chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dysstasia, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Headache, muscle and joint pain began sometime around 1am. It progressively got worse through the night. By morning around 10am Sunday, Sept. 23rd, I had severe headache, nausea, severe joint and muscle pain to the point I could not stand up. I had to lay down. It was so bad, I took a 1/2 of PERCOCET that I had left from my foot surgery in Dec. 2017. (Just for reference, I do not like taking prescription pain medicine. But I was desperate.) I also took a ZOFRAN to help me with the severe nausea. I ended up taking number 3 - 1/2 tablets of PERCOCET throughout the day. I was unable to do anything but use the restroom and laydown all day. This was the most pain I have experienced in years, if ever. Major foot surgery was not this painful. This pain encompassed my entire body. Some places on my skin hurt to touch but you could not see anything there. I was starting to feel some minor relief though that night while sleeping. The following morning I was feeling better but unable to go to work. I remained home all day. I did nothing but rested. Ibuprofen was sufficient now (800mg every 6 hours). I did work the following day, Tuesday, but still did not feel back to normal. I still have sore achy joints. The injection site is still very sore. I am assuming each day that passes, I will feel better. If I had not had my own pain and nausea medication, I would have been forced to go to the local Urgent Care.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain of skin
Clinical narrative: Headache, muscle and joint pain began sometime around 1am. It progressively got worse through the night. By morning around 10am Sunday, Sept. 23rd, I had severe headache, nausea, severe joint and muscle pain to the point I could not stand up. I had to lay down. It was so bad, I took a 1/2 of PERCOCET that I had left from my foot surgery in Dec. 2017. (Just for reference, I do not like taking prescription pain medicine. But I was desperate.) I also took a ZOFRAN to help me with the severe nausea. I ended up taking number 3 - 1/2 tablets of PERCOCET throughout the day. I was unable to do anything but use the restroom and laydown all day. This was the most pain I have experienced in years, if ever. Major foot surgery was not this painful. This pain encompassed my entire body. Some places on my skin hurt to touch but you could not see anything there. I was starting to feel some minor relief though that night while sleeping. The following morning I was feeling better but unable to go to work. I remained home all day. I did nothing but rested. Ibuprofen was sufficient now (800mg every 6 hours). I did work the following day, Tuesday, but still did not feel back to normal. I still have sore achy joints. The injection site is still very sore. I am assuming each day that passes, I will feel better. If I had not had my own pain and nausea medication, I would have been forced to go to the local Urgent Care.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: The day after the pt received the high dose flu shot (9/24) she noticed a grapefruit sized bump on her arm where she received the shot and was experiencing pain at the site. It was so bad that she woke up early 9/25 from the pain. She took some ADVIL to try to combat the pain and also confirmed that she did not have a fever.
Age: 70.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Musculoskeletal stiffness, Sleep disorder
Clinical narrative: PT EXPERIENCING NECK STIFFNESS ONE DAY AFTER RECEIVING HIS HIGH DOSE FLU SHOT. THE NECK STIFFNESS IS CAUSING SLEEP DISTURBANCE.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus generalised
Clinical narrative: Redness, swelling of arm. Itchness all over body.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal pain, Pain
Clinical narrative: Two days following the FLUZONE HIGH-DOSE 0.5ML I had serious intestinal cramping (never had anything like this in the past), had to leave my game of golf and drive home where I had explosive diarrhea with cramping throughout the day. The pain and diarrhea continued into the next day.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient did not suffer any adverse reactions. MENACTRA was given on 9/24/18. The patient was not due for a dose.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: 5-6 hrs after the shingles shot I developed severe headache and neck pain; muscle pain all over my body, high fever, chills, severe fatigue, unable to move and stayed in bed 36 hrs and felt weak for one week, soreness, redness, swelling at area of injection. I received new shingle shot at pharmacy care clinic on Sept 7, 18 and a few hrs later I developed severe headache, neck pain, muscle pain all over my body, weakness and spasm in lower legs high fever, chills, fatigue, soreness, redness, swelling in the area of injection. I did stay in bed for 36 hrs, unable to go bathroom or drink water or make a telephone call. On Sept 10th left the message for my primary care physician, I did not have problem with old shingle shot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms
Clinical narrative: 5-6 hrs after the shingles shot I developed severe headache and neck pain; muscle pain all over my body, high fever, chills, severe fatigue, unable to move and stayed in bed 36 hrs and felt weak for one week, soreness, redness, swelling at area of injection. I received new shingle shot at pharmacy care clinic on Sept 7, 18 and a few hrs later I developed severe headache, neck pain, muscle pain all over my body, weakness and spasm in lower legs high fever, chills, fatigue, soreness, redness, swelling in the area of injection. I did stay in bed for 36 hrs, unable to go bathroom or drink water or make a telephone call. On Sept 10th left the message for my primary care physician, I did not have problem with old shingle shot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: 5-6 hrs after the shingles shot I developed severe headache and neck pain; muscle pain all over my body, high fever, chills, severe fatigue, unable to move and stayed in bed 36 hrs and felt weak for one week, soreness, redness, swelling at area of injection. I received new shingle shot at pharmacy care clinic on Sept 7, 18 and a few hrs later I developed severe headache, neck pain, muscle pain all over my body, weakness and spasm in lower legs high fever, chills, fatigue, soreness, redness, swelling in the area of injection. I did stay in bed for 36 hrs, unable to go bathroom or drink water or make a telephone call. On Sept 10th left the message for my primary care physician, I did not have problem with old shingle shot.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, redness, and hotness around the area.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Differential white blood cell count normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Patient received abdominal pain, spine pain, stiffness, and weakness shortly after getting influenza vaccine. Patient requested a nitroglycerin tablet so pharmacy administered one to patient. Patient states she felt better after that but was still having weakness so was evaluated at the Hospital. Patient got cleared. Is feeling better today with no concerns.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Musculoskeletal stiffness, Spinal pain, Troponin normal
Clinical narrative: Patient received abdominal pain, spine pain, stiffness, and weakness shortly after getting influenza vaccine. Patient requested a nitroglycerin tablet so pharmacy administered one to patient. Patient states she felt better after that but was still having weakness so was evaluated at the Hospital. Patient got cleared. Is feeling better today with no concerns.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Swelling
Clinical narrative: Patient presents with mother due to On Saturday patient got his MCV and TDAP vaccines as per mom by the afternoon it was swollen patient started with fever mother took patient to Urgent Care. 11 yr old M presents to clinic for f/u after urgent care visit for adverse reaction TDAP and MCV vaccine. Pt was seen in clinic Sept 22 for 11 yr WCC, during that visit he received TDAP and Meningitis vaccine on the left arm via IM routes (Both vaccines on the same route, two different syringes and needles). Within 24 hours of getting the vaccine Mother reports patient developed redness, swelling, and warmth to the left arm where patient received the vaccine. Pt was seen in urgent care September 23 where he was diagnosed with a localized allergic vaccine reaction and family was recommended to use cool compress to the area and BENADRYL. On day of presentation Sept 24 patient reported less redness but endorsed swelling and warmth to the region. No pain per patient. Pt denied fever, chills, difficulty breathing, nausea, emesis or abdominal pain. No difficulty moving the arm. No discharge. 11 yr old M presents to clinic for left arm swelling, induration and erythema 2/2 adverse reaction to TDAP and Meningitis vaccine (unclear which vaccine as both vaccines given in same region). History and physical most consistent with localized allergic reaction-counseled mother to continue with ice packs to the area and BENADRYL prn. As area significantly red and indurated will treat for possible cellulitis with Cephalexin x 10 day course. If symptoms worsen informed mother to RTC or seek medical attention (red streaks, more swelling or redness, fever any discharge or pain to the area). History and physical not consistent with severe allergic reaction or anaphylaxis. Case discussed with employee at CDC who advised that this would be mild-moderate adverse reaction. Patient is not contraindicated to receive TDAP/Meningitis vaccine in the future.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site discolouration, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness and warm to touch on the same arm, with some hardening and some discoloration but not at the injection site (about 3 inches away from injection site). Discomfort relieved by TYLENOL taking the following day after the vaccine. Redness, warm, discoloration, and slight hardening still present on day two. Advised patient to see physician for evaluation.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Contusion, Erythema, Pyrexia, Rash, Secretion discharge
Clinical narrative: Intimidate rash then subsided after 20 minutes. Next day patient had fever of 102 all day and still had rash and two bruises. It appears one or both of the vaccines had some subcutaneous leakage that resulted in the redness.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient reported with red, itchy rash following vaccination (roughly 45 minutes). Patient given diphenhydramine and instructions to follow up with MD/hospital if symptoms persisted/worsened.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Malaise
Clinical narrative: A pink patch nearby the injection site (not at injection site). Patient felt ill 1 day after the vaccination. BENADRYL.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Electroencephalogram normal, Seizure
Clinical narrative: MMRV on 3/26/18 2 seizures back to back on 4/3/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site pain, Pain, Swelling
Clinical narrative: Patient received PROQUAD in (R) arm. Redness/swelling occurred same day and worse on (18) next day and painful at site. Next day (19th) redness increased but swelling improved and not c/o'ing of pain. On Thurs (19th) redness improving.
Age: 14.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Syncope
Clinical narrative: Patient was administered vaccine at approx. 9:00 AM within 3 minutes patient fainted. Patient was placed on the floor and within seconds gained consciousness. Emergency services were called to evaluate patient. They cleared patient and she left office with her mother.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at site. Pt c/o itching. Right site -> approx 5.5 cm round left site -> approx 2 cm round.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Fever, local red, warm to touch at site of injection and around arm - Tx ADVIL q 4-6hrs, Ice 20mins 2-3x dly: BENADRYL 25-50mg at HS; ZYRTEC AM.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site mass, Injection site swelling, Rash
Clinical narrative: Swelling on injection site to the size of baseball/softball with sensation of mass inside the injection site. Rash with fever on face, stomach. Approximately 15 places with bumps.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: Fever, severe chills, very nauseous, lower stomach pains, pain in arm from shoulder to elbow (couldn't use), exhausted, passed out. Had shot 10:20 in morning that day around 6 pm - 6:15 started feeling really bad. Next morning at 7:30 is when I passed out. Felt pain across the braline and stomach.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, severe chills, very nauseous, lower stomach pains, pain in arm from shoulder to elbow (couldn't use), exhausted, passed out. Had shot 10:20 in morning that day around 6 pm - 6:15 started feeling really bad. Next morning at 7:30 is when I passed out. Felt pain across the braline and stomach.
Age: 76.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pyrexia
Clinical narrative: 3 days after - felt bad, night had fever 101 - called Doc on call - Took TYLENOL. Broke out in mild shingles rash - Took Valacyclovir oral and cream. Rash gone in 2-3 days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pruritus, Rash
Clinical narrative: The patient received SHINGRIX. Patient just had soreness and redness at injection site. 5 days later 6 inch rash developed and increased itchiness.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema of eyelid, Eyelids pruritus
Clinical narrative: Patient received vaccination on Friday afternoon. Saturday morning the skin around her eyes was itchy and red. One week later she still has symptoms.
Age: 1.25
Sex: M
Vaccine: FLU4, HEP, HEPA, PNC13
Symptoms: Cough, Heart rate increased, Wheezing
Clinical narrative: Cough, wheeze, increased HR, observed x 1 hour, albuterol 4 puffs with resolution.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Dizziness immediately after vaccine was given.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chronic obstructive pulmonary disease, Dyspnoea, Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient reported sore arm - red and warm. COPD - mild SOB. "Feels sore".
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: His mother reports child passed out 2 hours after receiving the vaccination.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Rash
Clinical narrative: Rash back, neck, arms and groin w/fever. (Treatment) Loratadine 10 mg 1 tab daily; BENADRYL 25 mg. 1 cap at night #7.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injection site pain, Muscular weakness, Sensory loss
Clinical narrative: Pt reports that several hours following administration of the flu vaccine she noted decreased sensation in her right arm, from the base of her deltoid to her wrist. "Feels like my hand and arm are asleep". Has some mild injection site pain. No self tx last pm, noted symptoms had increased this am. Has FROM, decreased sensation, +2 radial pulses and mildly decreased hand strength compared to left. Given 400mg ibuprofen advised ice 15 minutes tid. F/U in ER if symptoms continue.
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine given, Hepatitis B was ordered.
Age: 99.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain, redness and swelling around the injection that involved all of the lateral aspect of the left upper arm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic shock, Dyspnoea, Nausea, Ocular hyperaemia, Throat tightness
Clinical narrative: Initial information regarding an unsolicited valid serious case received on 19-Sep-2018 from a consumer. This case involves a 56 years old female patient who experienced trouble breathing, anaphylaxis shock, eyes blood red and throat closed, nausea and vomiting while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, vaccination(s) and family history were not provided. It was also reported patient had allergy to eggs after the event and then later found out was not allergic to eggs. On 22-Sep-2009, the patient received a once dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE lot U3204AA, expiry date- 30-Jun-2010 via unknown route in the right arm. On an unknown date of 2009, patient developed a serious anaphylaxis shock (anaphylactic shock) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. On an unknown date, the patient developed a serious trouble breathing, eyes blood red and throat closed, nausea and vomiting following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. All the events were assessed as serious due to life threatening events. Consumer reported stayed in emergency room (ER) for 10 hours. Other relevant tests included no lab data. Final diagnosis was anaphylaxis shock, throat closed, eyes blood red and trouble breathing, nausea and vomiting. Patient was treated with IV fluids, IV Benadryl, and medicine for nausea to stop the vomiting. The outcome was reported as recovered / resolved for nausea and vomiting and unknown for rest of the events. List of documents held by sender : none.; Sender's Comments: This case involves a 56-year-old female patient who presented with Anaphylactic shock, Dyspnoea, Ocular hyperaemia and throat tightness following the vaccination with FLUZONE QUADRIVALENT. Time to onset is compatible with the role of vaccine. Further information including patient's concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Initial information regarding an unsolicited valid serious case received on 19-Sep-2018 from a consumer. This case involves a 56 years old female patient who experienced trouble breathing, anaphylaxis shock, eyes blood red and throat closed, nausea and vomiting while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, vaccination(s) and family history were not provided. It was also reported patient had allergy to eggs after the event and then later found out was not allergic to eggs. On 22-Sep-2009, the patient received a once dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE lot U3204AA, expiry date- 30-Jun-2010 via unknown route in the right arm. On an unknown date of 2009, patient developed a serious anaphylaxis shock (anaphylactic shock) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. On an unknown date, the patient developed a serious trouble breathing, eyes blood red and throat closed, nausea and vomiting following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. All the events were assessed as serious due to life threatening events. Consumer reported stayed in emergency room (ER) for 10 hours. Other relevant tests included no lab data. Final diagnosis was anaphylaxis shock, throat closed, eyes blood red and trouble breathing, nausea and vomiting. Patient was treated with IV fluids, IV Benadryl, and medicine for nausea to stop the vomiting. The outcome was reported as recovered / resolved for nausea and vomiting and unknown for rest of the events. List of documents held by sender : none.; Sender's Comments: This case involves a 56-year-old female patient who presented with Anaphylactic shock, Dyspnoea, Ocular hyperaemia and throat tightness following the vaccination with FLUZONE QUADRIVALENT. Time to onset is compatible with the role of vaccine. Further information including patient's concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Blood pressure decreased, Bradycardia, Hyperhidrosis, Hypotension, Immediate post-injection reaction
Clinical narrative: This initial spontaneous report was received on 21-SEP-2018 from the mother of a 14 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. He was taking no concomitant medications. In approximately 2017 (reported as about a year ago), the patient received his first dose of GARDASIL 9 0.5 ml for prevention of human papilloma virus (HPV). On 19-JUL-2018, he received his second dose of GARDASIL 9 0.5 ml (route and lot # not provided for either dose). On the same day, on 19-JUL-2018, his heart rate dropped and he passed out. The patient was given oxygen but he wasn't regaining consciousness (but "they got heart rate up") so an ambulance was called and he was taken to the Emergency Room (ER). The patient was not admitted to the hospital. No lab diagnostics or studies were performed. The patient recovered from the events "after a couple of days". Causality assessment was not provided. The mother was asking for compensation for the cost of the hospital visit for these events. Upon internal review, heart rate dropped/given oxygen and passed out/he wasn't regaining consciousness were considered to be medically significant events. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor, Syncope
Clinical narrative: This initial spontaneous report was received on 21-SEP-2018 from the mother of a 14 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. He was taking no concomitant medications. In approximately 2017 (reported as about a year ago), the patient received his first dose of GARDASIL 9 0.5 ml for prevention of human papilloma virus (HPV). On 19-JUL-2018, he received his second dose of GARDASIL 9 0.5 ml (route and lot # not provided for either dose). On the same day, on 19-JUL-2018, his heart rate dropped and he passed out. The patient was given oxygen but he wasn't regaining consciousness (but "they got heart rate up") so an ambulance was called and he was taken to the Emergency Room (ER). The patient was not admitted to the hospital. No lab diagnostics or studies were performed. The patient recovered from the events "after a couple of days". Causality assessment was not provided. The mother was asking for compensation for the cost of the hospital visit for these events. Upon internal review, heart rate dropped/given oxygen and passed out/he wasn't regaining consciousness were considered to be medically significant events. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Heart rate decreased, Loss of consciousness
Clinical narrative: This initial spontaneous report was received on 21-SEP-2018 from the mother of a 14 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. He was taking no concomitant medications. In approximately 2017 (reported as about a year ago), the patient received his first dose of GARDASIL 9 0.5 ml for prevention of human papilloma virus (HPV). On 19-JUL-2018, he received his second dose of GARDASIL 9 0.5 ml (route and lot # not provided for either dose). On the same day, on 19-JUL-2018, his heart rate dropped and he passed out. The patient was given oxygen but he wasn't regaining consciousness (but "they got heart rate up") so an ambulance was called and he was taken to the Emergency Room (ER). The patient was not admitted to the hospital. No lab diagnostics or studies were performed. The patient recovered from the events "after a couple of days". Causality assessment was not provided. The mother was asking for compensation for the cost of the hospital visit for these events. Upon internal review, heart rate dropped/given oxygen and passed out/he wasn't regaining consciousness were considered to be medically significant events. Additional information has been requested.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Seizure
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid serious case received from a health professional, Pharmacist. This case involves a 45 years old female patient who experienced seizure, while she received vaccine FLUZONE QUADRIVALENT prefilled syringe.. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe lot number UT6258MA (expiry date: 30-JUN-2019) via intramuscular route in the left arm. On an unknown date, The patient developed a serious seizure few hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Patient required visit  to Emergency Room (ER). Final diagnosis was seizure. Lab test not reported. It was not reported if the patient received a corrective treatment. (reporter did not know what treatment was given in ER). The patient outcome is reported as Unknown for seizure.; Sender's Comments: Patient experienced seizure after vaccination. Exact  time to onset is unknown. Event is listed with the vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information no conclusion can be drawn.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Headache, Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: You will need to get the lot number of the vaccine from Dr. I had the vaccine on the September 12, 2018 at approximately 1400 hours. On 13SEP and 14 SEP I was sick at home with a fever of 101 f severe body aches, dizziness, headache, nausea. I did call Dr. on Thursday 13SEP2018 to discuss and she told me the symptoms should disappear and if I got any worse to go to the emergency room On the 19SEP2018 I noticed the first round circle of blisters on my lower spine and a few appeared each day at bottom of back, one spot just below my buttocks and 5 or six more appeared on my thigh, behind my knee and my calf all on the left side of my body. These spots first appear as a raised red dots and feel as something is crawling under my skin.  By Sunday it had worsened to the point that I went to Hometown Urgent Care as my doctors office was closed. On Sunday 23SEP2018 the PA diagnosed  me with Shingles and put me on steroids Prednisone 20 mg tablets 2 times daily and Valacyclovir 1 gm. tablets 3 times daily and took me off work as she told me I was contagious. I called my primary care physician on Monday 24SEP2018 and discussed with her and she said it was a dead virus and she had never see a case where somebody contracted Shingles from a dead virus.  I told her I was extremely worried about missing work so I made an appointment for Tuesday 25SEP2018 at 2:00 pm at Hospital. Dr. confirmed the diagnosis that was made on Sunday by Urgent care and agreed that I should remain at home until no new sore broke out. She may write additional prescriptions if needed. So I am reporting this as this was not listed as a potential side effect or I would have chosen not to receive the vaccine as I have a job that requires me to be in the office as a quality professional for a pharmaceutical company.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: You will need to get the lot number of the vaccine from Dr. I had the vaccine on the September 12, 2018 at approximately 1400 hours. On 13SEP and 14 SEP I was sick at home with a fever of 101 f severe body aches, dizziness, headache, nausea. I did call Dr. on Thursday 13SEP2018 to discuss and she told me the symptoms should disappear and if I got any worse to go to the emergency room On the 19SEP2018 I noticed the first round circle of blisters on my lower spine and a few appeared each day at bottom of back, one spot just below my buttocks and 5 or six more appeared on my thigh, behind my knee and my calf all on the left side of my body. These spots first appear as a raised red dots and feel as something is crawling under my skin.  By Sunday it had worsened to the point that I went to Hometown Urgent Care as my doctors office was closed. On Sunday 23SEP2018 the PA diagnosed  me with Shingles and put me on steroids Prednisone 20 mg tablets 2 times daily and Valacyclovir 1 gm. tablets 3 times daily and took me off work as she told me I was contagious. I called my primary care physician on Monday 24SEP2018 and discussed with her and she said it was a dead virus and she had never see a case where somebody contracted Shingles from a dead virus.  I told her I was extremely worried about missing work so I made an appointment for Tuesday 25SEP2018 at 2:00 pm at Hospital. Dr. confirmed the diagnosis that was made on Sunday by Urgent care and agreed that I should remain at home until no new sore broke out. She may write additional prescriptions if needed. So I am reporting this as this was not listed as a potential side effect or I would have chosen not to receive the vaccine as I have a job that requires me to be in the office as a quality professional for a pharmaceutical company.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Dizziness, Formication, Headache, Herpes zoster
Clinical narrative: You will need to get the lot number of the vaccine from Dr. I had the vaccine on the September 12, 2018 at approximately 1400 hours. On 13SEP and 14 SEP I was sick at home with a fever of 101 f severe body aches, dizziness, headache, nausea. I did call Dr. on Thursday 13SEP2018 to discuss and she told me the symptoms should disappear and if I got any worse to go to the emergency room On the 19SEP2018 I noticed the first round circle of blisters on my lower spine and a few appeared each day at bottom of back, one spot just below my buttocks and 5 or six more appeared on my thigh, behind my knee and my calf all on the left side of my body. These spots first appear as a raised red dots and feel as something is crawling under my skin.  By Sunday it had worsened to the point that I went to Hometown Urgent Care as my doctors office was closed. On Sunday 23SEP2018 the PA diagnosed  me with Shingles and put me on steroids Prednisone 20 mg tablets 2 times daily and Valacyclovir 1 gm. tablets 3 times daily and took me off work as she told me I was contagious. I called my primary care physician on Monday 24SEP2018 and discussed with her and she said it was a dead virus and she had never see a case where somebody contracted Shingles from a dead virus.  I told her I was extremely worried about missing work so I made an appointment for Tuesday 25SEP2018 at 2:00 pm at Hospital. Dr. confirmed the diagnosis that was made on Sunday by Urgent care and agreed that I should remain at home until no new sore broke out. She may write additional prescriptions if needed. So I am reporting this as this was not listed as a potential side effect or I would have chosen not to receive the vaccine as I have a job that requires me to be in the office as a quality professional for a pharmaceutical company.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: You will need to get the lot number of the vaccine from Dr. I had the vaccine on the September 12, 2018 at approximately 1400 hours. On 13SEP and 14 SEP I was sick at home with a fever of 101 f severe body aches, dizziness, headache, nausea. I did call Dr. on Thursday 13SEP2018 to discuss and she told me the symptoms should disappear and if I got any worse to go to the emergency room On the 19SEP2018 I noticed the first round circle of blisters on my lower spine and a few appeared each day at bottom of back, one spot just below my buttocks and 5 or six more appeared on my thigh, behind my knee and my calf all on the left side of my body. These spots first appear as a raised red dots and feel as something is crawling under my skin.  By Sunday it had worsened to the point that I went to Hometown Urgent Care as my doctors office was closed. On Sunday 23SEP2018 the PA diagnosed  me with Shingles and put me on steroids Prednisone 20 mg tablets 2 times daily and Valacyclovir 1 gm. tablets 3 times daily and took me off work as she told me I was contagious. I called my primary care physician on Monday 24SEP2018 and discussed with her and she said it was a dead virus and she had never see a case where somebody contracted Shingles from a dead virus.  I told her I was extremely worried about missing work so I made an appointment for Tuesday 25SEP2018 at 2:00 pm at Hospital. Dr. confirmed the diagnosis that was made on Sunday by Urgent care and agreed that I should remain at home until no new sore broke out. She may write additional prescriptions if needed. So I am reporting this as this was not listed as a potential side effect or I would have chosen not to receive the vaccine as I have a job that requires me to be in the office as a quality professional for a pharmaceutical company.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Rash pruritic, Rash vesicular
Clinical narrative: You will need to get the lot number of the vaccine from Dr. I had the vaccine on the September 12, 2018 at approximately 1400 hours. On 13SEP and 14 SEP I was sick at home with a fever of 101 f severe body aches, dizziness, headache, nausea. I did call Dr. on Thursday 13SEP2018 to discuss and she told me the symptoms should disappear and if I got any worse to go to the emergency room On the 19SEP2018 I noticed the first round circle of blisters on my lower spine and a few appeared each day at bottom of back, one spot just below my buttocks and 5 or six more appeared on my thigh, behind my knee and my calf all on the left side of my body. These spots first appear as a raised red dots and feel as something is crawling under my skin.  By Sunday it had worsened to the point that I went to Hometown Urgent Care as my doctors office was closed. On Sunday 23SEP2018 the PA diagnosed  me with Shingles and put me on steroids Prednisone 20 mg tablets 2 times daily and Valacyclovir 1 gm. tablets 3 times daily and took me off work as she told me I was contagious. I called my primary care physician on Monday 24SEP2018 and discussed with her and she said it was a dead virus and she had never see a case where somebody contracted Shingles from a dead virus.  I told her I was extremely worried about missing work so I made an appointment for Tuesday 25SEP2018 at 2:00 pm at Hospital. Dr. confirmed the diagnosis that was made on Sunday by Urgent care and agreed that I should remain at home until no new sore broke out. She may write additional prescriptions if needed. So I am reporting this as this was not listed as a potential side effect or I would have chosen not to receive the vaccine as I have a job that requires me to be in the office as a quality professional for a pharmaceutical company.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Swollen tongue
Clinical narrative: I administered the vaccine at 05:50pm. patient seemed fine for at least 10 minutes. Was very talkative. She called me at 7pm complaining a feeling of a bubble in her throat and swollen tongue. I advised her to go to the emergency.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Anger, Decreased appetite, Dizziness, Fatigue, Hypersensitivity
Clinical narrative: 48 y/o female presents for "tetanus shot reaction". Tdap placed approximately x1 week ago. Notes initially felt mad/angry the day following vaccination for unknown reason. Also with mild sinus congestion, body aches, fatigue, dizziness, low appetite, and difficulty with sleep for 3 days thereafter. Symptoms had been gradually subsiding, but noted yesterday left arm feeling warm. When examined, saw erythema to left arm where injection had been placed. Associated slightly warm sensation, but otherwise no other symptoms. Admits symptoms overall have been decreasing over time and subsiding. Here to today to make sure not a more serious reaction to vaccine. Denies headache, confusion, neck stiffness, weakness, n/t, throat swelling/closure, sob, chest pain, n/v/d, lesions, abd pain. Patient was given Rx of Loratadine 10mg PO qd for allergic reaction. F/u scheduled in 1 week.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Insomnia, Pain, Sinus congestion, Skin warm
Clinical narrative: 48 y/o female presents for "tetanus shot reaction". Tdap placed approximately x1 week ago. Notes initially felt mad/angry the day following vaccination for unknown reason. Also with mild sinus congestion, body aches, fatigue, dizziness, low appetite, and difficulty with sleep for 3 days thereafter. Symptoms had been gradually subsiding, but noted yesterday left arm feeling warm. When examined, saw erythema to left arm where injection had been placed. Associated slightly warm sensation, but otherwise no other symptoms. Admits symptoms overall have been decreasing over time and subsiding. Here to today to make sure not a more serious reaction to vaccine. Denies headache, confusion, neck stiffness, weakness, n/t, throat swelling/closure, sob, chest pain, n/v/d, lesions, abd pain. Patient was given Rx of Loratadine 10mg PO qd for allergic reaction. F/u scheduled in 1 week.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: 48 y/o female presents for "tetanus shot reaction". Tdap placed approximately x1 week ago. Notes initially felt mad/angry the day following vaccination for unknown reason. Also with mild sinus congestion, body aches, fatigue, dizziness, low appetite, and difficulty with sleep for 3 days thereafter. Symptoms had been gradually subsiding, but noted yesterday left arm feeling warm. When examined, saw erythema to left arm where injection had been placed. Associated slightly warm sensation, but otherwise no other symptoms. Admits symptoms overall have been decreasing over time and subsiding. Here to today to make sure not a more serious reaction to vaccine. Denies headache, confusion, neck stiffness, weakness, n/t, throat swelling/closure, sob, chest pain, n/v/d, lesions, abd pain. Patient was given Rx of Loratadine 10mg PO qd for allergic reaction. F/u scheduled in 1 week.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site pain, Injection site reaction, Mobility decreased, Pain
Clinical narrative: ? Soreness in upper arm at injection site (for only about 24 hours after the injection. I expected this. ? Pink, splotchy skin, upper arm below injection site (Morning after injection and the day after that). ? Swollen upper arm (morning following injection (given Tues.; also: Wed., Thurs., Friday).  ? Minor pain upon pushing on swollen areas on arm, heat in pink areas) first and second days after injection; though no longer sore at injection site. ? Minor pain when raising or extending arm (Night of the day of injection, first and second days after injection only). ? Swollen, pink, puffy middle arm, especially above and at below elbow (Pink areas warm to the touch) late afternoon, day after injection plus two more days. ? Swollen, pink, puffy elbow area and about half way down lower arm (Two days after injection, late afternoon) ...swelling and pink moved down arm during the second, third forth days after the injection. ? Slightly impeded elbow bending due to swelling. Pain very minor and didn't restrict movement (Lasted first and second days after injection only). Note 1: Pink skin abated 4th day after shot; swelling gradually abated and was mostly gone by Sunday (5 days after injection). It gradually moved down arm just past the middle of my forearm over the course of four days. Note 2: During the entire time of the reaction, I felt generally normal: no fever or fatigue noted. The reaction did not impede my workout at the gym on the day after the shot nor any other activity. Note 3: The reaction was virtually completely resolved by Sunday afternoon, (fifth day after injection). Note 4: I have photos upon request. Note 5:  I received PVC 13 shot one year before the PNEUMOVAX 23 shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash macular
Clinical narrative: ? Soreness in upper arm at injection site (for only about 24 hours after the injection. I expected this. ? Pink, splotchy skin, upper arm below injection site (Morning after injection and the day after that). ? Swollen upper arm (morning following injection (given Tues.; also: Wed., Thurs., Friday).  ? Minor pain upon pushing on swollen areas on arm, heat in pink areas) first and second days after injection; though no longer sore at injection site. ? Minor pain when raising or extending arm (Night of the day of injection, first and second days after injection only). ? Swollen, pink, puffy middle arm, especially above and at below elbow (Pink areas warm to the touch) late afternoon, day after injection plus two more days. ? Swollen, pink, puffy elbow area and about half way down lower arm (Two days after injection, late afternoon) ...swelling and pink moved down arm during the second, third forth days after the injection. ? Slightly impeded elbow bending due to swelling. Pain very minor and didn't restrict movement (Lasted first and second days after injection only). Note 1: Pink skin abated 4th day after shot; swelling gradually abated and was mostly gone by Sunday (5 days after injection). It gradually moved down arm just past the middle of my forearm over the course of four days. Note 2: During the entire time of the reaction, I felt generally normal: no fever or fatigue noted. The reaction did not impede my workout at the gym on the day after the shot nor any other activity. Note 3: The reaction was virtually completely resolved by Sunday afternoon, (fifth day after injection). Note 4: I have photos upon request. Note 5:  I received PVC 13 shot one year before the PNEUMOVAX 23 shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: Fever 102.2, chills, lethargy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Facial pain, Fatigue, Nausea, Paraesthesia
Clinical narrative: Pain in joints, developed nausea, then severe tingling and pins and needles throughout entire body, herpes like rash accompanied by pain and itching under right eye, severe fatigue.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Pain in joints, developed nausea, then severe tingling and pins and needles throughout entire body, herpes like rash accompanied by pain and itching under right eye, severe fatigue.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report received from a pharmacy intern refers to a 65 year old patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date in June 2018, the patient was vaccinated with a dose of PREVNAR 13 and on 10-SEP-2018 the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route were not reported) (lot # R006465, expiry date: 24-OCT-2019) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-SEP-2018, the patient was vaccinated with an improperly stored dose of VAQTA (dose and route were unknown) lot # R012740 expiration date 09-AUG-2019 for prophylaxis. This was the first temperature excursion. No Digital Data Logger as involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA011220: US-009507513-1809USA011221.
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 16-months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II (lot # N013868, expiration date 04-MAY-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccine experienced a temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This was one of several reports received from the same reporter.
Age: 1.33
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 16-months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II lot # N013868, expiration date 04-MAY-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccine experienced a temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This was one of several reports received from the same reporter.