chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: right arm pit was tender; right arm pit was swelling; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non health-care professional.  This case is linked to case 2020SA229160 (same reporter).  This case involves a 14 years old male patient who experienced right armpit was tender and   swelling (tenderness, swelling), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 14-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6638AA) via an unknown route in the right deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-seriousright armpit was tender and swelling (tenderness, swelling), unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure via skin contact, Injection site extravasation, Needle issue, No adverse event, Underdose
Clinical narrative: patient only received a partial dose of vaccine  due to the vaccine leaking during administration/ No AE; vaccine leaking during administration; while administering the vaccine the liquid running down the patient's arm from the injection site/No AE; Initial information was received on 24-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 11 years old female patient who on 24-Aug-2020 only received a partial dose of 0.5mL of first dose of vaccine  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U659AA and expiry date 21-May-2021) via intramuscular route in the left arm meant for prophylactic vaccination as the vaccine was leaking during administration and while administering the vaccine the liquid running down the patient's arm from the injection site (underdose, needle issue and exposure via skin contact)  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) for immunisation.  It was case of actual medication error due to vaccine underdose. it was also a case of needle leak and exposure via skin contact.   Case details:  Caller reported that the full amount of the vaccine was drawn into the syringe, needle was inserted into patients arm and while administering the vaccine she noticed the liquid running down the patient's arm from the injection site.   Caller unsure of the volume of the vaccine that the patient received.    At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: itchiness at the injection site; swelling at the injection site; Initial information was received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves female patient (20-30 years) who had itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient was not pregnant. She had no concomitant medications.   On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ432AB, Expiry date: 30-Jun-2021, form: Pre-filled syringes) once via unknown route in the deltoid NOS for prophylactic vaccination.  On an unknown date, the patient developed a non-serious itchiness at the injection site (vaccination site pruritus) and swelling at the injection site (vaccination site swelling) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.  The patient was treated with INFLUENZA VACCINE (Flu seasonal vaccine).  At the time of report, the outcome of events was unknown.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, Feeling abnormal, Foetal disorder, Impaired work ability, Injected limb mobility decreased
Clinical narrative: I was newly pregnant (5-6 weeks) when I decided to follow my OB-GYN's guidance and opt in to get the flu shot at my (then) current employer. It was Oct 6, 2009 (I found an email dating back to that specific day where I mention the pain I was in to my husband, I should also be able to dig up DM's with a friend I was having the day on Chat). I had been administered the shot, went back to my desk, and pretty immediately started feeling an extreme heaviness in my entire arm that was injected. As more time passed that morning, I started to feel like I had a full-blown flu in my arm -- an achiness and paralyzed feeling. I ended up leaving work that day. In being 5 weeks pregnant, I was terrified that I had made a bad decision in getting that flu shot -- something felt so wrong about what happened.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Limb discomfort, Pain in extremity, Ultrasound antenatal screen abnormal
Clinical narrative: I was newly pregnant (5-6 weeks) when I decided to follow my OB-GYN's guidance and opt in to get the flu shot at my (then) current employer. It was Oct 6, 2009 (I found an email dating back to that specific day where I mention the pain I was in to my husband, I should also be able to dig up DM's with a friend I was having the day on Chat). I had been administered the shot, went back to my desk, and pretty immediately started feeling an extreme heaviness in my entire arm that was injected. As more time passed that morning, I started to feel like I had a full-blown flu in my arm -- an achiness and paralyzed feeling. I ended up leaving work that day. In being 5 weeks pregnant, I was terrified that I had made a bad decision in getting that flu shot -- something felt so wrong about what happened.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: The patient received her fluarix and her shingrix vaccines on 8-27-20.  Later that night, she started to experience chills, sore arm, upper body aches and fatigue, but was unable to sleep well.  On 8-28-20, she had a lot of aches, but generally felt better and slept much better.  On 8-29-20, she developed a rash on her chest, back, and upper stomach area.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash
Clinical narrative: The patient received her fluarix and her shingrix vaccines on 8-27-20.  Later that night, she started to experience chills, sore arm, upper body aches and fatigue, but was unable to sleep well.  On 8-28-20, she had a lot of aches, but generally felt better and slept much better.  On 8-29-20, she developed a rash on her chest, back, and upper stomach area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous ulcer, Eating disorder, Herpes zoster, Pain
Clinical narrative: Patient.  Developed disseminated areas of shingles.   Developed 12 days after vaccine. And presented to my office on 8/28 with vesicular aphthous ulcers in entire mouth painful and difficulty eating. Treatment of valacyclovir 1000 x 7days and f/u scheduled.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: developed shingles on an unspecified date in 2019.; late 2nd dose on 16Jun2020; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2018, the patient received the 1st dose of Shingrix. On 16th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and drug dose administration interval too long. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and developed shingles on an unspecified date in 2019. The patient was late for 2nd dose, which led to lengthening of vaccination schedule. The reporter consented to follow up. The HCP did not have the date or information on the shingles outbreak only that it occurred last year.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Induration, Injection site pruritus, Mobility decreased
Clinical narrative: 7/2: Initial itching around injection site; swelling to size of her hand that evening and became very hard. She went to the ER where she received ice and ibuprofen. She had a fever of 101.1F that night at home. Pain and swelling continued and increased. She had pain travel up to  her shoulder blade and arm pit. 7/3: Went to local urgent care and was told to ice and elevate (they wanted to do a cortisone injection, however, the patient has uncontrolled diabetes and they did not think this would be wise). 7/6: She was feeling better. 7/8: Pain returned but was up into her neck. She could not turn her head or lean it up or down. The outside of her neck hurt when she swallowed. Throat is not swelling and no difficulty in breathing, just "horrible" pain. 7/13: arm is feeling better, just sore and tender. Neck still hurting.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Odynophagia, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: 7/2: Initial itching around injection site; swelling to size of her hand that evening and became very hard. She went to the ER where she received ice and ibuprofen. She had a fever of 101.1F that night at home. Pain and swelling continued and increased. She had pain travel up to  her shoulder blade and arm pit. 7/3: Went to local urgent care and was told to ice and elevate (they wanted to do a cortisone injection, however, the patient has uncontrolled diabetes and they did not think this would be wise). 7/6: She was feeling better. 7/8: Pain returned but was up into her neck. She could not turn her head or lean it up or down. The outside of her neck hurt when she swallowed. Throat is not swelling and no difficulty in breathing, just "horrible" pain. 7/13: arm is feeling better, just sore and tender. Neck still hurting.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: 7/2: Initial itching around injection site; swelling to size of her hand that evening and became very hard. She went to the ER where she received ice and ibuprofen. She had a fever of 101.1F that night at home. Pain and swelling continued and increased. She had pain travel up to  her shoulder blade and arm pit. 7/3: Went to local urgent care and was told to ice and elevate (they wanted to do a cortisone injection, however, the patient has uncontrolled diabetes and they did not think this would be wise). 7/6: She was feeling better. 7/8: Pain returned but was up into her neck. She could not turn her head or lean it up or down. The outside of her neck hurt when she swallowed. Throat is not swelling and no difficulty in breathing, just "horrible" pain. 7/13: arm is feeling better, just sore and tender. Neck still hurting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Nausea
Clinical narrative: chills, shivers, nausea, muscle aches over the entire body but especially around the area of the injection, soreness at the sire of injection,.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood test, Dizziness, Injection site swelling, Pain, Throat irritation
Clinical narrative: Dizziness, hives, swelling at injection sites, body aches, itchy throat 20 minutes after shots. Was taken to ER and given Antihistamine and parent doesnt know what else.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Dizziness, hives, swelling at injection sites, body aches, itchy throat 20 minutes after shots. Was taken to ER and given Antihistamine and parent doesnt know what else.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Received injection about 2:30 PM. No adverse reactions that day, woke up around 6:00 AM with significant headache and muscle stiffness.  As I get migraines on occasion, I took a course of Sumatripin and got only slight relief.  That entire day I had extreme fatigue and muscle stiffness, and later that evening I developed a fever of 100.1 (which was controlled by Tylenol).  The injection site was the size and pain as a wasp sting.  The next day continued the fatigue and muscle stiffness, but none of the reactions got worse.  The  following day (today as I submit this) the fatigue and stiffness isn't as pronounced, though the injection site is still large, swollen and painful.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Received injection about 2:30 PM. No adverse reactions that day, woke up around 6:00 AM with significant headache and muscle stiffness.  As I get migraines on occasion, I took a course of Sumatripin and got only slight relief.  That entire day I had extreme fatigue and muscle stiffness, and later that evening I developed a fever of 100.1 (which was controlled by Tylenol).  The injection site was the size and pain as a wasp sting.  The next day continued the fatigue and muscle stiffness, but none of the reactions got worse.  The  following day (today as I submit this) the fatigue and stiffness isn't as pronounced, though the injection site is still large, swollen and painful.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Injection site rash, Injection site reaction, Rash, Rash erythematous
Clinical narrative: Less than 5 minutes after giving vaccines, pts mom reported pt had a rash, upon entering the room with NP, red scattered rash all over, no difficulty breathing, alert and crying , Benadryl 5 ml po given at 11:57, rash still spreading, decadron 4 mg  given at 12.07, rash has spread , pulse ox 98%, pt now scratching at rash.   At 12:15 I checked pt,   he drank some water, alert and whining, conts pulse ox on, Pulse ox 100 % and pulse 153.  tb,lpn  , AS PATIENT WAS LEAVING THE EXAM ROOM, MOM WALKED UP TO ME AND ASKED IF THE RASH HE WAS DEVELOPING ON HIS LEFT ARM WAS NORMAL. PATEINT HAD DEVELOPED WHELPS ON LEFT ARM WHERE MMR HAD BEEN INJECTED.  I HAD THE PATIENT GO BACK INTO THE EXAM ROOM.  INSTRUCTED NURSE TO GIVE 4 ML OF ORAL BENADRYL.  I WENT AND SPOKE WITH DR. AND AS I RETURNED TO EXAM ROOM THE RASH HAD SPREAD TO HEAD, SCALP,FACE, AND TORSO.  LUNGS SOUNDS CTA, NO WHEEZES, NO STRIDOR.  ORDERED NURSE TO INJECT 4 MG DECADRON IM.  PATIENT STAYED IN EXAM ROOM FOR OBSERVATION FOR A TOTAL OF 1 HR AFTER INJECTIONS.  UPON LEAVING OFFICE I NOTED HIS PULSE OX WAS STILL 100%, LUNGS CTA, PATIENT WAS ACTIVE AND ALERT, NORMAL RESPIRATIONS AND HEART SOUNDS.    TL,FNP-C
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Less than 5 minutes after giving vaccines, pts mom reported pt had a rash, upon entering the room with NP, red scattered rash all over, no difficulty breathing, alert and crying , Benadryl 5 ml po given at 11:57, rash still spreading, decadron 4 mg  given at 12.07, rash has spread , pulse ox 98%, pt now scratching at rash.   At 12:15 I checked pt,   he drank some water, alert and whining, conts pulse ox on, Pulse ox 100 % and pulse 153.  tb,lpn  , AS PATIENT WAS LEAVING THE EXAM ROOM, MOM WALKED UP TO ME AND ASKED IF THE RASH HE WAS DEVELOPING ON HIS LEFT ARM WAS NORMAL. PATEINT HAD DEVELOPED WHELPS ON LEFT ARM WHERE MMR HAD BEEN INJECTED.  I HAD THE PATIENT GO BACK INTO THE EXAM ROOM.  INSTRUCTED NURSE TO GIVE 4 ML OF ORAL BENADRYL.  I WENT AND SPOKE WITH DR. AND AS I RETURNED TO EXAM ROOM THE RASH HAD SPREAD TO HEAD, SCALP,FACE, AND TORSO.  LUNGS SOUNDS CTA, NO WHEEZES, NO STRIDOR.  ORDERED NURSE TO INJECT 4 MG DECADRON IM.  PATIENT STAYED IN EXAM ROOM FOR OBSERVATION FOR A TOTAL OF 1 HR AFTER INJECTIONS.  UPON LEAVING OFFICE I NOTED HIS PULSE OX WAS STILL 100%, LUNGS CTA, PATIENT WAS ACTIVE AND ALERT, NORMAL RESPIRATIONS AND HEART SOUNDS.    TL,FNP-C
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swelling, erythema begun within 24hr of injection.  Seen in clinic 8/27 concern for Cellulitis and Rx'd Cephalexin
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain, fatigue, headache, fever, shivering, diarrhea, starting mid-afternoon after I received the injection, continued for approximately 36 hours.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle pain, fatigue, headache, fever, shivering, diarrhea, starting mid-afternoon after I received the injection, continued for approximately 36 hours.
Age: 16.0
Sex: F
Vaccine: PNC, PPV, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: she had no side effects, no nothing from it; received Prevnar and Pneumovax 13 on the same day; This spontaneous report was received from a licensed practical nurse and refers to a 16-year-old female patient. The patient's medical history included tonsillectomy. Her current conditions included recurrent strep throat. Her historical drug included pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR). She had no prior vaccinations (within 4 weeks), no adverse events following prior vaccinations. No information regarding the patient's drug reactions or allergies and concomitant medications was provided. Her last office visit was on 16-JUN-2020. On 19-JUN-2020, the patient had pneumococcal conjugate vaccine (PCV) 23 titer test performed, which showed that she had no immunities built up and the physician recommended that she should be vaccinated.  On 08-JUL-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 (unit not provided) intramuscular injection, once, in her left deltoid, lot # S0005856 was confirmed to be not valid, expiration date 03-DEC-2020 and the second dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) 0.5 ml intramuscular injection, once, in her left deltoid, lot # CK0843, expiration date on an unknown date in March 2022, both for prophylaxis (reported as "was due and doctor felt like she needed it"). The patient had no side effects (reported as "no nothing from it"). The reporter stated that the suspect vaccines were administered on the same day according to the physician instructions. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S0005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a laywer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an outbreak of shingles. As a result of these symptoms, the had been seen and treated by medical providers was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter regarded the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; improperly stored vaccine administered to patient; This spontaneous report as received from a physician refers to a patient of unknown age and gender. Concomitant therapies, medical history and historical drugs were not provided.  On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot # T007396 (expiration date 29-AUG-2021), 0.5 milliliter for prophylaxis (strength, frequency and route of administration were not reported).    Temperature excursion was reported as 16.07 degree fahrenheit  (°F) for 25 minutes with no previous temperature excursion.   The call was made due to a digital data logger. No adverse symptoms were reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Cough, Injection site bruising, Pyrexia
Clinical narrative: develop a fever today; bruised at the injection site; that it could possibly be Covid 19; coughing a lot / "those symptoms" and she said that she was coughing a lot; This case was reported by a consumer via call center representative and described the occurrence of cough aggravated in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included flu vaccine (fir Flu vaccine refer case US2020170274 and US2020AMR170986). Concurrent medical conditions included meat allergy (unspecified long list of medication) and lung disease.   On 21st August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced cough aggravated, injection site bruising and suspected covid-19. On 24th August 2020, the patient experienced fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the cough aggravated, fever, injection site bruising and suspected covid-19 were unknown.   It was unknown if the reporter considered the cough aggravated, fever, injection site bruising and suspected covid-19 to be related to Shingrix.  Additional details were reported as follows: The patient had a long list of medications that she was allergic to.  The patient had a pre-existing lung disease and that when she gets the flu shot she becomes ill because the flu shot is made with a chicken protein.  She has since recovered from all of these events but she states she was not going to get a flu shot again. She does not know the name of the flu shots she received but said we could contact her doctor for that information. The patient received Shingrix and asked had any chicken or fowl protein in it.  The Shingrix received via intramuscularly in the right deltoid and the last few days she had been feeling those symptoms again [and that she has been doing everything she can to ward it off (such as exercise). Those symptoms meant by was coughing a lot.  She said normally she does have a cough (due to her pre-existing lung disease) but this cough that she has been having has been intense.  She also stated that she was concerned that it could possibly be Covid 19 because one never knows and there have been cases reported in her state.  She said she wears a mask when she goes out. She also reports that normally her body temperature was in the high 97 to low 98 range but she did develop a fever of about 100 degrees. She did take ibuprofen and that got it down to 98.8 degrees.  She also mentioned that she was bruised at the injection site.  The reporter consented to follow up. This case has been linked with case US2020170274 and US2020AMR170986 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR170986:same patient (Shingrix vaccine) US-GLAXOSMITHKLINE-US2020170274:same patient
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Malaise, Pneumonia, Vaccine positive rechallenge
Clinical narrative: Drug allergy for medications that she is allergic/becomes ill because the flu shot is made with a chicken protein ended with pneumonia; could not breathe; becomes ill; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of pneumonia (received Influenza vaccine on an unknown date and experienced Pneumonia, refer case US2020170274). Concurrent medical conditions included lung disease and drug allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pneumonia (serious criteria GSK medically significant), difficulty breathing and malaise. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the pneumonia, difficulty breathing and malaise were recovered/resolved.   The reporter considered the pneumonia and difficulty breathing to be related to Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. After receiving flu vaccine, the patient became ill because the flu shot was made with a chicken protein.  The patient stated that, she would stay sick for months. She said this happened 2 years in a row and she ended up going to the emergency room by ambulance because she could not breathe.  The patient also ended up with pneumonia which she got 3 times in a year and a half after the flu shots were received.  The patient had since recovered from all of these events, but she stated, she was not going to get a flu shot again.  The patient did not know the name of the flu shots she received but said we could contact her doctor for that information.  The patient was calling GlaxoSmithKline, because she wanted to know if Shingrix had any chicken or fowl protein in it.  She stated, she had the first shot of Shingrix on Friday 21st August 2020 and the last few days she was coughing a lot.  For the tolerance of dose of Shingrix, refer the linked case US2020AMR170918. This was 1 of 3 linked cases reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR170918:same patient (Shingrix vaccine) US-GLAXOSMITHKLINE-US2020170274:same patient
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster, Musculoskeletal pain, Pain in extremity
Clinical narrative: Stroke; Pain in his mid-section shoulder; Pain in his mid-section shoulder and left arm; Probably shingles; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, 7 days after receiving Shingrix, the patient experienced shingles. On 24th May 2020, the patient experienced shoulder pain and pain in arm. On 17th June 2020, the patient experienced stroke (serious criteria hospitalization and GSK medically significant). On 24th August 2020, the outcome of the stroke was recovered/resolved and the outcome of the shoulder pain was not recovered/not resolved. On an unknown date, the outcome of the pain in arm and shingles were unknown.   It was unknown if the reporter considered the stroke and shingles to be related to Shingrix. The reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: About one week later he began to experience pain in his mid-section shoulder and left arm.   The physician said it was probably shingles.  The patient then had a stroke in June and was hospitalized.  He was still experiencing the pain and wanted to know what he could do for it.   The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Patient noticed a quarter size rash around injection site. Later developed hives below injection site.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Pain
Clinical narrative: Seasonal flu vaccine: experienced fever, headache, chills, body ache, insomnia, sweating, shivering for 26 hours
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Seasonal flu vaccine: experienced fever, headache, chills, body ache, insomnia, sweating, shivering for 26 hours
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Hypotonia, Loss of consciousness, Pallor, Syncope
Clinical narrative: 1054 - Began administration of vaccinations. Administered in this order: Menactra, Vaqta, Trumemba, and Gardasil 9. Father also present in the clinic room. 1055 - Client became limp and lost consciousness about 5 seconds after administration of Gardasil 9. Client regained consciousness after 4 seconds and was alert x 4. Client removed mask in order to breathe easier. RN noticed when masked removed client's lips were pale. RN remained at client's side. Water and graham crackers provided to the client. Client stated never having fainted before after vaccine administration; father commented that client's mother has a history of fainting with immunization. Client stated having breakfast this morning. Client stated feeling fine. RN had client wait in clinic for 15 minutes. Client denied any problems after wait, stated feels fine. Client's lip color pink. Client left clinic escorted by father.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Full blood count normal, Platelet count normal
Clinical narrative: patient reported dependent bruising into forearm on the affected side, bruising resolving as anticipated
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Rash macular
Clinical narrative: inspection: faint pink appearance of skin left arm that has some blotchiness not circumscribed and warm but no induration or fluctuance.  Significant tenderness of deltoid muscle outside of the area where there is pink discoloration.; palpation: tender to palpation of most of the deltoid region on the left arm..
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Employee developed redness around injection site 1 day after given, spreading redness and induration 2 days after given--also noted warmth and tenderness. Redness and induration worsened 3 days after injection given (about 6cm in size). The employee was advise to use ibuprofen or acetaminophen for comfort as well as cool compresses on and off the site. There was no change 4 days after the injection, but she noticed improvment on days 5-6 after injection. I re-evaluated her on day 7 post-injection and the redness, induration, warmth, and pain were gone. ROM in shoulder was normal.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: Patient felt dizzy/faint after administration of vaccine. Assisted by staff to lie down. No signs or symptoms of respiratory distress. Blood pressure 122/60, pulse 93, pulse ox 97%. About 5 minutes after adverse event began, patient stated she was feeling better. Raised to sitting position and juice given. Blood pressure 112/68, pulse 71, pulse ox 99%, blood glucose 107. 2 minutes later, patient to standing position. Denied dizziness or symptoms of distress. Patient awake and alert. Pulse 83, pulse ox 98%.  12 minutes after event began, patient able to walk to personal vehicle driven by mother. Accompanied to parking lot by nurse and physician.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: redness and swelling - treated at urgent care with bactrim ds bid for 7 days
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: Patient was seated and received immunization, stayed seated, then had syncope episode while seated, falling forward.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Tonic convulsion
Clinical narrative: Tonic seizure with loss of consciousness which lasted for less than a minute.  Was laid flat and turned to the side. Made sure breathing was adequate. Called ambulance. She came around and talked before ambulance arrived. Took few sips of water. Was taken to hospital via ambulance.
Age: 1.08
Sex: M
Vaccine: HEP, MMR, PNC13
Symptoms: Blood test, Laboratory test, Pruritus, Rash, Swelling face
Clinical narrative: Pt had hives and rash all over body.  He had facial swelling, tongue swelling, and itching per mom.
Age: 1.08
Sex: M
Vaccine: HEP, MMR, PNC13
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Pt had hives and rash all over body.  He had facial swelling, tongue swelling, and itching per mom.
Age: 23.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: 911 Was called and he was evaluated because he passed out after the shot
Age: 29.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash, Scar
Clinical narrative: He claimed he experienced an abdominal rash with small blisters shortly after receiving the 1st vaccination and it lasted for several weeks.  He denied any itching or pain associated with the rash but that it did leave some scarring.  Rash did not spread, no hives or SOB
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Cough, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever, arm pain, fatigue, headache, and cough
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Abdominal pain upper, Cough, Dizziness, Epistaxis, Headache
Clinical narrative: Patient's mother called the day after child received vaccines. She states that when child returned to school following vaccination appointment, he became lightheaded, had a headache, stomachache and his nose began to bleed. She further states he had a sore throat, however she believes this is due to throat irritation related to coughing/gagging due to blood draining down throat during nose bleed. The child did not feel ill enough to leave school and finished the school day. Mother states patient was feeling somewhat better the following day, having c/o mild headache and stomacheache. Mother was instructed to discuss with PCP course of action related to finishing the HPV9 and/or Men B series. Patient's mother was agreeable.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Oropharyngeal pain, Retching, Throat irritation
Clinical narrative: Patient's mother called the day after child received vaccines. She states that when child returned to school following vaccination appointment, he became lightheaded, had a headache, stomachache and his nose began to bleed. She further states he had a sore throat, however she believes this is due to throat irritation related to coughing/gagging due to blood draining down throat during nose bleed. The child did not feel ill enough to leave school and finished the school day. Mother states patient was feeling somewhat better the following day, having c/o mild headache and stomacheache. Mother was instructed to discuss with PCP course of action related to finishing the HPV9 and/or Men B series. Patient's mother was agreeable.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020.; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.   Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).   Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.   The patient was 4 years old. On 19-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013488: US-009507513-2008USA013489: US-009507513-2008USA013490: US-009507513-2008USA013491: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013494:
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Facial pain, Neuralgia, Trigeminal neuralgia, Vocal cord paralysis
Clinical narrative: hearing loss in her left ear; trigeminal neuralgia; vocal cord paralysis; debilitating pain; debilitating pain; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-APR-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered intense facial and neurological pain and was diagnosed with trigeminal neuralgia. The patient also suffered hearing loss in her left ear and vocal cord paralysis. The patient's injuries were permanent in nature, and she experienced frequent outbreaks of debilitating pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all the events was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered all the events to be disability.  Upon internal review, hearing loss in her left ear was determined to be medically significant.
Sex: M
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: patient was administered expired VAQTA; This spontaneous report was received from a medical assistant, referring to a 2 year old male patient. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.   On 24-AUG-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular (indication, formulation, strength, anatomical site of vaccination was not reported; lot number S019435, expiration date reported as 23-AUG-2020, which was verified to be valid). No additional information were provided.     combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S019435; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: FLUN3
Symptoms: Lacrimation increased, Malaise
Clinical narrative: MY EYE STARTED WATERING; I FELT SO SICK; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history and concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported patient had the FluMist and stated it was the worst decision ever made as soon as patient got done with eye started watering (preferred term: Lacrimation increased) and  felt so sick  (preferred term: Malaise). it? was a live virus.    The outcome of my eye started watering and i felt so sick was unknown.     The comapny physician identified my eye started watering as an event from source document. The my eye started watering and i felt so sick were considered non-serious by comapny physician.
Sex: M
Vaccine: FLUN3
Symptoms: Blindness transient
Clinical narrative: TEMPORARY BLINDNESS; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported that patient had temporary blindness from his nasal flu vaccine when he was in the service. (preferred term: Blindness transient).     It was unknown if any action was taken with Flumist.    The outcome of the event temporary blindness was unknown.    The reporter considered the event temporary blindness serious due to important medical event.     Device Information:     Product As Reported: FLUMIST  Product Role: Suspect  Device code: Adverse Event Without Identified Device or Use Problem; Sender's Comments: Blindness transient is not listed in the company core data sheet of Quadrivalent/Live attenuated influenza vaccine (Q/LAIV). Due to limited information on relevant medical history, concurrent diseases, concomitant medications, exact start date of suspect drug, exact start date and circumstances leading to the events, complete etiologic and diagnostic workup ( Complete Ophthalmic examination, Imaging studies) it is not possible to make a conclusive assessment of the causal relationship of the event and suspect drug.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Joint swelling, Musculoskeletal pain
Clinical narrative: flu like symptoms; lost 16 lbs due; nash; "fatigue is not as bad"; less pain in r hands/pain in feet; swelling in hands/swelling in feet; pain in wrists/elbows/pain in knees/ankles/pain in hips; pain in shoulders; pain in neck; swelling in wrists/in elbows/in shoulders/in knees/in ankles/in hips; swelling in neck; This case was reported by a pharmacist via other and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received Shingrix and PNEUMOVAX. On an unknown date, less than a month after receiving Shingrix, the patient experienced influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling. On an unknown date, the outcome of the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and pneumonvax vaccinations a couple of weeks ago and had flu like symptoms that lasted 2-3 days.  The patient has recovered. The patient lost 16 lbs due to a recently being diagnosed with rash, patient had cholesterol checked 2 weeks and hepatologist was monitoring blood levels.  The patient mentioned all team of MDs had great communication.  Since starting therapy, the patient had not had any side effects noted fatigue was not as bad and had some minor improvements with less pain and swelling in hands, wrists, elbows, shoulders, knees, ankles, feet, neck, and hips on occasion.  The patient would get discouraged but had a great support from friends.  No further information or side effects provided by the patient.