chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date not reported) for long-term prevention of shingles and/or zoster-related conditions. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX), Plaintiff has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Refusal of vaccination
Clinical narrative: No additional adverse events reported; adult patient decided to refuse these doses after they were drawn up for unknown reasons; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-SEP-2020 (reported as yesterday), the patient came in for next planned dose in series of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot # S038698, expiration date: 01-DEC-2021 (strength and route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) subcutaneous injection, 0.5 ml, lot # S029456, expiration date: 19-SEP-2021 (strength and route of administration were not reported). The patient decided to refuse these doses after they were drawn up for unknown reasons (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: M
Vaccine: SMALL
Symptoms: Injection site scab, Injection site vesicles, Vaccination complication
Clinical narrative: Information was received on 17AUG2020 and 24AUG2020 from an Investigator.   A 55-year-old male developed satellite lesions after the administration of the open study drug (ACAM2000).  On 03AUG2020, the subject received the dose of the study drug. The subject reported that the scab from the inoculation site came off on 14AUG2020, and two other blisters also appeared later in the day. The site formed a new scab which appeared to have been removed. The two new blisters also appeared to have been popped up and their tops removed. The new blister ½ inch to the left of the initial site formed a scab. The blister 1/8 inch to the right of the initial site was slightly wet. No other information was provided at the time of the initial report.  Outcome: The outcome of the event was ongoing at the time of report.   The action taken with study drug was none.   The Investigator assessed the event satellite lesions as grade 1 (mild) and related to therapy with study drug.  Company Comment. In agreement with the investigator's assessment. Satellite lesion are considered when the lesions are located within 2.5  cm (1 in) of the vaccination site.  Despite it is not described in the label, this kind of complication are very common and considered listed. Satellite lesions are not required submission to the FDA.  Case will be kept in the database although it is from clinical trial and is not serious  Follow-up information was received on 08SEP2020: The follow-up information included update in outcome and SAE end date as described in the above narrative.  Outcome: The outcome of the event was reported as resolved on 30AUG2020.  Company Comment (18SEP2020): After review of the f/u information, the Company's assessment is unchanged with the event considered related to the study drug.; Sender's Comments: In agreement with the investigator's assessment. Satellite lesion are considered when the lesions are located within 2.5  cm (1 in) of the vaccination site.  Despite it is not described in the label, this kind of complication are very common and considered listed. Satellite lesions do not require submission to the FDA.  Case will be kept in the database although it is from clinical trial and is not serious  Company Comment (18SEP2020): After review of the f/u information, the Company's assessment is unchanged with the event considered related to the study drug.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; Late for a second dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was resolved with sequelae and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported.  After receiving 1st dose of Shingrix, the patient experienced shingles. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Boostrix. On 22nd September 2020, 1 days after receiving Boostrix, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were recovering/resolving.   It was unknown if the reporter considered the fever and fatigue to be related to Boostrix.  Additional details were provided as follows:  The age at vaccination was not reported. The following day of vaccination, the patient experienced fever and fatigue. At the time of reporting, the patient was recovering. Health care professional did not provide lot number and expiration date of the 1st dose. The did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Missed the deltoid muscle; Redness and swelling at injection site; Swelling at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 21st September 2020, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site swelling and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the pharmacist missed the deltoid muscle at the time of administration of Shingrix, which led to vaccine administered at inappropriate site. After vaccination with Shingrix, the patient had redness and swelling at injection site. The reporter stated that, the clinic had  photo of the redness and swelling. The reporter did not consent to follow up.
Age: 4.0
Sex: U
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient was given double IPV by receiving Ipol and Pediarix, no AE; Initial information received on 04-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4-years-old patient who received double dose of IPV (Inactivated Polio Vaccine) by receiving IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] (extra dose administered).  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant vaccinations included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) on 04-Sep-2020 for prophylactic vaccination. On 04-Sep-2020, the patient received a fourth dose of 0.5 mL (frequency: once) of suspect IPV (VERO) (lot number: P1F49, expiry date: 30-Nov-2020, strength: standard  via an intramuscular route in right leg) and a dose of DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (lot number and other dosing and administration details not reported) for prophylactic vaccination (extra dose administered).  It was an actual medication error case due to extra dose administered (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patients were given FLUBLOK QUADRIVALENT rather than the intended FLUZONE QUADRIVALENT, no AE; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case.  This case involves 140 patients who were given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] rather than the intended INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Between 08-Sep-2020 to 10-Sep-2020, the patients received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2002, expiry date: 18-May-2021, strength: standard) once via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered.  The nurse reports that the medical center ordered flu vaccines for both patients and staff. Both Flublok and Fluzone Quadrivalent were ordered. The plan was to administer the Fluzone Quadrivalent to staff and some patients and Flublok to other patients. But when flu vaccine administration began on 08-Sep-2020, Flublok was given to staff rather than the intended Fluzone. The discrepancy was discovered on 10-Sep-2020, when it was noted that the lot of the vaccine being administered was different from the one on pre-filled-out release forms for those vaccines. Between 08-Sep-2020 to 10-Sep-2020, 140 staff members (out of 3400 team members) had received the Flublok instead of the intended Fluzone.   At the time of report, the patients had no adverse event (AE) symptoms.  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: 72.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: an elder patient was given Fluzone Quadrivalent instead of Fluzone HD, no AE; Initial and follow-up information received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 72 years old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] (wrong product administered).  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  The patient did not receive any other vaccine.  On 10-Sep-2020, the patient was vaccinated with a 0.5 mL once dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe, lot: UJ427AA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm as prophylactic vaccination instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  It was an actual medication error due to wrong vaccine administered on same day.  Reporter wanted to know if the patient should be revaccinated and difference between two vaccines. For Fluzone Quadrivalent Product information (PI) reporter was not able to see the table and number as the print was too small.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 94.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Fluzone Quadrivalent accidently instead of Fluzone Quadrivalent High Dose /no AE; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a 94 years old male patient who was accidently vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLZ QIV T] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  concomitant vaccination(s) were unknown.   On 17-Sep-2020, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  This was an actual medication error case due to wrong vaccine administered (latency: on same day).  Reporter wanted to know if the patient should be revaccinated. Pharmacist reported that she did not realize the pharmacy received Fluzone Quadrivalent and the pharmacy only had the High-Dose before she left. The error was not discovered until after the dose and the box was being put away.    At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted. Was quickly brought back to conscious and stabilized.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Cold sweat, Discomfort, Dizziness, Loss of consciousness
Clinical narrative: I did receive a Quadrivalent Flu shot vaccine though I have not been able to confirm which exact variety it was so I choose the first flu vaccine type in item 17 above.  This was my first time getting the flu vaccine ever, so the nurse administering had me wait an extra 20mins after the injecting to make sure I had no adverse side effects. I felt fine immediately after and throughout that day.  Being that I had virtually no symptoms I actually forgotten that I had been given a shot until later that night when my arm felt sore and I thought massaging it would help alleviate the soreness. After realizing that my soreness was actually the remnants of pain from the injection site, I stopped.   Though even after stopping I felt the pain in my arm slowly permeate to my other joints and made me feel very uncomfortable. Thinking that it might just be my body needing food/water since I hadn't had anything since noon. After making my way towards my kitchen it was only until I made it to the bottom of stairs that I knew something was off and I felt like I was going to faint.  It was pretty much a slow train wreck in that at first I was forced to sit down because I was light headed and dizzy, then my vision started closing in and I could hear the tea kettle whistle in my ear as I slowly lied down and momentarily passed out. Maybe only a minute or so later I was back up though still reeling from the experience. Broke out into a cold sweat thereafter but that is where most of the symptoms subsided and I was able to get up, talk coherently, and see things in front of me clearly .  The whole episode took maybe 15-20 mins. Though the uneasiness/slight joint pains remained with me until I went to bed that night at 10PM.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Restlessness, Tinnitus, Visual impairment
Clinical narrative: I did receive a Quadrivalent Flu shot vaccine though I have not been able to confirm which exact variety it was so I choose the first flu vaccine type in item 17 above.  This was my first time getting the flu vaccine ever, so the nurse administering had me wait an extra 20mins after the injecting to make sure I had no adverse side effects. I felt fine immediately after and throughout that day.  Being that I had virtually no symptoms I actually forgotten that I had been given a shot until later that night when my arm felt sore and I thought massaging it would help alleviate the soreness. After realizing that my soreness was actually the remnants of pain from the injection site, I stopped.   Though even after stopping I felt the pain in my arm slowly permeate to my other joints and made me feel very uncomfortable. Thinking that it might just be my body needing food/water since I hadn't had anything since noon. After making my way towards my kitchen it was only until I made it to the bottom of stairs that I knew something was off and I felt like I was going to faint.  It was pretty much a slow train wreck in that at first I was forced to sit down because I was light headed and dizzy, then my vision started closing in and I could hear the tea kettle whistle in my ear as I slowly lied down and momentarily passed out. Maybe only a minute or so later I was back up though still reeling from the experience. Broke out into a cold sweat thereafter but that is where most of the symptoms subsided and I was able to get up, talk coherently, and see things in front of me clearly .  The whole episode took maybe 15-20 mins. Though the uneasiness/slight joint pains remained with me until I went to bed that night at 10PM.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Sleep disorder
Clinical narrative: Left arm swelling, small patch of redness at the injection site and pain not relieved by tylenol. Side effect of pain started few hours after injection and the swelling was seen in the morning.  The pain impacted her ability to sleep since the day of the vaccination.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm swelling and pain for 1 month
Age: 43.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Abdominal pain upper, Erythema, Myalgia, Nausea, Peripheral swelling
Clinical narrative: Right arm has considerable swelling, it is red and warm to the touch. Sleepiness, stomach pain and nausea. Muscle pain included
Age: 43.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Skin warm, Somnolence
Clinical narrative: Right arm has considerable swelling, it is red and warm to the touch. Sleepiness, stomach pain and nausea. Muscle pain included
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Decreased appetite, Lethargy, Myalgia
Clinical narrative: Severe ache in all  joints and muscles from torso to lower limbs; lethargy; weakness.  No elevation of temperature. No nausea, vomiting, but definite loss of appetite.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site reaction, Malaise, Muscle tightness
Clinical narrative: Generalized malaise and fatigue.  Warmth, redness and tight muscle at injection site.  All symptoms continued and progressed for 4 days then resolved.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Pain
Clinical narrative: Baby became very fussy and crying like in pain. Right leg was swollen and red down to his knee. I put a cold wet towel on it and gave him 1.25ml of Tylenol. This seemed to help and the swelling went down around 12:00 am.
Age: 12.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: vesicular rash to trunk of body 4 days after immunizations.  No fever or URI symptoms
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash/Hives on the from head to ankles. Very itchy.  Reaction was noticed within an hour of having the shot. Contacted the local ER and they asked me to come in to get looked at.  They gave me benadryl & prednisone.   Relieved symptoms fast.  The next morning just a little rash left.  I don't have all the information for the shot as they never gave me an after visit paper about flu shots or the information about the shot they gave me.
Age: 82.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Skin irritation
Clinical narrative: patient starting get a red arm from her wrist up.  Her caregiver said she needed to get to the doctor.  Doctor states pt has a skin irritation and gave her an antiobiotic.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling  on left arm from shoulder to forearm
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Pruritus
Clinical narrative: the patient had itching all over her body; Injection Site Bruising; This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 30th April 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2020191521) and Coumadin (had a history of taking Coumadin).   On 3rd September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 3 days after receiving Shingrix, the patient experienced generalized pruritus and injection site bruising. On an unknown date, the outcome of the generalized pruritus and injection site bruising were not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and injection site bruising to be related to Shingrix.  Additional details were reported as follows: The patient experienced itching and injection site bruising 3-4 days after receiving 2nd dose of Shingrix. The physician described itching as the patient itching all over her body. On 23rd September 2020, the patient had an appointment with her physician, results of appointment were unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020191521:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red, non-itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix. On 9th August 2020, 2 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and 2 days later broke out in red, non itchy rash over torso, abdomen, arms and legs.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Illness, Rash, Rash pruritic
Clinical narrative: Pretty sick after the vaccine; Super tired; Headache; Big rash on my torso that itches; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced sickness, tiredness, headache and itchy rash. On an unknown date, the outcome of the sickness, tiredness, headache and itchy rash were unknown.   It was unknown if the reporter considered the sickness, tiredness, headache and itchy rash to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that after the shingrix vaccine patient got pretty sick and being super tired and headache and also reported that seven days after the injection patient experience big rash on torso that tches and patient was asking is this normal. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Headache, Injection site pain, Injection site warmth
Clinical narrative: Cannot sleep; Left arm is sore and warm / Feels like a fever on her left arm; headaches; Left arm is sore/pain; Arm started to bother; Wakes up tired; May have pulled a muscle; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included knee pain and back pain.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced sleeplessness, extremities hot feeling of, headache, pain in arm, arm discomfort, tiredness and pulled muscle. The patient was treated with acetylsalicylic acid (Aspirin) and hydrocodone. On an unknown date, the outcome of the sleeplessness, extremities hot feeling of, headache, pain in arm and tiredness were not recovered/not resolved and the outcome of the arm discomfort and pulled muscle were unknown.   It was unknown if the reporter considered the sleeplessness, extremities hot feeling of, headache, pain in arm, arm discomfort, tiredness and pulled muscle to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix in middle or end of August. After a week and half ago her arm started to bother her and her left arm was sore and warm between the injection site and her elbow. The patient thought that she might had pulled muscele so she started to take hydrocodone from a previous knee and back problem and but that was not helped. The patient could not sleep and woke up with tired. The pain bothers her when she goes to bed and gets up.  The patient had headache  that are really not that bad but aspirin was not working. The patient claimed that it felt like a fever on her left arm because it was sore and warm.  The patient was so tired and she wanted to go to sleep but the pain wokes her up and she could not sleep. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Limb discomfort, Muscle strain, Pain in extremity
Clinical narrative: Cannot sleep; Left arm is sore and warm / Feels like a fever on her left arm; headaches; Left arm is sore/pain; Arm started to bother; Wakes up tired; May have pulled a muscle; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included knee pain and back pain.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced sleeplessness, extremities hot feeling of, headache, pain in arm, arm discomfort, tiredness and pulled muscle. The patient was treated with acetylsalicylic acid (Aspirin) and hydrocodone. On an unknown date, the outcome of the sleeplessness, extremities hot feeling of, headache, pain in arm and tiredness were not recovered/not resolved and the outcome of the arm discomfort and pulled muscle were unknown.   It was unknown if the reporter considered the sleeplessness, extremities hot feeling of, headache, pain in arm, arm discomfort, tiredness and pulled muscle to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix in middle or end of August. After a week and half ago her arm started to bother her and her left arm was sore and warm between the injection site and her elbow. The patient thought that she might had pulled muscele so she started to take hydrocodone from a previous knee and back problem and but that was not helped. The patient could not sleep and woke up with tired. The pain bothers her when she goes to bed and gets up.  The patient had headache  that are really not that bad but aspirin was not working. The patient claimed that it felt like a fever on her left arm because it was sore and warm.  The patient was so tired and she wanted to go to sleep but the pain wokes her up and she could not sleep. The reporter consent to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: consumer having a possible allergic reaction with a Flu vaccine; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient of unknown demographics who was having a possible reaction (hypersensitivity), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious consumer having a possible reaction (hypersensitivity), (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that Hospital was looking to re-challenge a patient with Fluzone Quadrivalent by diluting the vaccine and administering a small portion and wanting to know what fluid would be compatible with the Fluzone Quadrivalent for the dilution. They would like to know if there was anything, they can use to dilute the flu vaccine. They stated that they have an order for vaccine for a 9-year-old patient from an allergy clinic and they want to challenge with flu vaccine. It was not known if the patient has taken the fluzone in the past and this is a re-challenge. It is not known if the patient has experienced any reactions.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was not reported at the time of reporting.  There will be no information on the batch number for this case.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Anger, Crying, Emotional distress, Feeling abnormal, Insomnia
Clinical narrative: burning in the arm into which the Menactra vaccine was given and patient felt as his body were on fire; crying; did not feel normal for a long time after getting the vaccine; upset; pain all over his body; anger outbursts; pain in the arm into which the Menactra vaccine was given; experienced sleeplessness; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient's father).  This case involves a 14 years old male patient who had pain and burning in the arm into which the vaccine was given and felt as his body were on fire, upset and crying, pain all over his body, was upset, did not feel normal for a long time after getting the vaccine, sleeplessness and anger outbursts, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s) and family history were not provided.  The patient did not experience any symptoms like this with any of the other vaccines he has been given in the past.  Patient did not receive any concomitant vaccines at that time.  At the time of the event, the patient had ongoing Autism spectrum disorder, as he was on the autism spectrum. Patient was seeing a psychiatrist during this time but had been seeing a psychiatrist in relation to his autism even before being given Menactra.    On an unknown date, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date were not reported) via unknown route in an arm for prophylactic vaccination.  On an unknown date, approximately 3 years ago, the patient developed non-serious events of pain and burning in the arm into which the menactra vaccine was given (pain in extremity) ;(burning sensation) ; upset (depressed mood); crying (crying);pain all over his body (pain) ; and did not feel normal for a long time after getting the vaccine (feeling abnormal) ;sleeplessness (insomnia) and anger outbursts (anger) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the events. However, it took a year and a half for him to return to normal. Patient was now doing very well in school, and athletically, and now feels normal in his body again.   Reporter also stated that it would be a good idea to reconcile the minimum period of 4 years between Menactra injections recommended, with the minimum period of 8 weeks between Menactra injections recommended by the Advisory Committee.  There will be no information on the batch number for this case.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Pain in extremity, Skin burning sensation
Clinical narrative: burning in the arm into which the Menactra vaccine was given and patient felt as his body were on fire; crying; did not feel normal for a long time after getting the vaccine; upset; pain all over his body; anger outbursts; pain in the arm into which the Menactra vaccine was given; experienced sleeplessness; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient's father).  This case involves a 14 years old male patient who had pain and burning in the arm into which the vaccine was given and felt as his body were on fire, upset and crying, pain all over his body, was upset, did not feel normal for a long time after getting the vaccine, sleeplessness and anger outbursts, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s) and family history were not provided.  The patient did not experience any symptoms like this with any of the other vaccines he has been given in the past.  Patient did not receive any concomitant vaccines at that time.  At the time of the event, the patient had ongoing Autism spectrum disorder, as he was on the autism spectrum. Patient was seeing a psychiatrist during this time but had been seeing a psychiatrist in relation to his autism even before being given Menactra.    On an unknown date, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date were not reported) via unknown route in an arm for prophylactic vaccination.  On an unknown date, approximately 3 years ago, the patient developed non-serious events of pain and burning in the arm into which the menactra vaccine was given (pain in extremity) ;(burning sensation) ; upset (depressed mood); crying (crying);pain all over his body (pain) ; and did not feel normal for a long time after getting the vaccine (feeling abnormal) ;sleeplessness (insomnia) and anger outbursts (anger) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the events. However, it took a year and a half for him to return to normal. Patient was now doing very well in school, and athletically, and now feels normal in his body again.   Reporter also stated that it would be a good idea to reconcile the minimum period of 4 years between Menactra injections recommended, with the minimum period of 8 weeks between Menactra injections recommended by the Advisory Committee.  There will be no information on the batch number for this case.
Age: 50.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Fatigue, Headache, Pain, Pruritus
Clinical narrative: Pain, redness near injection site lasting 3-4 days from morning after vaccination. General fatigue and headache lasting 36 hours starting morning after vaccination.  Symptoms expected based on online information about AE?s.  Improved over time, but not completely by Day 5 (still some redness) Itching and welts (extensive) on legs, arms, stomach, back started 7PM on 30Sep2020 -5 days post vaccination.   Onset quickly - no other meds or change in food or other triggers for allergy symptoms.  Improvement by 6am 01Oct2020, but still some mild itching as of 9am.
Age: 50.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Urticaria
Clinical narrative: Pain, redness near injection site lasting 3-4 days from morning after vaccination. General fatigue and headache lasting 36 hours starting morning after vaccination.  Symptoms expected based on online information about AE?s.  Improved over time, but not completely by Day 5 (still some redness) Itching and welts (extensive) on legs, arms, stomach, back started 7PM on 30Sep2020 -5 days post vaccination.   Onset quickly - no other meds or change in food or other triggers for allergy symptoms.  Improvement by 6am 01Oct2020, but still some mild itching as of 9am.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling, Headache, Lacrimation increased, Pruritus, Rhinorrhoea
Clinical narrative: hives, itching, swollen eyes, runny nose,headaches, watery eyes. improved with benadryl at home, will continue anti histamine treatment today
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: hives, itching, swollen eyes, runny nose,headaches, watery eyes. improved with benadryl at home, will continue anti histamine treatment today
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: redness, small hard lump, warmness at injection site
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection, Migraine, Nausea, Vomiting
Clinical narrative: migraine within hours of vaccine that lasted three days. Nausea that began during the night that I got the vaccine--I vomited approximately 4 - 9 am. The day after the vaccine I experienced a herpes outbreak, the first in over a decade. I am still dealing with that outbreak six days later. I think the immune system gets so stressed responding to the vaccine that anything else latent in the body has time to rear up. That is what seems to be happening for me and others.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever on 19SEP2020 lasting one day. Rash similar to active measles, not roseola, starting on 22SEP2020 lasting to 24SEP2020.  No additional treatment needed.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Dyspnoea, Erythema, Immediate post-injection reaction, Visual impairment
Clinical narrative: Immediately after the shot, I saw stars, went completely red, felt dizzy, and experienced shortness of breath. All of the symptoms subsided within 5 or so minutes.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Tremor
Clinical narrative: Shaking chills, that lasted 8 hours + fatigue afterwards
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Injection site pain, Malaise, Mobility decreased
Clinical narrative: About 7 hours after administration of vaccine patient experienced flu like symptoms including body aches, mild fever and chills. Also patient vomited and felt very run down, she also reported a very sore arm at injection site difficult to lift her arm even into this next day. She has tried taking tylenol and ibuprofen but still is experiencing symptoms she will follow up with me on when she has completely resolved.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: About 7 hours after administration of vaccine patient experienced flu like symptoms including body aches, mild fever and chills. Also patient vomited and felt very run down, she also reported a very sore arm at injection site difficult to lift her arm even into this next day. She has tried taking tylenol and ibuprofen but still is experiencing symptoms she will follow up with me on when she has completely resolved.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: A fever of up to 103 for 4 days now and a chicken pox like rash all over her body
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Hyporesponsive to stimuli, Urine analysis normal
Clinical narrative: patient felt warm after delivery of HPV, Influenza, and depo-provera, walked to bathroom, became less responsive and knelt to the ground with assistance of clinic staff. did not return to baseline after 30 minutes and was sent to the ED
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful, hot, swollen, red raised patch about the size of a fist roughly 3? below the injection side. Soreness in arm,  numbness in hand.  Primary concern is that the area in question is not at the injection site, but very markedly below it.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Painful, hot, swollen, red raised patch about the size of a fist roughly 3? below the injection side. Soreness in arm,  numbness in hand.  Primary concern is that the area in question is not at the injection site, but very markedly below it.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Menveo was given in error today. Given booster on 8/31/20 and should not have received this vaccine. No adverse reaction from patient at this time.
Age: 42.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Headache, Tremor
Clinical narrative: tremors, shaking, headaches, every morning. lasts a few seconds and continues for about one hour
Age: 42.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Computerised tomogram, Dyskinesia, Fatigue, Headache, Migraine
Clinical narrative: tremors, shaking, headaches, every morning. lasts a few seconds and continues for about one hour
Age: 42.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Mood altered, Muscle spasms, Muscular weakness, Nausea, Pain
Clinical narrative: tremors, shaking, headaches, every morning. lasts a few seconds and continues for about one hour
Age: 42.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Seizure like phenomena
Clinical narrative: tremors, shaking, headaches, every morning. lasts a few seconds and continues for about one hour
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Macule, Papule, Pruritus, Rash
Clinical narrative: Rash onset of 08/31/2020, Generalized on legs, abdomen, and back. Less than 50 Lesions. Vesicles present as well as Papules. Itchy, mostly macular, papular, and vesicular.  No crusting, lasted for 3 days. Afebrile during this time .
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Body temperature increased, Bone pain, C-reactive protein normal, Disorientation
Clinical narrative: Mandatory flu vaccine for employees. I received injection around 1:45pm on 9/29/2020. Approximately 45 minutes later, I felt a little light headed. Continued job. Went to bed at 8pm and felt really exhausted. Woke up on 9/30/2020 at 1:30am with uncontrollable shaking. I was very disoriented. My husband (who is a nurse) took my temp and it was 104.8. My blood pressure was 156/82. He gave me a tylenol and took my temp 20 minutes later and it was 102,6. He then took me to ER. I was put in a  negative pressure room. They did a rapid Covid test, CBC and CRP. Covid was negative and lab work was within normal limits. The injection sight was swollen and warm to the touch. Every bone and muscle in my body was hurting. My throat was sore and scratchy but no shortness of breath. I had a temp of 100.7 in the ER and still very disoriented. Dr informed me that I was having a sever auto immune reaction to the flu vaccination. He stated rest, fluids and to return if symptoms persisted on 9/30/2020. My husband brought me home and I slept for almost 24 hours. I am still experiencing body aches and dizzy to stand or ambulate on 10/01/2020. I am fever free at this time. I have been told by my employer that I cannot return to work until I am fever free for 24 hours. Again, the body and bone aches persist.