chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Streptococcus test negative, Swelling face, Swelling of eyelid
Clinical narrative: 2 days post vaccination, small pimples/pock marks appeared scattered on patient arms, legs and bridge of her nose. (This was similar to a more severe rash after her first MMR vaccine that also presented with 103 fever. That reaction resolved within a day). There was no fever present,  but the pocks were itchy and She scratched them. The the pock at the bridge of her nose became lacerated from the constant scratching so I applied Neosporin to it several times a day and to other spots on her legs as needed. The bridge of her nose became red and irritated. Over the course of time, it started to swell and travel until her face, forehead, and ears were inflamed and swollen to the point of having her eyes nearly shut.   New sensitivities to previously used medications and topical cream emerged post-hospital release. This included facial swelling and redness after 5ml Robitussin in October 2019, and facial swelling and redness after Aquaphor was applied to the nostrils for chapped skin. Prior to this vaccination and subsequent required medical intervention, the patient was never ill or reactive to any environmental, food, or drug factors. All reactions are photo-documented.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Eye irritation, Headache, Pain, Pyrexia
Clinical narrative: within a few hours I got headache, body aches, fever ,stomach upset. By the 23rd I started having blurry vision and redness with a burning sensation in my eye's , I have been getting flu shots every year since 2008 and have never had these effects or anything close to these effects.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Vision blurred
Clinical narrative: within a few hours I got headache, body aches, fever ,stomach upset. By the 23rd I started having blurry vision and redness with a burning sensation in my eye's , I have been getting flu shots every year since 2008 and have never had these effects or anything close to these effects.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: RASH ON LEFT SIDE DELTOID
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Dry skin, Eczema, Erythema, Haemorrhage
Clinical narrative: Patient's arm was swollen and red at injection site immediately after vaccination. Redness and swelling continued for several days worsening to cover an area from shoulder to elbow, with limited range of motion in the arm since it hurt so badly to raise it. Patient expressed having a constant headache at her forehead for nearly a week. She was lethargic and cranky with fits of crying in between. (Highly unusual for her).  She simultaneously (evening of vaccination) developed a rash on the backs of her thighs that became rough and eczema-like within a day. The areas (arm and legs) were hot to the touch, red, and her legs were cracking and inflamed.   Consulted her pediatrician who said the reaction was in line with this vaccine. She suggested topical hydrocortisone cream (1%- otc) followed by Aquaphor 2xs daily for the legs. The eczema persisted for several months. The redness and scaly skin subsided in late August. Her legs sustained pigment loss where the reaction occurred.   Her 4th dose of of DTaP on 9/29/2020 caused an immediate relapse, and more severe reaction including a low grade fever. We are currently treating the same location on backs of her legs for the resulting eczema. This time the area appears to be more tender and bleeds.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Immediate post-injection reaction, Inflammation, Injection site erythema, Injection site movement impairment
Clinical narrative: Patient's arm was swollen and red at injection site immediately after vaccination. Redness and swelling continued for several days worsening to cover an area from shoulder to elbow, with limited range of motion in the arm since it hurt so badly to raise it. Patient expressed having a constant headache at her forehead for nearly a week. She was lethargic and cranky with fits of crying in between. (Highly unusual for her).  She simultaneously (evening of vaccination) developed a rash on the backs of her thighs that became rough and eczema-like within a day. The areas (arm and legs) were hot to the touch, red, and her legs were cracking and inflamed.   Consulted her pediatrician who said the reaction was in line with this vaccine. She suggested topical hydrocortisone cream (1%- otc) followed by Aquaphor 2xs daily for the legs. The eczema persisted for several months. The redness and scaly skin subsided in late August. Her legs sustained pigment loss where the reaction occurred.   Her 4th dose of of DTaP on 9/29/2020 caused an immediate relapse, and more severe reaction including a low grade fever. We are currently treating the same location on backs of her legs for the resulting eczema. This time the area appears to be more tender and bleeds.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Irritability, Lethargy, Pain, Pyrexia
Clinical narrative: Patient's arm was swollen and red at injection site immediately after vaccination. Redness and swelling continued for several days worsening to cover an area from shoulder to elbow, with limited range of motion in the arm since it hurt so badly to raise it. Patient expressed having a constant headache at her forehead for nearly a week. She was lethargic and cranky with fits of crying in between. (Highly unusual for her).  She simultaneously (evening of vaccination) developed a rash on the backs of her thighs that became rough and eczema-like within a day. The areas (arm and legs) were hot to the touch, red, and her legs were cracking and inflamed.   Consulted her pediatrician who said the reaction was in line with this vaccine. She suggested topical hydrocortisone cream (1%- otc) followed by Aquaphor 2xs daily for the legs. The eczema persisted for several months. The redness and scaly skin subsided in late August. Her legs sustained pigment loss where the reaction occurred.   Her 4th dose of of DTaP on 9/29/2020 caused an immediate relapse, and more severe reaction including a low grade fever. We are currently treating the same location on backs of her legs for the resulting eczema. This time the area appears to be more tender and bleeds.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Rash, Skin depigmentation, Skin exfoliation, Skin fissures, Skin warm
Clinical narrative: Patient's arm was swollen and red at injection site immediately after vaccination. Redness and swelling continued for several days worsening to cover an area from shoulder to elbow, with limited range of motion in the arm since it hurt so badly to raise it. Patient expressed having a constant headache at her forehead for nearly a week. She was lethargic and cranky with fits of crying in between. (Highly unusual for her).  She simultaneously (evening of vaccination) developed a rash on the backs of her thighs that became rough and eczema-like within a day. The areas (arm and legs) were hot to the touch, red, and her legs were cracking and inflamed.   Consulted her pediatrician who said the reaction was in line with this vaccine. She suggested topical hydrocortisone cream (1%- otc) followed by Aquaphor 2xs daily for the legs. The eczema persisted for several months. The redness and scaly skin subsided in late August. Her legs sustained pigment loss where the reaction occurred.   Her 4th dose of of DTaP on 9/29/2020 caused an immediate relapse, and more severe reaction including a low grade fever. We are currently treating the same location on backs of her legs for the resulting eczema. This time the area appears to be more tender and bleeds.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Tenderness, Vaccination complication
Clinical narrative: Patient's arm was swollen and red at injection site immediately after vaccination. Redness and swelling continued for several days worsening to cover an area from shoulder to elbow, with limited range of motion in the arm since it hurt so badly to raise it. Patient expressed having a constant headache at her forehead for nearly a week. She was lethargic and cranky with fits of crying in between. (Highly unusual for her).  She simultaneously (evening of vaccination) developed a rash on the backs of her thighs that became rough and eczema-like within a day. The areas (arm and legs) were hot to the touch, red, and her legs were cracking and inflamed.   Consulted her pediatrician who said the reaction was in line with this vaccine. She suggested topical hydrocortisone cream (1%- otc) followed by Aquaphor 2xs daily for the legs. The eczema persisted for several months. The redness and scaly skin subsided in late August. Her legs sustained pigment loss where the reaction occurred.   Her 4th dose of of DTaP on 9/29/2020 caused an immediate relapse, and more severe reaction including a low grade fever. We are currently treating the same location on backs of her legs for the resulting eczema. This time the area appears to be more tender and bleeds.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Patient got dizzy about 3 minutes, and also fainted about 3 times (in and out).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: At approximately 3:00 PM I started feeling achy took two advil, 3-4 hours later achy feeling again and nausea, took two more advil and rested in reclining chair. I awoke around 10:00 PM with shivers and aches took two more advil and slept til 5:00 AM awoke with severe aches, fever of 101, head/neck ache and took two more advil. Slept until 8:00 AM and felt like I was on the mend.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: The patient is not exhibiting any adverse symptoms; patient was supposed to received both VARIVAX and MMR II today (10/27/2020), but instead of MMR II, PROQUAD was administered; was supposed to received both VARIVAX and MMR II/ but instead ofMMR II, PROQUAD was administered; This spontaneous report has been received from a physician (also reported as a practice manager), referring to a 12 months old patient of unknown gender. The patient's current condition, concomitant medication and historical condition were unknown.  On 27-OCT-2020, the patient was supposed to receive both varicella virus vaccine live (oka/merck)(VARIVAX) (lot # SO38702 was evaluated and changed to the valid lot # S038702, expiration date: 01-DEC-2021; 1 injection) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, lot number and expiration date were unknown), but instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot# S031884 with expiration date: 07-APR-2021; 1 injection) was administered (wrong product administered and accidental overdose). The route and strength for all suspect vaccines were unknown. The indication for all suspect vaccines was prophylaxis. The patient was not exhibiting any adverse symptoms.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; he had received a dose of PROQUAD beyond the age recommended in the PI. PROQUAD had been administered on 12/04/2019; This spontaneous report was received from a physician and refers to a 15-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 12-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, dose number, vaccination site, route of administration, lot # and expiration date were not provided) for prophylaxis beyond the age recommended in the product information (PI). The reporter wanted to know if the dose needed to be repeated. No additional adverse events were reported.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: Took the flu vaccine two years ago and had the flu twice/ Suspected vaccination failure; Had the flu twice / Thought I was going to die; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   The patient's past medical history included shingles (experienced when patient was younger).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant and life threatening) and influenza (serious criteria life threatening). On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were reported as follows: The case was reported by patient him/herself on interactive digital media. The age at vaccination was not reported. The patient received flu vaccine two years ago and had the flu twice and the patient thought he/she was going to die, it was so bad. Patient stated that no more vaccines for him/herself no matter what anyone says, did not matter what you had (flu, cold, allergies, pneumonia, etc.) they probably would say it's the Covid virus, he/she had not lived all this time with no common sense. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. For tolerance of shingles vaccine refer case US2020AMR231599.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR231599:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: administered the liquid adjuvant portion of Shingrix without reconstituting it with the antigen component / receiving the shingrix shot that wasn´t mixed; administered the liquid adjuvant portion of Shingrix without reconstituting it with the antigen component; arm was sore; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were received as follows: The age at vaccination was not reported. The reporter reported that patient was administered the liquid adjuvant portion of Shingrix without reconstituting it with the antigen component, inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.   Follow up information received from Pharmacist on 27th October 2020: The patient's demographic details were updated. The patient received 50 mcg dose of Shingrix by intramuscular route. The reporter stated that, unknown after vaccination, the patient experienced sore arm for fewdays and was better at the time of reporting. It was unknown if the reporter considered the pain in arm to be related to Shingrix. The reporter stated that, the patient would get shot again in 4 weeks from the incident. The VAERS details were updated.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Vomiting
Clinical narrative: had vomits; muscle and joint pain; Muscle and joint pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received Shingrix. On 11th November 2020, less than a day after receiving Shingrix, the patient experienced myalgia, headache and joint pain. On 12th November 2020, the patient experienced vomiting. On an unknown date, the outcome of the myalgia and joint pain were unknown and the outcome of the headache was not recovered/not resolved and the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the myalgia, headache, vomiting and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and same day experienced headache, muscle and joint pain, the next day had vomits, 4 times and the headache continued.  The patient mentioned she visit her doctor and he said it was an adverse reaction to Shingrix The reporter consented to follow up and no vaccine data provided.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: The patient had a syncope event (fainted) within 10 minutes of receiving the vaccine; This is a spontaneous report from a contactable other health care professional (Other HCP) via a Pfizer sales representative. This Other HCP reported similar events for two patients. This is first of two reports. A female patient of unspecified age received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date (last winter either in 2019 or 2020) at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a syncope event (fainted) within 10 minutes of receiving the vaccine. She sat for 15 - 20 minutes and was fine after that. This occurred last winter either in 2019 or 2020. Event took place after use of product. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: A causal association between administration of TRUMENBA and the onset of fainted cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect vaccine.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, as appropriate.,Linked Report(s) : US-PFIZER INC-2020460082 same reporter/drug/AE, different patients
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report from a contactable other healthcare professional (HCP) via Pfizer sales representative. This other HCP reported similar events for 2 patients. This is the second of two reports. A female patient of unknown age received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. Concomitant medications and past drug/medical history were not reported. The teenaged patient fainted after the vaccination with meningococcal group b rlp2086 and was taken to urgent care for a follow up. Her parent declined additional doses. The patient's outcome was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of fainted cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect vaccine.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2020459986 same reporter/drug/AE, different patients
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Laboratory test, Urticaria
Clinical narrative: urticaria; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 4 year old female patient who experienced urticaria, while he/she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 11-Sep-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In Sep-2020, the patient developed a non-serious urticaria, (unknown latency), 24 hours following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. She went to the emergency room.  Relevant laboratory test results included: Body temperature - [103]  In the emergency room she was given an epipen.  At the time of reporting, the outcome of event urticaria was reported as unknown.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: The patient was given a 0.5ml dose of Daptacel in the right arm  today, instead of Adacel with no AE; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who received 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: not reported, expiry date: unknown) via unknown route on right arm on 03-Nov-2020 for prophylactic vaccination (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included INFLUENZA VACCINE.  It was an actual medication error due to the Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal injury, Seizure, Syncope
Clinical narrative: Patient lost consciousness displaying signs of syncope and brief convulsions  within 2 minutes following the vaccine administration. Patient fell out of chair causing minor injury to abdominal area. Patient was moved safely back to reclining chair with feet elevated until she regained consciousness.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV, TDAP, VARZOS
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: PATIENT STATES HE STILL HAS SORENESS IN HIS ARM AND CANNOT LIFT IT ABOVE HIS HEAD. HE STATES THAT HE TAKES IBUPROFEN AROUND THE CLOCK TO MANAGE THE PAIN. HE SYAS THE PAIN IS STILL A DAILY OCCURENCE OVER 2 MONTHS AFTER RECEIVING THE IMMUNIZATIONS IN HIS RIGHT ARM. THE IMMUNIZATIONS THAT HE RECEIVED IN THAT ARM WERE ADACEL AND SHINGRIX.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Injection site swelling, Nausea
Clinical narrative: Symptoms - nausea, diarrhea, shivering, headache, joint soreness in hips and knees, fever, redness and swelling at injection site.  Treatment - Tylenol and sleep  Outcome - day two after injection was better,  though still had minor symptoms. Day three after injection was back to normal
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Symptoms - nausea, diarrhea, shivering, headache, joint soreness in hips and knees, fever, redness and swelling at injection site.  Treatment - Tylenol and sleep  Outcome - day two after injection was better,  though still had minor symptoms. Day three after injection was back to normal
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Ear discomfort, Musculoskeletal chest pain
Clinical narrative: After the vaccination I suffered loss of hearing which is still ongoing, and the sensation of fullness and pressure is in the middle ear as if I'm landing from a plane ride. And I am currently under the care of an ENT Dr.  I suffer from chronic pain and muscle weakness.  The lower and center of the back is out, and I get spasms that move bilaterally around from the front to the back.  When getting up from a sitting position I have to get up a certain way because I suffer from extreme pain in the torso, and I can't stand if it's not done a certain way.  And In my front rib area I have horrendous pain ever since I've gotten the vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: Started to feel tired, body aches, headache. Couldn't function for 36 hours. Had to urinate constantly.  Slept most of the 36 hours. Some chills, sweating. Loss of appetite during that time. Missed a day of work.  Felt better about 2 days after. Redness at injection site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pollakiuria
Clinical narrative: Started to feel tired, body aches, headache. Couldn't function for 36 hours. Had to urinate constantly.  Slept most of the 36 hours. Some chills, sweating. Loss of appetite during that time. Missed a day of work.  Felt better about 2 days after. Redness at injection site.
Age: 70.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Dyspnoea
Clinical narrative: Dyspnea.  I was naive to the influenza vaccination. I have never had influenza vaccine before.  Dyspnea seem to have worsened in the last 2 weeks. Had recent examination 3 weeks ago and no new abnormalities was noted.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Hard, Red, Hot area size of Palm on Left thigh started or noticed next morning when Rising about 7:30 am on 11/24/20. Patient says it itches, mom reports temp 98.2 degrees, no other complaints. Mom put circle around redness 1 hr later starting to get smaller size, still hot, Red itchy area. Ice applied, tylenol,
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature abnormal, Chills, Fatigue, Flushing, Pain
Clinical narrative: Flushed face w/in 10 minutes - After 20 minutes, began with chills & severe shaking. Temp 99.3 - Took Aleve 4:30 went to Urgent care per Doctor's advice. Given injections of Prednisone & Antihistamine at 5:15pm. Told to take OTC Benadryl. Went home & to bed. Shaking ceased shortly after injections. 6pm temp at 101.2 ceased shortly after injections. 6pm temp at 101.2 8pm 100.6 - 10am 98.6 - tired, achy, but better by end of day.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Flushed face w/in 10 minutes - After 20 minutes, began with chills & severe shaking. Temp 99.3 - Took Aleve 4:30 went to Urgent care per Doctor's advice. Given injections of Prednisone & Antihistamine at 5:15pm. Told to take OTC Benadryl. Went home & to bed. Shaking ceased shortly after injections. 6pm temp at 101.2 ceased shortly after injections. 6pm temp at 101.2 8pm 100.6 - 10am 98.6 - tired, achy, but better by end of day.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphonia, Chills, Pain, Sinus headache
Clinical narrative: Body aches, shivering, sinus headache, tiredness, losing voice  Took Ibuprofen PM 11/23/2020to help with sleep
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Rash, Tenderness
Clinical narrative: 2 days after I received the shingles Vaccine I started having soreness in my right hip area and a rash in the same area started to form.  It got worse over the next 2 days with the growing larger from my lower back , along my right side.  I have soreness in that entire area.  I did a online appointment with MD Live and was diagnosed with Shingles.  I started taking valacyclovir.  I am very upset because this vaccine is not supposed to make you get shingles but I clearly did!
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Facial paralysis
Clinical narrative: Patient experiencing symptoms of Bell's Palsy
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Event to document - duplication of vaccine  Initial vaccine administered 08/2018 - by Dr  Duplicate Dose administered 11/17/2020 - by RPH
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia, Sleep disorder, Tremor
Clinical narrative: Patient started with fever (100F) in the middle of the night, shaking, muscle aches (really bad), unable to sleep. Pain on the site of the injection. Patient took Tylenol in the morning, one single dose and feels fatigued.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site paraesthesia, Paraesthesia, Tinnitus
Clinical narrative: Per patient: Tingling at injection site. This sensation traveled up his left arm to the neck and head. It has caused headaches and ringing in the left ear. The sensation is still present a month later.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Audiogram, Deafness unilateral
Clinical narrative: I woke up on the morning of 9/19/2020 with no hearing in left ear.  Completely deaf.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Chills, headache, low-grade fever (100 degrees), sore rash on injection arm.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Dysstasia, Headache, Lethargy, Musculoskeletal stiffness
Clinical narrative: 48 HOURS POST INJECTION SYMPTOMS STARTED: FEVER, COUGH, STIFF NECK, HEADACHE, LETHARGIC (PROBABLY FEVER-DOESN'T HAVE THEMOMETER)  BED BOUND 4 DAYS AND LOST TRACK OF 2 DAYS.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Time perception altered
Clinical narrative: 48 HOURS POST INJECTION SYMPTOMS STARTED: FEVER, COUGH, STIFF NECK, HEADACHE, LETHARGIC (PROBABLY FEVER-DOESN'T HAVE THEMOMETER)  BED BOUND 4 DAYS AND LOST TRACK OF 2 DAYS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue
Clinical narrative: Vaccine leakage between syringe and needle. Patient given another dose, same lot numer, same arm, approximately one inch above original injection site
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: The vaccination was painful at the site immediately. An hour or two later started feeling light headed and my skin became sensitive. Around 6pm, I became really fatigued and feeling nauseous. Around 9 started getting a fever, which peaked at 100.2 and began shivering uncontrollably. Today, I'm still very fatigued, achey and feverish.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Sensitive skin
Clinical narrative: The vaccination was painful at the site immediately. An hour or two later started feeling light headed and my skin became sensitive. Around 6pm, I became really fatigued and feeling nauseous. Around 9 started getting a fever, which peaked at 100.2 and began shivering uncontrollably. Today, I'm still very fatigued, achey and feverish.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Rash, Rash erythematous
Clinical narrative: The caller reports after receiving the Shingles vaccine, a rash on her back, circles the size of nickels that were raised and red. Mostly looked like Chicken Pox. She has seen a dermatologist for this and has received two biopsies.
Age: 43.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient said in the first 48 hours he didn't have pain, but then after 3 days he started feeling pain in his shoulder and he couldn't left more than 10 pounds. He feels its more of a nerve pain (Shooting pain per patient description)
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Balance disorder, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: AROUND 5:05PM THE FLU VACCINE WAS ADMINISTERED. PATIENT RAPIDLY FELT DIZZY,PALE AND STARTED TO SWEAT. SHE THEN FAINTED AND THEN STARTED TO CONVULSE ,BUT THEN RAPIDLY CAME BACK TO HER SENSES. AFTER THAT SHE STILL FELT WEAK, DIZZY AND WAS VERY PALE. WE PROCEED TO CALL 911 AROUND 5;15PM. PATIENT NEVER STOPPED BREATHING. SHE SAYS THAT WHEN SHE FELT DIZZY SHE HAD LOST HER BALANCE AND HAD BLURRY VISION. AFTER THE PARAMEDICS ATTEND HER SHE WALKED OUT OF THE PHARMACY WITH THE PARAMEDICS. HER MOTHER WHO WAS WITH HER SAYS THAT THIS HAS HAPPEND BEFORE IN OTHER OCCASIONS TYPICALLY WHEN SHE GETS NERVOUS OR ANXIOUS BECAUSE SHE IS TERRIFIED OF NEEDLES. THIS HAS HAPPEND WHEN SHE IS GETTING A SHOT OR GETTING A BLOOD TEST DONE
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure, Syncope, Vision blurred
Clinical narrative: AROUND 5:05PM THE FLU VACCINE WAS ADMINISTERED. PATIENT RAPIDLY FELT DIZZY,PALE AND STARTED TO SWEAT. SHE THEN FAINTED AND THEN STARTED TO CONVULSE ,BUT THEN RAPIDLY CAME BACK TO HER SENSES. AFTER THAT SHE STILL FELT WEAK, DIZZY AND WAS VERY PALE. WE PROCEED TO CALL 911 AROUND 5;15PM. PATIENT NEVER STOPPED BREATHING. SHE SAYS THAT WHEN SHE FELT DIZZY SHE HAD LOST HER BALANCE AND HAD BLURRY VISION. AFTER THE PARAMEDICS ATTEND HER SHE WALKED OUT OF THE PHARMACY WITH THE PARAMEDICS. HER MOTHER WHO WAS WITH HER SAYS THAT THIS HAS HAPPEND BEFORE IN OTHER OCCASIONS TYPICALLY WHEN SHE GETS NERVOUS OR ANXIOUS BECAUSE SHE IS TERRIFIED OF NEEDLES. THIS HAS HAPPEND WHEN SHE IS GETTING A SHOT OR GETTING A BLOOD TEST DONE
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Syncope
Clinical narrative: Patient was first of three family members receiving a flu shot. Patient was fine after administration and watched sibling and father get immunization. At this point he fainted, falling into the drywall and atop a small metal garbage can.  Patient came too within seconds of falling. Rested for a moment. Had no complaints of pain, no bruising or cuts. No longer dizzy either. Father felt no harm done and they chose to leave. A follow-up call next morning by pharmacy manager was done at 8:10am. Father said child is doing well and having no problems. I explained what a vasovagal response is, and that if alerted to this history we can do a better job of protecting him in case he faints. Father reports child getting "white as a ghost" many times before, but never going down. The father was very thankful for the call and the concern exhibited by all.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: rash and itching  all over the body  she said she had pain in the arm but was resolved in 2 days she was prescribed prednisone 10 mg today.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: soreness in the arm around 2 hours after vaccine given, continued soreness in the upper shoulder for the 7  days. Occasionally has trouble lifting arm to the side and above shoulder/head.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Nausea, Nervousness
Clinical narrative: Total body aches; 9 PM to 5 PM the next day Chills; 9 PM to 5 PM the next day Sense of being ungrounded, a nervousness; 9 PM to 5 PM the next day Nausea: 11 PM to 10 AM the next day Complete Exhaustion 9 PM to 3 PM on  3rd day from vaccination
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Total body aches; 9 PM to 5 PM the next day Chills; 9 PM to 5 PM the next day Sense of being ungrounded, a nervousness; 9 PM to 5 PM the next day Nausea: 11 PM to 10 AM the next day Complete Exhaustion 9 PM to 3 PM on  3rd day from vaccination
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: The patient noted that he felt moderate and sharp pain from the flu vaccination at the time of vaccination.  The pain is progressively severe over the past 3 weeks after receiving his immunization.  Patient had chills, nausea and fever for one day after the injection, and persistent pain with overhead activities.  No previous issues with the vaccine.    From this visit the provider prescribed diclofenac sodium 75mg twice daily.  The provider recommended that after 2 weeks of the medication if there is no improvement he will likely need imaging.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: pt called a few days after receiving vaccines stating that she was experiencing a lot of pain on both arms. rph on duty advised her to take some advil/Tylenol/aleve to see if that helped, and if not, contact doctor. pt stated that the pain in the right arm (shingrix arm) went away, but the pain in the left arm (fluzone HD and prevnar arm) did not get better, so she contacted the doctor. doctor told the pt that whoever administered the vaccine may have hit the tendon and that may be the reason why she's experiencing extended period of pain/discomfort. pt called pharmacy 11/24/20 because her doctor advised her to call the pharmacy to let them know what's going on.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted after about 5 minutes after administration.  We called 911 and patient was laid flat and monitored until emergency services responded.   Vitals were checked and found to be normal.  Blood pressure, heart rate, O2 sats and blood glucose were all within normal limits.  Patient was released home with mother.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient had a local reaction to the vaccine that got swollen, very red, painful, and feverish (warm to touch).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip blister, Mouth haemorrhage, Oral pain, Rash, Rash vesicular
Clinical narrative: Only took 1 shot 1 day later, lip blisters like cold sores . Rash on arms ,legs back liquid fill blister rash, roof of mouth was like it had been burned. lots of bleeding from mouth. scaring this went on for months
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: Only took 1 shot 1 day later, lip blisters like cold sores . Rash on arms ,legs back liquid fill blister rash, roof of mouth was like it had been burned. lots of bleeding from mouth. scaring this went on for months
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain
Clinical narrative: soreness, muscle aches; also, patient said she has some nerve damage from the flu vaccine administration
Age: 79.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction, Malaise, Rash
Clinical narrative: Patient reported feelings of malaise as well as injection site reaction and a rash on the trunk/torso.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Hypoaesthesia, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Swelling in l deltoid. States painful with numbness and tingling down arm and pain to back.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient experienced shoulder pan; decreased rang of motion.  Sometimes persistent pain that is like shooting pain on left arm. To him, it feels as if its a recurring pain.  Has regained back some range of motion and decrease in pain.
Age: 23.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Arthralgia, Injection site swelling, Injection site warmth
Clinical narrative: pain in left shoulder, no redness. swelling or warmth at injection site. pain usually 1-7 in shoulder to hand. Pain occasionally increases to 7 for unknown reasons. Has been applying hot packs with slow improvement.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Pt reports having repeat post injection site reactions again after 1st shot: arm soreness at the injection site a week ago, about 65 days after injection at the injection site, and then about 3 days ago, area at and around injection site became red and pt has been fatigued. The symptoms that appeared were like getting the shot again without getting the shot. Pt reports that the fatigue has improved but still sore and red at injection site.
Age: 37.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: RASH AT SITE AND ITCHING
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder, Weight bearing difficulty
Clinical narrative: My upper arm has been painful ever since I got the injection. Can barely lift anything heavy.  Interferes with my sleep since I cannot place weight on my arm.  Cannot lift my arm w/o pain.  Can only get my arm over my head by using my left arm to lift it.  Shame on our government for approving something like this and not caring at all how it could horribly affect people's lives.  I have had a flu shot for countless years and have NEVER experienced something like this.  I do not think I will ever regain normal use of my arm.  It has been 2 months now.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Tachycardia
Clinical narrative: Pt reported tachycardia that was bothersome while lying down approximately 3 hours after vaccination.  Pt reported less noticeable symptoms after 45 minute follow-up.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Dizziness, Full blood count, Nausea, Vomiting
Clinical narrative: within a minute of receiving the vaccine patient was dizzy, nauseated and vomited . Blod pressure went down to 98/68( was 106/68) on entry. Kept in trendelenburg position, it took one hour for patient to be able to sagfely walk out of clinic with her mother.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Nausea
Clinical narrative: headache, stomach ache, nauseau and diarrhea
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Contacted pharmacy on 11/21/20, and patient said injection site became sore, red and inflamed, advised to warm pack for 24 hours and contact physician if not markedly improved. Patient went to see physician on 11/24/20 and was diagnosed with cellulitis and put on a course of cephalexin.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 11/21/2020 1:00 PM - pain in right arm - treated with ice and tylenol - pain is reduced but is ongoing, treating with tylenol 11/22/2020 7:00 AM - nausea and headache upon waking. - continued until 9:00 PM 11/22/2020 11:00 AM - chills. - continued until 3:00 PM 11/22/2020 1:00 PM - shivering and fever of 100.6, treated with tylenol - continued until 3:00 PM 11/22/2020 - 3:00 PM - fever of 99.4, treated with tylenol - continued until 11/23/2020 10:00 AM 11/22/2020 - 7:00 PM - rash starting on upper chest and right side of neck.  rash continued to spread throughout the day on 11/23.  By 6:00 PM on 11/23 rash had spread to below breasts, upper chest, both sides of neck, sides of face, back of neck and around hairline.  Rash has subsided with antihistamine treatment but continues as of 11/24 8:00 PM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 11/21/2020 1:00 PM - pain in right arm - treated with ice and tylenol - pain is reduced but is ongoing, treating with tylenol 11/22/2020 7:00 AM - nausea and headache upon waking. - continued until 9:00 PM 11/22/2020 11:00 AM - chills. - continued until 3:00 PM 11/22/2020 1:00 PM - shivering and fever of 100.6, treated with tylenol - continued until 3:00 PM 11/22/2020 - 3:00 PM - fever of 99.4, treated with tylenol - continued until 11/23/2020 10:00 AM 11/22/2020 - 7:00 PM - rash starting on upper chest and right side of neck.  rash continued to spread throughout the day on 11/23.  By 6:00 PM on 11/23 rash had spread to below breasts, upper chest, both sides of neck, sides of face, back of neck and around hairline.  Rash has subsided with antihistamine treatment but continues as of 11/24 8:00 PM.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Patient experienced hives & red spots from injection site down to mid-area of upper arm. Also is experiencing swelling and slight bruising across upper arm.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient states that she felt pain immediately upon administration of vaccine. This pain has persisted since, making it difficult to raise and lower her arm. Upon evaluation by PCP, it was concluded that her diagnosis is tendonitis of anterior shoulder due to improper placement of vaccine. Doctor did not state whether he believes this to be permanent. Patient was seen by doctor on 11/20/20, medication prescribed was a medrol dosepak. Patient picked up medication on 11/24/20. She would like someone from Risk Management to contact her.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Tendonitis
Clinical narrative: Patient states that she felt pain immediately upon administration of vaccine. This pain has persisted since, making it difficult to raise and lower her arm. Upon evaluation by PCP, it was concluded that her diagnosis is tendonitis of anterior shoulder due to improper placement of vaccine. Doctor did not state whether he believes this to be permanent. Patient was seen by doctor on 11/20/20, medication prescribed was a medrol dosepak. Patient picked up medication on 11/24/20. She would like someone from Risk Management to contact her.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: swelling , pain and redness at site of injection and some "white little spots" around  swelling and pain more severe the first 2 days following vaccinatin  pt states left bandage on while taking hot showers for 2 days recommended Benadryl and Neosporin and follow up with md if not better in next 24-72 hours
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine that was administered was expired with expiration date of 6/30/2020. The patient did not have any symptoms or adverse effects.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT EXPERIENCED ITCHINESS AND REDNESS ABOUT A PALM SIZE AT THE AREA OF INJECTION. I ADVISED PATIENT TO CONTINUE MONITOR THE AREA IF IT CONTINUES TO SPEAD.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Joint injury, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Severe shoulder joint injury starting  4 days after the event.  Enough pain to make driving with that arm difficult; can not sleep on that side; cannot life arm up to get dishes, etc.  I presume this is a classic case of SIRVA. In fact, it is exactly like a  squash sports injury I had 20 years ago, only I have not been doing sports with my arms in a long time.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Muscle pain at injection site, arm, and shoulder, headache, chills, fatigue, nausea
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Scab
Clinical narrative: Pt states that she  developed a hard crusty lump in her left arm after getting shingles vaccine. However, our records state she received the shot in her right arm.