chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hard lump about one inch from the injection site. It is red, swollen and hot to the touch. It is also painful when touched. The redness spread the first 24 hours to about the size of a quarter then began to retract with warm compresses, however the size of the hard ball or knot has stayed the same. It's now almost 42 hours later and the redness is still about the size of a dime, it is still hot and swollen as well. The size of the ball remains the same.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Peripheral swelling, Rash vesicular, Skin warm, Urticaria
Clinical narrative: Patient, developed hives. The doctor has mention to me that that would be normal to get some hives but they are not some they are all over his body from head to toes. The arm were he got the hives is super swollen and very hot and the hives look like if he had chickenpox and shingles and the uniform hives that are super big. He has three different types of hives the ones on his head are very big and it feels very hard. Like if he had hit his head and he has a lot of them in the head. The ones on the legs and face look like chickenpox and the ones on his stomach are the uniform shaped ones and the shingle like are in the arms as well.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Blood culture, Blood glucose normal, C-reactive protein increased, CSF glucose increased, CSF protein increased
Clinical narrative: 4mo male developed complex febrile seizures which required intubation <12 hours after being given 4mo vaccines.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: CSF red blood cell count positive, CSF white blood cell count negative, Culture, Culture urine negative, Endotracheal intubation
Clinical narrative: 4mo male developed complex febrile seizures which required intubation <12 hours after being given 4mo vaccines.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Febrile convulsion, Haematocrit decreased, Haematocrit normal, Haemoglobin normal, Lymphocyte percentage increased
Clinical narrative: 4mo male developed complex febrile seizures which required intubation <12 hours after being given 4mo vaccines.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Neutrophil percentage decreased, Platelet count decreased, Red blood cell sedimentation rate increased, Specific gravity urine normal, Urine analysis normal
Clinical narrative: 4mo male developed complex febrile seizures which required intubation <12 hours after being given 4mo vaccines.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: White blood cell count normal
Clinical narrative: 4mo male developed complex febrile seizures which required intubation <12 hours after being given 4mo vaccines.
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dysphonia, Rhinorrhoea
Clinical narrative: About a day or two after receiving the shot, my child got a runny nose. She now has a cough and her voice is hoarse in addition to the runny nose.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Blood lactic acid, Cellulitis, Erythema, Full blood count
Clinical narrative: Cellulitis infection to left arm with noted erythema and pain, low grade fevers.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: Cellulitis infection to left arm with noted erythema and pain, low grade fevers.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperaesthesia, Injection site pain, Myalgia, Pain
Clinical narrative: Headache and mod to severe pain at injection site by 4 hrs followed by bad muscle and whole body aches and increased skin sensitivity by 10 hours after injection Feel terrible. Took Tylenol but didn?t help. Took Tramadol 50 mg this morning which seems to be helping. Have never had this reaction to a vaccine. And not sure that I am willing to get the second dose. I am a retired health care provider who believes in the value of vaccinations.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a pharmacy technician and refers to multiple unspecified patients. No information regarding the patient's medical history and concurrent conditions was provided. On unknown dates in 2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported). The doses of ZOSTAVAX were reconstituted with sterile diluent (MERCK) (lot number and expiration date were not reported). It was unknown if sterile diluent (MERCK) had any prior temperature excursions. On 13-APR-2017, the vaccines underwent a temperature excursion of 6 to 14 degrees Fahrenheit (also reported as 9.7 degrees Fahrenheit) for 1 hour and 15 minutes. Digital data logger was involved in the recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. No product quality complaint involved. This is an amended report, as corrected. This is a non-valid report and should have been forwarded to the Non-valid workflow, instead of being distributed.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Injection site vesicles
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to female patient of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in 2017 (reported as "about one year ago"), when she was 12 years old, the patient was vaccinated with the second dose of GARDASIL 9 (0.5 ml, intramuscularly for HPV prevention (lot number and expiration date were not reported). On an unknown date (reported as "an unspecified duration after getting the second dose"), the patient experienced severe blistering at the injection site. She decided not to get the third dose of GARDASIL 9 due to her adverse experience after the second dose. The outcome of injection site vesicles was reported as recovered on an unknown date. The causality between the event and therapy with GARDASIL 9 was not reported.
Sex: F
Vaccine: HPVX
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient did not have genital warts. The patient's medical history or concurrent conditions were not reported. On an unknown date (reported as from 2000-2004), the patient participated in a Human papillomavirus (HPV) vaccine study and years later she received a letter in which was confirmed that she had received the actual vaccine and not the placebo, therefore, the patient was vaccinated with GARDASIL or GARDASIL 9 for prophylaxis (dosage information, route, lot number and expiration date were not informed). A few years ago, on an unknown date, the patient found out that she had HPV, which obviously surprised her since the test was negative at the end of the study. The patient also reported that she read that the vaccine did not protect against all strains of HPV, but that it did protect against the ones that cause cervical cancer. However, in her early thirties she had two irregular pap smears which showed squamous cells, and she was supposed to get tested every 6 months although she did not have it in a little over a year. The patient also stated that she did not know if this was related to the vaccine or its effectiveness, but she thought she should let someone know in case something was wrong with the vaccine or if it possible to run any tests on her. The outcome of papilloma viral infection and smear cervix abnormal was unknown.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 1 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included a sterile diluent (manufacturer unknown). On 22-MAR-2018, the patient was administered an improperly stored M-M-R II (lot: N009172, expiry date: 20-MAR-2019) (product storage error). The vaccine was exposed to 47 degrees F to 77 degrees F (52.1 degrees F) for 11.25 Hours. There were no previous temperature excursions. The call was because of a digital data logger. The sterile diluent (manufacturer unknown) used to reconstitute M-M-R II was properly stored. No adverse effects were reported.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Swelling, Urticaria
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 year old female patient. The patient's pertinent medical history, drug  reactions, allergies, or concomitant medication were unknown by the reporter. On an unknown date and during her 15 month old check-up, the patient was vaccinated with LIQUID PEDVAXHIB for meningitis (dosage information, route and lot number were not informed). On an unknown date, the patient developed "hives and swelling on unspecified parts of the body". The patient was treated with BENYDRYL and unspecified steroids "at an unspecified Hospital Emergency Room and on an unknown date, was "discharged to home in good condition". The patient subsequently "recovered 3-4 days after receiving treatment." The outcome of urticaria and swelling was reported as recovered on an unknown date. The causality assessment between urticaria and swelling and therapy with LIQUID PEDVAXHIB was not provided.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Malaise, fever x 1 day.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injection site erythema, Tachycardia
Clinical narrative: Diarrhea. Tachycardia HR > 100bpm. Redness below injection site. Flu like symptoms.
Age: 37.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Injection site nodule, Pain, Pain in extremity, Skin warm
Clinical narrative: Pt has large knot at the injection site, rest of arm is warm to the touch and red. Pt is having pain throughout upper arm. Will have pt take MOTRIN at home for pain and swelling. Pt will follow-up if symptoms worsen or if he starts having discharge from injection site or fevers.
Age: 37.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Swelling
Clinical narrative: Pt has large knot at the injection site, rest of arm is warm to the touch and red. Pt is having pain throughout upper arm. Will have pt take MOTRIN at home for pain and swelling. Pt will follow-up if symptoms worsen or if he starts having discharge from injection site or fevers.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Found unresponsive the next morning face down in bassinet. Survived unresponsive ~ 1 week.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, the patient was vaccinated with two doses of PNEUMOVAX 23 injection, lot # N010109, expiration date 20-NOV-2018 (also reported as 20-JUN-2018) (exact dose, frequency and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA002687.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-APR-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX subcutaneous injection, lot number M015731 with expiration date on 30-MAR-2018 (strength, dose and anatomical location were not reported) for prophylaxis with sterile diluent (lot number M041812 with expiration date on 17-MAY-2019. No adverse effects were reported.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Blood cholesterol increased, Erythema, Gait disturbance, Pain, Product quality issue
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP reporting for herself. A 85-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose on 27Dec2017 for immunisation trying to prevent having pneumonia, administered by a pharmacist. Medical history was none (no cold or allergy). The patient's concomitant medications were not reported. The patient have had the side effects that just running her nuts: she experienced redness in her arm, red from her elbow to her shoulder on 28Dec2017 with outcome of recovered, swelling on 28Dec2017 with outcome of recovered, pain/started soreness was really bad, pretty quickly after on 28Dec2017 with outcome of unknown, itching on an unspecified date reported as worsened, she has been clawing herself all over here and there on an unspecified date with outcome of unknown, cholesterol is a little over 200 on an unspecified date with outcome of unknown. Swelling, redness and pain lasted about 6 weeks. The redness finally mostly went away (later confirmed that consumer recovered completely from redness), it took 6 weeks for the redness to get a lot better and came to normal. The itching had just gotten worse and worse. She has been clawing herself all over here and there and she has been to her family doctor and to two dermatologist and something was going to be done she was just desperate to know what to do next and how to get rid of it. The swelling got completely recovered in a week or two. The pain in that arm was okay. She was still experiencing the Itching, she has tried so many home remedies and has tried dermatologist family medicine man, nobody has been able to help her. She received treatment taken for itching, redness, swelling and pain: they have given her prescription medication and some over the counter (unspecified medications) to get all that and nothing has helped. She started out with Hydrocortisone and now she was using Nystatin cream and also something like Gold Bond cream, Cetaphil Moisturizing Cream. Also she has used this because it had some ZEASORB-AF, it was actually for athlete's foot but it soothed all over but nothing is lasting. Lab Work: she just had a regular checking cholesterol, every six months. Everything was fine there wasn't a thing that was out of line, except cholesterol which was a little over 200 but still the doctor said that it was good so don't worry about it. A Product Complaint was filed.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non HCP reporting for herself. A 85-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose on 27Dec2017 for immunisation trying to prevent having pneumonia, administered by a pharmacist. Medical history was none (no cold or allergy). The patient's concomitant medications were not reported. The patient have had the side effects that just running her nuts: she experienced redness in her arm, red from her elbow to her shoulder on 28Dec2017 with outcome of recovered, swelling on 28Dec2017 with outcome of recovered, pain/started soreness was really bad, pretty quickly after on 28Dec2017 with outcome of unknown, itching on an unspecified date reported as worsened, she has been clawing herself all over here and there on an unspecified date with outcome of unknown, cholesterol is a little over 200 on an unspecified date with outcome of unknown. Swelling, redness and pain lasted about 6 weeks. The redness finally mostly went away (later confirmed that consumer recovered completely from redness), it took 6 weeks for the redness to get a lot better and came to normal. The itching had just gotten worse and worse. She has been clawing herself all over here and there and she has been to her family doctor and to two dermatologist and something was going to be done she was just desperate to know what to do next and how to get rid of it. The swelling got completely recovered in a week or two. The pain in that arm was okay. She was still experiencing the Itching, she has tried so many home remedies and has tried dermatologist family medicine man, nobody has been able to help her. She received treatment taken for itching, redness, swelling and pain: they have given her prescription medication and some over the counter (unspecified medications) to get all that and nothing has helped. She started out with Hydrocortisone and now she was using Nystatin cream and also something like Gold Bond cream, Cetaphil Moisturizing Cream. Also she has used this because it had some ZEASORB-AF, it was actually for athlete's foot but it soothed all over but nothing is lasting. Lab Work: she just had a regular checking cholesterol, every six months. Everything was fine there wasn't a thing that was out of line, except cholesterol which was a little over 200 but still the doctor said that it was good so don't worry about it. A Product Complaint was filed.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Phone call from parents, reporting that patient is complaining of a small, tender lump (size of a pea) at injection site (received HPV vaccine 03/27/2018). Denies redness or drainage from the site. Nurse offered to assess site, recommended warm, moist packs to area, explained that can have tenderness at injection site for 1 week. Father states he will give it a couple more days and do the warm packs and then bring patient to be assessed.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Soreness to the injection area initially. Later in the evening patient reported body and muscle aches for the next 36 hours.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warm to the touch at injection site. Benadryl and ice didn't improve and warmth is increasing. Patient will be seeing an immediate care professional today.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Eyelid oedema, Headache, Herpes zoster
Clinical narrative: 89-year-old new patient to provider, was here to discuss shingles. She had her shingles vaccine on 03/29/2018. The following day, she developed some pain and headache in the right forehead area and over the weekend developed a rash over that same area. Upon exam on 4/4/2018, this was diagnosed as shingles.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: 89-year-old new patient to provider, was here to discuss shingles. She had her shingles vaccine on 03/29/2018. The following day, she developed some pain and headache in the right forehead area and over the weekend developed a rash over that same area. Upon exam on 4/4/2018, this was diagnosed as shingles.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Chills, Fatigue, Feeling cold, Pain
Clinical narrative: Starting about 5pm he noted aches in his legs and lower back and was cold. The aches have now spread to entire body along with chills and fatigue. Nasal drainage and congestion are also noted and were present on date of vaccination.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Starting about 5pm he noted aches in his legs and lower back and was cold. The aches have now spread to entire body along with chills and fatigue. Nasal drainage and congestion are also noted and were present on date of vaccination.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Upset stomach, mild fever, shivering. Mild swelling, redness and tenderness/pain at injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Upset stomach, mild fever, shivering. Mild swelling, redness and tenderness/pain at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Hypersomnia, Impaired work ability
Clinical narrative: Fatigue that I first noticed about 4 and 1/2 days after receiving the vaccine that lasted for about 10 days. Very unusual for me. Slept 15-17 hours a day, and on day 9, I was unable to even to go work and spent the entire day in bed, sleeping  22 hours and spent the other 2 hours on the couch. I had headache on days 5-9 and loose stools, 3-4 times a day on days 5-9. All symptoms resolved by day 10. On the first 1-2 days I had a sore arm at the injection site, but did not interfere with any activities and I expected that.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Fatigue that I first noticed about 4 and 1/2 days after receiving the vaccine that lasted for about 10 days. Very unusual for me. Slept 15-17 hours a day, and on day 9, I was unable to even to go work and spent the entire day in bed, sleeping  22 hours and spent the other 2 hours on the couch. I had headache on days 5-9 and loose stools, 3-4 times a day on days 5-9. All symptoms resolved by day 10. On the first 1-2 days I had a sore arm at the injection site, but did not interfere with any activities and I expected that.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous, Rash vesicular
Clinical narrative: He experienced posterior left trunk pain followed by a rash, a week after receiving the SHINGRIX vaccine, which spread to his anterior left trunk, with gradually worsening pain so he presented to the ER for further evaluation.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, MMRV
Symptoms: Miliaria
Clinical narrative: 2 days after vaccinations were given, Dad reports that patient developed a rash ("heat bumps") from neck down to groin. No trouble breathing or other symptoms noted. Dad gave BENADRYL and used hydrocortisone cream to skin per the advice of a family member who is an MD. He did not take the child to a physician or ER. Rash resolved in 3 days. This was reported on 4/5/18 when returning to the health department for additional vaccines. Client was referred to pediatrician for an evaluation before receiving further vaccinations.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site bruising, Pain, Swelling
Clinical narrative: Pain, swelling, redness to elbow. Bruising at site of injection (P.S. Husband had no adverse reaction - administered at same time!) (No fair!)
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Irritability, Poor quality sleep, Pyrexia, Vomiting
Clinical narrative: Fever, irritability, poor appetite, vomiting, poor sleep.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Emotional disorder, Erythema, Immediate post-injection reaction, Petechiae
Clinical narrative: Pt. very upset after immunization. Large area of red, non papular, petechiae under chin and clavicle appeared immediately after immunization. Examined by Dr. in clinic.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot swollen area at inj. site. Afebrile.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Cyanosis, Flushing, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Immediately after administration of the vaccine, patients face became flushed and he developed cyanosis. O2 saturations were 91%. Patient was given 0.3mg of epinephrine and 25mg of BENADRYL. An 02 tank was called for but O2 saturations increased to 99%. Heart rate rose from 80-112. EMS was called for and patient was transported to Hospital Emergency room.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Disorientation, Syncope
Clinical narrative: Patient received all 3 vaccines above at an office visit. Approximately 10 minutes after administration patient fainted. Providers laid her flat and she came to roughly 30-45 seconds after start of episode. Patient was a bit disoriented for a few minutes. After this, she felt at her baseline, and left clinic with her family.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Drug level therapeutic, Seizure
Clinical narrative: Patient had witnessed seizure lasting 2.5 minutes one day after receiving SHINGRIX vaccine at local pharmacy.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Yellow skin
Clinical narrative: This spontaneous report was received from a consumer referring to a female patient of unknown age. The patients' concurrent conditions, concomitant therapy, medical history and historical drugs were not reported. On an unknown date in February 2018 (reported as approximately a month ago), the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot # and expiry date were not reported) for pneumococcal infection. On an unknown date in February 2018, within hours after the vaccination (also reported as immediately afterwards), the patient's entire upper arm (left or right arm unspecified) became swollen with a yellow tint for unspecified amount of days. The events outcome was unknown. No product quality complaint was involved. Causality assessment was not provided.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm warm to touch, swollen, and red. It was itchy x 2 days, that has resolved. Area has moved towards R elbow. Denies SOB, fever. Has been taking BENADRYL at night and icing it w/ good effect. Does feel a little under the weather but denies fever, congestion, malaise.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Culture throat, Headache, Musculoskeletal stiffness, Myalgia, Nuchal rigidity
Clinical narrative: After the vaccine was administered, the following day patient developed nucchal rigidity, stiff neck, headaches, and fever. He continually had low grade fevers, headaches and muscle aches for months following the vaccine. Mom brought him in on multiple occasions to the office to be seen following the vaccine for these same symptoms. Prior to the vaccine he had not exhibited these symptoms.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Streptococcus test, Urine analysis
Clinical narrative: After the vaccine was administered, the following day patient developed nucchal rigidity, stiff neck, headaches, and fever. He continually had low grade fevers, headaches and muscle aches for months following the vaccine. Mom brought him in on multiple occasions to the office to be seen following the vaccine for these same symptoms. Prior to the vaccine he had not exhibited these symptoms.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lethargy, Pain, Pyrexia
Clinical narrative: Severe pain at injection site within 2 hours. Chills, fever, lethargy and body aches within 12 hours still persistent.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Day 1: Injection site soreness, fatigue, muscle ache, headache treated with Advil and sleep. Day 2: Same as Day 1. Day 3: Same as Day 1 and 2 with evening chills and nighttime diaphoresis. Day 4: Better morning and daytime but evening onset same as earlier with additional evening onset of hives treated with systemic BENADRYL (50) and topical BENADRYL and ADVIL with resolution of hives within an hour or so. Less nighttime diaphoresis. Increased nausea. Day 5: Better during the day evening return of symptoms with hives and swollen lower lip treated with the same dose of BENADRYL and ADVIL. Day 6: Recovering. Day 7: I believe resolved.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Myalgia, Nausea, Urticaria
Clinical narrative: Day 1: Injection site soreness, fatigue, muscle ache, headache treated with Advil and sleep. Day 2: Same as Day 1. Day 3: Same as Day 1 and 2 with evening chills and nighttime diaphoresis. Day 4: Better morning and daytime but evening onset same as earlier with additional evening onset of hives treated with systemic BENADRYL (50) and topical BENADRYL and ADVIL with resolution of hives within an hour or so. Less nighttime diaphoresis. Increased nausea. Day 5: Better during the day evening return of symptoms with hives and swollen lower lip treated with the same dose of BENADRYL and ADVIL. Day 6: Recovering. Day 7: I believe resolved.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: The 2nd dose of the SHINGRIX shot caused a headache and fever. Fever ran from 2am until 7am. Headache started around 2am as well and I still have it at noon.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient starts having arm and shoulder pain about 15 minutes after injection. Patient experienced chills, exhaustions, body aches, and fever about 7 hours after.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient starts having arm and shoulder pain about 15 minutes after injection. Patient experienced chills, exhaustions, body aches, and fever about 7 hours after.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Coordination abnormal, Gait disturbance, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: It has been almost six months since I had a flu shot at my place of work. I am unable to raise my left arm and any movement causes severe pain. I wake up at night when I move in bed and am not guarding my arm. The pain is excruciating.  The nurse who administered my flu shot, injected me in highest point of my deltoid. I felt pain with the injection. I felt pain driving home and by early evening I was taking a pain reliever. The pain was so severe I could not sleep on my left side (the arm that was injected). This is incredibly painful, to the point of nausea. I also have poor range of motion and am unable to lift with that arm. It is a serious injury.  To date, I have lingering shoulder pain, reduced range of motion, tingling of my entire body (especially during the night), numbness, muscle weakness and lack of coordination.  At times I do have difficulty walking or balancing and I my vision has become worse. I believe this pain is permanent.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Musculoskeletal pain, Nausea
Clinical narrative: It has been almost six months since I had a flu shot at my place of work. I am unable to raise my left arm and any movement causes severe pain. I wake up at night when I move in bed and am not guarding my arm. The pain is excruciating.  The nurse who administered my flu shot, injected me in highest point of my deltoid. I felt pain with the injection. I felt pain driving home and by early evening I was taking a pain reliever. The pain was so severe I could not sleep on my left side (the arm that was injected). This is incredibly painful, to the point of nausea. I also have poor range of motion and am unable to lift with that arm. It is a serious injury.  To date, I have lingering shoulder pain, reduced range of motion, tingling of my entire body (especially during the night), numbness, muscle weakness and lack of coordination.  At times I do have difficulty walking or balancing and I my vision has become worse. I believe this pain is permanent.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia, Sleep disorder, Visual impairment
Clinical narrative: It has been almost six months since I had a flu shot at my place of work. I am unable to raise my left arm and any movement causes severe pain. I wake up at night when I move in bed and am not guarding my arm. The pain is excruciating.  The nurse who administered my flu shot, injected me in highest point of my deltoid. I felt pain with the injection. I felt pain driving home and by early evening I was taking a pain reliever. The pain was so severe I could not sleep on my left side (the arm that was injected). This is incredibly painful, to the point of nausea. I also have poor range of motion and am unable to lift with that arm. It is a serious injury.  To date, I have lingering shoulder pain, reduced range of motion, tingling of my entire body (especially during the night), numbness, muscle weakness and lack of coordination.  At times I do have difficulty walking or balancing and I my vision has become worse. I believe this pain is permanent.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported severe arm pain at the site of injection followed by redness, swelling, warmth and a knot in the arm. Upon the suggestion of the physician she called the pharmacy to report the event.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 75-year-old female patient who receive SHINGRIX (batch number 9XC39, expiry date unknown. On 18th January 2018, the patient received SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, injection site erythema and injection site reaction. The patient was treated with NSAID's and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site warmth, injection site pain and injection site erythema were recovered/resolved and the outcome of the injection site reaction was unknown. The reporter considered the injection site warmth, injection site pain and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were reported as follows: The patient experienced an injection site reaction described as heat, redness, and soreness at the injection site. On day 5 or 6, the patient visited to the pharmacy with a worsening of her symptoms. The patient used NSAIDs and a cold compress as treatment. The pharmacist stated the patient also reported tightness in addition to the other symptoms. The healthcare professional and patient reported tightness in addition to the other symptoms. The healthcare professional and patient reported adverse event through VAERS. No further details were provided regarding the report of tightness. No further medical intervention or physician's visit was required. This was 1 of 3 cases, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Skin warm
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 62-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concomitant products included VALTREX. On 23rd March 2018 08:28, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, fatigue, erythema of extremities and skin warm. On an unknown date, the outcome of the headache, fatigue, erythema of extremities and skin warm were not recovered/not resolved. The reporter considered the headache, fatigue, erythema of extremities and skin warm to be almost certainly related to SHINGRIX. Additional information was received were as follows: The patient reportedly was prescribed with the course of VALTREX in February. No details were provided regarding diagnosis or exact duration. But the therapy was completed prior to the administration of SHINGRIX. No concomitant vaccines were administered. The patient received the SHINGRIX on the right arm. The health care professional reported that the patient returned to the clinic on 26th March 2018. The patient reported experiencing headache and fatigue over the weekend and she presented with the "whole upper part" of her arm red and warm to the touch. The patient was referred to her physician for further evaluation. The health care professional was unable to provide a more definite information regarding start of reaction.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Hypotension, Influenza like illness, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 18-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 15th March 2018, the patient received the 2nd dose of BEXSERO. In March 2018, less than a month after receiving BEXSERO, the patient experienced chills. On 16th March 2018, the patient experienced influenza-like symptoms and fever. On 26th March 2018, the patient experienced low blood pressure and vomiting. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, low blood pressure and vomiting were recovered/resolved. The reporter considered the influenza-like symptoms, fever, chills, low blood pressure and vomiting to be related to BEXSERO. Additional information was received as follows: On 29th January 2018, the patient received 1st dose of BEXSERO and experienced adverse events (refer case US2018GSK056258). On 16th March 2018, 1 day after receiving 2nd dose of BEXSERO, the patient experienced influenza-like symptoms and fever. On 26th March 2018, 11 days after receiving 2nd dose of BEXSERO, the patient experienced low blood pressure and vomiting. The patient went to the hospital on 16th March 2018, he did not stay overnight, but stayed at the infirmary for 24 hours. Adverse events took a week to recovered. This case has been linked to the case US2018GSK056258, reported by same reporter for the same patient. This case has been linked to the case US2018051278 and US2018GSK057910 (brother's case), reported for the patient from same family.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Influenza, Influenza like illness, Influenza virus test positive, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 18-year-old male patient who received BEXSERO. Concurrent medical conditions included ulcerative colitis. Concomitant products included APRISO, REMICADE and VSL Probiotic Sachets. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced influenza-like symptoms, influenza and sickness. On an unknown date, the outcome of the influenza-like symptoms, influenza and sickness were recovered/resolved. The reporter considered the influenza-like symptoms, influenza and sickness to be related to BEXSERO. Additional details were provided as follows: The reporter was the mother of the patient. The patient immune suppressed. In 2018, the patient received the 1st dose of BEXSERO. In 2018,  the patient started getting sicker with flu like symptoms and tested positive for the flu. This case has been linked to the case US2018051277 and US2018GSK056258 for another patient (twin brother) and linked to US2018GSK057910, reported for the same patient.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Exercise tolerance decreased, Feeling cold, Muscle spasms, Pulmonary function test normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 79-year-old male patient who received SHINGRIX. On 16th March 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced wheezing. On 16th March 2018, the patient experienced dry cough, dry heaves, chilliness and spasms. On 23rd March 2018, the patient experienced exercise capacity decreased. On 22nd March 2018, the outcome of the dry cough was resolved with sequelae. On an unknown date, the outcome of the dry heaves and wheezing were recovering/resolving and the outcome of the exercise capacity decreased, chillness and spasms were unknown. The reporter considered the dry cough, dry heaves, exercise capacity decreased, wheezing, chillness and spasms to be almost certainly related to SHINGRIX. Additional information was received as follows: When the patient was in the office after receiving the vaccine, he felt chilly. On the way to home, the patient developed a dry cough, but because the patient was used to gets such types of cough periodically, he did not considered dry cough serious. When the patient went home after 30 minutes, the cough had become more pronounced and the patient was told that it was coming from his lungs. On 16th March 2018, the cough was worsen during the night and the patient described it as a spasm type of cough that the patient could not control. Cough caused the patient to have dry heaves and reports that the cough was worse when he laid in certain positions. The patient was thought about going to the emergency room but he did not. On 17th March 2018 and 18th March 2018, the patient still had the cough but it was not as bad as it was on 16th March 2018. On 19th March 2018, the patient saw his physician and his lung function and oxygen levels were all normal. On 22nd March 2018, Thursday or Friday, 23rd March 2018, although he felt he had been left with wheezing. The wheezing was getting less and less daily. On 23rd March 2018, the patient exercised with his trainer and noted that he was not able to accomplish the same goals as he accomplished the week before due to the wheeze. Reporter gave permission for his physician to be contacted and provided the information.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Retching, Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 79-year-old male patient who received SHINGRIX. On 16th March 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced wheezing. On 16th March 2018, the patient experienced dry cough, dry heaves, chilliness and spasms. On 23rd March 2018, the patient experienced exercise capacity decreased. On 22nd March 2018, the outcome of the dry cough was resolved with sequelae. On an unknown date, the outcome of the dry heaves and wheezing were recovering/resolving and the outcome of the exercise capacity decreased, chillness and spasms were unknown. The reporter considered the dry cough, dry heaves, exercise capacity decreased, wheezing, chillness and spasms to be almost certainly related to SHINGRIX. Additional information was received as follows: When the patient was in the office after receiving the vaccine, he felt chilly. On the way to home, the patient developed a dry cough, but because the patient was used to gets such types of cough periodically, he did not considered dry cough serious. When the patient went home after 30 minutes, the cough had become more pronounced and the patient was told that it was coming from his lungs. On 16th March 2018, the cough was worsen during the night and the patient described it as a spasm type of cough that the patient could not control. Cough caused the patient to have dry heaves and reports that the cough was worse when he laid in certain positions. The patient was thought about going to the emergency room but he did not. On 17th March 2018 and 18th March 2018, the patient still had the cough but it was not as bad as it was on 16th March 2018. On 19th March 2018, the patient saw his physician and his lung function and oxygen levels were all normal. On 22nd March 2018, Thursday or Friday, 23rd March 2018, although he felt he had been left with wheezing. The wheezing was getting less and less daily. On 23rd March 2018, the patient exercised with his trainer and noted that he was not able to accomplish the same goals as he accomplished the week before due to the wheeze. Reporter gave permission for his physician to be contacted and provided the information.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Nausea
Clinical narrative: Nausea, lightheaded, confused.
Age: 44.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Hypersensitivity, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Initially, pain and swelling in the area of the injection site. Flu-like symptoms evolved over a 24-hour period. Redness, pain, and swelling persisted for a few days. Patient was evaluated on 03/21. Therefore local findings, but no fever or systemic findings. Impression was that this was likely a reaction to the PREVNAR vaccine, based on location. Treatment with an antihistamine and topical steroid was initiated. Empiric treatment with an antibiotic was also provided, out of deference to patient history of prior endocarditis. Impression clinically was that this was an allergic response, not infectious. The patient showed a good response to treatment, and reported significant improvement by telephone follow-up, a few days later.
Age: 44.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Vaccination complication
Clinical narrative: Initially, pain and swelling in the area of the injection site. Flu-like symptoms evolved over a 24-hour period. Redness, pain, and swelling persisted for a few days. Patient was evaluated on 03/21. Therefore local findings, but no fever or systemic findings. Impression was that this was likely a reaction to the PREVNAR vaccine, based on location. Treatment with an antihistamine and topical steroid was initiated. Empiric treatment with an antibiotic was also provided, out of deference to patient history of prior endocarditis. Impression clinically was that this was an allergic response, not infectious. The patient showed a good response to treatment, and reported significant improvement by telephone follow-up, a few days later.
Age: 76.0
Sex: F
Vaccine: FLU4, HEPA, VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Scab, Skin lesion
Clinical narrative: Shingles began 9 days after the zoster shot, treated with 10 day course of acyclovir. Gabapentin for the pain. Lesions persisted active for three weeks. Scabs formed by then. Neuralgia persists. Continuing to take gabapentin bid.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt started with arm redness and swelling morning after vaccine. Today (2 days post) warmth, redness, severe swelling. No fluctuance. Swelling is documented past elbow to forearm and all throughout axilla. Itchy and painful to touch.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Oedema peripheral
Clinical narrative: Pt started with arm redness and swelling morning after vaccine. Today (2 days post) warmth, redness, severe swelling. No fluctuance. Swelling is documented past elbow to forearm and all throughout axilla. Itchy and painful to touch.