chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Patient reported normal soreness in her arm the day of and after vaccination.  It faded, but she still notices that her arm is sore at the injection site (well below the shoulder) if she grabs or rubs the arm.  There is no soreness unless she grabs or rubs it.  The patient did mention that this was her first ever flu shot and she did receive the high dose shot, as appropriate for her age.
Age: 74.0
Sex: F
Vaccine: FLUA4, MMRV
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: I received a MMR Vaccine on left arm and a flu shot on right arm on 9/9/2020 at pharmacy.  Both shots were painful when they were given . Where the  MMR vaccine was given started to hurt me in the area 1 - 1/2 days later.  To date having pain, aching, and a sore left arm where the MMR vaccine was given.  I have been using a heat pad, Ben gay, ice and ibuprofen and has not helped.  Amount of aching pain varies throughout the day, sometimes severe.  Sometimes it keeps me from having a good night?s sleep.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient has had significant arm pain, can't move arm from 11-25 to 11-30.  Patient now reporting able to move arm better.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain
Clinical narrative: It has been over two weeks, and I still cannot raise my arm above my head without major pain
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: Redness and soreness at the injection site days two through five, Diarrhea, nausea, stomach pain, chills and fever (100.5) began at about 55 hours after injection, intense for four hours. Tiredness and body ache on days three and four.  The diarrhea, nausea, pain and fever were bad enough to make me report it...
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Redness and soreness at the injection site days two through five, Diarrhea, nausea, stomach pain, chills and fever (100.5) began at about 55 hours after injection, intense for four hours. Tiredness and body ache on days three and four.  The diarrhea, nausea, pain and fever were bad enough to make me report it...
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Vaccination failure
Clinical narrative: hearing loss; ZOSTAVAX was not effective for long-term or permanent shingles prevention; Information has been received from a lawyer regarding a case in litigation concerning to apatient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On 20-JAN-2013, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist (lot number, expiry date, dosage, anatomical location and route of administration were not provided). On an unknown date, the patient was treated at a hospital for the following injury resulting from her use of zoster vaccine live (ZOSTAVAX): hearing loss. Plaintiff claimeed had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and 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. Additionally, it was considered that zoster vaccine live (ZOSTAVAX) was not effective for long-term or permanent shingles prevention. The outcome of the hearing loss was not recovered. The outcome of vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event hearing loss was determined to be medically significant.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Failure to thrive, Weight gain poor
Clinical narrative: the consumer is not able to gain weight, has fallen below the 'failure to thrive threshold'; diarrhea; This spontaneous report as received from a family member via a company representative refers to a 5-month-old male patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number, expiration date, dose and route of administration were not provided).  On 14-AUG-2020, the patient experienced side effects. He was not able to gain weight, fell below the failure to thrive threshold and experienced diarrhea.  The outcome of failure to thrive and diarrhea was unknown.  The relatedness between the vaccine and the events of failure to thrive and diarrhea was not reported.  Upon internal review, the event of failure to thrive was determined to be medically significant.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, Pneumonia
Clinical narrative: Got pneumonia; Date of vaccination 2016/2017; This spontaneous report as received from a currently 77-year-old male patient, referring to himself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.    On an unspecified date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (reported as "pneumonia")' on an unknown date in 2017, pt received another dose of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (strengths, doses, routes of administration, anatomical locations, lots numbers, and expirations dates were not reported) (inappropriate schedule of product administration).          On an unknown date, the patient experienced pneumonia .    The outcome of pneumonia, and the causality assessment between pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) and the aforementioned event were not reported.  Upon internal review, pneumonia was determined to be a medically significant event.  This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2003USA009026:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Has an active case right now; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information were received as follows: The age at vaccination was not reported. Till the time of reporting, the patient was having active case of shingles even after receiving the Shingrix shot, both doses were received in 2019. The physician contacted the patient's insurance to have another shot covered because he did not think her immunity had built up appropriately. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: I got a shingles rash, when I got a shot to avoid shingle rash/ suspected vaccination failure; I got a shingles rash, when I got a shot to avoid shingle rash; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age group was not reported, but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient wanted to know why he/she got a shingles rash, when he/she got a shot of Shingrix to avoid a shingles rash. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; Information has been received from a current 71 year old female consumer with drug allergies to sulfa and penicillin and a history of stroke who on an unspecified date was vaccinated with a dose of zoster vaccine live  (lot# not reported), subcutaneously. The patient experienced shingles and had had pain for over 6 years from shingles. It was unknown if the patient sought medical attention. Unspecified treatments were given for adverse effect. At the time of reporting the patient had not recovered from the shingles.  Information was also received from a lawyer regarding a case in litigation regarding the currently 79 year old (76 year old at vaccination). No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 206, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long term prevention of shingles and/or Zoster related conditions as prescribed by a healthcare provider at a medical office. Subsequent to patient inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the vaccine, the patient suffered from shingles in addition 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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case is linked to cases 2020SA296404, 2020SA296528, 2020SA296430, 2020SA296471, 2020SA296492, 2020SA296544, 2020SA296581, 2020SA296589, 2020SA296655, 2020SA296676, 2020SA296689, 2020SA296710, 2020SA296764, 2020SA296765, 2020SA296803, 2020SA296817, 2020SA296865, 2020SA296885, 2020SA296898, 2020SA296916, 2020SA296968, 2020SA297003, 2020SA297018, 2020SA297058, 2020SA297073, 2020SA296492, 2020SA296528, 2020SA296710, 2020SA296430 and 2020SA297065.  This case involves patient (unknown demographic) who had flu (influenza), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication 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 expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) after administration of INFLUENZA VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccine positive rechallenge
Clinical narrative: got the flu every time; Initial information was received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves a male patient (age unspecified) who experienced flu (influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication and family history were not provided. It was reported that, patient got flu every time he got flu shot.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome reported as unknown for influenza.
Age: 1.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 1-year old received 2-doses of 0.5 mL of Fluzone Quadrivalent Standard on the same day by accident with no adverse event; 1-year old received 2-doses of 0.5 mL of Fluzone Quadrivalent Standard on the same day by accident with no adverse event; Initial information regarding an unsolicited valid non-serious case via agency (Reference number- 00313940) was received from a nurse and transmitted to Sanofi on 13-Oct-2020.  This case involved a 1 years old patient who received 2 doses of 0.5 ml of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] standard on the same day by accident (scheduled monthly dosing taken more frequently and extra dose administered) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination, on 12-Oct-2020.  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.   At the time of reporting, no adverse event was reported.  It was a case of actual medical error due to scheduled monthly dosing taken more frequently and extra dose administered.  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: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Immediate post-injection reaction, Pain, Tinnitus
Clinical narrative: experienced ringing in her ears; body aches all over; Initial information regarding an unsolicited valid non-serious case via agency (Reference number- 00335425) was received from a consumer and transmitted to Sanofi on 28-Oct-2020.  This case involved a 36 years old female patient who experienced ringing in her ears (tinnitus) and body aches all over (pain), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 21-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via intramuscular route in the upper arm for prophylactic vaccination.  On 21-Oct-2020, the patient developed non-serious experienced ringing in her ears (tinnitus) and body aches all over (pain), immediately after the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was body aches all over and experienced ringing in her ears.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from tinnitus and recovered from pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Flu-like achiness and diffuse pain from the waist up starting the evening of the vaccine and continuing for the next 2 days.
Age: 47.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Back pain, Headache, Injection site pain, Muscle spasms, Pain
Clinical narrative: Patient received the two vaccines, after about 10-15 minutes after the vaccine he came back to the pharmacy counter in excruciating pain spasming and pain in the low back that was radiating up his right arm and shoulder. The patient was having trouble speaking through the pain and quickly started complaining of a headache along with the lower back spasm and pain. The patient agreed to an epipen shot due to this reaction and within 2 minutes the headache and radiating pain had subsided. The patients lower pain was still spasming for about 5 more minutes and he did not want 911 or an ambulance called. He called his wife because he did not want to drive home. By the time he left at 12:15 all of his symptoms were gone. He will be following up with his primary care and will also call the pharmacy tomorrow with a follow up.
Age: 47.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient received the two vaccines, after about 10-15 minutes after the vaccine he came back to the pharmacy counter in excruciating pain spasming and pain in the low back that was radiating up his right arm and shoulder. The patient was having trouble speaking through the pain and quickly started complaining of a headache along with the lower back spasm and pain. The patient agreed to an epipen shot due to this reaction and within 2 minutes the headache and radiating pain had subsided. The patients lower pain was still spasming for about 5 more minutes and he did not want 911 or an ambulance called. He called his wife because he did not want to drive home. By the time he left at 12:15 all of his symptoms were gone. He will be following up with his primary care and will also call the pharmacy tomorrow with a follow up.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: About 8 hours after the vaccine injection, my arms and especially my legs began to feel very weak.  10 hours after the injection, I had to crawl up the stairs on my hands and knees, and my husband had to help lift me into bed.  The next day, my arms and legs were still weak.  So I called my family doctor and he wasn't aware of this side-effect of the vaccine.  About 3 days after the injection, I started to feel normal strength in my legs and arms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Approx 8 hours post innoculation, I had chills, fever and body aches. Conditions subsided after taking Tylenol.  However, I did have to take Tylenol 16 hours later as conditions returned.    By 24 hours, I was better.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion/ the GARDASIL 9 was given to 3 different patients./ ABOVE 47 degrees Fahrenheit (54.2F) for 0 hours 30 minutes; no adverse effect; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On an unspecified date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, lot# 1637648, expiration date 19-JUN-2022 (route was not provided) for prophylaxis.      Digital Data Logger registered a temperature excursion above 47 Fahrenheit degrees (54.2 Fahrenheit degrees) for 0 hours 30 minutes and 0 seconds.      This is one of three reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA009546: US-009507513-2011USA009526:
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: pregnant patient called on 11/30/2020 stating the flu shot received on 10/26/2020 has caused pain in  her arm and it has continued since shot and has progressed in recent days
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: There have been no reported side effects at this time.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: PAIN AND NUMBNESS IN ARM
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Dizziness, Heart rate increased, Pyrexia, Rash
Clinical narrative: Patient was experiencing aches and chills prior to arrival, did not inform pharmacy staff or note on form.  After receiving vaccinations, chills worsened and patient began running a fever of greater than 100 degrees.  Later that evening hives began to form on trunk and progressively got worse until patient's entire back was completely covered in a rash. Patient's wife also noted slightly higher HR of 94 bpm (normal for patient is 60 bpm).  Next morning (11/28), in addition to fever and hives,  patient was described as dizzy, weak and confused by wife, who called the pharmacy.  Recommended they go to the ER immediately.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: SARS-CoV-2 test negative, Urticaria
Clinical narrative: Patient was experiencing aches and chills prior to arrival, did not inform pharmacy staff or note on form.  After receiving vaccinations, chills worsened and patient began running a fever of greater than 100 degrees.  Later that evening hives began to form on trunk and progressively got worse until patient's entire back was completely covered in a rash. Patient's wife also noted slightly higher HR of 94 bpm (normal for patient is 60 bpm).  Next morning (11/28), in addition to fever and hives,  patient was described as dizzy, weak and confused by wife, who called the pharmacy.  Recommended they go to the ER immediately.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: SEVERAL SMALL PATCHES OF HIVES, NON SPREADING, TREATED WITH BENADRYL ORAL
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: A patient received improperly stored vaccine; This spontaneous report was received from an administrator and refers to an unknown number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of improperly stored vaccines: measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot S027467 exp. date:02-MAR-2020 (formulation, strength, dose, frequency and route of administration were not reported) as a prophylaxis. Administered dose of vaccine experienced the temperature excursion of 12.2 degrees Fahrenheit for 1 hour and 30 minutes. Data logger was involved. There was a previous excursion reported of 12.2 degrees Fahrenheit  for 1 hour.; Sender's Comments:  US-009507513-2011USA013430: US-009507513-2011USA013458:
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Hypoacusis, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; hearing issues; balance problems; herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia, hearing issues and balance problems. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of the report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of herpes zoster, postherpetic neuralgia, hearing issues and balance problems to be related to zoster vaccine live (ZOSTAVAX).  The events of herpes zoster, postherpetic neuralgia, hearing issues and balance problems were considered to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and 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 would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Immune system disorder
Clinical narrative: received an immunosuppressive treatment after receiving first dose; This case was reported by a pharmacist via call center representative and described the occurrence of immune system disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced immune system disorder. The patient was treated with infliximab (Remicade). On an unknown date, the outcome of the immune system disorder was unknown.   It was unknown if the reporter considered the immune system disorder to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The pharmacist called and asked for information in interaction between Shingrix and Remicade. Remicade was prescribed after first dose and the reporter did not know indication. The patient need to receive second dose for Shingrix. No further information was provided.
Sex: U
Vaccine: PNC13
Symptoms: Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Numbness in hand; tingling in hand; shooting pain; This is a spontaneous report from a Pfizer-sponsored program a contactable pharmacist reported that a patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and tingling in hand like shooting pain. The patient outcome of the events was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 16.0
Sex: M
Vaccine: MENB, UNK
Symptoms: Fatigue, Lethargy, Rash, Sleep disorder
Clinical narrative: has a small quarter sized rash on this right cheek; tired; lethargic; did not sleep well; This is a spontaneous report from a contactable consumer(patient's parent). A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) via an unspecified route of administration on 22Nov2020 at single dose for immunization and meningococcal vaccine a/c/y/w(trade name not reported) via unspecified route on 22Nov2020 at unspecified dosage for immunization. The patient medical history and concomitant medications were not reported.  The patient received Trumenba and Meningococcal ACWY Vaccine yesterday(22Nov2020). He was very tired and lethargic and did not sleep well on 22Nov2020. He is still tired and lethargic today and has a small quarter sized rash on this right cheek on 23Nov2020. The outcome of the events "tired" and "lethargic" was not recovered and of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient had a terrible flu; Initial information was received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via the social media.  This case involves a patient (unknown age and gender) who experienced terrible flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included influenza vaccine for prophylactic vaccination.  The patient's medical history, concomitant therapy, medical treatment(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 expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious terrible flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There would be no information available on batch number for this case.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Muscular weakness, Myalgia, Product administered at inappropriate site
Clinical narrative: SORENESS IN MUSCLE/TENDON REDUCED RANGE OF MOTION, WEAKNESS IN ARM. Suspect the vaccination was given too anteriorly in the deltoid, and affected his should ROM
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Tendon pain
Clinical narrative: SORENESS IN MUSCLE/TENDON REDUCED RANGE OF MOTION, WEAKNESS IN ARM. Suspect the vaccination was given too anteriorly in the deltoid, and affected his should ROM
Age: 6.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt. given HPV vaccine before scheduled time. No sign no reaction.
Age: 78.0
Sex: F
Vaccine: FLUX, RV1
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Next day, 11/20/2020, arm swelling and redness at site of injection. Redness has continued down arm towards right elbow. Extreme itching. Rubbing alcohol applied to skin to avoid itching.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient had shingles 4 days after receiving the vaccine
Age: 76.0
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Malaise, Vomiting
Clinical narrative: PATIENT REPORTED THAT SHE WOKE UP FEELING ILL ON SATURDAY 11/28 AND THEN  DEVELOPED CHILLS ON SUNDAY 11/29  WHILE DRIVING. SHE HAD TO PULL OVER TO THE  SIDE OF THE ROAD AND LATER SHE THREW UP. SHE BELIEVES THIS TO BE FROM HER FLU VACCINATION FRIDAY EVENING.
Age: 9.0
Sex: F
Vaccine: FLUA4
Symptoms: Diarrhoea, Nausea
Clinical narrative: Caller stated that  she was given the flu injection and the next morning she was nausea with diarrhea throughout the day. Caller spoke with primary physician and didn't make an appt due to the corvid. Patient stated she has not had any adverse affects since 9/15/2020.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal pain upper, Back pain, Computerised tomogram, Dysgeusia, Faeces discoloured
Clinical narrative: Stomach Pain , Metal taste,intestinal problems , black stool, Lower back Pain , fatigue.  The patient schedule an appointment to have test done due to the side affects of the vaccine
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Fatigue
Clinical narrative: Stomach Pain , Metal taste,intestinal problems , black stool, Lower back Pain , fatigue.  The patient schedule an appointment to have test done due to the side affects of the vaccine
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, RV5
Symptoms: Electroencephalogram abnormal, Infantile spasms
Clinical narrative: Patient developed infantile spasms starting 6 days after vaccines were given.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: 11:00 tightness in chest started making it difficult to exhale completely. Notified charge nurse around 11:30 - 11:45. Symptoms got progressively worse (more tightness and more shortness of breath). Walked down to ER for treatment. Was given dexamethazone and Benadryl IM injection. Approximately 20-25 minutes later symptoms began to dissipate. Symptoms were gone by time of discharge (around 2:00).
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever/chills and severe muscle aches/soreness for about 18 hours post vaccination - then resolved
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: possible seizure activity on morning of 11/16/2020. Pt received vaccines on 11/12/2020.
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema
Clinical narrative: Red scratch marks from and over injection site; Headache; Vaccination site redness; This spontaneous report was received from a pharmacy student, reporting on a male patient of unknown age. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On 10-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), pre-filled syringe, at a dose of 0.5 milliliter, subcutaneously for prophylaxis (lot # T021485, which was verified to be a valid lot number, expiration date reported and, upon internal validation, established as 15-MAR-2022).  On an unspecified date in November 2020, the patient experienced headache, redness at the injection site and red scratch marks from and over injection site. It was unknown by the reporter when this started exactly or how long, if treatment was given for the events or if laboratory diagnostics/studies were performed. The patient did not seek medical attention. The outcome of scratch, vaccination site erythema and headache was unknown.   The reporter considered headache, scratch and vaccination site erythema were caused by Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T021485; expirationdate: 15-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Feeling hot, Pain, Peripheral swelling, Rash macular
Clinical narrative: cellulitis; warm sensation; pain; red blotches; arm was swollen; This is a spontaneous report based on the information received by Pfizer from Sanofi (Manufacture Report No: 2020SA066748). A contactable consumer reported that a female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 13Oct2020 at single dose for immunisation. Medical history and concomitant medications were not reported. Patient had 13-val conj vac (dipht crm197 protein) injection on 13Oct2020 and severe reaction. In 2020, she was diagnosed with cellulitis. She had warm sensation, pain, red blotches and whole arm was swollen. Outcome of events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got sick; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involved a patient with unknown demographics who got sick every winter, while patient received vaccine INFLUENZA VACCINE.  It was reported that, patient received flu shot (influenza vaccine) couple of time and always either caught a different strain, or unluckily got sick every winter. Medical history, medical treatment, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, from past 20 plus years patient refused the flu shot and never caught the flu and the past 10 plus years did not even caught a winter cold.   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for illness.  There would be no information available on the batch number for this case.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a male patient of 16 year, was given Flublok Quadrivalent with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (reference number: 00334480) and transmitted to Sanofi on 27-Oct-2020.  This case involved a 16-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ445AA and expiration date 17-MAR-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 27-Oct-2020.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   It was  a case of an actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting, patient had no adverse event.  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 available on the batch number for this case.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: injection was given via subcutaneous route, no AE; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from a nurse via Information (Reference number- 00358374).  This case involves a 48 year old female patient for whom vaccination was given via subcutaneous route (incorrect route of product administration) with influenza quadrival a-b vaccine [Fluzone quadrivalent] suspension for injection 0.5 ml once (lot number and expiry date unknown) in unknown administration site for prophylactic vaccination.  Medical history, medical treatments, vaccinations, family history and concomitant medications were not provided.  This was a case of an actual medication error case due to the event inappropriate route of vaccination (latency: unknown). The needle was short and was less than an inch and probably about 2 cm long.   No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Muscle spasms, Muscular weakness, Pain, Pain in extremity
Clinical narrative: pt states 2 days after received vaccine pt states she started having weakness and pain in arm, muscle spasms throughout entire body, and 5 days later she's having weakness in legs and arms, pain and headache. she went to emergency room we don't have records yet
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Headache, Pain
Clinical narrative: body aches, hot/chills starting 8 hours after vaccine and lasting for 24-36 hours; headache starting 20 hours after vaccine and lasting for   2.5 days
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: Shoulder pain, unable to use the right arm without pain. Pain is also present when sleeping. Range of motion in the right arm is compromised.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site erythema, Pain in extremity
Clinical narrative: Shingrix 1st dose - 10/18/20 Left shoulder and arm sorness. All joints in body became sore. Sore for aprox 48-72 hours. Symptoms resolved naturally.  Shingrix 2nd dose - 11/19/20 Left hip/shoulder/collarbone/shoulderblade sore . 1/2" red ring around left arm below vaccination site. Lasted aprox. 2 days. Symptoms naturally resolved.   Did not seek medical attention.
Age: 13.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Face injury, Loss of consciousness
Clinical narrative: Not sure which Tdap vaccine was given.  He lost consciousness, hitting his face on window of reception.  Placed on floor until woke up and then monitored for a short time and given juice.
Age: 29.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient reported to us on 11/30/2020 that she has felt a lingering "pinching pain" located approximately 1 inch below the injection site (specific vaccine unknown) that started within 1 day of recieving the Fluzone Quad vaccination and Energix-B vaccination in her left arm.  She has had no such symptoms in her other arm (right) in which she received the Boostrix vaccine.  Her primary care provider initially told her to treat pain with over-the-counter NSAIDS.  She reported that they have helped with the pain but it continues to return if she stops taking them.  She says she is going to follow-up with her primary care provider about the ongoing issue because it showing no signs of improvement over a month after receiving the vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: redness, swelling, irritation at injection site
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Blood culture negative, CSF culture negative, CSF white blood cell count increased, Chest X-ray normal, Culture urine negative
Clinical narrative: Patient received above vaccinations on 11/12/2020. Symptoms of fever began 11/21/2020. Emesis began overnight 11/22-11/23. Went to Emergency department for evaluation where partial septic workup done and empiric therapy with Ceftriaxone begun. Child noted to be lethargic, diminished sensorium and not improving; on 11/24, underwent lumbar puncture. Results demonstrated CSF WBC of 551, consistent with meningoencephalitis; Cultures in blood, urine and  CSF (including enteroviral panel, VZV) all negative. Chest X-ray, stool studies also negative.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Depressed level of consciousness, Encephalitis, Enterovirus test negative, Lethargy, Lumbar puncture abnormal
Clinical narrative: Patient received above vaccinations on 11/12/2020. Symptoms of fever began 11/21/2020. Emesis began overnight 11/22-11/23. Went to Emergency department for evaluation where partial septic workup done and empiric therapy with Ceftriaxone begun. Child noted to be lethargic, diminished sensorium and not improving; on 11/24, underwent lumbar puncture. Results demonstrated CSF WBC of 551, consistent with meningoencephalitis; Cultures in blood, urine and  CSF (including enteroviral panel, VZV) all negative. Chest X-ray, stool studies also negative.