chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: She has lost the range of her left arm [and no longer to extend the arm due to pain]; Her arm was very painful after the administartion of the vaccine and gradually got worse; This is a spontaneous case initially reported by other non-health professional to Company (reference number: SEQ19-05254) on 22-Oct-2019 concerning a female patient of unspecified age.   The patient's medical history and concomitant medications were not reported.   On 02-Oct-2019 the patient was administered Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] for prevention of seasonal influenza.  On the same date, an unknown amount of time after vaccination, the patient's arm was very painful and gradually got worse.  On an unspecific date, the patient had lost the range of her left arm and she could no longer extend the arm due to pain.  The outcome of the events was not reported.   The reporter assessed the case as serious and did not provide causality assessment.  Company comment: The patient experienced vaccination site pain and injected limb mobility decreased, after administration of the suspect vaccine Flucelvax QIV. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced vaccination site pain and injected limb mobility decreased, after administration of the suspect vaccine Flucelvax QIV. Chronology is plausible. More information regarding patient's medical history and concomitant drugs is needed. Based on provided information, causal role of the suspect product is assessed as related.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Amnesia, Asthenia, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Muscle aches; Passed out; Difficulty breathing; Wheezing; Voice was a whisper; Dizzy eyes glossy; Really dizzy [and weak]; [Really dizzy] and weak; Loss of memory; Fever; This is a serious spontaneous case reported by other non-health care professional (consumer) (reference number: SEQ19-05437) and initially received on 23-Oct-2019, concerning a 40-year-old, female patient.  The patient's medical history included allergies to grains, yeast, corn, melon and grasses.  No relevant concomitant medications were reported.  On 24-Sep-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, route of administration: intramuscular, anatomical location: left deltoid, dose, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, after vaccination, the patient experienced difficulty breathing, wheezing, voice was a whisper, fever, muscle aches, dizzy eyes glossy.  On the same day, later that afternoon, the patient became really dizzy and weak and passed out in her hotel at about 7pm that evening. The patient also called her mom but did not remember calling her. Patient stated that she was preparing to see an allergist on 06-Nov-2019.  At the time of initial reporting, all events were considered resolved.  The reporter assessed the case as serious and thought that events might be a reaction to the flu vaccine.  The reporter assessed the case as possibly related to suspected Afluria Quadrivalent vaccine.  Company comment: The patient developed loss of consciousness, dyspnoea, wheezing, dysphonia, glassy eyes, dizziness, asthenia, amnesia, pyrexia, myalgia after administration of Afluria Quadrivalent. Chronology is plausible. The patient's atopic constitution may have contributed to development of the events. More information regarding patient's medical history is needed. Based on provided information, causal role of the suspect product is assessed as related.; Reporter's Comments: The patient thought the events might be a reaction to the flu vaccine.; Sender's Comments: The patient developed loss of consciousness, dyspnoea, wheezing, dysphonia, glassy eyes, dizziness, asthenia, amnesia, pyrexia, myalgia after administration of Afluria Quadrivalent. Chronology is plausible. The patient's atopic constitution may have contributed to development of the events. More information regarding patient's medical history is needed. Based on provided information, causal role of the suspect product is assessed as related.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Glassy eyes, Loss of consciousness, Myalgia, Pyrexia, Wheezing
Clinical narrative: Muscle aches; Passed out; Difficulty breathing; Wheezing; Voice was a whisper; Dizzy eyes glossy; Really dizzy [and weak]; [Really dizzy] and weak; Loss of memory; Fever; This is a serious spontaneous case reported by other non-health care professional (consumer) (reference number: SEQ19-05437) and initially received on 23-Oct-2019, concerning a 40-year-old, female patient.  The patient's medical history included allergies to grains, yeast, corn, melon and grasses.  No relevant concomitant medications were reported.  On 24-Sep-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, route of administration: intramuscular, anatomical location: left deltoid, dose, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, after vaccination, the patient experienced difficulty breathing, wheezing, voice was a whisper, fever, muscle aches, dizzy eyes glossy.  On the same day, later that afternoon, the patient became really dizzy and weak and passed out in her hotel at about 7pm that evening. The patient also called her mom but did not remember calling her. Patient stated that she was preparing to see an allergist on 06-Nov-2019.  At the time of initial reporting, all events were considered resolved.  The reporter assessed the case as serious and thought that events might be a reaction to the flu vaccine.  The reporter assessed the case as possibly related to suspected Afluria Quadrivalent vaccine.  Company comment: The patient developed loss of consciousness, dyspnoea, wheezing, dysphonia, glassy eyes, dizziness, asthenia, amnesia, pyrexia, myalgia after administration of Afluria Quadrivalent. Chronology is plausible. The patient's atopic constitution may have contributed to development of the events. More information regarding patient's medical history is needed. Based on provided information, causal role of the suspect product is assessed as related.; Reporter's Comments: The patient thought the events might be a reaction to the flu vaccine.; Sender's Comments: The patient developed loss of consciousness, dyspnoea, wheezing, dysphonia, glassy eyes, dizziness, asthenia, amnesia, pyrexia, myalgia after administration of Afluria Quadrivalent. Chronology is plausible. The patient's atopic constitution may have contributed to development of the events. More information regarding patient's medical history is needed. Based on provided information, causal role of the suspect product is assessed as related.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient was given the Pneumonia vaccine Wednesday 10/30/2019 afternoon around 12:40pm. At the time of injection she had no reaction. Patient called into the office Friday 11/1/2019 with complaints of the injection site being "hard as a rock, sore and swollen." She also stated the pain was slightly better than yesterday. It was documented in the chart and physician has been informed.
Age: 73.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, X-ray limb normal
Clinical narrative: The thumb of right hand started aching. Woke me up during the night, too. By morning (10/24/2019), hand was swollen, especially area above thumb, which was also red and raised. Using fingers or thumbs was extremely painful. Lasted all day; a bit better by 10 PM. Next morning, pain much less but still achy; able to use hand again. Still red above thumb; finger swelling less by 2 PM. This happened with the first dose of Shingrix on 7-25-2019, with symptoms beginning 7-27-19. Then I had the vaccine in my left arm and problems began in my left hand, especially the thumb. I saw a doctor for that one at the walkin clinic on 7-29-19; I told her I thought it was the Shingrix causing it. She had me x-ray it anyway, which showed no problem. I purposely had the 2nd dose in my right arm, to see if it would cause the problem on that side or whether it had been a coincidence caused by something else. No coincidence! I anticipate that my hand will slowly return to normal, as happened in July. I decided to report this, since it is not listed as a possible side effect in any literature I've read. (I used to conduct research studies using medications, so I know how important this is). This first vaccine was also made by glaxo-smith-kline, Lot # B5HP5.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Delusion, Erythema, Heart rate increased, Hypoaesthesia oral, Pruritus
Clinical narrative: Extreme high temperature which caused delusions, heart rate went to 120 for over 24 hours, lips red and itchy, tongue numb.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Extreme high temperature which caused delusions, heart rate went to 120 for over 24 hours, lips red and itchy, tongue numb.
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Arm still hurts 3 weeks after shot.  I can't lift up my arm or rotate it outward. I can't sleep on that side.  The pain has been getting worse. Pain felt in the lower deltoid about 5 fingers down from top of shoulder
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Dry mouth, Urticaria
Clinical narrative: Dry mouth and hives all over the body
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Blood test normal, Irritability, Laboratory test normal, Urine analysis normal, Urticaria
Clinical narrative: Pt broke out in inflamed hives through out entire body. Fussy.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Received the employee required flu vaccine on 9/20/19 at the Occupational Health Office. By 9/22/19, reactions started to occur. Reactions consisted of rash: hives, itching, redness, swelling, inflammation, and severe pain of the chest, neck, and face. From these symptoms, I was unable to sleep or function in daily life because of pain and other symptoms mentioned starting on 9/22/19. This rash and the symptoms interfered with work and then ability to wear hospital OR gowns during the scrub rotation of the Program. The gowns rubbed against the rash on my neck which further aggravated the rash.   I went to primary care doctor on 10/3/19 to get evaluated and for lab to be drawn. Labs tests showed increase in lymphocytes and eosinophils- the primary care doctor concluded an allergic reaction to something in my body.  On 10/4/19 I took the day off because of how severe the allergic reaction was. On 10/4/19 I went to the allergist first thing in the morning with the same reactions as mentioned plus had a hoarse and sore throat due to the extensive inflammation around the neck/throat area. Allergist prescribed Prednisone 40mg for 5 days and a steroid cream- Triamcinolone Acetonide Ointment 0.1% as needed for rash. Took prescribed Prednisone for 5 days, and 2 days later, rash returned: hives, itching, redness, swelling, inflammation, dryness, and severe pain of the chest, neck, and face. Side effects of Prednisone was severe (insomnia) that it was not recommended to take again along with the side effects of the steroid cream (extremely dry/painful skin). Allergist recommended patch testing to see if any chemicals or metals that may be reacting to my body. Patch testing was available after waiting 2 weeks after the last dose of Prednisone so the steroids will not interact with the results of the patch testing.  Patch testing was placed on 10/28/19, first patch test read and removed on 10/30/19, and final read on 11/1/19. Results from the patch testing showed allergic response to Thimerosal. In addition, took off work on 10/29/19 due to lack of sleep from the rash and symptoms of the rash (hives, itching, redness, swelling, inflammation, and severe pain of the chest, neck, and face).  I have been taking Benadryl and Claritin to try to ease the symptoms with little luck. I went to another allergist on 10/29/19, and he prescribed montelukast, zyrtec, and hydralazine to help with the inflammation, allergic reaction, and sleep (but with little luck, the symptoms of the effects of the flu shot still persists).   Rash has continued to this day and has spread to other areas of the body- entire face/ears, traps, upper back, and arms (starting around 10/14/19). The rash and effects of the flu shot is still currently affecting everyday life including effecting work (concentration/ coming in to work/ wearing OR scrubs and normal clothing) and ability to sleep at night. The lack of sleep interferes with work as well. As mentioned, the rash is currently still very itchy, red, swollen, dry, with inflammation, and severe pain of the chest, neck, and face.
Age: 2.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Mom noticed red itchy spottty rash L upper arm this am. Tried 1% HTC x2 without relief. Incraesed redness and 'fels hard' in the area by afternoon.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Dry eye, Facial paralysis, Herpes ophthalmic
Clinical narrative: PATIENT REPORTS BELL'S PALSY IN LEFT EYE AND HERPES IN RIGHT EYE ONE WEEK AFTER HAVING SHINGLES SHOT. SAYS HER RIGHT EYE IS EXPERIENCING DRYNESS AND SOME LOSS OF VISION.
Age: 26.0
Sex: M
Vaccine: FLU4, HEPA, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: This patient was given the pediatric version of the Hep A (Havrix) vaccine when he should have been given the adult version.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 doses of the Fluzone Quadrivalent 4 days apart.  First one was received at the Local Health Department and 2nd dose was received at his PCP office.  No complaints of any symptoms.
Age: 35.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient was given a Prevnar-13 vaccine when a Pneumovax 23 vaccine was indicated and ordered by the provider. Patient was not due for a Prevnar-13 vaccine at time of administration.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness around injection site 1-2 days later. Expanding & tx with ABX for cellulitis
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Agitation, Dyspnoea, Tremor
Clinical narrative: I had a pneumovax vaccine the day before. I had to go to the ER. Shortness of breath-severe agitation, shaking
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Secretion discharge, Sinus disorder, Sinus headache
Clinical narrative: one hour following, wanted to vomit. two hours later, lie down, head hurt, could not focus. Headache continued for 6 HRS until I could walk and function. Presently, my sinuses bother me, mucous and headaches. year 2018, I refused senior flu shot and got regular shot. This year 2019, I made mistake and got senior shot. I weigh 102 lbs I should not have to take a shot that is 5X stronger.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: one hour following, wanted to vomit. two hours later, lie down, head hurt, could not focus. Headache continued for 6 HRS until I could walk and function. Presently, my sinuses bother me, mucous and headaches. year 2018, I refused senior flu shot and got regular shot. This year 2019, I made mistake and got senior shot. I weigh 102 lbs I should not have to take a shot that is 5X stronger.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Rash
Clinical narrative: Rash (size of palm) Diarehha
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Nausea, Rash
Clinical narrative: HA, rash, red rash, swollen, hot to touch, sick to stomach, weak & tired
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm, Swelling
Clinical narrative: HA, rash, red rash, swollen, hot to touch, sick to stomach, weak & tired
Sex: F
Vaccine: HEP, MMR
Symptoms: Product storage error
Clinical narrative: Improperly stored doses; This spontaneous report has been received from an other health care professional referring to a 10 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with improperly stored vaccines measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II),  by intramuscular route, (strength, frequency, dose, anatomical location, and expiration date were not provided) for prophylaxis and hepatitis b virus vaccine (unspecified)(HEPATITIS B VIRUS VACCINE (UNSPECIFIED)) by intramuscular route (strength, frequency, dose, anatomical location, and expiration date were not provided).  Lot number S012472 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported.; Physician reported that 6 month old received first dose of ROTATEQ yesterday.; This spontaneous report was received from a physician referring to a 6 month old patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-OCT-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, dose, frequency, and indication were unknown) with  lot # S004399 and expiration date 06-NOV-2020 for prophylaxis. No adverse events were reported. Sibling 6 month old twin also received dose yesterday.  This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hypoaesthesia, Nasopharyngitis, Peripheral coldness
Clinical narrative: Shivering; Getting very cold; Very very tired like I'm coming down with something; Hands are cold and numb; Hands are numb; This case was reported by a consumer via sales rep and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019 04:00, the patient received the 2nd dose of Shingrix. In October 2019, 21 hrs 30 min after receiving Shingrix, the patient experienced shivering, cold, tiredness, cold hands and numbness in hand. On an unknown date, the outcome of the shivering, cold, tiredness, cold hands and numbness in hand were unknown.   It was unknown if the reporter considered the shivering, cold, tiredness, cold hands and numbness in hand to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient started getting very cold shivering very very tired like coming down with something, and hands were cold and numb after vaccination. The patient was watching 6 1/2 month old grandchild and hoping that this is not causing him to be in any kind of danger. The patient did not think to ask that since it was immunization and did not think it would cause a baby any harm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Injection site pain, Pain in extremity, Pruritus
Clinical narrative: sensitive hands; sore hands; itching /itching on her body; red hand; sore arm / sore arm where she got the injection; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th October 2019, 1 days after receiving Shingrix, the patient experienced fever. On 21st October 2019, the patient experienced injection site pain, increased skin sensitivity, pain in arm, generalized pruritus and red hands. On 21st October 2019, the outcome of the fever, increased skin sensitivity, pain in arm and generalized pruritus were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the red hands was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, increased skin sensitivity, pain in arm, generalized pruritus and red hands to be related to Shingrix.  Additional case details were reported as follows: The patient received Shngrix on an unknown arm. On Sunday, the patient ran a fever, but that resolved Monday morning.  On Monday, 2 days after vaccination, the patient noticed that her hands were very red, painful and sensitive to temperature changes like hot or cold water. They were more sensitive to hot water.  The patient also had a little itching on her body.  On day of reporting, her hands were less red and sensitive and no longer painful, the itching had also resolved.  She also had a sore arm where she got the injection, which was improving. The reporter consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: sensitive hands; sore hands; itching /itching on her body; red hand; sore arm / sore arm where she got the injection; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th October 2019, 1 days after receiving Shingrix, the patient experienced fever. On 21st October 2019, the patient experienced injection site pain, increased skin sensitivity, pain in arm, generalized pruritus and red hands. On 21st October 2019, the outcome of the fever, increased skin sensitivity, pain in arm and generalized pruritus were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the red hands was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, increased skin sensitivity, pain in arm, generalized pruritus and red hands to be related to Shingrix.  Additional case details were reported as follows: The patient received Shngrix on an unknown arm. On Sunday, the patient ran a fever, but that resolved Monday morning.  On Monday, 2 days after vaccination, the patient noticed that her hands were very red, painful and sensitive to temperature changes like hot or cold water. They were more sensitive to hot water.  The patient also had a little itching on her body.  On day of reporting, her hands were less red and sensitive and no longer painful, the itching had also resolved.  She also had a sore arm where she got the injection, which was improving. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Fever; Inhibition of activities of daily living; Severe reaction; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, activities of daily living impaired and adverse reaction. On an unknown date, the outcome of the fever, activities of daily living impaired and adverse reaction were unknown.   It was unknown if the reporter considered the fever, activities of daily living impaired and adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The pharmacist reported that patient received Shingrix experienced, severe reactions to include inhibition of activities of daily living and fever 102 degree Fahrenheit. The reporter did not have specific information a the time of the call. The reporter consent to follow up. This is 1 of the 6 linked cases reported by the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis/swollen and redness at the administrated site/the upper left deltoid/It is indurated and erythematous; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: AG8353, expiry date: Jun2021), via an unspecified route of administration on 25Oct2019 at single dose in left deltoid for immunization. There is no medical history. Concomitant medication included influenza vaccine (FLU) on 25Oct2019 at single dose in right arm for immunization. It was reported that the patient experienced swollen and redness at the administrated site, there was a 3cm diameter oval to the extremity; the upper left deltoid, it was indurated and erythematous, it was tender and very warm to the touch, there was no fluctuance, drainage, or bleeding, it was a localized reaction. Date this started was unknown but the patient was seen in the office and diagnosed with cellulitis on 28Oct2019. Cellulitis was reported as serious per medically significant. The patient was treated with cefalexin (CEPHALEXINE) (500mg capsule for 1 by mouth twice a day for 10 days, given a quantity of 20) for this diagnosis. The outcome of the event was not resolved at time of the report.; Sender's Comments: Based on the information currently available, the vaccination with PREVNAR 13 might have played a contributory role in triggering the onset of cellulitis localized at the vaccination site.  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
Sex: U
Vaccine: PNC13
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Cellulitis/swollen and redness at the administrated site/the upper left deltoid/It is indurated and erythematous; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: AG8353, expiry date: Jun2021), via an unspecified route of administration on 25Oct2019 at single dose in left deltoid for immunization. There is no medical history. Concomitant medication included influenza vaccine (FLU) on 25Oct2019 at single dose in right arm for immunization. It was reported that the patient experienced swollen and redness at the administrated site, there was a 3cm diameter oval to the extremity; the upper left deltoid, it was indurated and erythematous, it was tender and very warm to the touch, there was no fluctuance, drainage, or bleeding, it was a localized reaction. Date this started was unknown but the patient was seen in the office and diagnosed with cellulitis on 28Oct2019. Cellulitis was reported as serious per medically significant. The patient was treated with cefalexin (CEPHALEXINE) (500mg capsule for 1 by mouth twice a day for 10 days, given a quantity of 20) for this diagnosis. The outcome of the event was not resolved at time of the report.; Sender's Comments: Based on the information currently available, the vaccination with PREVNAR 13 might have played a contributory role in triggering the onset of cellulitis localized at the vaccination site.  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
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus
Clinical narrative: Severe itching all over body, beet red chest and underarms.  I was given Prednosone dosepack for 1 week
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient called saying her muscle hurts in her arm where the shot was given. She stated that the pain radiates down into her chest from the arm.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a high dose FluZone (influenza) vaccine at age 64 years when high dose is indicated for patient's 65 years and older
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a high dose FluZone (influenza) vaccine at age 64 years when high dose is indicated for patient's 65 years and older
Age: 51.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given pediatric dose of Hep A and Hep B by medical assistant. Patient didn't report any symptoms or reactions from administration of vaccines.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Influenza virus test negative
Clinical narrative: Chills, myalgias, headache, malaise, fatigue; severe enough to take sick day from work.  Rapid flu test negative.  Treated with naproxen, acetaminophen, prednisone 10 mg, rest.  Improved towards end of day, and largely resolved next day except for minor right deltoid soreness.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Myalgia
Clinical narrative: Chills, myalgias, headache, malaise, fatigue; severe enough to take sick day from work.  Rapid flu test negative.  Treated with naproxen, acetaminophen, prednisone 10 mg, rest.  Improved towards end of day, and largely resolved next day except for minor right deltoid soreness.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain
Clinical narrative: Client reported "burning" sensation when receiving influenza vaccination on 10/17/2019.  Client reports she woke up early the next morning with extreme pain in her left shoulder.  Client reported this pain to administrator and was referred to follow-up with doctor.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Myalgia, Rash macular, Skin warm, Tenderness
Clinical narrative: 2 HOURS AFTER THE SHOT SHE HAD MUSCLE SORENESS.  LATER IN THE EVENING A RED BLOTCH APPEARED 2 INCHES DOWN FROM THE INJECTION SITE AND IT IS WARM TO THE TOUCH AND TENDER.  2 DAYS LATER, THE SORENESSS HAS SLIGHTLY RELIEVED FROM , BUT THE REDNESS IS STILL AS INTENSE. THERE ARE NO NON-LOCAL SIDE EFFECTS.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: red, warm, raised area at the injection site.   inches
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth, Pregnancy
Clinical narrative: quarter sized raised, warm, red mark that was itchy for 2 days.   Baby due date is 11/20/19
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given  pediatric dose of Hep A by medical assistant. Patient didn't report any symptoms or reaction from receiving the dose of Hep A.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: Patient presented with soreness to left deltoid region, unable to lift arm and the pain was radiating to the upper neck, the pain started the next day and has persisted for >1 month
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: X-ray limb abnormal
Clinical narrative: Patient presented with soreness to left deltoid region, unable to lift arm and the pain was radiating to the upper neck, the pain started the next day and has persisted for >1 month
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, warmth, itchy at injection site for two days
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Peripheral swelling, Skin mass
Clinical narrative: patients armed swelled and bruised. knot/bolus was sitting in arm but no allergic reaction occurred. patient was given a small dose of benadryl but epinephrine was not neccessary
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red blotch, warm to the touch, 2.5 inches in diameter
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood bilirubin increased, Dyspnoea, Dyspnoea exertional, Haematocrit decreased
Clinical narrative: Presented to the ED on 10/30/2019  with worsening SOB, generalized weakness, and purple rash on bilateral upper and lower extremities and tachycardia.   Pt reports the only change in the past week was the fact that she had the influenza vaccination administered on Thursday 10/24/2019  and  she noticed the rash on Saturday  10/26/2019.  Starting Tuesday 10/29/2019 she noticed dyspnea on exertion and some shortness of breath at rest.  Pt denies any new medications, insect bites or recent illness.  PE was ruled per CT.   Admitting diagnosis is Hemolytic anemia and tachycardia.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Haemoglobin decreased, Haemolytic anaemia, Rash, Red blood cell count decreased, Tachycardia
Clinical narrative: Presented to the ED on 10/30/2019  with worsening SOB, generalized weakness, and purple rash on bilateral upper and lower extremities and tachycardia.   Pt reports the only change in the past week was the fact that she had the influenza vaccination administered on Thursday 10/24/2019  and  she noticed the rash on Saturday  10/26/2019.  Starting Tuesday 10/29/2019 she noticed dyspnea on exertion and some shortness of breath at rest.  Pt denies any new medications, insect bites or recent illness.  PE was ruled per CT.   Admitting diagnosis is Hemolytic anemia and tachycardia.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Nodule
Clinical narrative: Employee called occupational health office today  at 0802  complaining of a large knot in her right axilla (she is a physician and believes it to be an enlarged lymph node), approximately the size of an orange. She reports a temperature of 101 last night but denies any today. Spoke with her again at approximately 1530 and she states the knot has decreased now to approximately the size of a clementine, continues to deny fever. She did not seek any treatment as of this time. She states if it doesn't resolve my Monday morning, she would see a physician.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Patient described the day after receiving the injections that redness and pain at the injection site.  He has had fever and chills, highest recorded temperature reading is 100.3F.  The patient had a virtual visit on 10/31.  It was requested to draw around the redness and if increases to be seen.  He came in on 11/1 due to increase in size.  The redness covered from mid deltoid down to an 1/2 inch to the elbow.  it is warm to the touch.  A couple of raised areas like welts, but mainly flat.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Patient described the day after receiving the injections that redness and pain at the injection site.  He has had fever and chills, highest recorded temperature reading is 100.3F.  The patient had a virtual visit on 10/31.  It was requested to draw around the redness and if increases to be seen.  He came in on 11/1 due to increase in size.  The redness covered from mid deltoid down to an 1/2 inch to the elbow.  it is warm to the touch.  A couple of raised areas like welts, but mainly flat.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Large >baseball in size red area.  Slightly warm to the touch.  Not raised but itchy
Age: 16.0
Sex: F
Vaccine: DTAP, FLU4, HEP, HPV9, MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient was given DTAP instead of Td as DTAP is inappropriate for her age.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Vaccine was mixed with Merck diluent instead of the diluent that comes with the shingrix vaccine
Age: 12.0
Sex: F
Vaccine: DTAP, HEP, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received DTAP instead of Td per age requirements.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: CLIENT DID NOT HAVE AN ADVERSE REACTION. CLIENT WAS ACCIDENTALLY GIVEN A FLU SHOT ON 10/11/2019 AT OUR FLU CLINIC AND THEN AGAIN ALONG WITH VACCINES ON 10/25/2019.   UNFORTUNATELY, FLU SHOT WAS NOT YET ENTERED INTO SYSTEM FROM FLU CLINIC ON 10/11/2019.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Chest pain, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: 10 minutes after vaccine administration, vomited, complained of chest pain, and became pale and sweaty. Was laid on the table and symptoms rapidly improved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Malaise
Clinical narrative: Sore Arm (Same and Shot 1), Not the same as shot 1: Chills, Headache and Body Ache, Exhaustion, Shivering, Stomach Pain, Possible Fever (Didn't feel well enough to take temp)
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore Arm (Same and Shot 1), Not the same as shot 1: Chills, Headache and Body Ache, Exhaustion, Shivering, Stomach Pain, Possible Fever (Didn't feel well enough to take temp)
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Muscle aches; This case was reported by a nurse via sales rep and described the occurrence of chills in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills and muscle ache. The patient was treated with analgesic, nos, analgesic, nos, analgesic, nos (Analgesic). On an unknown date, the outcome of the chills and muscle ache were recovered/resolved.   It was unknown if the reporter considered the chills and muscle ache to be related to Shingrix.  Additional details were provided as follows: The lot number was not known for Shingrix. The patient experienced chills and muscle aches, but no fever. Both the events subsided within 24 hours. The reporter given permission for follow up.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Redness at the injection site; Swelling at the injection site; Neck and shoulder stiffness; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site swelling and musculoskeletal stiffness. On an unknown date, the outcome of the injection site erythema, injection site swelling and musculoskeletal stiffness were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and musculoskeletal stiffness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix quadrivalent at a pharmacy and experienced redness and swelling at injection site and also experienced neck and shoulder stiffness. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Pain; muscle pain; tiredness; headache; shivering; fever; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain, muscle pain, tiredness, headache, shivering and fever. On an unknown date, the outcome of the pain, muscle pain, tiredness, headache, shivering and fever were unknown.   It was unknown if the reporter considered the pain, muscle pain, tiredness, headache, shivering and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient received a Shingrix booster on the day before reporting date and experienced side effects such as pain, muscle pain, tiredness, headache, shivering and fever. The reporter was inquiring about how it would take for them to go away.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain; muscle pain; tiredness; headache; shivering; fever; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain, muscle pain, tiredness, headache, shivering and fever. On an unknown date, the outcome of the pain, muscle pain, tiredness, headache, shivering and fever were unknown.   It was unknown if the reporter considered the pain, muscle pain, tiredness, headache, shivering and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient received a Shingrix booster on the day before reporting date and experienced side effects such as pain, muscle pain, tiredness, headache, shivering and fever. The reporter was inquiring about how it would take for them to go away.
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia
Clinical narrative: nerve pain up and down her arm; This case was reported by a other health professional via sales rep and described the occurrence of nerve pain in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced nerve pain. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the nerve pain to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had nerve pain up and down her arm for 2 days following administration.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Sluggishness
Clinical narrative: Tired; Upset stomach; Sluggish; This case was reported by a consumer via sales rep and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received Shingrix. On 24th October 2019, 1 days after receiving Shingrix, the patient experienced tiredness, upset stomach and sluggishness. On an unknown date, the outcome of the tiredness, upset stomach and sluggishness were unknown.   It was unknown if the reporter considered the tiredness and sluggishness to be related to Shingrix. The reporter considered the upset stomach to be possibly related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be between 84 or 85 years. The patient day after vaccination experienced slight upset stomach, tired and sluggishness. The GSK employee stated that the stomach issues are listed as possible side effects for Shingrix and refered the patient to the doctor for treatment recommendations for these side effects.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache; Body ache; Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   On 21st October 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 23rd October 2019, 2 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced chills. On an unknown date, the patient experienced headache and general body pain. On an unknown date, the outcome of the chills, headache and general body pain were unknown.   It was unknown if the reporter considered the chills, headache and general body pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and Flu shot and at the time of reporting woke up with chills, headache and body aches was this a reaction.