified intravenous treatment. He also claimed that the pneumonia vaccine was administered to him improperly (It was unclear which type of pneumonia vaccine). It was unknown the date of discharged from hospitalization. The outcome of "went wrong", "fluid in my bicep" was reported as recovering. The causality assessment between PNEUMOVAX 23, "went wrong" and "fluid in my bicep" was not provided. The reporter considered went wrong and fluid in my bicep to be medically significant events.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Injection site inflammation, Joint range of motion decreased, Myositis
Clinical narrative: This spontaneous report was received from an unspecified reporter via a vendor, this information was from website, concerning a 67-year-old-male-patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was a former bodybuilder. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) intramuscular injection for prophylaxis (dose, strength, lot # and expiration date were not provided). On 19-DEC-2018 (reported as on Wednesday), the patient captioned a photo of himself and stated that he went in for a pneumonia shot and landed up here with fluid in his bicep on an unknown date, the patient also reported that he was hospitalized after the vaccine went wrong, and he experienced serious adverse event. Additionally, the patient received an unspecified intravenous treatment. He also claimed that the pneumonia vaccine was administered to him improperly (It was unclear which type of pneumonia vaccine). It was unknown the date of discharged from hospitalization. The outcome of "went wrong", "fluid in my bicep" was reported as recovering. The causality assessment between PNEUMOVAX 23, "went wrong" and "fluid in my bicep" was not provided. The reporter considered went wrong and fluid in my bicep to be medically significant events.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema
Clinical narrative: This spontaneous report was received from an unspecified reporter via a vendor, this information was from website, concerning a 67-year-old-male-patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was a former bodybuilder. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) intramuscular injection for prophylaxis (dose, strength, lot # and expiration date were not provided). On 19-DEC-2018 (reported as on Wednesday), the patient captioned a photo of himself and stated that he went in for a pneumonia shot and landed up here with fluid in his bicep on an unknown date, the patient also reported that he was hospitalized after the vaccine went wrong, and he experienced serious adverse event. Additionally, the patient received an unspecified intravenous treatment. He also claimed that the pneumonia vaccine was administered to him improperly (It was unclear which type of pneumonia vaccine). It was unknown the date of discharged from hospitalization. The outcome of "went wrong", "fluid in my bicep" was reported as recovering. The causality assessment between PNEUMOVAX 23, "went wrong" and "fluid in my bicep" was not provided. The reporter considered went wrong and fluid in my bicep to be medically significant events.
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema, Vaccination complication, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from an unspecified reporter via a vendor, this information was from website, concerning a 67-year-old-male-patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was a former bodybuilder. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) intramuscular injection for prophylaxis (dose, strength, lot # and expiration date were not provided). On 19-DEC-2018 (reported as on Wednesday), the patient captioned a photo of himself and stated that he went in for a pneumonia shot and landed up here with fluid in his bicep on an unknown date, the patient also reported that he was hospitalized after the vaccine went wrong, and he experienced serious adverse event. Additionally, the patient received an unspecified intravenous treatment. He also claimed that the pneumonia vaccine was administered to him improperly (It was unclear which type of pneumonia vaccine). It was unknown the date of discharged from hospitalization. The outcome of "went wrong", "fluid in my bicep" was reported as recovering. The causality assessment between PNEUMOVAX 23, "went wrong" and "fluid in my bicep" was not provided. The reporter considered went wrong and fluid in my bicep to be medically significant events.
Age: 0.33
Sex: F
Vaccine: PNC13, RV5
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old infant, female patient. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were unknown. On 05-DEC-2018, the patient was vaccinated with ROTATEQ (Strength, dose and frequency were not reported) of lot # R002517 with an expiry date of September 2019, orally for vaccination. On the same day, the patient developed a temperature of 102.9 fahrenheit (F) (39.3 degree Celsius) with vomiting. The patient sought medical attention and was taken to an unspecified emergency department. The patient was treated with an unspecified TYLENOL and an unspecified ondansetron. The medical assistant reported that the patient was not admitted to the hospital. There were no lab diagnostics/studies performed. No product quality complaint was associated with this report. The outcome of the events of pyrexia and vomiting was reported to be recovered on 07-DEC-2018. The causality assessment was not provided.