chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: she could not use her arm; Headache/My head hurt so bad; Sick; Swelling up; Rash/This rash is spreading/ little spot on the side of her nose, on the side of her face; she came home and she felt her arm was a little swollen up; she could not eat anything; Itch; scratching; This is a spontaneous report from a contactable consumer (patient). A 70-year-old (as reported) female patient received first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration in Oct2019 at single dose for not to get sick.  Medical history included asthma, cholesterol. Concomitant medication included simvastatin (Expiration Date: 04Mar2020) at 20 mg, once daily at night at bed time for cholesterol, montelukast sodium (SINGULAIR, Expiration Date: 03Mar2020) at 10 mg, by mouth at bed time once a day for asthma. The patient previously took unspecified medications (pneumonia shot). Consumer stated, when she got the shot (pneumococcal 13-val conj vac (dipht crm197 protein)) in Oct2019 and this was not her first pneumonia shot (Unspecified medications), at that night she could not use her arm and it was like bad and she had to put it in the front so, she was thinking that and the headaches she had and she had it for like three or four days she was very sick, the headache, the swelling up, it was just horrible but, she felt it was okay but, she noticed she kept scratching this little spot on the side of her nose not on her nose but, on the side of her face and she was looking in the mirror and she did put Vaseline on it again but, it looked like it had got bigger so, she looked at it and it was a rash which she thought it was okay and it would go away. At time of the report,  it had been going on for three weeks and the rash had taken over her face, it was slowly taking over her face. She had been very sick and she was old and when you get that sick it was scary. The patient had an appointment with Primary Care tomorrow and she could call back with more details. The patient was just given pneumococcal 13-val conj vac (dipht crm197 protein) and she came home and she felt her arm was a little swollen up so, she put ice and stuff and by the night time she could not use it and she was sick. Treatment included she took something for her headache because, her head hurt so bad and she could not eat anything. The patient had an appointment that was Friday. She have an appointment on Monday morning at 09 o'clock so, they have already put in for a dermatologist so, they can get a closer look at it because, it had spread and they could see how it had spread since she was there Friday. They just squeezed her in and lady told her did not put anything on it, if it itches or so put cold compress because, it did itched and wait till she come in Monday so they can get a look at it and try to figure out what had happened here or was it something else and not the pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Condition aggravated, Cough, Dysphonia, Dyspnoea
Clinical narrative: 10 Min after vaccination pressure felt in head and headache 3hrs after itchy throat, uncontrolled coughing, runny nose got worse but also stuffy slight muscle aching  5 hrs after vaccination muscle pain worsens voice becomes hoarse and cough worse, body become hot but started having chills, lips felt tight, headache  worsened, shortness of breath and wheezing. All around general sick feeling.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Head discomfort, Headache, Malaise, Myalgia, Nasal congestion
Clinical narrative: 10 Min after vaccination pressure felt in head and headache 3hrs after itchy throat, uncontrolled coughing, runny nose got worse but also stuffy slight muscle aching  5 hrs after vaccination muscle pain worsens voice becomes hoarse and cough worse, body become hot but started having chills, lips felt tight, headache  worsened, shortness of breath and wheezing. All around general sick feeling.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Oral discomfort, Rhinorrhoea, Skin warm, Throat irritation, Wheezing
Clinical narrative: 10 Min after vaccination pressure felt in head and headache 3hrs after itchy throat, uncontrolled coughing, runny nose got worse but also stuffy slight muscle aching  5 hrs after vaccination muscle pain worsens voice becomes hoarse and cough worse, body become hot but started having chills, lips felt tight, headache  worsened, shortness of breath and wheezing. All around general sick feeling.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Two female adult patients received Flulaval in the deltoid muscle and the next day experienced leg pain moving from upper leg to foot. No previous medical issues that might have contributed or cause pain. Seen in the ER neither patient had blood clots or any other condition to explain pain.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Laboratory test, Muscular weakness, Pain in extremity
Clinical narrative: It?s 3 weeks later and I?m experiencing numbness tingling & pain in my left arm. It?s very weak & hard too lift up.  I?m at the er now to see what the pry could be. I called my doctor & they advised me to come to the er.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: It?s 3 weeks later and I?m experiencing numbness tingling & pain in my left arm. It?s very weak & hard too lift up.  I?m at the er now to see what the pry could be. I called my doctor & they advised me to come to the er.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient received flu shot around 11:40 am, that evening she experience bad lower back pain that radiated down both legs more so on right than left.  Patient states it took a couple of days for the back and leg pain to resolve.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain, Lymph node pain, Lymphadenopathy, Migraine
Clinical narrative: Severe fatigue 24 hours after vaccine and continuing for 7 days. Enlarged, painful lymph node around left collar bone. Migraine. Painful injection site for 7 days.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Malaise, Pain in extremity
Clinical narrative: Patient said he felt sick within a couple hours of getting vaccine. He could barely walk up the stairs, his arm ached and his joints hurt.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reported prolonged shoulder pain after injection
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Received vaccine in the morning on upper left arm, a couple hours later it was sore (which has happened years earlier but usually goes away in a day or two).  Three days later it still hurt to where patient couldn't put her coat on or lift her arm without it hurting, it is still that way to this day.
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Joint stiffness, Musculoskeletal pain
Clinical narrative: Left shoulder soreness began a couple of hours after injection. Right shoulder sore after 5 days. Pain continueing 3 weeks after injection. Left arm cannot be raised above shoulder level. Wrist and fingers stiff and achy. Shoulder pain on both arms. Left is worse. Wrists and fingers ache on both hands.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Left shoulder soreness began a couple of hours after injection. Right shoulder sore after 5 days. Pain continueing 3 weeks after injection. Left arm cannot be raised above shoulder level. Wrist and fingers stiff and achy. Shoulder pain on both arms. Left is worse. Wrists and fingers ache on both hands.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema
Clinical narrative: My daughter recieved the flu vaccine on 11/8/2019. She currently has a very large red patch at the injection sight. No bruising, just redness. Does not seem to irritate or bother her.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Hypersensitivity, Rash, Urticaria
Clinical narrative: Narrative: Pt seen in the ED on 10/24/18 for allergic reaction to flu shot. Was given prescriptions for Epipen (qty 1) and famotidine 20 mg PO BID for 5 days. Symptoms: ]. RASH; URTICARIA; DYSPNEA Treatment Drugs Used: 1. EPINEPHRINE Dose: Units: Freq: Route: 2. FAMOTIDINE Dose: 20 Units: Freq: BID Route:
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Pt. states that she received HD influenza immunization and a day later, began having shortness of breath (pt is asthmatic), which later resulted in a hospitalization. Pt states that she hasn't had an "attack" in years and attributed the shortness of breath to the Immunization.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Nausea
Clinical narrative: I am a 56 year old male in good health. I received the first dose of the Shingrix vaccine in late August 2019. I had no side effects. When I went to the pharmacy to have the second dose on October 29, 2019 the pharmacist asked me if I had experienced any flu like symptoms related to the first dose. I replied no. The pharmacist administered the second dose of the Shingrix vaccine on October 29, 2019. Later that night I developed a bad headache, fever and chills, nausea and stomach cramping, and body aches. These symptoms continued throughout the day on October 30. The symptoms have lessened today, October 31 although I have a "worn out" feeling as a result of this.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I am a 56 year old male in good health. I received the first dose of the Shingrix vaccine in late August 2019. I had no side effects. When I went to the pharmacy to have the second dose on October 29, 2019 the pharmacist asked me if I had experienced any flu like symptoms related to the first dose. I replied no. The pharmacist administered the second dose of the Shingrix vaccine on October 29, 2019. Later that night I developed a bad headache, fever and chills, nausea and stomach cramping, and body aches. These symptoms continued throughout the day on October 30. The symptoms have lessened today, October 31 although I have a "worn out" feeling as a result of this.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood pressure increased, Chills, Fatigue, Headache, Injection site oedema
Clinical narrative: At local store was given Fluzone HD PF 19-20 inj sq R arm and Prevnar 13 inj IM L arm 10/14/19. Experienced L arm deltoid edema,pain > R arm, chills first day, 2nd day fatigue/malaise and headache. Went to primary care a week later for another issue and was surprised to find that my b/p which normally runs 130s/80s was now 140s/101 -90s, pulse in 90s. Have had continuing low grade headache and elevated b/p since. Since a rare s/e of Pneumovax has been CVA and I have experienced continuing elevated (unusual for me) b/p since Pneumovax was given 22 days ago, I have concerns about this vaccine. I won't be taking the sequel 13.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Malaise
Clinical narrative: At local store was given Fluzone HD PF 19-20 inj sq R arm and Prevnar 13 inj IM L arm 10/14/19. Experienced L arm deltoid edema,pain > R arm, chills first day, 2nd day fatigue/malaise and headache. Went to primary care a week later for another issue and was surprised to find that my b/p which normally runs 130s/80s was now 140s/101 -90s, pulse in 90s. Have had continuing low grade headache and elevated b/p since. Since a rare s/e of Pneumovax has been CVA and I have experienced continuing elevated (unusual for me) b/p since Pneumovax was given 22 days ago, I have concerns about this vaccine. I won't be taking the sequel 13.
Sex: M
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: My then 2 year old son got the flu shot. That night he developed a stutter that has not gone away.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: I got two vaccines on 11/2/19, a flu shot (Fluarix quadrivalent) and Shingrix (1st dose). Within 6 hrs was feeling some muscle aches and slight fever. Both worsened and persisted for an additional 24 hrs or so.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgraphia, Injection site hypoaesthesia, Injection site joint pain, Injection site pain, Injection site paraesthesia
Clinical narrative: Pharmacy came to worksite on 10/3/19 and gave flu shots to employees. I received Fluarix QIV PFS 2019-2020 Injection 0.5 ML. To date, 10/31/19, having burning, numbness, tingling, muscle & joint pain in upper left arm where injection was given. Arm is "shaky" at times and writing is difficult.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Pharmacy came to worksite on 10/3/19 and gave flu shots to employees. I received Fluarix QIV PFS 2019-2020 Injection 0.5 ML. To date, 10/31/19, having burning, numbness, tingling, muscle & joint pain in upper left arm where injection was given. Arm is "shaky" at times and writing is difficult.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Starting about 1 hour after administration of the vaccination, the patient started to feel some dull pain which has decreased over time but is still present to this day.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Exposure during pregnancy
Clinical narrative: Pt had abdominal pain and went to ED for treatment one day following HPV vaccination. Pt is pregnant.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchospasm, Chest X-ray, Cough, Injection site erythema, Injection site swelling
Clinical narrative: Received 2 vaccine doses, 2.5 months apart. Both times: notable local injection site redness and swelling (expected). Within 24 hours: nausea, subjective fever, feeling unwell. Within 48 hours: intense sneezing and rhinorrhea with a non-productive cough. Within 36 hours: Subjective  fever with clear productive coughing, unrelenting, with 3-4 pillow  orthopnea persisting to reporting date accompanied by severe bronchspasm (almost refractory to albuterol nebulizer treatment q6h). All symptoms slowly improving slowly after day 6 but persisting to date of report.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Orthopnoea, Productive cough, Pyrexia
Clinical narrative: Received 2 vaccine doses, 2.5 months apart. Both times: notable local injection site redness and swelling (expected). Within 24 hours: nausea, subjective fever, feeling unwell. Within 48 hours: intense sneezing and rhinorrhea with a non-productive cough. Within 36 hours: Subjective  fever with clear productive coughing, unrelenting, with 3-4 pillow  orthopnea persisting to reporting date accompanied by severe bronchspasm (almost refractory to albuterol nebulizer treatment q6h). All symptoms slowly improving slowly after day 6 but persisting to date of report.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Received 2 vaccine doses, 2.5 months apart. Both times: notable local injection site redness and swelling (expected). Within 24 hours: nausea, subjective fever, feeling unwell. Within 48 hours: intense sneezing and rhinorrhea with a non-productive cough. Within 36 hours: Subjective  fever with clear productive coughing, unrelenting, with 3-4 pillow  orthopnea persisting to reporting date accompanied by severe bronchspasm (almost refractory to albuterol nebulizer treatment q6h). All symptoms slowly improving slowly after day 6 but persisting to date of report.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed mild swelling and redness at the site on the afternoon of 11/13/2019 and reported to mother. She marked out boarders and gave him benadryl. Area is sore and redness grew outside of marked boarder since yesterday. Afebrile
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Exostosis, Limb discomfort, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: The evening of the shot I had swelling and extreme discomfort and was unable to move my arm above horizontal. The selling subsided however the pain and inability to lift the arm continued in spite of taking 600 mg of ibuprofen three times per day and icing the area. On 10/24/ after still having no relief, I visited my PCP who advised me ti increase the ibuprofen to 800 mg tid and continue with ice and if still no relief prescribed a medrol dosepak. Upon completing the dosepak, still no relief so I have been referred to an orthopedic MD who has prescribed physical therapy, however advised pain could last up to 2 years
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: X-ray abnormal
Clinical narrative: The evening of the shot I had swelling and extreme discomfort and was unable to move my arm above horizontal. The selling subsided however the pain and inability to lift the arm continued in spite of taking 600 mg of ibuprofen three times per day and icing the area. On 10/24/ after still having no relief, I visited my PCP who advised me ti increase the ibuprofen to 800 mg tid and continue with ice and if still no relief prescribed a medrol dosepak. Upon completing the dosepak, still no relief so I have been referred to an orthopedic MD who has prescribed physical therapy, however advised pain could last up to 2 years
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Erythema, Fall, Gait inability, Head injury
Clinical narrative: After the vaccine was given we went out to the waiting room to get proof of the vaccine for the school.  Patient went and sat down as I went to the receptionist for the print out.  As I was waiting I turned around and patient was face down on the floor.  I ran over to her and she was stiff and unconscious. I turned her over some and was yelling and telling he to wake up.  At that point Dr.  made it out and patient looked up at me and ask why I was yelling.  I asked if she was ok and she just acted confused.   I asked patient if she could get up and patient said no.  Dr. did some kind of test on her phone and checked her blood pressure and heart and said everything was ok.  But patient was still confused and didnt seem to be able to get up, Dr. had the medical assistant get a wheelchair.  I could see a red mark on patient head where she hit the floor.  Dr. got an ice pack for he head.  Dr. asked if I wanted her to call the ambulance and i said if she cant help her.  That's when the medical assistant came with the wheelchair.  So Dr. said let me check her again and still patient said she couldn't walk so I lifted/help patient get into the wheelchair.  Dr. checked her and said everything looked ok, and said take her to the emergency room.  I took patient to hospital  and at this point patient was able to walk.  The hospital ran more test and said she was ok, and released patient.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test normal, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: After the vaccine was given we went out to the waiting room to get proof of the vaccine for the school.  Patient went and sat down as I went to the receptionist for the print out.  As I was waiting I turned around and patient was face down on the floor.  I ran over to her and she was stiff and unconscious. I turned her over some and was yelling and telling he to wake up.  At that point Dr.  made it out and patient looked up at me and ask why I was yelling.  I asked if she was ok and she just acted confused.   I asked patient if she could get up and patient said no.  Dr. did some kind of test on her phone and checked her blood pressure and heart and said everything was ok.  But patient was still confused and didnt seem to be able to get up, Dr. had the medical assistant get a wheelchair.  I could see a red mark on patient head where she hit the floor.  Dr. got an ice pack for he head.  Dr. asked if I wanted her to call the ambulance and i said if she cant help her.  That's when the medical assistant came with the wheelchair.  So Dr. said let me check her again and still patient said she couldn't walk so I lifted/help patient get into the wheelchair.  Dr. checked her and said everything looked ok, and said take her to the emergency room.  I took patient to hospital  and at this point patient was able to walk.  The hospital ran more test and said she was ok, and released patient.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient's arm is red, swollen and tender from shoulder to elbow. She says it's been hurting for over a week.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Eye movement disorder, Tremor
Clinical narrative: AFTER ADMINISTERING THE PAPILLOMA VIRUS VACCINE (GARDASIL), THE PATIENT PRESENTED WITH DIZZINESS, TREMBLING AND EYE DEVIATION.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Tenderness, warm feeling , a some pain around injection site on left arm.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site inflammation, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: TIME LINE FOR SIDE EFFECTS FOLLOWING IMMUNIZATIONS All events listed below occurred in October 2019, none accompanied by fever, all controllable by ibuprofen. (I was part of the original shingles prevention study in the late 1990's and early 2000s. I received the placebo but developed no symptoms. Received the real thing at the end of the study when I was about 73.)  - 10/01 - received flu vaccine - 10/06 - severe pain in both knees 24 hours after usual leg press (190#) at gym, subsides next day - 10/10 - received Shingrix vaccine - 10/12 - swelling and tenderness at injection site, 2x2 inch square inflamation - 10/25 - sudden onset of moderate pain in both hips - 10/26 - pain spreads to knees and ankles - 10/27 - pain in all joints and neck - 10/28 - pain in hips only - 10/29 - hip pain subsides, severe rash develops on back (waist to shoulders, see photo) - 10/30 - rash subsides - 10/31 - slight rash remaining
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: TIME LINE FOR SIDE EFFECTS FOLLOWING IMMUNIZATIONS All events listed below occurred in October 2019, none accompanied by fever, all controllable by ibuprofen. (I was part of the original shingles prevention study in the late 1990's and early 2000s. I received the placebo but developed no symptoms. Received the real thing at the end of the study when I was about 73.)  - 10/01 - received flu vaccine - 10/06 - severe pain in both knees 24 hours after usual leg press (190#) at gym, subsides next day - 10/10 - received Shingrix vaccine - 10/12 - swelling and tenderness at injection site, 2x2 inch square inflamation - 10/25 - sudden onset of moderate pain in both hips - 10/26 - pain spreads to knees and ankles - 10/27 - pain in all joints and neck - 10/28 - pain in hips only - 10/29 - hip pain subsides, severe rash develops on back (waist to shoulders, see photo) - 10/30 - rash subsides - 10/31 - slight rash remaining
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Chest pain, Computerised tomogram head, Electrocardiogram, Facial pain
Clinical narrative: Severe head pain, lower jaw/facial pain mild chest pain, swollen left arm, hand hives, swollen eye lids
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain in jaw, Peripheral swelling, Swelling of eyelid, Urticaria
Clinical narrative: Severe head pain, lower jaw/facial pain mild chest pain, swollen left arm, hand hives, swollen eye lids
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Hypersensitivity, Rash, Urticaria
Clinical narrative: Pt seen in the ED on 10/24/18 for allergic reaction to flu shot. Was given prescriptions for Epipen (qty 1) and famotidine 20 mg PO BID for 5 days. Symptoms: , 1. RASH; URTICARIA; DYSPNEA Treatment Drugs Used: 1 - EPINEPHRINE Dose: Units: Freq: Route: 2 - FAMOTIDINE Dose: 20 Units: Freq: BID Route:
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Nurse administered Flulaval quadrivalent 2018/2019 formula for the 2019/2020 season after medication had expired on 06/30/2019.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13
Symptoms: Rash
Clinical narrative: Lacy reticular rash all over body
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No adverse effects; patient, who is pregnant, received a dose of GARDASIL 9; her flu vaccine, but instead gave Gardasil; This spontaneous prospective pregnancy report as received from a medical assistant and refers to a 38-year-old female pregnant patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The patient became pregnant with LMP of 27-JUN-2019 and EDD of 02-APR-2020. On 14-OCT-2019, the patient was accidently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the deltoid, # R011630, expiration date 12-DEC-2020 for prophylaxis instead of unspecified influenza virus vaccine (dose, site, route of administration, lot # and expiration date were not reported). No adverse effects reported.
Age: 17.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Eye irritation, Headache, Oropharyngeal pain
Clinical narrative: the patient reported having a mild headache, eye irritation, and sore throat; the patient reported having a mild headache, eye irritation, and sore throat; the patient reported having a mild headache, eye irritation, and sore throat; This spontaneous report was received from a physician via company representative,  referring to a 17-year-old male patient. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reporter.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for complete the series (prophylaxis) and  sterile diluent (strength, dose, route of administration, and anatomical site of vaccination, lot number and expiration date were not reported). It was mention a used of sterile diluent (MERCK STERILE DILUENT).      On an unknown date, the patient reported having a mild headache, eye irritation and sore throat (Oropharyngeal pain) to a the physician. The outcome of headache, oropharyngeal pain and eye irritation was reported as resolved. The patient stated that he sought for medical attention and not treatment was given for the adverse events.  The causality assessment between the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the occurrence of the aforementioned events was not reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Patient was administered an improperly stored ROTATEQ.; No adverse event; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 01-NOV-2019, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis, lot# 1660935 and expiration date on 06-OCT-2020 (anatomical location, route of administration, dose and strength date were not reported) which was improperly stored. The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vaccine underwent temperature excursions of 51.28 degrees Fahrenheit (°F) as a total time and highest temperature above 47 degrees Fahrenheit (°F) (9 degrees Celsius (°C) for a time frame of 2 hours and 16 minutes, which was not called by the digital data logger with a supported outcome. There were no previous temperature excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: muscle pain; tiredness; headache; shivering; low grade fever; redness; swelling; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (experienced pain, swelling and redness at the injection site, see case US2019GSK203632).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 6th November 2019, less than a day after receiving Shingrix, the patient experienced localized erythema, local swelling, tiredness, headache, shivering and low grade fever. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the localized erythema, local swelling, muscle pain, tiredness, headache, shivering and low grade fever were unknown.   It was unknown if the reporter considered the localized erythema, local swelling, muscle pain, tiredness, headache, shivering and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced localized reaction and was little red and swollen. The patient also experienced muscle pain in her back and legs, tiredness, headache, shivering, and low grade fever. The patient said that  there was no severe flu like reaction. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: muscle pain; tiredness; headache; shivering; low grade fever; redness; swelling; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (experienced pain, swelling and redness at the injection site, see case US2019GSK203632).   On 6th November 2019, the patient received the 2nd dose of Shingrix. On 6th November 2019, less than a day after receiving Shingrix, the patient experienced localized erythema, local swelling, tiredness, headache, shivering and low grade fever. On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the localized erythema, local swelling, muscle pain, tiredness, headache, shivering and low grade fever were unknown.   It was unknown if the reporter considered the localized erythema, local swelling, muscle pain, tiredness, headache, shivering and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced localized reaction and was little red and swollen. The patient also experienced muscle pain in her back and legs, tiredness, headache, shivering, and low grade fever. The patient said that  there was no severe flu like reaction. The patient consented to follow up.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: Muscle weakness; Fever; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness and fever. On an unknown date, the outcome of the muscle weakness and fever were unknown.   It was unknown if the reporter considered the muscle weakness and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had extreme muscle weakness and fever.The reporter asked had anyone died from this vaccine.  The patient concerned about getting 2nd dose. The reporter asked also was there any contraindication to giving it to a person with type 2 herpes. The reporter asked who should not get the vaccine. The reporter asked had been diagnosed with herpes 2, or your reaction to the 1stinjection was severe muscle pain and fever.Enough to be bed ridden, what was the mortality rate from this vaccine. The reporter asked I should be getting my second dose soon, but not sure after the problems I had with it.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood cholesterol increased, Blood pressure increased, Chest pain, Contraindication to vaccination, Herpes zoster
Clinical narrative: worse shingles; pain; Neck pain; increase blood pressure; increase cholesterol; elevated liver function tests; Weight loss; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had punch biopsy of his left wrist by a dermatologist), knee operation, blister (had the blisters on the left side of his face  forehead and chin, around his waist and between his legs) and crushing injury of back (crushed lumber and cervical vertebrae). Concurrent medical conditions included shingles (began with the shingles episode in early March and April 2019), urticaria and pain.   On 23rd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss. On an unknown date, the outcome of the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss were unknown.   It was unknown if the reporter considered the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient had active case of shingles, urticaria, and pain all over his body before he received both his first and 2nd dose. The patient had the blisters on the left side of his face forehead and chin, around his waist and between his legs. The patient noted that the vaccine probably super charged the issues, but does not blame GSK because he stated the doctors were aware he had the issues before he received the vaccine and everything he has read about the vaccine says that he should not receive the vaccine with active case. The patient noted that had an episode of pain in his chest and neck that he thought he was having a heart attack and thought he was going to die. The patient had increased blood pressure off and on, and his cholesterol went up to 236 from 215. The patient lost 20 pounds by changing his eating habits. The patient did not consent to follow up.      Lab Comments: On an unknown date nuclear medicine test was done. On an unknown date Blood pressure was noted. elevated liver function tests was around July, August or September 2019.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test normal, Liver function test increased, Neck pain, Weight decreased
Clinical narrative: worse shingles; pain; Neck pain; increase blood pressure; increase cholesterol; elevated liver function tests; Weight loss; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had punch biopsy of his left wrist by a dermatologist), knee operation, blister (had the blisters on the left side of his face  forehead and chin, around his waist and between his legs) and crushing injury of back (crushed lumber and cervical vertebrae). Concurrent medical conditions included shingles (began with the shingles episode in early March and April 2019), urticaria and pain.   On 23rd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss. On an unknown date, the outcome of the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss were unknown.   It was unknown if the reporter considered the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient had active case of shingles, urticaria, and pain all over his body before he received both his first and 2nd dose. The patient had the blisters on the left side of his face forehead and chin, around his waist and between his legs. The patient noted that the vaccine probably super charged the issues, but does not blame GSK because he stated the doctors were aware he had the issues before he received the vaccine and everything he has read about the vaccine says that he should not receive the vaccine with active case. The patient noted that had an episode of pain in his chest and neck that he thought he was having a heart attack and thought he was going to die. The patient had increased blood pressure off and on, and his cholesterol went up to 236 from 215. The patient lost 20 pounds by changing his eating habits. The patient did not consent to follow up.      Lab Comments: On an unknown date nuclear medicine test was done. On an unknown date Blood pressure was noted. elevated liver function tests was around July, August or September 2019.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash, Varicella virus test
Clinical narrative: worse shingles; pain; Neck pain; increase blood pressure; increase cholesterol; elevated liver function tests; Weight loss; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included biopsy (had punch biopsy of his left wrist by a dermatologist), knee operation, blister (had the blisters on the left side of his face  forehead and chin, around his waist and between his legs) and crushing injury of back (crushed lumber and cervical vertebrae). Concurrent medical conditions included shingles (began with the shingles episode in early March and April 2019), urticaria and pain.   On 23rd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss. On an unknown date, the outcome of the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss were unknown.   It was unknown if the reporter considered the shingles, chest pain, neck pain, increased blood pressure, blood cholesterol increased, raised liver function tests and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient had active case of shingles, urticaria, and pain all over his body before he received both his first and 2nd dose. The patient had the blisters on the left side of his face forehead and chin, around his waist and between his legs. The patient noted that the vaccine probably super charged the issues, but does not blame GSK because he stated the doctors were aware he had the issues before he received the vaccine and everything he has read about the vaccine says that he should not receive the vaccine with active case. The patient noted that had an episode of pain in his chest and neck that he thought he was having a heart attack and thought he was going to die. The patient had increased blood pressure off and on, and his cholesterol went up to 236 from 215. The patient lost 20 pounds by changing his eating habits. The patient did not consent to follow up.      Lab Comments: On an unknown date nuclear medicine test was done. On an unknown date Blood pressure was noted. elevated liver function tests was around July, August or September 2019.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: Tendernes in arm; Fever; Chills; Exhaustion; nausea; Huge red knot on arm at least 3.5 inches around; felt terrible; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd October 2019, 6 hrs after receiving Shingrix, the patient experienced fever, chills, exhaustion, nausea, erythema and feels awful. On an unknown date, the patient experienced weakness of arms. On 8th October 2019, the outcome of the fever, chills, exhaustion, nausea, erythema and feels awful were recovered/resolved. On an unknown date, the outcome of the weakness of arms was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, exhaustion, nausea, erythema, feels awful and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in an unknown arm. The patient reported that, around 9 am received dose of Shingrix vaccine. By 3 pm, the patient experienced fever, chills, exhaustion, nausea, erythema, feels awful and weakness of arms. After vaccination the patient had huge red knot on her arm at least 3.5 inches around. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nodule, Pyrexia
Clinical narrative: Tendernes in arm; Fever; Chills; Exhaustion; nausea; Huge red knot on arm at least 3.5 inches around; felt terrible; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd October 2019, 6 hrs after receiving Shingrix, the patient experienced fever, chills, exhaustion, nausea, erythema and feels awful. On an unknown date, the patient experienced weakness of arms. On 8th October 2019, the outcome of the fever, chills, exhaustion, nausea, erythema and feels awful were recovered/resolved. On an unknown date, the outcome of the weakness of arms was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, exhaustion, nausea, erythema, feels awful and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in an unknown arm. The patient reported that, around 9 am received dose of Shingrix vaccine. By 3 pm, the patient experienced fever, chills, exhaustion, nausea, erythema, feels awful and weakness of arms. After vaccination the patient had huge red knot on her arm at least 3.5 inches around. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Injection site pain, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore Throat; Feeling tired; Runny nose; Fast heartbeat; Come down with a cold; Left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 31st October 2020) for prophylaxis.   Concurrent medical conditions included joint replacement (Artificial right elbow).   On 1st November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 1st November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 3rd November 2019, the patient experienced sore throat, tiredness, runny nose, heart rate increased and cold. On 3rd November 2019, the outcome of the heart rate increased was recovered/resolved. On an unknown date, the outcome of the sore throat, tiredness, runny nose, pain in arm and cold were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, tiredness, runny nose, heart rate increased, pain in arm and cold to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 3rd November 2019 around 6:30 pm, 2 days after vaccinaiton, the patient experienced sore throat, tiredness, runny nose, heart rate increased and cold. The patient reported that, had fast heartbeat while sitting down watching television. The patient statyed that, had left upper arm pain for the past 3 days from the date of reporting and on the day of reporting the arm hurts only if pushed down. This was one of 2 linked cases, reported by same reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rhinorrhoea
Clinical narrative: Sore Throat; Feeling tired; Runny nose; Fast heartbeat; Come down with a cold; Left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 31st October 2020) for prophylaxis.   Concurrent medical conditions included joint replacement (Artificial right elbow).   On 1st November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 1st November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 3rd November 2019, the patient experienced sore throat, tiredness, runny nose, heart rate increased and cold. On 3rd November 2019, the outcome of the heart rate increased was recovered/resolved. On an unknown date, the outcome of the sore throat, tiredness, runny nose, pain in arm and cold were not recovered/not resolved.   It was unknown if the reporter considered the sore throat, tiredness, runny nose, heart rate increased, pain in arm and cold to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 3rd November 2019 around 6:30 pm, 2 days after vaccinaiton, the patient experienced sore throat, tiredness, runny nose, heart rate increased and cold. The patient reported that, had fast heartbeat while sitting down watching television. The patient statyed that, had left upper arm pain for the past 3 days from the date of reporting and on the day of reporting the arm hurts only if pushed down. This was one of 2 linked cases, reported by same reporter.