chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: The shot was given to me on the top right arm near the shoulder on Thursday, 24 May around 4:30 PM during my yearly check-up. I was told because of my age, 65 that I needed to have part A of the pneumonia shot and I would receive part B at age 66. One week later on Wednesday, 30 May when I got home from work and changed clothes I notice a large area on my right arm near my shoulder where the shot was given was a very large bright pink and bumpy area with some fever. I called  Practice Center around 4:40 PM and spoke with a nurse, and I told her what had happened. My arm was not that way that morning when I took a shower and went to work and now it was broken out with a fever. I was told to come to their walk-in clinic because they would be closed by the time I arrived. I went to the walk-in clinic and waited about an hour before being seen around 6:15 PM. First the nurse saw me and did not know what to do and called in a doctor (don't remember her name) then she called in a second doctor who looked at my arm and both said they did not know what it was. I then asked if maybe they had received a bad batch of medicine because that was the only change I had in that one week time period. I was given a prescription for a cream, that I already had, and they took a picture of my arm with and iPhone and the photo was placed in my file, and told if it got worse to come back. I returned on that Friday, 1 June because now the bright pink bumpy area on my arm have gone down my arm to the elbow. The nurse looked again and the same two doctors looked said they were not sure had happened and took another photo to put in my file. They did say they had another person who got the same shot a day after I did came in on Thursday, 31 May and they were puzzled. Again I asked if maybe they received a bad batch of medicine could they check on it, and no respond from them. At this point if the area was going to spread more I was going to go to the emergency room. It slowly got better and did not spread after that, and I showed it to a family member who suggested I call the CDC and ask if anyone else had this happen to them. That is when I was directed to VAERS and I am filling out the form. Additional information for Item 18: The shot was Pneumonia Vaccine. 13 Component Cojugate Type.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Expired product administered, Scab
Clinical narrative: Patient received the small pox vaccine from an expired vial. Vial was reconstituted in May and the vaccine was administered on July 14, 2018.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Expired product administered, Injection site scab
Clinical narrative: Patient received the small pox vaccine from an expired vial. The vial was reconstituted in May of 2018 and the vaccine was administered on July 14, 2018.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray normal, Full blood count, Pyrexia, White blood cell count normal
Clinical narrative: Developed fever of 103.7 at 3am on 7/31/18- seen in clinic that afternoon; given Tylenol at home by mother.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SITE OF INJECTION RED, SWOLLEN, WARM TO TOUCH.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: Severe joint pain from head to toe, severe muscle aches, profound shivering, headache and injection site swelling, warmth and tenderness all the way into Scilla and up into neck.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Skin warm, Swelling, Tenderness
Clinical narrative: Severe joint pain from head to toe, severe muscle aches, profound shivering, headache and injection site swelling, warmth and tenderness all the way into Scilla and up into neck.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Received immunization on 7/31/18 and discovered a red rash in the evening on 8/1/18. Patient stated the rash was located under the right breast, under the right arm, and across the back almost to waist. Patient stated the rash was not itchy and does not hurt. It was bright red during/after hot shower, but it now pink and is not bumpy.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2013, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or singles. In or about 10-MAY-2013, the patient sought subsequent treatment from a physician for blistering vesicular outbreak that was diagnosed as severe herpes or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-APR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 06-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 16-JAN-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-AUG-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date later in 2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient who experienced received a dose of vaccines ACT-HIB via unknown route and site of administration and by mistake also received full dose of PENTACEL via unknown route and site of administration instead of HEPATITIS B VACCINE (Lot number was not reported for all of the vaccines) on 23-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was not reported if the patient received a corrective treatment. It was unknown if patient experienced any adverse event or not. 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. Documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, HIBV
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old male patient who experienced accidentally received a 0.5 ml dose of vaccine ActHIB lot UI903AA (exp date: 21Nov2019) via intramuscular route in the right thigh with a 0.5 ml (full dose) of PENTACEL lot C5506AA (exp date: 05Sep2019) via intramuscular route in the left thigh on 23-Jul-2018 instead of HEPATITIS B VACCINE (lot number unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTARIX for Immunisation. This is a case of actual medication error due to wrong vaccine administered and extra dose administered. It was unknown if patient experienced any adverse event or not. 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. Documents held by sender: none.
Age: 0.58
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a seven-months old patient who received PENTACEL injection, without the HIB. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 20-Jul-2018, the patient received a 0.5 ml third dose of suspect PENTACEL via unknown route in unknown administration site. Lot number and expiry date was reported as Lot C5420AA exp. date 02-September-2018, NDC Not available per provider; Lot C5230AA exp 02-September-2018 NDC Not available per provider. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that MA staff member gave a PENTACEL injection without the HIB (missed dose of HIB) as the diluent was not available to administer the HIB portion. HCP notified the consumer and MA administrator was counseled. Plan is to administer ACTHIB for missed dose at future date. 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. Documents held by sender: none.
Age: 23.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 23 years old patient who was accidentally given expired vaccine, no AE, TENIVAC. This was medication error case due to expired vaccine used. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 25-Jul-2018, the patient received a dose of 0.5 ml of suspect TENIVAC lot U5280AA, exp date 15-March-2018 via intramuscular route in the left arm. The patient had not reported any side effect. Lab data and corrective treatment: not applicable. The patient outcome is reported as not Applicable for patient was accidentally given expired vaccine. 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. Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Body temperature decreased, Brain oedema, Seizure
Clinical narrative: Initial information received on 25-Jul-2018 regarding an unsolicited valid serious case received from a consumer or other healthcare professional. This case involves Adult female patient (age not reported), who experienced began to seize/ she had fluid on her brain causing uncontrollable seizures, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date (reported as in 1989), the patient received a first round of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine a safer alternative (a-cellular pertussis) (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious seize/ she had fluid on her brain causing uncontrollable seizures (seizure) 48 hours following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. This event was assessed as medically significant. It was reported that they would have to wait and see if their baby girl would be handicapped. On an unknown date, the patient developed a non-serious temperature dropped (body temperature decreased) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine. It was reported that the doctors children was also had an intolerance from which the mother of the child was consulted at hometown. Other relevant tests included No Lab data was reported. Final diagnosis was within 48 hours my sister began to seize/ she had fluid on her brain causing uncontrollable seizures. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for within 48 hours my sister began to seize/ she had fluid on her brain causing uncontrollable seizures and as Unknown for temperature dropped. Documents held by the sender: None. Sender's Comments: This case concerns a patient who presented with seizure episode within 48 hours after vaccination with DAPTACEL. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 0.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA208858, 2018SA208860, and 2018SA208862 (same reporter). This case involves a 12 months old patient who was vaccinated with 0.5 ml fourth single dose expired dose of vaccine ACT-HIB lot UI719AAA (expiry date: 18-Oct-17), in the right thigh on 25-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; PREVNAR 13; and VARICELLA VACCINE. It was a case of actual medication error due to expired vaccine used and drug dose administration interval too short (patient took fourth dose at 12 months only). It was unknown whether patient experienced any adverse event to product. 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. Document held by sender: None
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a health professional, Nurse. This case is linked to case 2018SA208053 (4 year old male, same reporter). This case involves a 4 years old patient (unknown gender) who received 0.5ml dose of vaccines ADACEL lot U5898AA via unknown route in the left arm and 0.5ml dose of MENACTRA lot U5 839AA via unknown route in the left arm on 20-Jul-2018, instead of 1st dose of PROQUAD and 5th dose of DIPHTHERIA TETANUS ACELLULAR PERTUSSIS. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to Inappropriate age at vaccine administration (patient received ADACEL at aged 04-year) and wrong vaccine administered. It was not reported whether the patient experienced any adverse reaction. 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. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a health professional (Nurse). This case is linked to case 2018SA208051 (4-year-old patient unknown gender, same reporter). This case involves a 4 years old male patient, who received vaccines, ADACEL and MENACTRA instead of 1st dose of PROQUAD and 5th dose of DIPHTHERIA TETANUS ACELLULAR PERTUSSIS. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 20-Jul-2018, the patient received a 0.5 ml single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5839AA via unknown route in the left arm. On 20-Jul-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5898AA via unknown route in the left arm. It was a case of actual medication error due to Inappropriate age at vaccine administration (patient received ADACEL at aged 04-year) and wrong vaccine administered. It was not reported whether the patient experienced any adverse reaction. 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. List of documents held by the sender: None.
Age: 4.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 4 years old male patient who inadvertently received two doses of ADACEL and IPOL on 25-Jul-2018 and again on 27-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Jul-2018, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in left leg administration site. On 27-Jul-2018 he also received a dose of the same vaccine with an unknown batch number via unknown route in right arm administration site. On 25-Jul-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in the left leg. On 27-Jul-2018 he also received a dose of the same vaccine with an unknown batch number via unknown route in right arm. It was a case of actual medication error due to extra dose administered. It was unknown if the patient experienced any adverse event or not. 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. Documents held by sender: None.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA207851, 2018SA208858, and 2018SA208862 (same reporter). This case involves a 12 months 6 days old patient (unknown gender) who was vaccinated with an expired vaccine ACT-HIB VACCINE lot UI719AAA, (expiry date: 18-Oct-17), dose 4 in the right thigh on 13-Feb-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; PREVNAR 13; and VARICELLA ZOSTER VACCINE. It was a case of actual medication error due to expired vaccine used and inappropriate schedule of vaccine administered. It was unknown whether patient experienced any adverse event to product. 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. Documents held by sender: None
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA207851, 2018SA208858, and 2018SA208860 (same reporter). This case involves a 18 months old patient (unknown gender) who was vaccinated 0.5 ml fourth single dose expired dose of vaccine ACT-HIB lot UI719AAA (expiry date: 18-Oct-17), in the left thigh on 10-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; PREVNAR 13; MMR vaccine, DAPTACEL and VARICELLA ZOSTER VACCINE. It was a case of actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse event to product. 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. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever, rash all over body.
Age: 1.08
Sex: M
Vaccine: HEP, PNC13
Symptoms: Crying, Injection site discolouration, Injection site erythema, Injection site plaque, Injection site swelling
Clinical narrative: Mother stated pt was fine after injections. Went home and pt fell asleep and woke up crying in pain and mother noticed a small red bump to injection site. Bump continued to grow. When they came to clinic the color and pigmentation were abnormal to left thigh with erythema plaque, circular, 6x6cm, and was slightly warm to touch. Mother to use cool compresses and give patient Tylenol or Ibuprofen prn for pain. Patient will return to clinic on Monday.
Age: 1.08
Sex: M
Vaccine: HEP, PNC13
Symptoms: Injection site warmth, Pain
Clinical narrative: Mother stated pt was fine after injections. Went home and pt fell asleep and woke up crying in pain and mother noticed a small red bump to injection site. Bump continued to grow. When they came to clinic the color and pigmentation were abnormal to left thigh with erythema plaque, circular, 6x6cm, and was slightly warm to touch. Mother to use cool compresses and give patient Tylenol or Ibuprofen prn for pain. Patient will return to clinic on Monday.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Nausea, Pain in extremity, Peripheral coldness
Clinical narrative: My hands are ice cold and feel nauseated. Stomach doesn't feel good - don't want to eat.  Left arm is sore.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Swelling face, Urticaria
Clinical narrative: Swollen face, hives on face and chest, extreme fatigue, headache.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Nausea, headache, pain, body aches, basically flu-like symptoms with headache and nausea.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Elevated temp (99.5); swelling, heat and pain at injection site; general malaise; muscle and joint pains/aches.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: Elevated temp (99.5); swelling, heat and pain at injection site; general malaise; muscle and joint pains/aches.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV1
Symptoms: Abdominal X-ray, Decreased eye contact, Emotional distress, Enema administration, Hypotonia
Clinical narrative: Ever since the vaccinations that occurred on 7/30/18 happened, my son hasn't been the same. After receiving the shots, my son slept all day which isn't like him. The night of 7/31/2018 into the early morning of 8/1/2018 my son began to have 4 hour long episodes of screaming, arching of the back (due to inflammation in the brain) inconsolable screeches, limp in the legs and arms, wouldn't make eye contact or nurse.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, PPV, RV1
Symptoms: Noninfective encephalitis, Opisthotonus, Screaming, Somnolence
Clinical narrative: Ever since the vaccinations that occurred on 7/30/18 happened, my son hasn't been the same. After receiving the shots, my son slept all day which isn't like him. The night of 7/31/2018 into the early morning of 8/1/2018 my son began to have 4 hour long episodes of screaming, arching of the back (due to inflammation in the brain) inconsolable screeches, limp in the legs and arms, wouldn't make eye contact or nurse.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain in extremity, Pruritus
Clinical narrative: Patient returned on Friday 7/27 saying that her arm was red and sore, which had started the day after the shot. I advised her to keep an eye on it, ice if necessary and if it continued or worsened to contact her MD. Patient called again on Thursday Aug 3 and stated it hadn't gotten worse, but she now started itching and feeling like she had "shingles".
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded after administration of HPV vaccine. Patient assisted to lying down on exam table and given cool cloth on forehead. Blood pressure taken 104/64. Patient remained lying down for approximately 10 min. Patient then states she feels better and assisted to sitting position. Patient given a drink of Mountain Dew. After sitting for several minutes patient assisted to standing. Patient states she now feels normal.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Incomplete course of vaccination, Pruritus
Clinical narrative: Patient experienced blistering and itching at the waistline. Patient phoned pharmacy to ask if this was normal. Pharmacist stated that this was not listed as a normal adverse event. Patient stated they would go to primary care provider for examination. Patient was examined by her physician this morning. Physician diagnosed Herpes Zoster without complication. Physician has prescribed valacyclovir 1000 mg three times daily for 10 days. Pharmacist has counseled patient and recommended that she not complete the SHINGRIX series due to adverse event.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood glucose normal, Dyspnoea, Dystonia, Electroencephalogram normal, Foaming at mouth
Clinical narrative: The following day after getting vaccines, patient was napping and became dystonic, was unable to catch her breath for about 30 seconds to a minute and then started foaming from the mouth. During the episode, I rolled her to her side and suctioned her mouth with a bulb syringe. She was mildly interactive after event but was extremely sleepy. We took her to the hospital where she was observed. A FSBS was completed that was normal, vitals were within normal limits the entire stay, and an EEG was completed that was normal. She was diagnosed with Sandifer syndrome.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Sandifer's syndrome, Somnolence
Clinical narrative: The following day after getting vaccines, patient was napping and became dystonic, was unable to catch her breath for about 30 seconds to a minute and then started foaming from the mouth. During the episode, I rolled her to her side and suctioned her mouth with a bulb syringe. She was mildly interactive after event but was extremely sleepy. We took her to the hospital where she was observed. A FSBS was completed that was normal, vitals were within normal limits the entire stay, and an EEG was completed that was normal. She was diagnosed with Sandifer syndrome.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received the first SHINGRIX vaccine on 7/3/2018. Broke out with Shingles on 7/6/2018. Verified by Dr. on 7/6/2018. As of 8/2/2018, still have Shingles.
Age: 1.83
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, RV5, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: ROTATEQ was administered to a 22month old patient. No adverse reaction was noted.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 21 year old male patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 06-JUL-2018, the patient was vaccinated with a fourth dose of GARDASIL 9, lot # N025428, expiration date: 19-JUN-2020, intramuscularly for prophylaxis. There was no adverse event reported.
Age: 0.08
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 1-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-JUN-2018, the patient was vaccinated with a 0.5 ml dose of VAQTA intramuscular injection, lot # N026997 with expiration date on 10-NOV-2018 in error instead of an unspecified hepatitis b vaccine (manufacturer unknown). The reporter confirmed there was no product confusion. No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a from a nurse practitioner, who was reporting on herself, a female patient of an unknown age, via company representative. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, also reported as "some time during the past 12 years", the patient was vaccinated with GARDASIL, intramuscularly for prevention of HPV (dose, lot# and expiration date were not reported). On an unknown date, the patient experienced burning that was very painful. The outcome of the event was reported as recovered, on an unknown date. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-JUN-2015, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, varicella pneumonia was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 11-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a male patient of unknown age regarding himself. No information was provided regarding the patient's pertinent medical history, drug reactions or allergies or concomitant medications. In March 2016, the patient was vaccinated with ZOSTAVAX (dose, route, and lot# were not provided). In March 2016 (also reported as 72 hours after the vaccination), the patient experienced rash. The patient reported that the rash never improved and he continued to experience it. The causality between the rash and ZOSTAVAX was not specifically stated. The patient stated he would contact his lawyer but disconnected the call before providing anymore information. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Nausea
Clinical narrative: Tenderness and pain at injection area, slight nausea, general muscle soreness, tiredness. Taking ibuprofen.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Vision blurred
Clinical narrative: More redness at site. Blurred vision.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Vaccination site swelling
Clinical narrative: Parents noticed swelling and redness at site of vaccine the morning after the  vaccine. When patient came to office, site was warm to touch, red and swollen. Dr. dx with cellulitis. Dr. prescribed; clindamycin oral, probiotics and Benadryl.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Dizziness, Emotional distress, Eye pain, Headache
Clinical narrative: The evening of 7/30/18 he became very emotional around 10:00 PM about a situation. This seemed irrelevant to the vaccine at the time. At 8:30 AM he woke with a fever of 102.7, tingling legs, dizzy, joint pain in all limbs, heart racing, headache mainly behind the eyes, ringing of ears. On the way to the ER around 9:00 AM his throat felt like lumps inside. Fever went down about an hour later. Slept most of the day once released from ER. ER Dr. stated it was a reaction to the vaccine. On 8/1 felt better but still some joint aches.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Palpitations, Paraesthesia, Pyrexia, Sensation of foreign body, Tinnitus
Clinical narrative: The evening of 7/30/18 he became very emotional around 10:00 PM about a situation. This seemed irrelevant to the vaccine at the time. At 8:30 AM he woke with a fever of 102.7, tingling legs, dizzy, joint pain in all limbs, heart racing, headache mainly behind the eyes, ringing of ears. On the way to the ER around 9:00 AM his throat felt like lumps inside. Fever went down about an hour later. Slept most of the day once released from ER. ER Dr. stated it was a reaction to the vaccine. On 8/1 felt better but still some joint aches.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: The evening of 7/30/18 he became very emotional around 10:00 PM about a situation. This seemed irrelevant to the vaccine at the time. At 8:30 AM he woke with a fever of 102.7, tingling legs, dizzy, joint pain in all limbs, heart racing, headache mainly behind the eyes, ringing of ears. On the way to the ER around 9:00 AM his throat felt like lumps inside. Fever went down about an hour later. Slept most of the day once released from ER. ER Dr. stated it was a reaction to the vaccine. On 8/1 felt better but still some joint aches.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMRV, PNC13
Symptoms: Pyrexia, Rash, Skin warm, Varicella post vaccine
Clinical narrative: Within 24 hours she developed a fever of 103.4, treated with Acetaminophen and the fever came down. Within 48 hours this passed. She developed a hot rash on her arm that was approximately  3 in x 2 inches. And on 8/2/2018 it appears she has chicken pox.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Ascending bilateral weakness, paresthesias of hands and feet. Likely GBS.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: Ascending bilateral weakness, paresthesias of hands and feet. Likely GBS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Rash
Clinical narrative: Chills, nausea, and fatigue beginning within approximately 12 to 18 hours of vaccination and lasting about 36 to 48 hours after vaccination. Rash appeared on left arm (that was vaccinated) within 4 days of vaccination. Rash subsequently appeared on right arm, abdomen, and legs. Rash has improved with use of hydrocortisone cream.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Decreased appetite, Discomfort, Injection site erythema, Injection site swelling, Rash generalised
Clinical narrative: On 7/26/2018 patient was vaccinated around 6 pm. Pt was put to bed at 8:00 pm, 2 hours after receiving the vaccination. On 7/27/2018, the next day upon waking up at 7 am, we noticed a some mosquito-bite type bumps on her body. Didn't worry at that time thinking she may have been bitten by mosquitos. At 7 pm, the same day, we noticed those bumps all over her body and her face. They were approximately 0.5 inches in size, red, and a few of them had little fluid inside. On 7/28/2018 we removed the Band-Aid from the injection site and noticed redness and swelling that was about an inch in size. The bumps were itchy and causing her a lot of discomfort. Patient had no appetite for about three days. Pt had not eaten any new foods. Pt was not exposed to other children as she does not attend preschool or daycare. She was completely healthy at the time of the vaccination. (pictures of injury available upon request).
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Rash pruritic
Clinical narrative: On 7/26/2018 patient was vaccinated around 6 pm. Pt was put to bed at 8:00 pm, 2 hours after receiving the vaccination. On 7/27/2018, the next day upon waking up at 7 am, we noticed a some mosquito-bite type bumps on her body. Didn't worry at that time thinking she may have been bitten by mosquitos. At 7 pm, the same day, we noticed those bumps all over her body and her face. They were approximately 0.5 inches in size, red, and a few of them had little fluid inside. On 7/28/2018 we removed the Band-Aid from the injection site and noticed redness and swelling that was about an inch in size. The bumps were itchy and causing her a lot of discomfort. Patient had no appetite for about three days. Pt had not eaten any new foods. Pt was not exposed to other children as she does not attend preschool or daycare. She was completely healthy at the time of the vaccination. (pictures of injury available upon request).
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt reports redness, hardness, and warm to the touch around and at injection site.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Dysstasia, Neuralgia
Clinical narrative: Extreme lower back nerve pain on left side, cannot stand for long.