chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Biopsy skin abnormal, Blood test normal, Dizziness, Electromyogram abnormal
Clinical narrative: Extreme soarness of muscles in both thighs, lasting 3 days (this has recently recurred for 3 days).  Parathesia in hands, face and head and feet, still continuing. Headaches, dizziness, feeling off-balance and stumbling. Heaviness and weakness in legs. These symptoms still persist.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Limb discomfort, Muscular weakness, Myalgia
Clinical narrative: Extreme soarness of muscles in both thighs, lasting 3 days (this has recently recurred for 3 days).  Parathesia in hands, face and head and feet, still continuing. Headaches, dizziness, feeling off-balance and stumbling. Heaviness and weakness in legs. These symptoms still persist.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Small fibre neuropathy
Clinical narrative: Extreme soarness of muscles in both thighs, lasting 3 days (this has recently recurred for 3 days).  Parathesia in hands, face and head and feet, still continuing. Headaches, dizziness, feeling off-balance and stumbling. Heaviness and weakness in legs. These symptoms still persist.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Hypersensitivity, Tic
Clinical narrative: NOTE: I AM NOT POSITVE TDAP WAS BOOSTRIX. I looked up what clinic gives, and I am not 100% that this was the one given to my son. Patient has started eye tics on the second day after receiving DTAP. He has also needed allergy medicine which he does not always need. But primary concern are tics.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Injection site pain, Myalgia
Clinical narrative: Redness at site and surrounding tissue for 5 days, soreness /tenderness at site for 6 days, (muscle pain and joint aches, tiredness, chills, upset stomach, low grade fever) for 30 hrs. Alternated EXTRA STRENGTH TYLENOL and ibuprofen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness at site and surrounding tissue for 5 days, soreness /tenderness at site for 6 days, (muscle pain and joint aches, tiredness, chills, upset stomach, low grade fever) for 30 hrs. Alternated EXTRA STRENGTH TYLENOL and ibuprofen.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Breath sounds abnormal, Hyperhidrosis, Loss of consciousness, Nausea, Presyncope
Clinical narrative: Patient experienced a vasovagal event at the time of vaccine injection. Symptoms included syncope x 10 seconds, snorting, diaphoresis. After regaining consciousness, stated felt nauseous. All symptoms resolved in 5 minutes.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient experienced a vasovagal event at the time of vaccine injection. Symptoms included syncope x 10 seconds, snorting, diaphoresis. After regaining consciousness, stated felt nauseous. All symptoms resolved in 5 minutes.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test normal, Computerised tomogram normal, Fatigue, Headache, Hypoaesthesia
Clinical narrative: 6 hours after - all over body aches. 24 hours after - exhaustion, muscle fatigue, body aches, swelling at site of injection. 30 hours after - severe headache, back of neck pain, right foot went numb for 20 minutes. 40 hours after - all of the above plus vomiting. 46 hours after - all of the above plus left hand went numb for 5 minutes.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Muscle fatigue, Neck pain, Pain, Vomiting
Clinical narrative: 6 hours after - all over body aches. 24 hours after - exhaustion, muscle fatigue, body aches, swelling at site of injection. 30 hours after - severe headache, back of neck pain, right foot went numb for 20 minutes. 40 hours after - all of the above plus vomiting. 46 hours after - all of the above plus left hand went numb for 5 minutes.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Urticaria
Clinical narrative: He got vaccine done on a Saturday and by that evening had flu like symptoms and the next morning woke up with hives on his legs.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Recombinant Zoster Vaccine, RZV. Pain and reduced range of motion in upper right arm. For the past 4 weeks the pain has increased and I am unable to move my arm to some positions. It is inhibiting my ability to perform everyday tasks. It is painful while sleeping. I hope this is not permanent.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Speech disorder
Clinical narrative: Difficulty breathing, shortness of breath. Continued cough and difficulty talking could not catch breath. Used prescribed inhaler, outcome was effective.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Laboratory test, Pallor, Syncope
Clinical narrative: The patient had an episode of syncope 25 minutes post immunization. She was found on the floor of the elevator- awake and pale.
Age: 27.0
Sex: M
Vaccine: MNQ, YF
Symptoms: Chest discomfort, Chest pain, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Pt experienced difficulty breathing/swallowing, numbness/tingling in left foot, lightheadedness and chest pain/tightness 30 minutes following vaccination. Pt states that symptoms have persisted intermittently since receiving vaccine.
Age: 27.0
Sex: M
Vaccine: MNQ, YF
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt experienced difficulty breathing/swallowing, numbness/tingling in left foot, lightheadedness and chest pain/tightness 30 minutes following vaccination. Pt states that symptoms have persisted intermittently since receiving vaccine.
Age: 0.58
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 months old patient (gender not reported), who was vaccinated with a dose of PENTACEL (batch number: C5462AA and expiry date: 26-Jul-2019) via intramuscular route in the right thigh and also received a dose of ACTHIB (batch number: UI894AAA and expiry date: 28-Sep-2019) in the left thigh (route not reported) (dose and dose in series were not reported for both the vaccines) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation on an unknown date. It was a case of actual medication error due to extra dose administered. It was also reported that the patient received both ACTHIB and PENTACEL on the same day, their intended action was administration of the third PENTACEL dose by the doctor. No side effects 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. Documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Needle issue, Underdose
Clinical narrative: Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old female patient who did not receive the full dose of menactra and needle broke off, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Aug-2018, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5984AC via intramuscular route in left arm. It was a case of actual medication error due to vaccine underdose and syringe issue. (Other relevant tests included No lab data.) Final diagnosis was needle broke off and did not receive the full dose of MENACTRA. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for did not receive the full dose of menactra and as Not Applicable for needle broke off. 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 sender: none.
Age: 0.92
Sex: U
Vaccine: DTAP, DTAPIPV, IPV, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves an 11-month patient (gender not reported)who was vaccinated with a dose of 0.5 ml IMOVAX POLIO via intramuscular in right thigh on 23-Jul-2018 and it was reported that the vaccine underwent a temperature excursion (opened vial 51.9F for 1 hour 45 min). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL, INFANRIX, ACTHIB, and PREVNAR all for Immunization. It was an actual medication error due to product storage error. It was reported that the patient had no side effects. 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 and Module VI of the 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 sender: none.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220773, 2018SA220774, 2018SA220775 and 2018SA220766 (same reporter). This case involves a four years old patient (four years one month old, gender not reported) who experienced patient received a dose of PENTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on 24-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. It was not reported 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 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: 9.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Drug dose omission
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 years old male patient who experienced weren't able to administer the fifth Dtap because of his age, while he received vaccines ADACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; and IPOL for Immunisation. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. On an unknown date, the patient did not received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Missed dose. (Other relevant tests included No lab test). Final diagnosis was weren't able to administer the fifth Dtap because of his age. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for weren't able to administer the fifth Dtap because of his age. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves three 5 years old patients (gender not reported) who received a dose of vaccine PENTACEL lot number not reported on an unknown date, instead of vaccine POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer lot number not reported. 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 as Wrong vaccine administered. It was reported that, this would be for the DTAP fifth dose and Polio fourth dose. It was unknown if any adverse event was occurred. 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: 5.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old male patient who received ADACEL instead of DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA VACCINE for Immunisation. On 09-Jul-2018, the patient received a dose of suspect ADACEL lot U5898AA via unknown route. On an unknown date, the patient received a dose of suspect DAPTACEL lot number not reported via unknown route. It was a case of actual medication error due to wrong vaccine administered. Reported that the injection was intended as dose 5th in the DAPTACEL series. 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 and Module VI of the 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: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash erythematous, Scab
Clinical narrative: Started w/red rash w/blisters under chin on neck, Progressed to left side w/small patches w/blisters on arm, neck, back and breast, hair line. Some localized pain at hair line; left side. Doctor diagnosed as shingles - give VALTREX orally for 7 days, no topical medication. I took TYLENOL for pain Shingles pretty clear by 8/4, except for 1 small patch at hairline, scab off 8/8/18.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Contusion, Fatigue, Feeling abnormal
Clinical narrative: Within 12 hours started with sore arm which last until felt like I got punched in the arm where shot was giving very much fatigue. Lasting a good week. Red at shot site, warm little swelling not bad fever 102 for a week shivering, headache. My Right that when I did have Shingles the spots that had flared up those spots bruised off and on for some time like how the shingles felt strange but it did happen. Min stomach pain. I didn't send this form in when I got the paperwork was waiting for my left arm to stop hurting before I filed this. Planning on second shot at 6 month as recommended from CDC when returned my call.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within 12 hours started with sore arm which last until felt like I got punched in the arm where shot was giving very much fatigue. Lasting a good week. Red at shot site, warm little swelling not bad fever 102 for a week shivering, headache. My Right that when I did have Shingles the spots that had flared up those spots bruised off and on for some time like how the shingles felt strange but it did happen. Min stomach pain. I didn't send this form in when I got the paperwork was waiting for my left arm to stop hurting before I filed this. Planning on second shot at 6 month as recommended from CDC when returned my call.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Within 12 hours started with sore arm which last until felt like I got punched in the arm where shot was giving very much fatigue. Lasting a good week. Red at shot site, warm little swelling not bad fever 102 for a week shivering, headache. My Right that when I did have Shingles the spots that had flared up those spots bruised off and on for some time like how the shingles felt strange but it did happen. Min stomach pain. I didn't send this form in when I got the paperwork was waiting for my left arm to stop hurting before I filed this. Planning on second shot at 6 month as recommended from CDC when returned my call.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Vomiting
Clinical narrative: Mother and father report to health dept with patient on 8/7/18 at 9:13am. Mother is concerned about redness and swelling on child's upper left arm (deltoid area). Grandparent's noticed redness and swelling Friday afternoon 8/3/18. Child woke up Saturday complaining of pain in left arm and had some "spit up", not enough to be called vomit according to mother. By Sunday, redness and swelling had intensified. On Monday the redness and swelling started to diminish with the border becoming more noticeable. Some warmth present at site today with slight redness, a darker red at border edges measuring 6 1/2 inches wide with 4 3/4 inches long. Mother states she administered acetaminophen during the first 24 hours and BENADRYL liquid on Saturday and BENADRYL cream Sunday night. Nurse advised mother to continue to administer pain medication as needed and as instructed on package. Advised to apply a cool washcloth ten minutes four times a day. To seek emergency care and medical care as needed. Informed that health department will follow up later this week for update on patient's status.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash, Rash erythematous
Clinical narrative: Left arm rash lasting 4 days, then on 5th day rash became intensely red and spreading upward to clavicle and down left arm, with clear margin, soft tissue induration and pain. Took oral antibiotic AUGMENTIN and antihistamine cetirizine. 80% improved within 10 hours, but appears to be recurring 20 hours later.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Irritability, Myalgia
Clinical narrative: Approximately 2 hours after being injected with the Zoster (SHINGRIX) vaccine I began to experience extreme fatigue, muscle aches, chills, a mild headache and irritability, in addition to having a sore upper arm with a red, blotchy appearance. This lasted about 36 hours. This was the same reaction I had to the first dose of SHINGRIX which I received in mid June, but did not report. I was hoping that my body would react less the second time it encountered the SHINGRIX vaccine, but that was not the case. I am happy to be protected from shingles, since I had chickenpox as a kid, but I am not happy about the severity of this reaction. I have never had a vaccine reaction like it.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Approximately 2 hours after being injected with the Zoster (SHINGRIX) vaccine I began to experience extreme fatigue, muscle aches, chills, a mild headache and irritability, in addition to having a sore upper arm with a red, blotchy appearance. This lasted about 36 hours. This was the same reaction I had to the first dose of SHINGRIX which I received in mid June, but did not report. I was hoping that my body would react less the second time it encountered the SHINGRIX vaccine, but that was not the case. I am happy to be protected from shingles, since I had chickenpox as a kid, but I am not happy about the severity of this reaction. I have never had a vaccine reaction like it.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: Red, raised rash noted over bilateral arms, legs, one on face and two on torso with itchiness associated with rash. Also red, swollen and warmth noted at injection site. Rash started around 9am on 8/9/18 on legs then arms the face and torso. After seeing employee health, employee had taken Benadryl for the itchiness and was excused from work until signs and symptoms resolved. Employee states she is very sensitive to vaccines on the past hence why several months between doses were given and that she was not feeling well in July.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Red, raised rash noted over bilateral arms, legs, one on face and two on torso with itchiness associated with rash. Also red, swollen and warmth noted at injection site. Rash started around 9am on 8/9/18 on legs then arms the face and torso. After seeing employee health, employee had taken Benadryl for the itchiness and was excused from work until signs and symptoms resolved. Employee states she is very sensitive to vaccines on the past hence why several months between doses were given and that she was not feeling well in July.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Flushing, Pruritus generalised
Clinical narrative: Full body flushed and itchy beginning less than 15 minutes after vaccine given.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Chills, Decreased appetite, Injection site pain, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bronchitis. Previously administered products included ZOSTAVAX. On 25th May 2018, the patient received the 1st dose of SHINGRIX. On 25th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced fever, tremor, appetite absent, general body pain, injection site pain, chills and nausea. On 8th June 2018, the patient experienced bronchitis. On 28th May 2018, the outcome of the fever, tremor, appetite absent, general body pain, injection site pain, chills and nausea were recovered/resolved. On an unknown date, the outcome of the bronchitis was unknown. It was unknown if the reporter considered the bronchitis, fever, tremor, appetite absent, general body pain, injection site pain, chills and nausea to be related to SHINGRIX. Additional information was received as follows: The patient stated that she did not have bronchitis in 40 years. The patient received SHINGRIX on the left arm. The patient stated that soon after the injection, she experienced injection site pain and she also experienced body aches, fever, chills, shaking, nausea, could not eat. These symptoms lasted approximately 3 days. The patient stated that 2 weeks after receiving SHINGRIX, she came down with what she believed was bronchitis. She went to visit her physician for the possible bronchitis and was treated. The patient was not sure that it was bronchitis, but that was what it felt like. This case has been linked to the case US2018139523, reported by the same reporter for same events.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bronchitis. Previously administered products included ZOSTAVAX. On 25th May 2018, the patient received the 1st dose of SHINGRIX. On 25th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced fever, tremor, appetite absent, general body pain, injection site pain, chills and nausea. On 8th June 2018, the patient experienced bronchitis. On 28th May 2018, the outcome of the fever, tremor, appetite absent, general body pain, injection site pain, chills and nausea were recovered/resolved. On an unknown date, the outcome of the bronchitis was unknown. It was unknown if the reporter considered the bronchitis, fever, tremor, appetite absent, general body pain, injection site pain, chills and nausea to be related to SHINGRIX. Additional information was received as follows: The patient stated that she did not have bronchitis in 40 years. The patient received SHINGRIX on the left arm. The patient stated that soon after the injection, she experienced injection site pain and she also experienced body aches, fever, chills, shaking, nausea, could not eat. These symptoms lasted approximately 3 days. The patient stated that 2 weeks after receiving SHINGRIX, she came down with what she believed was bronchitis. She went to visit her physician for the possible bronchitis and was treated. The patient was not sure that it was bronchitis, but that was what it felt like. This case has been linked to the case US2018139523, reported by the same reporter for same events.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Feeding disorder, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bronchitis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, appetite absent, general body pain, nausea, chills and tremor. On an unknown date, the outcome of the fever, appetite absent, general body pain, nausea, chills and tremor were unknown. It was unknown if the reporter considered the fever, appetite absent, general body pain, nausea, chills and tremor to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter reported that the patient experienced fever, chills, body aches, shaking, nausea and could not eat.  The reporter stated that the patient went to the emergency room. The reporter stated that her pharmacist informed her that this patient in the area had a similar reaction to SHINGRIX that was similar to her reaction. The reporter stated that she was assuming that this patient experienced the some same symptoms but could not be sure. The reporter did not have any additional details regarding this patient or event. This case has been linked to the case US2018139522, reported by the same reporter for similar events.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included bronchitis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, appetite absent, general body pain, nausea, chills and tremor. On an unknown date, the outcome of the fever, appetite absent, general body pain, nausea, chills and tremor were unknown. It was unknown if the reporter considered the fever, appetite absent, general body pain, nausea, chills and tremor to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter reported that the patient experienced fever, chills, body aches, shaking, nausea and could not eat.  The reporter stated that the patient went to the emergency room. The reporter stated that her pharmacist informed her that this patient in the area had a similar reaction to SHINGRIX that was similar to her reaction. The reporter stated that she was assuming that this patient experienced the some same symptoms but could not be sure. The reporter did not have any additional details regarding this patient or event. This case has been linked to the case US2018139522, reported by the same reporter for similar events.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of injection site pain (2 years ago without any problems except for soreness at the injection site). Concurrent medical conditions included fibromyalgia. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced fatigue, headache, injection site swelling and injection site pain. On 2nd August 2018, the patient experienced injection site bruising. In August 2018, the patient experienced difficulty sleeping, nausea, fever and chills. In August 2018, the outcome of the difficulty sleeping, fever and chills were recovered/resolved. On an unknown date, the outcome of the fatigue, headache, nausea and injection site swelling were recovering/resolving and the outcome of the injection site bruising and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site bruising, difficulty sleeping, headache, nausea, injection site swelling, injection site pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received initial SHINGRIX vaccine in the early afternoon in the left deltoid. Her left arm gradually became sore towards the evening and continues to be very sore. She reports it was at the date of reporting, she was bruised at the site of the injection and was about the size of a fifty cent piece. The patient was not sure if her fibromyalgia was compounding the pain and bruising at the injection site. The patient 12 hours post vaccination, began to have fever and chills in the middle of the night following the vaccine, along with a headache that began right before she went to bed. The patient 12 hours post vaccination, did have difficulty sleeping that night but that had resolved. The fever and chills had resolved but her other symptoms were gradually improving.  The patient 36 hours post vaccination, did suffer from nausea a day before date of reporting which was slowly resolving. The patient was not sure if she should receive the second SHINGRIX vaccine and was advised to consult with her physician on what would be best for her. The patient had provided contact details of her physician.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Limb discomfort, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of injection site pain (2 years ago without any problems except for soreness at the injection site). Concurrent medical conditions included fibromyalgia. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced fatigue, headache, injection site swelling and injection site pain. On 2nd August 2018, the patient experienced injection site bruising. In August 2018, the patient experienced difficulty sleeping, nausea, fever and chills. In August 2018, the outcome of the difficulty sleeping, fever and chills were recovered/resolved. On an unknown date, the outcome of the fatigue, headache, nausea and injection site swelling were recovering/resolving and the outcome of the injection site bruising and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site bruising, difficulty sleeping, headache, nausea, injection site swelling, injection site pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received initial SHINGRIX vaccine in the early afternoon in the left deltoid. Her left arm gradually became sore towards the evening and continues to be very sore. She reports it was at the date of reporting, she was bruised at the site of the injection and was about the size of a fifty cent piece. The patient was not sure if her fibromyalgia was compounding the pain and bruising at the injection site. The patient 12 hours post vaccination, began to have fever and chills in the middle of the night following the vaccine, along with a headache that began right before she went to bed. The patient 12 hours post vaccination, did have difficulty sleeping that night but that had resolved. The fever and chills had resolved but her other symptoms were gradually improving.  The patient 36 hours post vaccination, did suffer from nausea a day before date of reporting which was slowly resolving. The patient was not sure if she should receive the second SHINGRIX vaccine and was advised to consult with her physician on what would be best for her. The patient had provided contact details of her physician.
Age: 4.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220773, 2018SA220774, 2018SA220775 and 2018SA218532 (same reporter). This case involves a four years old patient (four years three months old, gender not reported) who experienced patient received a dose of PENTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on 24-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. It was not reported 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 holders compliance with the requirements set out in Directive and Module VI of the 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: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220766, 2018SA220773, 2018SA220775 and 2018SA218532 (same reporter). This case involves a four years old patient (gender not reported) who experienced patient received a dose of PENTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on 30-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. It was not reported 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 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: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves three patients of an unknown demographics who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients 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. It was not reported if the patients 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 and Module VI of the 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: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: 6-12-18 evening - headache, chills, fever, body aches. 6-13-18 headache, chills, fever, body aches. 6-14-18 body aches, weakness. 6-15-18 hives after going outside for first time since injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 6-12-18 evening - headache, chills, fever, body aches. 6-13-18 headache, chills, fever, body aches. 6-14-18 body aches, weakness. 6-15-18 hives after going outside for first time since injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Approx. 8 hours after immunization with swelling redness at medial (R) arm, to area just above elbow joint; length 20 cm x width 12 cm at 6 cm from elbow approx. arm are 27/at left 25. Min edema 1" at injection site. T 99.1.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 9/12/18 Pt called this am with C/O Lt shoulder (top to elbow) very painful/swollen mild heat no redness. Advised ice 20min on 2-3x this site - watch for headache/fatigue call PCP or ER over week. Will ck on her Monday.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: About eleven hours after second SHINGRIX dose, I experienced pain at site of injection, muscle pains and headache, then during night developed low grade fever, sweats and chills, muscle spasms or tetany (involuntary sustained muscle contraction) mostly in back from low back up to top and into shoulders, sensation in eyes when moving them (which reminded me of flu in past or when I got Lyme Disease ). Next day (12th) continued with body and muscle aches, headache, eye sensation, stomach ache, fatigue but no fever or chills or muscle spasm. Then on (13th) improving but still have some muscle aches, low back discomfort, headache and some eye sensation with fatigue, no stomach ache. I did not go to doctor since symptoms improving and also I was warned there might be reaction.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Muscle contractions involuntary, Muscle spasms, Musculoskeletal discomfort, Myalgia
Clinical narrative: About eleven hours after second SHINGRIX dose, I experienced pain at site of injection, muscle pains and headache, then during night developed low grade fever, sweats and chills, muscle spasms or tetany (involuntary sustained muscle contraction) mostly in back from low back up to top and into shoulders, sensation in eyes when moving them (which reminded me of flu in past or when I got Lyme Disease ). Next day (12th) continued with body and muscle aches, headache, eye sensation, stomach ache, fatigue but no fever or chills or muscle spasm. Then on (13th) improving but still have some muscle aches, low back discomfort, headache and some eye sensation with fatigue, no stomach ache. I did not go to doctor since symptoms improving and also I was warned there might be reaction.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tetany
Clinical narrative: About eleven hours after second SHINGRIX dose, I experienced pain at site of injection, muscle pains and headache, then during night developed low grade fever, sweats and chills, muscle spasms or tetany (involuntary sustained muscle contraction) mostly in back from low back up to top and into shoulders, sensation in eyes when moving them (which reminded me of flu in past or when I got Lyme Disease ). Next day (12th) continued with body and muscle aches, headache, eye sensation, stomach ache, fatigue but no fever or chills or muscle spasm. Then on (13th) improving but still have some muscle aches, low back discomfort, headache and some eye sensation with fatigue, no stomach ache. I did not go to doctor since symptoms improving and also I was warned there might be reaction.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Pt received PNEUMOVAX on R deltoid on 7/18 and last night noticed warmth, swelling redness around site of infection. Tenderness was so great that it was difficult to sleep or move her arms. Examined R upper arm, +warmth, and erythema surrounding site; Exam and history is concerning for a delayed localized reaction to the vaccine; Pt has never had a reaction to prior vaccination, even tetanus. She is afebrile. Pt was given instructions to take prednisone 40mg x 1 dose in office, ZYRTEC 10mg/day, and apply cold compress; Will report this vaccine adverse event to VAERS Lot R000579 Exp 09SEP2019.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Insomnia
Clinical narrative: Pt received PNEUMOVAX on R deltoid on 7/18 and last night noticed warmth, swelling redness around site of infection. Tenderness was so great that it was difficult to sleep or move her arms. Examined R upper arm, +warmth, and erythema surrounding site; Exam and history is concerning for a delayed localized reaction to the vaccine; Pt has never had a reaction to prior vaccination, even tetanus. She is afebrile. Pt was given instructions to take prednisone 40mg x 1 dose in office, ZYRTEC 10mg/day, and apply cold compress; Will report this vaccine adverse event to VAERS Lot R000579 Exp 09SEP2019.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of both VARIVAX lot # N017700, expiry date 09-JUN-2019 or lot # N023960, expiry date: 01-SEP-2019 and M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). It was unknown which of the lots of VARIVAX and M-M-R II were administered to the patient. Also, the nurse reported that sterile diluent (MERCK) used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for VARIVAX was between -14 degree C to -10 degree C (-9.9 degree C) for a time frame of 3 hours and 57 minutes and for M-M-R II was between 9 degree C to 25 degree C (13.4 degree C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004216: US-009507513-1808USA004217: US-009507513-1808USA004218: US-009507513-1808USA004219: US-009507513-1808USA004220.