chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Skin warm
Clinical narrative: Pt phones provider's office reporting redness to left arm. Pt states redness is "a couple inches diameter around injection site and a spot below it", a bump on injection site and a line under his arm. He reports temp of 99.2 F starting last night, "went down since then", stiff fingers and cramping in the arm. Pt denies adverse reaction/allergy to vaccine in the past. Per Dr., pt having an immune response to the vaccine as it has been within 24-48 hours from when the vaccine has been received, have pt ice area, draw a line around the reddened area and monitor it for increasing redness outside the marked line, pt can take ibuprofen as well. RN phones pt with Dr. further direction, pt verbalizes understanding and is agreeable to plan. RN advises pt to call provider if redness increases outside of line drawn, temperature increases, arm becomes warm to the touch, symptoms do not improve. Pt verbalizes agreement to do so if needed. Pt denies further questions/concerns/needs at this time.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: developed cellulitis in her right arm on an unspecified date; This spontaneous report was received from an office manager via a company representative referring to a currently 76-year-old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe (lot # S021740 with expiration date 25-MAR-2021; dose, frequency and route were not reported) for prophylaxis. On an unknown date the patient developed cellulitis in her right arm. On an unknown date, the patient was hospitalized due to the event. The pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe was not available for investigation but the office had an unused pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe with same lot number which could be returned.  The outcome of the event was unknown. The causality assessment was not provided.   The reporter requested a lot check because this was the third adverse event report for this lot number of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(one of three reports from the same reporter).  Upon interval review, cellulitis in the arm was determined to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2003USA003225: US-009507513-2003USA003005:
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Rash, Swelling face, Urticaria
Clinical narrative: Patient reports she received TDAP on 2/25/20. Patient states the day after vaccine had rash on torso that spread to arm/face. Patient states did not improve on Sunday went to UC. Patient was given medrol injection, prednisone for 1 week. Patient states went to ER last night - with hives on face, swelling of face, numbing around cheeks/mouth. Patient states she was given medrol, was prescribed pepcid, prednisone 60 mg for 5 days.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Pt was given both DTaP-IPV and Varicella in the right leg, mother could not tell me specifically where the reaction was from.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms of extreme chills and entire body shivering, muscle and joint pain, leg pain, fatigue, .  Lasted for two days
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Flu like symptoms of extreme chills and entire body shivering, muscle and joint pain, leg pain, fatigue, .  Lasted for two days
Age: 9.0
Sex: F
Vaccine: HEPA, IPV, TD
Symptoms: Hyperhidrosis, Malaise, Pallor
Clinical narrative: Patient received Hepatitis A, IPV, and Td and left the nurses office.   The nurse observed that the father was supporting the patient and she was returned back to the nurse's office for further assessment.  Presented with diaphoresis, pale, general malaise, yet alert responsive and able to answer questions about how she was feeling.  Parents reported that she was really apprehensive about having to get vaccines today.  O2 SATS 77-86%, BP WN range.  Patient was able to ambulate with parents out of the office.  With instructions to parents to report to the ER if any further attention is warranted and parents verbalized understanding with the interpreter.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: Fever, tiredness,redness, soreness, swelling and tenderness.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: Fever, tiredness,redness, soreness, swelling and tenderness.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site urticaria
Clinical narrative: Hives developed on inner right thigh within 5 minutes of vaccine administration and spread to abdomen and face within 10 minutes. Benadryl 8 mg orally was given
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: intermittent headache (1 day), sinus pain (3 days - possibly from dry air rather than vaccine), lower back pain (3 days), soreness at injection site (2 days). very sore & aching balls (4 hours), tremors in arm muscles of injected arm (2 days duration), extreme fatigue (2 days), extreme chills/shivering at night (2 days), night sweating after chills ended on 2nd night (as with a fever), complete numbness in hand of injected arm (intermittent, for 2 days) As a young child (6 or 7), I had chickenpox, measles, and mumps.  I never got a smallpox vaccination (no scar), maybe because I'd had chickenpox?  I got the sugar cube polio vaccine in grade school - probably 3rd grade (1961?), since I recall my younger sister & brother also getting the sugar cube.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Night sweats, Sinus pain, Testicular pain, Tremor
Clinical narrative: intermittent headache (1 day), sinus pain (3 days - possibly from dry air rather than vaccine), lower back pain (3 days), soreness at injection site (2 days). very sore & aching balls (4 hours), tremors in arm muscles of injected arm (2 days duration), extreme fatigue (2 days), extreme chills/shivering at night (2 days), night sweating after chills ended on 2nd night (as with a fever), complete numbness in hand of injected arm (intermittent, for 2 days) As a young child (6 or 7), I had chickenpox, measles, and mumps.  I never got a smallpox vaccination (no scar), maybe because I'd had chickenpox?  I got the sugar cube polio vaccine in grade school - probably 3rd grade (1961?), since I recall my younger sister & brother also getting the sugar cube.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and consumers, referring to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   In 2018, the patient was prescribed and administered with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and zoster-related conditions, by the pharmacist at a pharmacy.   On an unknown date, subsequently, the patient was treated by a health care provider in the medical office for shingles.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was considered as not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Vaccine positive rechallenge
Clinical narrative: chills; aches; This case was reported by a pharmacist and described the occurrence of chills in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st on 15th November 2019 refer case US2019231625).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced chills and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills and general body pain were unknown.   The reporter considered the chills and general body pain to be probably related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had chills and general body pain and no more difficulty in breathing with 2nd dose.
Sex: F
Vaccine: PPV, UNK, UNK, UNK
Symptoms: Allergy to vaccine, Drug hypersensitivity, Food allergy
Clinical narrative: Allergy: Pneumococcal Vaccine; Sertraline; Simvastatin; Prozac; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician report that a 58-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunisation. Co-suspect drug inlcuded, sertraline (manufacture unknown, Tablet) at 100 mg, simvastatin (manufacture unknown, Tablet) at 10 mg, fluoxetine hydrochloride (PROZAC, tablet) at 10 mg, these drugs are all orally from an unspecified date for unspecified indications. The patient's medical history included active allergies to iodinated diagnostic agents on 23Dec2008 with reactions anaphylactic, active allergies to latex exam glove miscellaneous (Not Specified) on 14Jul2003, allergy to bee stings on 14Jul2003, allergy to dairy on 21Jun2016, allergy to fish (not sea food), shellfish, soy on 21Jun2018. The patient's concomitant medications were not reported. The patient experienced allergy to pneumococcal vaccine on 20Oct2015, allery to sertraline 21Sep2018, allergy to simvastatin on 28Jul2015, allergy to fluoxetine hydrochloride on 21Sep2018.  The action taken in response to the event for sertraline, simvastatin and fluoxetine hydrochloride was unknown. The outcome of the events was not resolved.   Pfizer is a marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and sertraline in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of  pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and sertraline has submitted the same report to the regulatory authorities  Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: raised swelling and redness at the injection site after administration of Prevnar 13; raised swelling and redness at the injection site after administration of Prevnar 13; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced raised swelling and redness at the injection site after administration of Prevnar 13. Event took place after use of product. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Anticonvulsant drug level, Condition aggravated, Seizure
Clinical narrative: 12/21/19 - Seizure lasting > 7 minutes. Has Seizure Disorder Last Seizure 5/2019. On Keppra 700 mg BID & No missed doses per caretaker. Keppra level < 2.5Mg/ml (10-40 range) Treated with IV Keppra & sent home with increase Keppra dose to 750mg BID
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Local reaction, Pain, Rash
Clinical narrative: Child received Flu vaccine yesterday. Mom says this morning he woke up with his L deltoid area red. Child went to school and starting having mild pain on the arm and the rash got raised and bigger. Denies any respiratory symptoms such as sob, worsening wheezing, swelling of upper airways. 1. Allergic reaction to drug - Local allergic reaction to fLu vaccine (vaccine received 24 hours ago).  Marked area with ink to monitor progression.  Give medicines as prescribed.  May apply cool packs for 15 minutes as needed for comfort.  RTC if rash started to get bigger, child start having respiratory difficulties, worsening of wheezing, sob.   Benadryl Allergy 12.5 mg/5 mL oral liquid - Take 10 mL every 4-6 hours by oral route as needed for 2 days.      ibuprofen 100 mg/5 mL oral suspension - Take 15 mL every 6-8 hours by oral route as needed for 3 days.         PEDIATRIC ALLERGIST REFERRAL
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Child received Flu vaccine yesterday. Mom says this morning he woke up with his L deltoid area red. Child went to school and starting having mild pain on the arm and the rash got raised and bigger. Denies any respiratory symptoms such as sob, worsening wheezing, swelling of upper airways. 1. Allergic reaction to drug - Local allergic reaction to fLu vaccine (vaccine received 24 hours ago).  Marked area with ink to monitor progression.  Give medicines as prescribed.  May apply cool packs for 15 minutes as needed for comfort.  RTC if rash started to get bigger, child start having respiratory difficulties, worsening of wheezing, sob.   Benadryl Allergy 12.5 mg/5 mL oral liquid - Take 10 mL every 4-6 hours by oral route as needed for 2 days.      ibuprofen 100 mg/5 mL oral suspension - Take 15 mL every 6-8 hours by oral route as needed for 3 days.         PEDIATRIC ALLERGIST REFERRAL
Age: 1.58
Sex: M
Vaccine: UNK
Symptoms: Confusional state, Crying, Dyspnoea, Febrile convulsion, Respiratory arrest
Clinical narrative: Suspected febrile seizure. Parents report the patient stopped responding and was not breathing, but also describes the patient as crying and gasping.  Denies any tonic-clonic activity.  Reports confusion for several minutes afterwards
Age: 1.58
Sex: M
Vaccine: UNK
Symptoms: Unresponsive to stimuli
Clinical narrative: Suspected febrile seizure. Parents report the patient stopped responding and was not breathing, but also describes the patient as crying and gasping.  Denies any tonic-clonic activity.  Reports confusion for several minutes afterwards
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased, Nasopharyngitis, Tremor
Clinical narrative: Woke up early morning with terrible cold. Could not control it with any number of covers. Then later when try to get out of bed, I could not , not even get to the bathroom, Had to urinate right on bed. When finally with much effort got seated on bed, my legs we trembling and could not get up. Could not mark numbers on cell because I was trembling al over. Finally was able to phone my neiborhg who took care of me for the next days. Even today after 11 days my knees are weak
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Upon awaking the next day I started out with a feeling of general body aches. Then a headache. Then full blown body aches, chills, mild fever extreme lethargy, headache and arm pain. I felt as though I had a bad case of the flu. I was whipped out for the entire day. I took Advil and lay in bad all day. I felt terrible that night while trying to sleep. My injection sight really hurt as well as my neck. I'm not sure if this qualifies for a report, but I thought it may be a good idea to let you know that the side effects were pretty bad. This is my second dosage for Shingles. My first dosage was ok. Arm hurt but not as bad, some chills but nothing like this. Today, two days after the vaccine, I feel pretty normal. A little tired and my arm still hurts some.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Upon awaking the next day I started out with a feeling of general body aches. Then a headache. Then full blown body aches, chills, mild fever extreme lethargy, headache and arm pain. I felt as though I had a bad case of the flu. I was whipped out for the entire day. I took Advil and lay in bad all day. I felt terrible that night while trying to sleep. My injection sight really hurt as well as my neck. I'm not sure if this qualifies for a report, but I thought it may be a good idea to let you know that the side effects were pretty bad. This is my second dosage for Shingles. My first dosage was ok. Arm hurt but not as bad, some chills but nothing like this. Today, two days after the vaccine, I feel pretty normal. A little tired and my arm still hurts some.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: intussusception, self-resolved
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Severe head ache, shivering, tiredness, muscle pain.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: paresthesia and tingling down the left arm and down the left side of the back x 3 weeks after the injection. No rash or pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Rash, Urticaria
Clinical narrative: 1.) WITHIN FIRST 2-3 HOURS POST INJECTION-HOT, SWOLLEN, INCREASED TENDERNESS (L) DETOID RASH 2.) @ 26 HOURS POST INJECTION - HIVES/RASH-BILATERAL UPPER EXTREMITY PROGRESSION TO CHEST, TORSO, BACK, POPLITEAL & NECK, FACE SCALP
Sex: U
Vaccine: HPV9, HPV9, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient waited 6 months to get the second dose; This spontaneous report as received from a medical assistant refers to a 16-year-old patient on unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-SEP-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) lot # S005524, expiration date 29-SEP-2021 (dose and route of administration was not reported) for prophylaxis. The patient waited 6 months to get the second dose and on 09-MAR-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005524; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Site of injection was red and sore to touch immediately after injection. After several hours, the  area around the injection site began to swell. Mom noted increased swelling the following morning and the area of the arm around the injection site felt firm.  Mother directed to use an ice compress as needed and to monitor injection site for any increased swelling or discomfort.  Pt did not experience any fevers, shortness of breath, wheezing, hives, or rash.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient  came in today.  I gave her her second Shingrix shot on 3/9/20.  Her arm is red and hot to the touch.  Probably a 3 inch diameter.  I think she needs an antibiotic.  She states I should have to pay for her doctor's visit to do that.  I shared your phone number with her since she wanted money.  I followed protocol by using an alcohol swab and a the barrier bandage when I gave the immunization.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Grip strength decreased, Musculoskeletal stiffness, X-ray limb abnormal
Clinical narrative: Patient received vaccine on 12/12/19.  She contacted me on 1-20-20 that she was having stiffness on the right side down into her hand so that she was having a hard time opening a jar. She contacted her physician who told her to wait a couple weeks but she was still having problems.  I then contacted GSK to determine if any other patients had had similar reactions to Patient.  They couldn't see that anyone had anything other than from the list of side effects of decreased mobility or muscle pain.  Patient contacted me again on March 10 and told me she was still having problems.  She had been back to the doctor and I believe that he had done an x-ray of the arm and didn't see anything but arthritis.  He suggested she get an MRI.  That is all the information I have at this time
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fatigue, shiver and fever at 100.4 for 2 days. Pain around the arm and armpit stayed 4 days.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Petechiae
Clinical narrative: Patient developed petechiae within 24yhr, got worse over 48hrs and then stabilized.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives on the extremities
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Ear infection, Ear pain, Pyrexia
Clinical narrative: Fever, ear pain
Age: 22.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pain, Rash, Rash papular, Rash pruritic, Skin tightness
Clinical narrative: "22 y/o F presented to clinic complaining of rash that is spreading over her entire body. PT describes the rash as feeling tight on the skin, itchy, and stinging. PT states that she received her vaccines for Hep A and HPV yesterday and attributes the rash to a reaction to on of those shots. PT denies any difficulty breathing, SOB, or wheezing. PT does not appear to be in any acute distress."  Once seen by medical professional her skin condition was described as such: "erythematous papules noted spread diffusely across entire body. No weeping, lesions, or open sores"
Age: 53.0
Sex: F
Vaccine: HEP, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Rxn started 12 hours after injection, redness, swelling and burning sensation to injection site.  Pain which was relieved by Tylenol.
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: swollen left upper arm/cellulitis
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site discolouration, Injection site induration, Irritability, Pyrexia
Clinical narrative: Mom reported that symptoms started about  half hour after the vaccinations were given.  She said the thigh areas where the shots were given  had become hard and purplish color.  Child was fussy and had a fever later that night. Symptoms had resolved 18 hours later.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Apnoea, Cyanosis, Pallor
Clinical narrative: Upon administering all three vaccines, the child cried intensely, paused her breathing, turned a pale blue color.  Parents held and picked up child, fanning then blowing air into child's face, and calling her name.  Child alert,  breathin, and waiting with parents in Lobby.  RN present and reports this is a rare occurrence; a Valsalva incident.  Interpreted this info to parents in Spanish.  RN notifies NP.  NP assesses child.  Water given to family; juice and crackers given to child.  Parents advised to monitor child.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Swelling
Clinical narrative: Patient has experienced muscle pain, some swelling, and painful injection site since date of vaccination (>40 days) at reporting
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Dr. called me on 3/12  at 4pm. Patient had gone to see Dr. today because she could not move her left arm. She received 3 vaccines on 3/10/20. Flu and shingrix in the right arm and PV23 in the left arm. Dr. said after examining patient he said it looked like the vaccine was given "too posterior" and felt it may  have been injected into a joint. Dr. said he plans to put patient on a steriod.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Headache, Insomnia
Clinical narrative: This was second one. I had adverse reaction to first one as well -- same pharmacy, on Dec. 27, 2019. First reaction started morning after a late afternoon shot. This one started a few hours after shot, with trembling. Ended up being much worse than first time, with trembling, weakness, intense muscle and joint pain. So much pain I couldn't sleep or even move. Headache, and I never get headaches. Just felt incredibly awful. It was as bad as chemo, except without sweating. (My last chemo was almost a year ago, but this brought back all those feelings.) I was better about 30 hours after the second dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia, Tremor
Clinical narrative: This was second one. I had adverse reaction to first one as well -- same pharmacy, on Dec. 27, 2019. First reaction started morning after a late afternoon shot. This one started a few hours after shot, with trembling. Ended up being much worse than first time, with trembling, weakness, intense muscle and joint pain. So much pain I couldn't sleep or even move. Headache, and I never get headaches. Just felt incredibly awful. It was as bad as chemo, except without sweating. (My last chemo was almost a year ago, but this brought back all those feelings.) I was better about 30 hours after the second dose.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Blood creatine phosphokinase normal, Blood test normal, Bursitis, C-reactive protein normal
Clinical narrative: Patient was given a TDap vaccination October 8 at the 30 week pregnancy checkup. Baby was due December 14, and gave birth December 21. There were no pregnancy complications. Injection was given high on the shoulder. Patient had no pain or injury to the shoulder prior to injection.  A few hours after the injection the pain was debilitating and patient was unable to lift the right arm at the shoulder. Examination and blood tests showed no signs of infection. Patient was unable to move their arm at the shoulder for approximately two weeks. Patient started attending physical therapy at two weeks and condition slowly began to improve though still exhibited loss of motor control and pain. An MRI showed ?nonspecific mild edema of the supraspinatus muscle" and "mild right subacromial/subdeltoid bursitis" though physical therapist observed worse symptoms than what MRI showed. As of March 12, condition is still improving though patient still has not recovered full active range of motion.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Exposure during pregnancy, Full blood count, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient was given a TDap vaccination October 8 at the 30 week pregnancy checkup. Baby was due December 14, and gave birth December 21. There were no pregnancy complications. Injection was given high on the shoulder. Patient had no pain or injury to the shoulder prior to injection.  A few hours after the injection the pain was debilitating and patient was unable to lift the right arm at the shoulder. Examination and blood tests showed no signs of infection. Patient was unable to move their arm at the shoulder for approximately two weeks. Patient started attending physical therapy at two weeks and condition slowly began to improve though still exhibited loss of motor control and pain. An MRI showed ?nonspecific mild edema of the supraspinatus muscle" and "mild right subacromial/subdeltoid bursitis" though physical therapist observed worse symptoms than what MRI showed. As of March 12, condition is still improving though patient still has not recovered full active range of motion.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging abnormal, Metabolic function test normal, Muscle oedema, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient was given a TDap vaccination October 8 at the 30 week pregnancy checkup. Baby was due December 14, and gave birth December 21. There were no pregnancy complications. Injection was given high on the shoulder. Patient had no pain or injury to the shoulder prior to injection.  A few hours after the injection the pain was debilitating and patient was unable to lift the right arm at the shoulder. Examination and blood tests showed no signs of infection. Patient was unable to move their arm at the shoulder for approximately two weeks. Patient started attending physical therapy at two weeks and condition slowly began to improve though still exhibited loss of motor control and pain. An MRI showed ?nonspecific mild edema of the supraspinatus muscle" and "mild right subacromial/subdeltoid bursitis" though physical therapist observed worse symptoms than what MRI showed. As of March 12, condition is still improving though patient still has not recovered full active range of motion.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Patient was given a TDap vaccination October 8 at the 30 week pregnancy checkup. Baby was due December 14, and gave birth December 21. There were no pregnancy complications. Injection was given high on the shoulder. Patient had no pain or injury to the shoulder prior to injection.  A few hours after the injection the pain was debilitating and patient was unable to lift the right arm at the shoulder. Examination and blood tests showed no signs of infection. Patient was unable to move their arm at the shoulder for approximately two weeks. Patient started attending physical therapy at two weeks and condition slowly began to improve though still exhibited loss of motor control and pain. An MRI showed ?nonspecific mild edema of the supraspinatus muscle" and "mild right subacromial/subdeltoid bursitis" though physical therapist observed worse symptoms than what MRI showed. As of March 12, condition is still improving though patient still has not recovered full active range of motion.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Pain, Pyrexia
Clinical narrative: Fever, chills, localized heat/swelling/redness. Fever, chills, and generalized pain resolved with Tylenol every 4 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Fever, chills, localized heat/swelling/redness. Fever, chills, and generalized pain resolved with Tylenol every 4 hours.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: Patient still has bruising and pain from injection site
Age: 52.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Influenza like illness, Nasopharyngitis
Clinical narrative: The day after receiving injection, the patient called to notify us of feeling pretty bad with flu like symptoms, cold and headache. Patient was counseled these are potential side effects and can be expected after receiving Prevnar 13. Patient was counseled to take OTC Tylenol or ibuprofen to help with the pain and fever.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site mass, Pyrexia
Clinical narrative: Patient had the reaction a few hours after the getting the vaccine. She experienced a headache, fever of 102F, and a large lump at the site of injection.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation, No adverse event, Product preparation issue
Clinical narrative: RPh accidentally gave JUST the adjuvant.  The powder vial had not been reconstituted.  Discovered after the shot was given in left arm,  when labels were pulled off vials, powder was still in the vial.  RPh notified patient asap,  a second adjuvant was then used to reconstitute the powder, the vaccine was then given in right arm.   No adverse rxn noted, patient stayed in store.  Patient said he felt fine.  MD will be notified via fax.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Pain at time of injection.  By the evening I could not raise my arm.  I had to lift my left arm with my right to roll over in bed.  I have had difficulty putiing on clothing, putting on my seatbelt,cannot lay on my left side, and simply raising or twiting my arm.  I have tried oral anitinflammatory OTC,, oral cortisone, and had one cortisone injection in November.  The cortisone gave some temporary relief, but pain is back and increasing.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt came in pharmacy today (3/12/2020) to report that his arm had been sore since his shingrix shot on 2/29/2020.  He said it started being sore about 12 hours after the shot and has not gotten better or worse.  This is his second shot in the series as be said he received his first in his doctors office sometime in the fall.  He said no redness, swelling or lumps or any other sign of allergic reaction, just arm soreness.  He reported no unusual adverse reactions after the first vaccine.  I called his primary care office this evening to report to them.  I also instructed the patient to call as well if the soreness is not improved by tomorrow.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: The injection was given in the hip side unkown.   The patient stated he had swelling and redness in a large area. At 4 days post injection he came in to shows pictures of the site. He said he had been applying hydrocortisone cream and it had improved but was still red and swollen so he felt it should be reported. I advised trying benadryl cream instead of hydrocortisone.
Age: 73.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Two shots were administered, one in each shoulder.  Once the shots were injected, patient immediately felt pain in both shoulders. This pain  has persisted for 5 straight months resulting in a visit to ER,  and visits to primary doctor..  As of this week, patient is currently taking  pain medication to deal with the pain.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient states that he developed a rash on chest and shoulder area.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mass, Pain
Clinical narrative: Redness, pain with movement, baseball sized lump
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient had second shingrix shot on 2/28/2020 and she started with pruritic maculopapular erythematous rash on trunk and all extremities on 2/29/2020 that has been persistent up until seen today on 3/12/2020. She has had no other skin contacts of concern and no otc/prescription medications. No fevers,chills. No other family members in her house have symptoms.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hypersensitivity, Sneezing, Throat tightness
Clinical narrative: Patient stated the day after receiving the above vaccines she experienced excessive sneezing and throat tightness. No MD visit required. Symptoms eventually improved.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area warm, red, and mildly tender Patient was seen in our office 2-27-20 Patient was seen at ED 3-3-20
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother states patients arm was swollen and red where injection was administered and will give Benadryl for further treatment.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation, Skin lesion, Urticaria
Clinical narrative: Around 7 pm she noticed some hives on the back of her neck, and they seemed moist. They travelled down to her upper back after 2 days. The lesions seem to be drying now and they haven't migrated anymore, as of today. Treatment today involved Benadryl this afternoon around 3pm. They don't itch at all, don't burn, just noticing the lesions on the skin. The lesions are only irritating if she lays on her back.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Self Treatment recommended by nurse. If condition worsens send to designated clinic
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported.     On 03-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # S024366 with expiration date reported as "02-MAR-2021", for prophylaxis (route of administration and anatomical location were not reported). Concomitant therapies included sterile diluent(MERCK STERILE DILUENT) which was properly stored. It was reported that the vaccine was exposed to a temperature of -14°C to -10°C for 2 hours 30 minutes and -9°C to 8°C for 5 hours 40 minutes. No previous temperature excursion was reported. A digital data logger was involved.  Lot # S024366 was determined to be a valid lot # for varicella virus vaccine live (oka/merck)(VARIVAX), expiration date was reported as "02-MAR-2021", but after internal review, it was determined as 06-AUG-2021.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer on 04-MAR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 17-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles and zoster-related conditions (additional dosage regimen information was not provided). Subsequently, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to mental and physical pain and suffering, medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages, and would continue to suffer such losses and damages in the future.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Deafness unilateral, Ear discomfort, Lumbar puncture, Magnetic resonance imaging brain abnormal, Optic neuritis
Clinical narrative: This currently 35 year old male patient started Gardasil 9 on 26Nov2020; On 02Mar2020 the caller woke up and had difficulty seeing out of his right eye/They suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis/his vision is getting worse; the patient also developed hearing loss in his right ear/He explains that it feels as if he bas water in his right ear; This spontaneous report was received from a 35 years old male patient referring to himself. The patient's medical history, concurrent condition, concomitant therapies and drug allergies were not provided.  On an unknown date (reported as 26-NOV-2020), 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) (strength, dose detail, route, lot# and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). On 28-JAN-2020, the patient received his second injection of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot# and expiration date were not provided).   On 02-MAR-2020, the patient woke up and had difficulty seeing out of his right eye. The patient went to the emergency department on the same day. He had a brain magnatic resonance imaging (MRI) and a lumber spinal tap, which suspected that he had multiple sclerosis at one time during his visit, but he was eventually given the diagnosis of optic neuritis. From 02-MAR-2020 to 06-MAR-2020, the patient had been to the emergency department every day. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) injections from 04-MAR-2020 to 06-MAR-2020 for treatment, but these did not improve his vision in fact his vision seemed to be getting worse. He stated that he only had peripheral vision in his right eye and be only had 10 percent of his vision in that eye as well. On an unknown date of March 2020 (also reported as some point of time this last week), the patient also developed hearing loss in his right ear. He explained that he did not notice at first, because of his vision issue, but this was an issue when listening to music. He explained that it felt as if he had water in his right ear. He explained that his vision was getting worse and he would be visiting a neurologist in the future. Medical attention had been sought.  The outcome of optic neuritis and hearing loss was reported as not recovered. The causality between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and optic neuritis, hearing loss was not provided.  Upon internal review, optic neuritis and hearing loss in right ear were determined to be medically significant.; Sender's Comments:  US-009507513-2003USA004150: US-009507513-2003USA003782: