chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site cellulitis, Injection site reaction, Urticaria
Clinical narrative: Patient's body broke out in welts and hives mainly to bilateral arms and legs. Left leg (thigh) at the site of the vaccine injection was identified as reaction vs. cellulitis. Area was marked and parents were advised if it spreds, gets warm to the touch to return for evaluation. Mom was instructed to give the child 2ml of children's Benadryl q8'prn
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called 1/20/20 and said her arm has hurt since she received the vaccination. It has been sore and she has trouble lifting her arm above her shoulder.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Injection site pain, Rash, Vomiting
Clinical narrative: After patient arrived back home he reportedly experienced pain at infection site, localized rash, vomiting, and diarrhea. He is not a great historian and it is unclear exactly how long after the injection the symptoms started, or how long they lasted, and he did not seek any medical attention at the time. He showed no signs of adverse reaction while still in clinic on day of injection. He has made a full recovery.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Patient described running a fever and waking up with chills that lasted a few hours. He had a rash on his upper arm that extended to his shoulder.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Syncope
Clinical narrative: 01/09/2020 7AM: sore arm, headache, queasy stomach & lightheadedness noted. Approx. 10 mins later I fainted spent the rest of day in bed, sleeping 50% of time & reading 50% of time Pupils equal & reactive
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Glaucoma, Rhinorrhoea
Clinical narrative: Two days after shot got runny (dripping) nose. When standing or sitting nose would drip onto food, book, floor or shirt sleeve. No problem when laying down to sleep. Problem went away after 2 1/2 months. Note In Dec. 2017 was found to have Glaucoma and prescribed eye drops for daily use. These may or may not have contributed to longevity of my nose problem. Note Regular dose flue shots received in previous years did not cause any problems. Patient comment High Dose flu shots may not be suitable for all seniors. Because of my problem, I have since refused to have flu shots. I've learned to live with this as well as other side effects of "preventative" medicine which "might" contribute to longer life.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus, Rash
Clinical narrative: Skin rash & itching at injection site
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Redness, heat & pain @ sight
Age: 51.0
Sex: M
Vaccine: MMR, UNK
Symptoms: Rash
Clinical narrative: Patient Age: 51 years old; pin point size rash all over his back; This spontaneous report was received from a pharmacist and refers to a 51-year-old male patient. The patient had no pertinent medical history, no drug reactions or allergies and did not take any concomitant medications. On 01-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, (lot # R030812, expiration date 24-OCT-2020, therapy type rHA) (dose was not reported), due to the unknown vaccination history, diluted in sterile diluent (manufacturer unknown) (dose, lot # and expiration date were not reported). On an unknown date, he experienced a pin point size rash all over his back. The patient did not receive any treatment for the event and had no laboratory studies performed.. On an unknown date in approximately January 2020 (reported as "over this past weekend"), the patient sought medical attention and presented to the pharmacy. The outcome of rash was reported as not recovered. The relatedness between the suspect therapies and adverse events was not reported.
Age: 18.0
Sex: U
Vaccine: HEPA, MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; 18 years old patient received a dose of proquad and a dose of vaqta for adults; 18 years old received a dose of proquad; This spontaneous report was received from a medical assistant referring to a 18-year-old patient of unknown gender. Information regarding the patient's concurrent condition, pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On 11-DEC-2019, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age group) 1 dosage form (DF) lot # S025736 was an invalid lot for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live and expiration date reported as 13-MAY-2022 and a dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 DF lot # S012250 expiration date reported as 07-JUL-2020 (incorrect dose administered) via unknown route for prophylaxis. Other suspect therapy included sterile diluent (lot/batch # and expiry date were not reported). No known adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from an medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 16-JAN-2020, the patient was vaccinated with an improperly stored dose (product storage error) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lo number S023651, expiration date 26-JAN-2021(dose and route of administration were not reported). There was no adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was prescribed to take 1 dose of PPSV23 a year later, but skipped PPSV23; This spontaneous report was received from a consumer regarding a female patient of unknown age. The patient's concurrent condition and concomitant medications were not reported. The patient's historical vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). On an unknown date, the patient was prescribed to take 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) a year later (date reported as December 2017) after receiving dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) in December 2016, but the patient skipped pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Inappropriate schedule of product administration).
Sex: M
Vaccine: FLU3
Symptoms: Needle issue, Underdose
Clinical narrative: Some of the shot leaked out and some went in the patient,no AE.; while administering fluzone HD to a male patient,the needle might have failed or was not on correctly,no AE.; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from an other health professional.  This case involves male patient (age unknown) who was vaccinated with vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ311AB and expiration date 30-Jun-2020) and some of the shot leaked out and some went in the patient (underdose) , while administering  and  also the needle might have failed or was not on correctly (needle issue)  on an unknown date.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to underdose.  It is also a case of needle issue.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient inadvertently received an expired dose of ActHIB, NO AE; Initial information received on 10-Jan-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 2 years old male patient who was vaccinated with inadvertently an expired 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ActHIB] (lot number UI913AAA and expiration date 14-Nov-2019) via Intramusculary in the right vastus lateralis on 10-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX).  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Walking aid user
Clinical narrative: Within several hours extream pain in ankles - over several days pain all over increased - had to use a walker - med helped slightly got better Within one hour extream pain in ankles - every thing repeated still hurting/using walker
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Oral herpes
Clinical narrative: Chills, headache, fatigue, muscle soreness. Day three after inoculation developed herpes simplex blisters on lip
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Sick in bed.  Fever, Weak, Headache for about a week.  Skin was blotchy. and arm was swallen, and painful
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash macular
Clinical narrative: Sick in bed.  Fever, Weak, Headache for about a week.  Skin was blotchy. and arm was swallen, and painful
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Areflexia, CSF protein increased, Extraocular muscle paresis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome, Miller-Fisher variant, onset 1/5/2020. Had unstable gait, arreflexia, pupillary dilation, extraocular motion weakness, and palate dysfunction. Treated with IVIG, improvement shown.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Immunoglobulin therapy, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal abnormal, Miller Fisher syndrome, Mydriasis
Clinical narrative: Guillain Barre syndrome, Miller-Fisher variant, onset 1/5/2020. Had unstable gait, arreflexia, pupillary dilation, extraocular motion weakness, and palate dysfunction. Treated with IVIG, improvement shown.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Palatal disorder
Clinical narrative: Guillain Barre syndrome, Miller-Fisher variant, onset 1/5/2020. Had unstable gait, arreflexia, pupillary dilation, extraocular motion weakness, and palate dysfunction. Treated with IVIG, improvement shown.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Injection hurt. Within 5 min became little lightheaded, dizzy.  Within 45 minutes left arm, shoulder clavicle to left neck became painful; became more dizzy, lightheaded, perspiring, nauseated with dry heaves. Used cool cloth on head and neck to prevent fainting. Took 800mg ibuprofen.  Used cool for pain in arm but made the pain worse, started to use heat with some relief. Experienced weakness and severe left arm, should neck pain nausea for about 48hrs.  Had vomiting and lightheaded with perspiring  2 more times within 24hrs of shot. I couldn't use my left arm for anything due to the severe pain. After the 48hrs, pain lessened to soreness,  the generalized weakness lessened.  I took 800mg of Ibuprofen for first 32-48 hrs with min relief. Then by day 3 and 4 the left arm has some soreness only in upper arm.  I do not want to take this vaccine again. I had to rest for the 3 -4 days and unable to perform  my daily personal care using the left arm due to the severe pain and weakness.   Hopefully no long term effects from this shot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Nausea, Neck pain, Pain in extremity, Retching
Clinical narrative: Injection hurt. Within 5 min became little lightheaded, dizzy.  Within 45 minutes left arm, shoulder clavicle to left neck became painful; became more dizzy, lightheaded, perspiring, nauseated with dry heaves. Used cool cloth on head and neck to prevent fainting. Took 800mg ibuprofen.  Used cool for pain in arm but made the pain worse, started to use heat with some relief. Experienced weakness and severe left arm, should neck pain nausea for about 48hrs.  Had vomiting and lightheaded with perspiring  2 more times within 24hrs of shot. I couldn't use my left arm for anything due to the severe pain. After the 48hrs, pain lessened to soreness,  the generalized weakness lessened.  I took 800mg of Ibuprofen for first 32-48 hrs with min relief. Then by day 3 and 4 the left arm has some soreness only in upper arm.  I do not want to take this vaccine again. I had to rest for the 3 -4 days and unable to perform  my daily personal care using the left arm due to the severe pain and weakness.   Hopefully no long term effects from this shot.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Injection hurt. Within 5 min became little lightheaded, dizzy.  Within 45 minutes left arm, shoulder clavicle to left neck became painful; became more dizzy, lightheaded, perspiring, nauseated with dry heaves. Used cool cloth on head and neck to prevent fainting. Took 800mg ibuprofen.  Used cool for pain in arm but made the pain worse, started to use heat with some relief. Experienced weakness and severe left arm, should neck pain nausea for about 48hrs.  Had vomiting and lightheaded with perspiring  2 more times within 24hrs of shot. I couldn't use my left arm for anything due to the severe pain. After the 48hrs, pain lessened to soreness,  the generalized weakness lessened.  I took 800mg of Ibuprofen for first 32-48 hrs with min relief. Then by day 3 and 4 the left arm has some soreness only in upper arm.  I do not want to take this vaccine again. I had to rest for the 3 -4 days and unable to perform  my daily personal care using the left arm due to the severe pain and weakness.   Hopefully no long term effects from this shot.
Age: 29.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Local reaction, Tenderness, Urticaria, Vaccination complication
Clinical narrative: Adverse reaction to vaccine properly administered. Localized reaction To right arm, 5x6cm erythematous irregular shaped raised welt on right posterior upper arm. Tender to palpation. No blisters, no open lesions, no head in the center. Antihistamines recommended.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired vaccine. No adverse effects noted per parent.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Vaccination complication
Clinical narrative: hearing loss; Zostavax related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the prevention of shingles and/or zoster related conditions (dose, route, and lot # not provided). Subsequently to inoculation, the patient was treated for hearing loss and zoster vaccine live (ZOSTAVAX) related injuries (unspecified). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for this injuries. As a further proximate result, the patient has suffered ongoing significant medical and related expenses as a result of theses injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. As a further proximate result, the patient has suffered and will continue to suffer diminished capacity for the enjoyment of life, diminished quality of life, increased risk premature death, aggravation of preexisting conditions and activation of latent conditions, and other losses and damages. The outcome of the events was not recovered. Causality assessment between events and suspect therapy was considered as related.  Upon internal review, hearing loss was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; the patient was administered a dose of VARIVAX on 24-DEC-2019, that had been improperly stored; This spontaneous report was received from a vaccine coordinator (also reported as office manager), referring to patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided.   On 24-DEC-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number S021926 has been verified to be a valid, expiration date reported and validated as 15-JUL-2021). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse events were reported for the patient.  According to the reporter, the temperature excursion was 1.2 degrees Celsius for a time frame of 3 hours and 9 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dysphagia
Clinical narrative: About a half hour after getting vaccination, it seemed like I was having trouble swallowing.  A few hours later, it seems to be resolved.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Bronchitis, Chills, Erythema, Fatigue
Clinical narrative: I had the side effects pain, redness, swelling, severe muscle pain, tiredness, headache, shivering, fever and upset stomach for 3 days. But it did not stop after a week of the redness, swelling sever muscle pain, the redness went away, the swelling seems to have gone but I never regain total use of the arm  inoculated, it hurts every day and I am having tingling in my fingers.  I don't have much of a grip anymore.  I had to exercise it a lot get use of it to run a calculator and I am still not where I was before the shot.  I went to Dr office after the shot because I came down with bronchitis and complained then to the PA Dr but she did not listen when I tried to tell her that my right arm hasn't been right since the Shingle shot and I told her I would not be going back for the second part of the Shingle shot and the only thing she said was okay.  My arm hurts , my fingers go num and I can't lift it for any length of time.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Grip strength decreased, Headache, Hypoaesthesia, Injected limb mobility decreased, Musculoskeletal disorder
Clinical narrative: I had the side effects pain, redness, swelling, severe muscle pain, tiredness, headache, shivering, fever and upset stomach for 3 days. But it did not stop after a week of the redness, swelling sever muscle pain, the redness went away, the swelling seems to have gone but I never regain total use of the arm  inoculated, it hurts every day and I am having tingling in my fingers.  I don't have much of a grip anymore.  I had to exercise it a lot get use of it to run a calculator and I am still not where I was before the shot.  I went to Dr office after the shot because I came down with bronchitis and complained then to the PA Dr but she did not listen when I tried to tell her that my right arm hasn't been right since the Shingle shot and I told her I would not be going back for the second part of the Shingle shot and the only thing she said was okay.  My arm hurts , my fingers go num and I can't lift it for any length of time.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: I had the side effects pain, redness, swelling, severe muscle pain, tiredness, headache, shivering, fever and upset stomach for 3 days. But it did not stop after a week of the redness, swelling sever muscle pain, the redness went away, the swelling seems to have gone but I never regain total use of the arm  inoculated, it hurts every day and I am having tingling in my fingers.  I don't have much of a grip anymore.  I had to exercise it a lot get use of it to run a calculator and I am still not where I was before the shot.  I went to Dr office after the shot because I came down with bronchitis and complained then to the PA Dr but she did not listen when I tried to tell her that my right arm hasn't been right since the Shingle shot and I told her I would not be going back for the second part of the Shingle shot and the only thing she said was okay.  My arm hurts , my fingers go num and I can't lift it for any length of time.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: I had the side effects pain, redness, swelling, severe muscle pain, tiredness, headache, shivering, fever and upset stomach for 3 days. But it did not stop after a week of the redness, swelling sever muscle pain, the redness went away, the swelling seems to have gone but I never regain total use of the arm  inoculated, it hurts every day and I am having tingling in my fingers.  I don't have much of a grip anymore.  I had to exercise it a lot get use of it to run a calculator and I am still not where I was before the shot.  I went to Dr office after the shot because I came down with bronchitis and complained then to the PA Dr but she did not listen when I tried to tell her that my right arm hasn't been right since the Shingle shot and I told her I would not be going back for the second part of the Shingle shot and the only thing she said was okay.  My arm hurts , my fingers go num and I can't lift it for any length of time.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Influenza virus test, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt is being seen at urgent care today 1/21/202 for NVD and  reported fever 101.9. had vaccine at her PCP (not here at urgent care)
Age: 39.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Dizziness, Headache, Nausea, Swelling
Clinical narrative: Patient called on 1/21/20 to inform me she had a reaction to the Prevnar injection. She went in to the ER room over the weekend. She experienced major swelling, headache, chills, nausea, dizzy. She was prescribed Keflex.  Dr felt there was an infection going on.
Age: 39.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Headache, Hypoaesthesia, Injection site erythema, Nausea
Clinical narrative: Patient called on 1/21/20 to inform me she had a reaction to the Prevnar injection. She went in to the ER room over the weekend. She experienced major swelling, headache, chills, nausea, dizzy. She was prescribed Keflex.  Dr felt there was an infection going on.
Age: 39.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Palpitations, Peripheral swelling, Pyrexia
Clinical narrative: Patient called on 1/21/20 to inform me she had a reaction to the Prevnar injection. She went in to the ER room over the weekend. She experienced major swelling, headache, chills, nausea, dizzy. She was prescribed Keflex.  Dr felt there was an infection going on.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Injection site has egg sized lump that mom describes as red, hot and swollen. No pain or fever.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Crying, High-pitched crying, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: The evening after the vaccines she had different (high pitched cry) inconsolable, Tylenol given and did not help.  Lasted approximately 2-3 hours.  Her left leg was swollen red warm to the touch and was a dark purple color.  The second day she cried more.  Mother reports it "took about three days for her to stop crying"
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Injection site warmth
Clinical narrative: The evening after the vaccines she had different (high pitched cry) inconsolable, Tylenol given and did not help.  Lasted approximately 2-3 hours.  Her left leg was swollen red warm to the touch and was a dark purple color.  The second day she cried more.  Mother reports it "took about three days for her to stop crying"
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: pt is complaining that arm is swollen, she says the throbbing and redness has decreased but is still there after 6 days. she says it is getting better though but is worried about how long it was
Sex: U
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: We contacted Seqirus with a question about whether or not the Flucelvax Quadravalent vaccine had a beyond use date.  We were counseled that it does, and that the vial should be discarded 28 days after the stopper has initially been pierced.  This information is not contained in the product information that accompanies the vaccine, nor in the online version.  I spoke with a supervisor who told me that this change was made 6 weeks ago, and that had I called before that date we would have been advised that it could be used through the expiration date on the vial.  She acknowledged that this advice was discordant from what is provided in the product information.  She stated there was no current guidance from the manufacturer as to whether a patient who had been administered the product after the BUD needed to have the dose repeated or if other risks to such patients were present.    I am seeking advice from the FDA/CDC as to how to address the change in manufacturing recommendation.  Specifically, should a patient who received the vaccine according to the FDA approved product information be contacted and offered a repeat dose?  If so, will the manufacturer bear the cost of this?  What type of notification will go out to health care providers and the general public regarding this change in product information?      1. The CDC indicates that some vaccines have a BUD from the manufacturer, and others do not.  When they do not, and the vial does not require reconstitution, the vaccine can be used through the expiration date printed on the label:      2. The CDC guidelines advise to use the package insert to know the manufacturer specification.       3. The CDC advises that any dose given outside the BUD window be repeated:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: Fatigue, nausea, reduced appetite, recurrent fever, lasting just over one month.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: almost 24 hours later, redness, swelling, soreness, fever, and cold chills
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chest pain, Chills, Dizziness
Clinical narrative: Dizziness, weakness, muscle pain, headache, fever up to 105.0 the first night, pain in chest, shivering, lack of balance walking. Second day fever was 100.4 all day with shivers, muscle pain and headache. Third day shivers, headache fever 98.5 Fourth day fatigue. Fifth day went to Doctors Office and explained the reaction of the vaccine. Still not completely back to prior, condition, but glad it is over.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Dizziness, weakness, muscle pain, headache, fever up to 105.0 the first night, pain in chest, shivering, lack of balance walking. Second day fever was 100.4 all day with shivers, muscle pain and headache. Third day shivers, headache fever 98.5 Fourth day fatigue. Fifth day went to Doctors Office and explained the reaction of the vaccine. Still not completely back to prior, condition, but glad it is over.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Patient husband called and described his wife as having chills, nausea, vomiting.  I recommended the patient call PCP and get further advise for treatment
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: pain at injection site and weakness limited by pain. resolved several days after receiving a course of oral methylprednisolone dose pack.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: 3in. diameter red warm raised welt at injection site, extremely painful, lasted 6 days and site is still slightly painful.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Lymphadenitis, Muscular weakness
Clinical narrative: patient report swolloen armpit and pain at the site of injection. patient only reported those events on 01202020. patient states arm still hurts and feel weak at times.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site discolouration, Injection site nodule, Injection site reaction, Purulent discharge, Rash
Clinical narrative: Site developed a nodule. After a couple of weeks the skin above the nodule turned purple. 12-30-2019 the nodule formed a white head right in the center and drained about ½ tsp of thick yellow pus. Area drained again 1-4-2020. Was seen by a doctor and told to wait and see and that it had likely drained all and would heal. Area again drained thick yellow pus 1-21-2020. Patient had no fevers, no excessive swelling. Currently is being re-evaluated. Patients sibling also had an exaggerated skin rash response to same vaccine on the same dya, same lot number. No abscess in sibling, and rash resolved itself in a couple of days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient said the injection itself was excruciating.    She had swelling about the size of a softball with redness and fever around the injection site.  Patient also stated that she pain all over and was in bed for over 48 hours.  This was the patient's second shot in the series and she stated that it was much worse than the reaction to the first shot.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site warmth, X-ray normal
Clinical narrative: Extremely painful at the time of injection. Warm to touch later with some soreness. By the next day it was very sore, even with Ibuprofen. It continued to be very sore and got to the point that it hurt to move my arm in certain ways. The pain was from the injection site down the deltoid muscle. I could NOT lay on my left side in bed, it would hurt too bad. I could not lift my arm up in front of me, any higher than shoulder high with out much pain.  It is finally starting to feel somewhat better, after two months. But, at times it still bothers me. I do believe this pain is from the injection.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose decreased, Cardiac pacemaker evaluation, Chest X-ray normal, Computerised tomogram normal, Disorientation
Clinical narrative: Day of vaccine starting experiencing what has been diagnosed as psychogenic non-epileptic seizures. Beginning 10/18/19 - many episodes consisting of wooziness, unaware of surroundings, disoriented, fatigued. Beginning 12/31/19 - seizure-like episodes lasting 5-15 minutes. No pain, legs move involuntarily, extremities shake, labored breathing.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyskinesia, Dyspnoea, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Day of vaccine starting experiencing what has been diagnosed as psychogenic non-epileptic seizures. Beginning 10/18/19 - many episodes consisting of wooziness, unaware of surroundings, disoriented, fatigued. Beginning 12/31/19 - seizure-like episodes lasting 5-15 minutes. No pain, legs move involuntarily, extremities shake, labored breathing.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Psychogenic seizure, Seizure, Seizure like phenomena, Tremor
Clinical narrative: Day of vaccine starting experiencing what has been diagnosed as psychogenic non-epileptic seizures. Beginning 10/18/19 - many episodes consisting of wooziness, unaware of surroundings, disoriented, fatigued. Beginning 12/31/19 - seizure-like episodes lasting 5-15 minutes. No pain, legs move involuntarily, extremities shake, labored breathing.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Urine analysis normal
Clinical narrative: Day of vaccine starting experiencing what has been diagnosed as psychogenic non-epileptic seizures. Beginning 10/18/19 - many episodes consisting of wooziness, unaware of surroundings, disoriented, fatigued. Beginning 12/31/19 - seizure-like episodes lasting 5-15 minutes. No pain, legs move involuntarily, extremities shake, labored breathing.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: myalgia, headache, chills, GI upset, tiredness
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Headache, Nausea
Clinical narrative: Headache  Nausea Chills/ low grade fever Aches Weakness Stomach ache
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Headache  Nausea Chills/ low grade fever Aches Weakness Stomach ache
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient came to the pharmacy 1 month after shot complaining of sore arm, stating after the shot her arm was hurting to the point where she couldn't use it. Advised to take OTCs and go to MDs office is issues persist.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Started with typical soreness and an orange-sized area of erythema at the injection site. This lasted for 4-5 days and went away. Approximately a week after that the patient noticed dozens of red itchy spots on her right shoulder. Patient itched the sores with enough vigor that they bled. She showed me a picture taken of her right shoulder (dated 1/4/2020) that showed a presentation similar to what one might see with childhood chicken pox. Patient had a visit with her PCP who recommended she come show her pharmacist. Today, I had her show me the right shoulder and it was much improved but still had remnants of scabbed over small lesions. Patient never experienced pain with these, just intense itching.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab, Skin abrasion, Skin lesion
Clinical narrative: Started with typical soreness and an orange-sized area of erythema at the injection site. This lasted for 4-5 days and went away. Approximately a week after that the patient noticed dozens of red itchy spots on her right shoulder. Patient itched the sores with enough vigor that they bled. She showed me a picture taken of her right shoulder (dated 1/4/2020) that showed a presentation similar to what one might see with childhood chicken pox. Patient had a visit with her PCP who recommended she come show her pharmacist. Today, I had her show me the right shoulder and it was much improved but still had remnants of scabbed over small lesions. Patient never experienced pain with these, just intense itching.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: Twelve hours after receiving shot, pt began to experience extreme redness and swelling going down her arm from the injection.  She also experience pain radiating up her arm involving the shoulder and neck.  On 1/21/2020 she consulted a physician who diagnosed cellulitis and administered Rocephin IM and oral Clindamycin.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Twelve hours after receiving shot, pt began to experience extreme redness and swelling going down her arm from the injection.  She also experience pain radiating up her arm involving the shoulder and neck.  On 1/21/2020 she consulted a physician who diagnosed cellulitis and administered Rocephin IM and oral Clindamycin.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient has been experiencing excruciating pain in her arm since the influenza vaccine was administered on 1/1/20.  She also has limited range of motion in her arm.  Patient has been taking  ibuprofen over the counter but she is still having pain.  Patient has not seen a doctor regarding the adverse reaction yet.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site discomfort, Injection site pain, Limb discomfort, Product administered at inappropriate site
Clinical narrative: Pt received flu vaccine at 2:30pm on 10/8/19 in Rt arm at her worksite given by her assistant manager. Pt states it was given too high. She says she noted Rt shoulder discomfort starting about 630pm that day. She continued to have pain and was seen by me the next day. Prior flu vax without probs. States always gets some redness. Denied weakness numbness or tingling. No radiation into arm at that time. No systemic Sx. No Prior RUE inj or problems. Pain at time of 10/9/19 visit was 2/10 with last dose Ibuprofen 800 greater than 6hrs earlier. She has noted Rt upper shoulder pain since injection. I saw pt on 10/16/19 in for an unrelated Left arm complaint - I asked her about her Rt arm injection site pain at that time and she said it had resolved. I did not see or hear from pt again until today 1/14/20. xray Rt shoulder 1/14/20 Negative. Pt referred to orth for further eval and treatment. W/C inj report filed 1/14/20.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb normal
Clinical narrative: Pt received flu vaccine at 2:30pm on 10/8/19 in Rt arm at her worksite given by her assistant manager. Pt states it was given too high. She says she noted Rt shoulder discomfort starting about 630pm that day. She continued to have pain and was seen by me the next day. Prior flu vax without probs. States always gets some redness. Denied weakness numbness or tingling. No radiation into arm at that time. No systemic Sx. No Prior RUE inj or problems. Pain at time of 10/9/19 visit was 2/10 with last dose Ibuprofen 800 greater than 6hrs earlier. She has noted Rt upper shoulder pain since injection. I saw pt on 10/16/19 in for an unrelated Left arm complaint - I asked her about her Rt arm injection site pain at that time and she said it had resolved. I did not see or hear from pt again until today 1/14/20. xray Rt shoulder 1/14/20 Negative. Pt referred to orth for further eval and treatment. W/C inj report filed 1/14/20.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Urticaria
Clinical narrative: Hives 3 days after Hep A vaccine and influenza
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Anaphylactic reaction, Asthma, Condition aggravated, Hypersensitivity, Pneumonia
Clinical narrative: Hives 3 dAys after Hep A VAccine + inFlueNZA. DX at ER (R) middle lobe pneumoNiA. AnAphylAxis, Allergic reActioN. ON 1/12/2020. She wAs given Epinephrine. Solumedrol + ZAntAc + IV Fluids. Returned on 1/12/20 + treAted  for An AsthmA exAcerbAtioN + Allergic reaction tx with 3 DuoNeb tx + DecAdroN + BenAdryl positive for RSV. SENt home oN AmoxicilliAn given breathing tx + Steriod + IV fluiDs.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Respiratory syncytial virus test positive, Urticaria
Clinical narrative: Hives 3 dAys after Hep A VAccine + inFlueNZA. DX at ER (R) middle lobe pneumoNiA. AnAphylAxis, Allergic reActioN. ON 1/12/2020. She wAs given Epinephrine. Solumedrol + ZAntAc + IV Fluids. Returned on 1/12/20 + treAted  for An AsthmA exAcerbAtioN + Allergic reaction tx with 3 DuoNeb tx + DecAdroN + BenAdryl positive for RSV. SENt home oN AmoxicilliAn given breathing tx + Steriod + IV fluiDs.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Pain in extremity, Tremor
Clinical narrative: At 5:30 AM on 1/21/20 while on toilet started shaking, started to shower felt lightheaded in tub. Mom witnessed him uncontrolably shaking x 1 hour. NO LOC, taken to bed continued to shake, fell asleep (no fever) woke to come in for office visit. C/O (L) arm pain from injections Able to walk out from office today.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Head injury, Syncope
Clinical narrative: Patient received injection Influenza and Trumenba and had mere syncope episode in which he bumped his head on the wall the doctor was called into the room and patient was examined he had no bumps, cuts or bruising and the patient left office with no further incidents.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Computerised tomogram head, Dysphagia, Electrocardiogram, Electromyogram
Clinical narrative: could not walk, weak difficulty breathing
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Guillain-Barre syndrome, Haematology test, Housebound, Hypoaesthesia
Clinical narrative: could not walk, weak difficulty breathing
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunoglobulin therapy, Intensive care, Laboratory test, Loss of control of legs, Lumbar puncture
Clinical narrative: could not walk, weak difficulty breathing
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia, Respiratory distress
Clinical narrative: could not walk, weak difficulty breathing
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dyspnoea, Gait inability
Clinical narrative: could not walk, weak difficulty breathing
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Altered state of consciousness, Brain oedema, Encephalitis, Fatigue, Intensive care
Clinical narrative: General weakness ensued immediately after injection date. Condition worsened over following week resulting in slurred speech and ER treatment. During ER visit condition worsened quickly to state of unresponsiveness. Stroke initially suspected then ruled out after CT scans, MRI, labs etc. Intensive treatment from internists, neurologists, infectious medicine, cardiology over following days resulted in recovery to date. On Monday, January 20 was told the diagnosis was "post encephalitis vaccine syndrome" Without extreme measures from Hospital doctors and staff and the fact that I am a very strong and healthy 66 year old I likely would have died or been significantly impaired permanently. minigitis was also suspected but ruled out after normal Lumpar Punture. Encephalitis suspected and advised as resulting from post vaccine complication/reaction.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Unresponsive to stimuli
Clinical narrative: General weakness ensued immediately after injection date. Condition worsened over following week resulting in slurred speech and ER treatment. During ER visit condition worsened quickly to state of unresponsiveness. Stroke initially suspected then ruled out after CT scans, MRI, labs etc. Intensive treatment from internists, neurologists, infectious medicine, cardiology over following days resulted in recovery to date. On Monday, January 20 was told the diagnosis was "post encephalitis vaccine syndrome" Without extreme measures from Hospital doctors and staff and the fact that I am a very strong and healthy 66 year old I likely would have died or been significantly impaired permanently. minigitis was also suspected but ruled out after normal Lumpar Punture. Encephalitis suspected and advised as resulting from post vaccine complication/reaction.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal X-ray, Asthenia, Borrelia test negative, Chest X-ray normal, Computerised tomogram head normal
Clinical narrative: General weakness ensued immediately after injection date. Condition worsened over following week resulting in slurred speech and ER treatment. During ER visit condition worsened quickly to state of unresponsiveness. Stroke initially suspected then ruled out after CT scans, MRI, labs etc. Intensive treatment from internists, neurologists, infectious medicine, cardiology over following days resulted in recovery to date. On Monday, January 20 was told the diagnosis was "post encephalitis vaccine syndrome" Without extreme measures from Hospital doctors and staff and the fact that I am a very strong and healthy 66 year old I likely would have died or been significantly impaired permanently. minigitis was also suspected but ruled out after normal Lumpar Punture. Encephalitis suspected and advised as resulting from post vaccine complication/reaction.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysarthria, Echocardiogram normal, Encephalitis post immunisation, Immediate post-injection reaction, Laboratory test normal
Clinical narrative: General weakness ensued immediately after injection date. Condition worsened over following week resulting in slurred speech and ER treatment. During ER visit condition worsened quickly to state of unresponsiveness. Stroke initially suspected then ruled out after CT scans, MRI, labs etc. Intensive treatment from internists, neurologists, infectious medicine, cardiology over following days resulted in recovery to date. On Monday, January 20 was told the diagnosis was "post encephalitis vaccine syndrome" Without extreme measures from Hospital doctors and staff and the fact that I am a very strong and healthy 66 year old I likely would have died or been significantly impaired permanently. minigitis was also suspected but ruled out after normal Lumpar Punture. Encephalitis suspected and advised as resulting from post vaccine complication/reaction.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Unresponsive to stimuli, West Nile virus test negative, X-ray normal
Clinical narrative: General weakness ensued immediately after injection date. Condition worsened over following week resulting in slurred speech and ER treatment. During ER visit condition worsened quickly to state of unresponsiveness. Stroke initially suspected then ruled out after CT scans, MRI, labs etc. Intensive treatment from internists, neurologists, infectious medicine, cardiology over following days resulted in recovery to date. On Monday, January 20 was told the diagnosis was "post encephalitis vaccine syndrome" Without extreme measures from Hospital doctors and staff and the fact that I am a very strong and healthy 66 year old I likely would have died or been significantly impaired permanently. minigitis was also suspected but ruled out after normal Lumpar Punture. Encephalitis suspected and advised as resulting from post vaccine complication/reaction.