chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARlVAX; This spontaneous report was received from a registered nurse, referring to a 15-year-old female patient. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 23-AUG-2020, at the age of 15-year-old the patient was administered improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX), injection, administered subcutaneously (strength, dose, vaccination scheme, anatomical site of vaccination were not reported; lot number S030223, which has been verified to be valid, expiration date reported and validated as 26-SEP-2021) as propylaxis (product storage error), as concomitant therapy a properly stored of sterile diluent (MERCK STERILE DILUENT) injection (lot number S015772, which has been verified to be valid, expiration date reported and validated as 12-FEB-2022) was used as medication dilution to reconstitute the vaccine. The vaccine administered experienced a temperature and time frame from 9 degrees Celsius to 25C (8.7C) for 7 hours and 25 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: 3 patients reported on the document who received ROTATEQ after an excursion was reported/Temperature 48F Time frame 17 minutes; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions and allergies and concomitant medications were not reported.   On 13-JUL-2020, at the age of 4-months-old, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliters, by oral route (formulation, strength, vaccination scheme were not reported; lot number S004400, which has been verified to be valid, expiration date was not reported, but upon internal review was established as 14-NOV-2020) as prophylaxis. The vaccine administered experienced a temperature excursion of 48 degrees Fahrenheit for a time frame of 17 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA006635: US-009507513-2009USA006229: US-009507513-2009USA007901:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: 3 patients reported on the document who received ROTATEQ after an excursion was reported/Temperature 48F Time frame 17 minutes; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions and allergies and concomitant medications were not reported.   On 17-JUL-2020, at the age of 10-weeks-old the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliters, by oral route (formulation, strength, vaccination scheme were not reported; lot number S004400, which has been verified to be valid, expiration date was not reported, but upon internal review was established as 14-NOV-2020) as prophylaxis. The vaccine administered experienced a temperature excursion of 48 degrees Fahrenheit for a time frame of 17 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA006635: US-009507513-2009USA006229: US-009507513-2009USA007900:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around 21-OCT-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of preventing shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "shortly after receiving the vaccine"), the pt suffered a bad case of shingles. It was reported that as a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and sustained severe, serious, progressive and permanent personal and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   By the time of reporting, the patient was considered to be not recovered from the event. Moreover, the event was considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the reported event was considered to be disabling.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effects reported; 33 year old male patient was administered dose one of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 33-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in December 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), on an unknown date in February 2020, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on 18-SEP-2020 (reported as today), he would be vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (site and route of administration, lot# and expiration date were not reported for any) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: bad reaction; This case was reported in a literature article and described the occurrence of adverse reaction in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   The reporter considered the adverse reaction to be related to Flu vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of bad reaction, in a female patient of unspecified age, who was vaccinated with unspecified flu vaccine (manufacturer unknown) for prophylaxis. This case corresponds to Participant reported in this literature article. The patient was a part of study that aimed to understand how the vaccine decision-making process differed between parents with a child diagnosed with autism and parents with a child that did not have autism. Interviews were conducted in September-December 2018 with 24 racially and demographically diverse parents of children at two clinics serving patients, one of which only serves families of children with autism. [In this study, 24 parent participants were interviewed. The majority were female (92%), and aged 40-49 years (46%). Fourteen parent participants had children with autism interviewed (ASD), and the remaining ten had neurotypical children]. The patient was at least at least 18 years of age and currently had a child who had ASD. No information on patient medical or family history or concurrent condition or concomitant medication was reported. On an unspecified date, the patient had unspecified Flu vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age at vaccination was not reported.  On an unknown date, an unspecified time after vaccination, the patient had really bad experience with the flu vaccine to the point where the patient was hospitalized for a week after one time. The patient reported to have a really bad reaction. After that, patient had never given her child a flu vaccine, neither one of them. The case was considered as serious due to hospitalization. Treatment was unknown. Outcome was not provided. The authors stated "From our results, parents of a child with autism were more likely to consider the idea that vaccines were linked to autism in their decision-making process, and were less likely to be influenced by personalized recommendations from the child's health care provider. In our study, we found that concerns about vaccines, the parent provider relationship, and risk perception were most salient".
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; pain; itching; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix two months ago from the date of reporting and had developed shingles two weeks ago, with pain and itching. The patient received from her primary care doctor. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for herpes zoster were not provided.
Sex: U
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from contactable Other HCP via Pfizer Sales Representative. An infant patient (less than 1 years old, unknown gender) received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose for immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced diarrhea after receiving the first dose of Prevnar 13. Outcome of event was unknown.     No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: FLUA4
Symptoms: Haemorrhage
Clinical narrative: Bled after the shot; This spontaneous case was received on 15-Sep-2020, from Med Communications (reference number: SEQW20-01722), reported by other health professional and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.  On 19-Aug-2020, the patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported] as a prevention of seasonal influenza. The batch number was not reported.  On an unspecified date, after receiving Fluad Quadrivalent, the patient bled after the shot. It was reported that the patient did not experience any other adverse event besides bleeding after the injection.  At the time of initial reporting on 15-Sep-2020, the outcome of the event was not reported.   The event hemorrhage' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  The reporter did not provide a causality assessment.  This case is linked with the case 202004615 (same reporter).  Company comment: The patient developed haemorrhage on an unspecified date after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for the event of haemorrhage is assessed as unassessable, due to the lack of information regarding event onset date and type of bleeding.; Sender's Comments: The patient developed haemorrhage on an unspecified date after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information about medical history and concomitant medications was provided. Considering all above mentioned, causal relationship for the event of haemorrhage is assessed as unassessable, due to the lack of information regarding event onset date and type of bleeding.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal discomfort, Adverse event, Asthenia, Chills, Diarrhoea
Clinical narrative: Adverse event - light headache, diarrhea, upset stomach, tiredness, weakness, sleeping a lot, shivering starting on day after vaccines. Upset stomach continued a few days after receiving vaccines.  Treatment - Had to wear an undergarment, took immodium, Pedialyte Has been 9 days since she got the vaccines and feels better.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, SARS-CoV-2 test
Clinical narrative: Adverse event - light headache, diarrhea, upset stomach, tiredness, weakness, sleeping a lot, shivering starting on day after vaccines. Upset stomach continued a few days after receiving vaccines.  Treatment - Had to wear an undergarment, took immodium, Pedialyte Has been 9 days since she got the vaccines and feels better.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swollen red arm
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High doses given to a 40 year-old patient.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Neck pain, Vomiting
Clinical narrative: Less than 12 hours after receiving the flu vaccine I had a severe headache with neck and joint pain and vomited several times. The headache lasted until about 7pm and the N/V subsided about 7am
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Chills, Dyspnoea, Tremor
Clinical narrative: SHORTNESS OF BREATH, SHAKES AND CHILLS, ANXIETY
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: PT SAID ARM WAS SWOLLEN AND PAINFUL FROM SHOULDER TO ELBOW. HE WENT TO HIS PRIMARY DOCTOR NEXT MORNING AND THEY TOLD HIM TO WATCH FOR SIGNS OF INFECTION, TAKE TYLENOL AS NEEDED, AND TO REPORT TO PHARMACY SO THEY COULD REPORT.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Myalgia, Pain of skin, Peripheral swelling
Clinical narrative: Patient received both fluzone HD and pneumovax on 9/21.  He came into pharmacy 9/23 showing me his arm.  Most of his upper arm was red and slightly swollen.  It was itching the night the shots were given but that has ceased.  Patient also said his skin and muscle was very sore.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Muscle spasms, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Extreme body chills and muscle cramping started 7 hours after injection and didn?t subside until next morning. Ran a low grade fever for the entire day after vaccination as well as developing a mild cough. All symptoms faded within two days except for stiffness in the neck.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Headache, Neck pain
Clinical narrative: JOINT ACHES,NECK PAIN,HEADACHE,SEVERE CHILLING,SOME ABDOMINAL CRAMPING
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Body covered in chicken pox like rash. No fever or other symptoms. Started a week after vaccine was given and rash is still current.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Nausea, Urticaria
Clinical narrative: itchy area surrounding location of vaccination; welts; the area around the shot looked like a spider bite about a silver dollar large; felt warm to the touch; nausea
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Returned to clinic next day for us to observe the injection site to be red, swollen and hot to touch. Advised for cool compresses and OTC Benadryl cream
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Vomiting
Clinical narrative: Pt stated he threw up starting the next morning and thinks it was from the vaccine- it eased up by the night time and feels fine today
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Eye swelling, Swelling face, Wheezing
Clinical narrative: Patient received vaccine in office at approximately 10:45am. At approximately 11:45am, patient began experience swelling in eyes, face. Grandmother took him to an Urgent Care facility where he began having wheezing and difficulty breathing. Urgent Care staff immediately administered Decadron 10mg IM. Wheezing and difficulty breathing improved quickly. Urgent Care prescribed Prednisone 10mg Oral Tablets: Take 3 tablets for 3 days, 2 tablets for 3 days, 1 tablet for 4 day. Patient was also referred to Allergist for evaluation, scheduled 9/24/20.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Brain natriuretic peptide increased, C-reactive protein increased, Chest pain
Clinical narrative: Chest pain, fever, N&V. Symptoms: CHEST PAIN, UNSPECIFIED(R079). Diagnosed with myopericarditis  F/U 29 Mar 2007- wtih smallpox-associated myopericarditis documetned durign recent admission. Feels fine, sx's resolved, still taking NSAIDS.  During admission, his LVEF was mildly depressed, received 1-2 days of steroids only.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation, Electrocardiogram T wave abnormal, Electrocardiogram repolarisation abnormality
Clinical narrative: Chest pain, fever, N&V. Symptoms: CHEST PAIN, UNSPECIFIED(R079). Diagnosed with myopericarditis  F/U 29 Mar 2007- wtih smallpox-associated myopericarditis documetned durign recent admission. Feels fine, sx's resolved, still taking NSAIDS.  During admission, his LVEF was mildly depressed, received 1-2 days of steroids only.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Myocarditis, Myoglobin blood increased, Nausea, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Chest pain, fever, N&V. Symptoms: CHEST PAIN, UNSPECIFIED(R079). Diagnosed with myopericarditis  F/U 29 Mar 2007- wtih smallpox-associated myopericarditis documetned durign recent admission. Feels fine, sx's resolved, still taking NSAIDS.  During admission, his LVEF was mildly depressed, received 1-2 days of steroids only.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Troponin increased, Vomiting
Clinical narrative: Chest pain, fever, N&V. Symptoms: CHEST PAIN, UNSPECIFIED(R079). Diagnosed with myopericarditis  F/U 29 Mar 2007- wtih smallpox-associated myopericarditis documetned durign recent admission. Feels fine, sx's resolved, still taking NSAIDS.  During admission, his LVEF was mildly depressed, received 1-2 days of steroids only.
Age: 55.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient is 55 years old and was given a HD flu shot.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Per FOC-patient developed L arm numbness to include fingers. Redness and swelling at site of injection. FOC called PCP.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Peripheral swelling
Clinical narrative: PT STATED THAT HER ARM BEGIN TO SWELL AND IT KEEPS GETTING BIGGER, THE SITE IS SPREADING DOWN HER ARM, IT IS RED AND HOT TO TOUCH
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: Patient stated prior to vaccination he has a tendency to get lightheaded and even pass out when given a flu shot. I gave him the shot and after about 5 minutes (while sitting on the ground) the patient passed out. The patient lost consciousness for about 30 seconds then came back. I had the patient lay down with his feet up and when he was ready I sat him up and gave him some water. After several minutes he stood up and I stayed with him for another 5 minutes. He then proceeded to walk around the store for about 10 minutes until he told me he felt better and left.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Injection site pruritus, Injection site rash, Paraesthesia, Rash pruritic
Clinical narrative: 2 days after receiving vaccine patient developed a rash that was itchy and tingling at the injection site. The rash cleared  at that area but redeveloped  about a week later under her breast moving around to her spine. The rash is not painful but is itchy and tingling.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Joint stiffness, Loss of consciousness, Staring, Syncope
Clinical narrative: brief faint <1min with both hands stiffness, staring eyes, Her conscious  was back <1min. After fainting spell, everything came back normal. No other treatment.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Extensive swelling of vaccinated limb
Clinical narrative: PATIENT'S DAUGHTER CALLED TO REPORT THAT WITHIN 3 HOURS OF RECEIVING VACCINATIONS, PATIENT'S ARM WAS SWOLLEN FROM DELTOID TO WRIST "3 TIMES THE NORMAL SIZE". PATIENT WENT TO EMERGENCY ROOM AND WAS TOLD IT WAS CELLULITIS FROM  VACCINATIONS.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Eye disorder, Musculoskeletal stiffness, Syncope, Tremor
Clinical narrative: Faint, eyes opening, mild stiff, no shaking lasted<15 sec. No other treatment.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: The patient called to say that her arm has been very sore after receiving her flu vaccine yesterday. She said she barely slept last night due to the pain, and that it hurt too badly to lift her arm today.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Rash pruritic
Clinical narrative: She had an itchy rash widespread on body and her knees hurt.  She took 1 diphenhydramine 25mg.  She did not have to go to the doctor and said that she is feeling fine now.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: syncope reaction without warning signs (no dizziness), unresponsive for 30 seconds, revived with ammonia salts, vomiting after consciousness regained
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin discolouration, Skin warm, Swelling
Clinical narrative: Extreme swelling, hot, pain,  fever, change in color of arm,...size of area  and described symptoms, enlarged down arm, around inside of arm, traveling to inside bend  of arm.  The size of my arm did NOT even resemble the normal size of my other arm!!! The  main discoloration lasted two weeks and I still have some noticeable discoloration on affected arm.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pt had area of swelling around injection site.  he reported no pain in area of swelling except tenderness at injection site.  swelled area is about 4 inches in diameter and about 1/2 inch high at the highest point.  he says the swelling appeared the morning after the vaccination (this morning 9/23/20).  he showed us the site at about noon today and said it had not changed when I checked on him at 4pm
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Arm was painful after shot. Next day had significant redness and swelling present. Was looked at by another healthcare provider who agreed this was not a normal reaction to the shot.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is under 18 and was given Flublok  No initial adverse effects. Parents notified of Flublok incorrectly administered and institutional event report done.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea, Pyrexia
Clinical narrative: Shiver, Nausea, high fever, muscle ache in my arm at the spot of injection.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm and 101 fever.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient called pharmacy on 9/23/20 and reported that BOTH her arms were swollen
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Lethargy, Ocular hyperaemia
Clinical narrative: Two days after getting the vaccine, I had redness and itchiness in my left eye.  The redness and itchiness would subside slightly if I used a cold compress or took Benadryl. The next day, I began to feel lethargic throughout the day.  The lethargy lasted for about 7 days, and the redness and itchiness in my left eye lasted for about 10 days.  All symptoms have subsided.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: Arthralgia
Clinical narrative: he has experienced shoulder pain
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Joint lock, Pyrexia, Tremor
Clinical narrative: Within 4 hours of injection, patient experienced a high fever, locked joints of the fingers, intense chills and shakes. Most violent symptoms happened within the first 18 hours of injection and symptoms subsided very quickly.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Hypoaesthesia
Clinical narrative: pt experienced numb pinky and ring finger on right hand
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Patient said she began to experience a breakout of shingles within the follow day of receiving the vaccine. Patient knew it was shingles because she had shingles before.  She eventually followed up with her doctor who advised her to not get the 2nd dose of shingrix and she agreed she would not get it either.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Heart rate decreased, Immediate post-injection reaction, Syncope
Clinical narrative: Pt fainted right after I gave her flu and prevnar immuniztions , We  gave her water ,called store manager and also called 911. I did hold the pt  while she was sitting on the chair until she waked up;  so pt was on the chair for the whole time. No fall. I did check her blood pressure until paramedic gets here. pt's heart rate was very low 49 but her blood pressure was fine. The paramedic offered pt to take her to the hospital but pt refused . She wanted her daughter to pick her up. I was with the pt until her daughter picked her up around 1.38pm. Pt was feeling better when she was leaving pharmacy ,she walked her self .
Age: 17.0
Sex: F
Vaccine: FLUN4
Symptoms: Back pain, Chills, Epistaxis
Clinical narrative: Patient developed epistaxis (unilateral, left side), chills and back pain. The chills and back pain only occurred on 9/21 and did not last more than a day. The epistaxis was 9/21 and 9/22.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site about 4 hours after. Used ice pack and ibuprofen. But got worse overnight, became painful and red with more swelling.
Age: 0.33
Sex: F
Vaccine: UNK, UNK
Symptoms: Wrong product administered
Clinical narrative: MMR given instead of Prevnar PCV13
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Confusional state, Dysarthria, Hypoaesthesia
Clinical narrative: I administered a high dose flu vaccine to a patient this morning around 11:59am. The patient does have a history of prior stroke. The patient's wife just called to report that she believes he may have had some sort of TIA event after the shot. She stated he had symptoms of numbness in his left arm, slurred speech, and confusion. She stated she understood the importance of seeking emergent medical care within the first hour of symptoms; however, when I asked her if she had her husband evaluated she stated that she was "headed that way earlier" but felt like he had improved so she took him home and got him something to eat. I strongly advised that she seek emergent medical care due to the symptoms he was having. She stated he is napping. I advised her that I felt very strongly that he should seek immediate medical care. She stated she understood. I followed up with the patient's wife about an hour later. She stated that she woke the patient up and she believes he is okay now. I reiterated that I strongly believe she needs to seek emergent medical care (call EMS, take him to the emergency room, etc). Wife reports that patient has had ~3 similar events this year already, one as recent as August 2020. She reports she has previously called EMS and they have evaluated him and held him for observation. She stated again that she does not believe emergent medical care is necessary. She stated she understood that I advised her to seek emergency medical care; however, she does not feel it is necessary given his history of similar episodes.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Immediate post-injection reaction, Pruritus
Clinical narrative: itchy right away, red arm the next day
Age: 1.75
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Body temperature increased, Cyanosis, Febrile convulsion, Postictal state, White blood cell count increased
Clinical narrative: Reported cyanotic spell that happened 12 hours after administration. Lasted less than one minute. Taken to ED, and was told she had a postictal state and febrile seizure. Temperate was 100.5 reportedly at ED.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Patient came in received flu shot- signed all necessary documents. Patient called today on 9/23 stating that she could not lift her arm and that she wanted every single contact we have as she is seeking a lawyer. Spoke to Pharmacy Manager regarding incident.
Sex: F
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient has a history of nervousness with vaccinations and medical care. After receiving the vaccine, patient fainted. Emergency services were called and took vitals. Parent and EMT agreed further care was not needed and it was likely nerves.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: patient has a small raised black head looking mark on his arm almost 2 months later
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Started breaking out in hives morning of 9/16, hives got progressively worse throughout that day and continued for 4 days. Started taking oral Benadryl 50 mg every 6 hours evening of the 16. Started Medrol dose pack morning of 9/18. Oral meds not helping, so went to urgent care clinic and received IM Decadron.  Hives improved slightly, but then worsened again.  Returned to urgent care and received second shot of Decadron on Sunday 9/20. Hives improved again and finally went away.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: patient states that after she received the two vaccines, she developed redness/puffiness/swollen/painful to touch  from the injection site down to the elbow.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site pain, Injection site rash
Clinical narrative: Patient complains of being very cold. She has a painful rash at the injection site.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: stomach discomfort and  repeated diarrhea
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Lip swelling
Clinical narrative: patient began exhibiting swelling of lips 36 hours following vaccine administration; no shortness of breath
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on both arms. On left leg and left side on back.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient head Gardasil immunization yesterday along with meningitis immunization. The next day his shoulder was swollen and red and painful with some itching. It was so swollen he cannot use the arm and twice the size of normal. We gave Motrin Tylenol and Zyrtec. We also put ice on it to bring the swelling down. I am reporting that the patient did not recover because we are still treating it. I have all confidence that he will recover.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: VOMITING
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received the high dose flu vaccine prior to turning 65. Patient has not experienced and adverse effects from receiving the wrong vaccination
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient started to develop a frozen neck a couple of days following the vaccination. It had started on her left side and moved to the other side. She saw her doctor and was instructed to go to physical therapy.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Injection site erythema, Injection site irritation, Injection site swelling, Nausea
Clinical narrative: injection site irritation, red swollen and nausea stomach ache
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Developmental regression, Dysphemia, Electroencephalogram normal, Language disorder
Clinical narrative: Approximately 10 days after vaccination, fever went to 103 degrees; following this febrile rxn, she started stuttering and lost some of her language skills,  approximately 60% vocabulary.  This lasted about a week and she slowly began to talk again, but with a stutter.  Her stuttering has improved gradually.  Now she stutters about 1-2 times/day.  She forgets her words 1-2 times a week.  per mom, language skills have improved about 80-90%.  In the past, she has had fever up to 102 degrees at approximately 4-5 months of age, but there was no developmental regression then.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Approximately 10 days after vaccination, fever went to 103 degrees; following this febrile rxn, she started stuttering and lost some of her language skills,  approximately 60% vocabulary.  This lasted about a week and she slowly began to talk again, but with a stutter.  Her stuttering has improved gradually.  Now she stutters about 1-2 times/day.  She forgets her words 1-2 times a week.  per mom, language skills have improved about 80-90%.  In the past, she has had fever up to 102 degrees at approximately 4-5 months of age, but there was no developmental regression then.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Encephalitis, Magnetic resonance imaging brain
Clinical narrative: Encephalitis. Currently on anti inflammatory
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Localised infection
Clinical narrative: Patients arm became infected.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient reported redness on arm in which pneumovax received that spread down to elbow area; did not have any pain at the time associated with rash;  the redness developed approximately two days post injection and was not noted prior
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt came in c/o redness to site, swelling , and fever. Pt was diagnosed with cellulitis of left arm e and given oral ABT's and prednisone.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives appeared on left upper arm  from 9/14-9/11/2020. Occasional hives show on arm 9/12 - to current date.  On 9/23/20, hives appeared on both legs above ankle.  Each incident was treated with an ice pack. Took 1 antihistamine capsule on 9/13/20. On 9/23/2020, took 1 antihistamine tablet.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 20cmX12cm R upper arm redness, swelling, warmth, and discomfort
Age: 12.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: On 9/19 he developed a large, red, itchy area around the vaccine administration site which was hot to the touch.  He was seen at an Urgent Care .   The area increased in size and discomfort and was seen the following day in the emergency room.  He was given an oral steroid, a Rocephin injection, and antibiotic was changed to Keflex.  He was discharged on oral Prednisone and Bactrim. He was seen again in the office on 9/21/20 when the site was slightly improved and complained of more itching than pain.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: HEADACHE, MUSCLE PAIN IN THE WHOLE BODY,MILD FEVER, CHILLS AND UNCONTROLLABLE TREMBLING FOR HOURS UNTIL THE NEXT DAY.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased, Muscular weakness
Clinical narrative: Patient states she had severe muscle weakness and inability to move from bed for 2 days. States it was severe all over muscle weakness as well as flu-like symptoms. Muscle weakness seems more severe than typical adverse event.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Dysarthria, Feeling cold, Irritability, Tremor
Clinical narrative: Patient waited around store for 15 minutes no symptoms. Patient calls me 4 hours later stating she thinks she is having an allergic reaction or something with the vaccine. Patient is very irritable, slurred speech, shaking and freezing. I informed patient that some of these effe cts have been reported but she was really worried. I told her if she thought she was having an allergic reaction that she could take a Benadryl that it is really safe. I told her if she is still worried to maybe call 911 and have the ambulance come take a look with her. Tried to call patient back later this evening and did not get an answer
Age: 58.0
Sex: F
Vaccine: FLUR4
Symptoms: Skin reaction, Skin warm, Tenderness
Clinical narrative: large red area that is warm and tender to the touch
Age: 76.0
Sex: M
Vaccine: FLUR4
Symptoms: Somnolence
Clinical narrative: Patient reports sitting in his car waiting until 20 minutes had passed before leaving the pharmacy parking lot. He wanted to stay close to the pharmacy, but not be exposed to other patrons during this time. He began driving home and about 30 minutes after receiving the vaccine he "fell asleep" while driving. He awoke in the other lane of the road and didn't experience any other issues (no headache, chest pain, aura, no other symptoms). No damage or injury was sustained due to driving while the incident occurred. He came back to the pharmacy several hours later and wanted to make us aware that this had happened to him so that other people didn't have to experience similar issues.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Site swelled up and gradually increase in diameter. Approximately 4 inches wide. Area is hot, throbbing, raised, hard and arm is difficult to raise.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site erythema, Myalgia, Pain in extremity
Clinical narrative: Sore arm, much redness around injection site, chills, muscle aches
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pain
Clinical narrative: I felt awful - body aches, chills, severe headache - especially back of neck, all of my body felt like it was super sensitive, as if everything hurt.  Felt like I had been run over.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Sensitive skin
Clinical narrative: I felt awful - body aches, chills, severe headache - especially back of neck, all of my body felt like it was super sensitive, as if everything hurt.  Felt like I had been run over.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: 100 fever, muscle and joint aches, loss of appetite
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Feeding intolerance, Oral herpes, Oral pain
Clinical narrative: Patient reported cold sores to her right and central upper lip, under her tongue, and into the back of her throat that started a day after receiving the two vaccines.  She reports that today (5 days after vaccines and 4 days after onset of sores) that the pain is improving and she feels she is through the worst of it.  She experienced pain and problems being able to tolerate eating.  Prescribed viscous lidocaine to help with pain.  Denied fevers and body aches.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Arthralgia, Blood glucose increased, Fatigue, Feeling hot, Inflammation
Clinical narrative: Patient was feeling fine while leaving the pharmacy. Aches and pains in joints (shoulders, knees, ankles) started approximately two hours after leaving the pharmacy. The back area around kidney and appendix felt tender and inflammed. Patient felt feverish, but when measured resulted in 97.2F. Patient felt exhausted and laid down around 3-4pm. Woke up around 7pm with sugar levels being approximately 300 despite missing dinner, which went down with insulin. Woke up this morning with no aches/pains with sugars normal. Patient followed up with primary care provider via phone and did not need any additional medical support. Patient states did not do anything else that day and did not meet anyone else; he believes its a reaction from the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Tenderness
Clinical narrative: Patient was feeling fine while leaving the pharmacy. Aches and pains in joints (shoulders, knees, ankles) started approximately two hours after leaving the pharmacy. The back area around kidney and appendix felt tender and inflammed. Patient felt feverish, but when measured resulted in 97.2F. Patient felt exhausted and laid down around 3-4pm. Woke up around 7pm with sugar levels being approximately 300 despite missing dinner, which went down with insulin. Woke up this morning with no aches/pains with sugars normal. Patient followed up with primary care provider via phone and did not need any additional medical support. Patient states did not do anything else that day and did not meet anyone else; he believes its a reaction from the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Arthralgia, Blood glucose increased, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Patient was feeling fine while leaving the pharmacy. Aches and pains in joints (shoulders, knees, ankles) started approximately two hours after leaving the pharmacy. The back area around kidney and appendix felt tender and inflammed. Patient felt feverish, but when measured resulted in 97.2F. Patient felt exhausted and laid down around 3-4pm. Woke up around 7pm with sugar levels being approximately 300 despite missing dinner, which went down with insulin. Woke up this morning with no aches/pains with sugars normal. Patient followed up with primary care provider via phone and did not need any additional medical support. Patient states did not do anything else that day and did not meet anyone else; he believes its a reaction from the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Myalgia, Neuropathy peripheral
Clinical narrative: Patient was feeling fine while leaving the pharmacy. Aches and pains in joints (shoulders, knees, ankles) started approximately two hours after leaving the pharmacy. The back area around kidney and appendix felt tender and inflammed. Patient felt feverish, but when measured resulted in 97.2F. Patient felt exhausted and laid down around 3-4pm. Woke up around 7pm with sugar levels being approximately 300 despite missing dinner, which went down with insulin. Woke up this morning with no aches/pains with sugars normal. Patient followed up with primary care provider via phone and did not need any additional medical support. Patient states did not do anything else that day and did not meet anyone else; he believes its a reaction from the vaccine.
Age: 87.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt reports pain and difficulty moving her arm  for a little less than 1 month after administration.  She reports seeking medical care in ER where she was given a sling and  told to alternate between ice and heat in order to help with symptoms.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Abdominal distension, Dysphonia, Feeling cold, Nausea
Clinical narrative: Hoarseness. Severe stomach upset and feeling of fullness. Followed by nausea and multiple bouts of vomiting. Shaking and chills. No fever.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Vomiting
Clinical narrative: Hoarseness. Severe stomach upset and feeling of fullness. Followed by nausea and multiple bouts of vomiting. Shaking and chills. No fever.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation
Clinical narrative: Patient said they had normal adverse side affects but then 5 days later her arm was still red and inflamed. After seeing a doctor she said they said it was Cellulitis. It may have been to poor shot placement and cleaning  technique.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Sore arm, pain and after 6 days development a full case of shingles, with rash on the left hand side of my back, which continue across my left hand side onto my left breast.
Age: 55.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Rash
Clinical narrative: SkinRash
Age: 67.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: DIAGNOSIS of CELLULITIS ON 9-22-20 AT URGENT CARE. REDNESS, SWELLING + PAIN THROUGHOUT ARM. FEVER. PATIENT PRESCRIBED ORAL Doxycycline + INSTRUCTED TO RETURN TO URGENT CARE ON 9/24/20 FOR FOLLOW UP
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Shingrix shot given IM in (L) Deltoid 9/21/20 at 2:43PM. Pt called today on 9/23/20 to let us know about redness and swelling to about size of 1/2 egg. She declined medical treatment and really just wanted to let us know. She will let us  know of any further changes
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt was given 7 days of Valacyclovir for shingle tx. & Outbreak of Shingle VALACYCLOVIR
Age: 8.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Local reaction, Rash
Clinical narrative: Local Reaction, Rash on face the following day (unclear if related)
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles rash appeared the day after vacc. on back of neck, soon later diagnosed by doctor
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Pt had vaccine 9/11/2020. 9/23/2020 mom noticed red papular rash all over body. Mom sent picture to Doctor.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Chills, Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: After 2nd dose, I had N/V, fever, chills & extreme fatigue. The extreme fatigue is still present today (3 years later). My doctor advised me to contact CDC & inform them. I have chronic stiffness and my life has never been the same. My doctor says the auto immune disease I now have is probably the result of the shingles vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: After 2nd dose, I had N/V, fever, chills & extreme fatigue. The extreme fatigue is still present today (3 years later). My doctor advised me to contact CDC & inform them. I have chronic stiffness and my life has never been the same. My doctor says the auto immune disease I now have is probably the result of the shingles vaccine.