chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: hives; Initial information was received on 22-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-professional.  This case involves female patient (age unknown) who experienced hives (urticaria), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for unknown indication.  On an unknown date, the patient developed non-serious hives (urticaria) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported that, the patient is on a time limit, and need information before she gets her 3 shot of IMOVAX.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome was unknown for urticaria.
Sex: U
Vaccine: DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a patient (unspecified age and gender) for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Dysarthria, Full blood count, Headache, Immune thrombocytopenia
Clinical narrative: After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased, Platelet transfusion, Rash, Subarachnoid haemorrhage
Clinical narrative: After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subdural haematoma
Clinical narrative: After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Thrombocytopenia, Ultrasound scan
Clinical narrative: After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory failure, Subarachnoid haemorrhage, Thrombocytopenia
Clinical narrative: After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Dysarthria, Full blood count, Headache, Immune thrombocytopenia
Clinical narrative: Thrombocytopenia
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased, Platelet transfusion, Rash, Subarachnoid haemorrhage
Clinical narrative: Thrombocytopenia
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subdural haematoma
Clinical narrative: Thrombocytopenia
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Thrombocytopenia, Ultrasound scan
Clinical narrative: Thrombocytopenia
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: Thrombocytopenia
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory failure, Subarachnoid haemorrhage, Thrombocytopenia
Clinical narrative: Thrombocytopenia
Sex: F
Vaccine: DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: temperature excursion of unknown cause at 0.7C for 25 hours and 24 minutes /no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 year old female patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL] (batch number and expiry date not provided) via an unknown route at an unknown administration site for prophylactic vaccination and and INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE] (batch number: UJ452AB and expiry date: 30-Jun-2021]) via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Reporter reported a temperature excursion of unknown cause. PENTACEL, IPOL, FLUZONE QUADRIVALENT MDV AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened Ipol MDVs and opened Fluzone quadrivalent MDVs. See related cases. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone quadrivalent MDVs were administered post excursion. See related cases. Caller with question on viability of administered vaccines. Additional Description of event Adverse events :MA reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT MDV AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened Ipol MDVs and opened Fluzone quadrivalent MDVs. See related cases. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone quadrivalent MDVs were administered post excursion  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Muscle and joint pain moderate to severe whole body, chills with no fever, headache, nausea. This ran from approximately midnight Friday thru Sunday morning.  The longest lingering was the headache.
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: pentacel, ipol, fluzone quadrivalent mdv and prefilled syringes, menactra, adacel, and daptacel at 0.7C for 25 hours and 24 minutes/no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 3 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 9 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate irregular, Influenza like illness, Myalgia
Clinical narrative: Pt received dose #2 Moderna COVID vaccine 1/26/21 @ Vaccine Clinic. Pt presented to PVH ED 1/29/21 @ 0732 for workup. "Patient states that she got her Covid vaccine 3 days ago, had 1 day of myalgias, flulike symptoms, yesterday she felt much better however she felt that her heart was beating irregularly and she was feeling anxious. This persisted through the night. She denies any chest pain, shortness of breath. Patient is scheduled for follow-up with her cardiologist later next week." Afib, tachycardia, palpitations. Rhythm self converted. Given NS bolus and discharged home without further escalation of care. Entered by PSS for tracking.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Rash erythematous, Tenderness
Clinical narrative: itching near the injection area; red rash around band of her left arm; local reaction with arm pain, little tenderness while rubbing her left arm; Initial information received on 26-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (HCP) via Medical Information (Reference number- 00447170).  This case involves a 65 years old female patient who experienced itching near the injection area (injection site pruritus), red rash around band of her left arm (vaccination site rash) and local reaction with arm pain, little tenderness while rubbing her left arm (vaccination site pain), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 23-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ519AA, expiry date: 30-JUN-2021, Strength: High Dose, via intramuscular route in the left deltoid for prophylactic vaccination.  On 26-Oct-2020, the patient developed a non-serious itching near the injection area (injection site pruritus), red rash around band of her left arm (vaccination site rash) and local reaction with arm pain, little tenderness while rubbing her left arm (vaccination site pain) three months three days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Reporter can be contacted by Sanofi: Yes Potential PTC(Product Technical complaint): No, Description: Call transferred from Sanofi Pasteur customer service. HCP reports she experienced adverse reaction to FLUZONE HIGH-DOSE QUADRIVALENT. Caller also has question regarding the difference between FLUZONE QUADRIVALENT and FLUZONE HIGH-DOSE QUADRIVALENT. Additional Description of event: Caller reports local reaction with arm pain for 3 days following the injection. She reports a few days later she experienced a red rash around band of her left arm. Caller also reports some itching near the injection area for one day. Caller reports she did not feel right after administration and states she probably will not receive the high-dose formulation next influenza season. While on phone, caller states she is experiencing a little tenderness while rubbing her left arm now. She does report that office physician confirmed other patients had strange rashes on back, chest, and arms following administration of FLUZONE HIGH-DOSE QUADRIVALENT. First time product used: Yes and Still using product: No.  No laboratories details reported.  No corrective treatment receive by patient.  On 27-Oct-2020, the patient recovered from injection site pruritus.  The event outcome was reported as unknown for other events.
Age: 51.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: patient received an expired dose of Menactra with no adverse event; Initial information received on 27-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (Medical Assistant) via Global Medical Information (Reference number-00448383).  This case involves a 51 years old male patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6486AC, expiration date: 10-JAN-2021, strength: standard) via intramuscular route in the left arm for prophylactic vaccination on 12-Jan-2021 (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant medication given.  It was an actual medication error due to expired vaccine used (latency: same day).  Description: A Medical Assistant wanting to know how to proceed after a consumer received an expired dose of Menactra. Product used and still using product: yes.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash macular, Skin warm
Clinical narrative: A sizeable red/warm/itchy blotch appeared on my right arm where I had the Moderna COVID vaccine on Monday 01/18. The blotch appeared on 01/25, 7 days after the injection. I did not experience any immediate symptoms following the vaccine, just a sore arm. I spoke with a Dr. about the rash. She said no concerns at this time unless it grows or other symptoms appear.
Age: 33.0
Sex: F
Vaccine: DTAP, TD
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 33 year old female received Daptacel and not prescribed Tenivac tetanus vaccine, no AE; 33 year old female received dose of Daptacel, no AE; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case.  This case involves a 33 years old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 26-Jan-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5611AA and expiry date: 03-Apr-2021) (frequency once dose) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on same day).  It was also reported that a nurse reporting that a 33 year old female received Daptacel and not prescribed Tenivac tetanus vaccine.  Reporter relationship: health care professional (HCP), Product used: used and still using product: no  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: had slight fever; shivers; tired; headache / slight lingering headache; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, shivers, tiredness and headache. On an unknown date, the outcome of the fever, shivers and tiredness were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fever, shivers, tiredness and headache to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 2nd dose of Shingrix and experienced slight fever, shivers, tiredness and headache. The events went away within 12 hours except headache. The patient had been feeling slight lingering headache ever since.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Fever; Flu like symptoms; This case was reported by a consumer and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 2nd May 2018, refer case US2020248569). Concurrent medical conditions included injection site pain (left arm pain at the injection site from dose 1 was not resolved at the time of receiving 2nd dose).   On 30th August 2018, the patient received the 2nd dose of Shingrix. On 30th August 2018, less than a day after receiving Shingrix, the patient experienced fever and influenza-like symptoms. On an unknown date, the outcome of the fever and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The patient received 2nd dose of Shingrix and on the same day, she developed fever, that lasted for 36 hours and then resolved and flu like symptoms, that resolved completely after 2 days. The patient did not have vaccine information for this adverse event.  The reporter did not consent to follow-up. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248587:same reporter US-GLAXOSMITHKLINE-US2020248569:Same reporter US-GLAXOSMITHKLINE-US2020248580:Same reporter US-GLAXOSMITHKLINE-US2020248583:Same reporter
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: Day 1: 7 hours after the vaccine shot, I experienced mild fatigue and chills. Overnight, I had night sweats and insomnia. (Night sweats are a symptom that started after the first vaccine shot, and had dwindled until the second brought them up again).   Day 2: The next morning, I experienced intense fatigue, dizziness, chills, fever, headache with light and sound sensitivity, nausea, and intense fatigue. I was unable to get out of bed most of the day. I could not sit up without intense effort to even drink water. At approximately 11am, I took 600mg Tylenol, then was able to sleep for 3 hours. When I woke up my symptoms were much better, though I still had mild fatigue and achiness.   Day 3:  I was mildly fatigued but otherwise felt good.   Day 4: I awoke with a series of small rashes on my torso (front, back, and sides), as well as my inner arm. They were red, flat, not raised, and mildly itchy, One was around my umbilicus, a few under my breasts, and other splotched in random other places on my torso. My inner ears were also mildly itchy. I put generic rash cream on the rashes on my torso and arms, and the itchiness subsided. The redness decreased throughout the day, though they were all still visible by evening.    Day 5: I awoke and my entire torso was bright red *except* the places where the rashes had been the day before, which were normal skin color. Ears are itchy again, and skin is very mildly itchy. Other than that, no other symptoms. No trouble breathing, good energy.   I have never had rashes or an allergic reaction like this before. I assume it's an allergic reaction, due to the itchy inner ears and skin.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Insomnia, Mobility decreased, Nausea, Night sweats
Clinical narrative: Day 1: 7 hours after the vaccine shot, I experienced mild fatigue and chills. Overnight, I had night sweats and insomnia. (Night sweats are a symptom that started after the first vaccine shot, and had dwindled until the second brought them up again).   Day 2: The next morning, I experienced intense fatigue, dizziness, chills, fever, headache with light and sound sensitivity, nausea, and intense fatigue. I was unable to get out of bed most of the day. I could not sit up without intense effort to even drink water. At approximately 11am, I took 600mg Tylenol, then was able to sleep for 3 hours. When I woke up my symptoms were much better, though I still had mild fatigue and achiness.   Day 3:  I was mildly fatigued but otherwise felt good.   Day 4: I awoke with a series of small rashes on my torso (front, back, and sides), as well as my inner arm. They were red, flat, not raised, and mildly itchy, One was around my umbilicus, a few under my breasts, and other splotched in random other places on my torso. My inner ears were also mildly itchy. I put generic rash cream on the rashes on my torso and arms, and the itchiness subsided. The redness decreased throughout the day, though they were all still visible by evening.    Day 5: I awoke and my entire torso was bright red *except* the places where the rashes had been the day before, which were normal skin color. Ears are itchy again, and skin is very mildly itchy. Other than that, no other symptoms. No trouble breathing, good energy.   I have never had rashes or an allergic reaction like this before. I assume it's an allergic reaction, due to the itchy inner ears and skin.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Photophobia, Pruritus, Pyrexia, Rash
Clinical narrative: Day 1: 7 hours after the vaccine shot, I experienced mild fatigue and chills. Overnight, I had night sweats and insomnia. (Night sweats are a symptom that started after the first vaccine shot, and had dwindled until the second brought them up again).   Day 2: The next morning, I experienced intense fatigue, dizziness, chills, fever, headache with light and sound sensitivity, nausea, and intense fatigue. I was unable to get out of bed most of the day. I could not sit up without intense effort to even drink water. At approximately 11am, I took 600mg Tylenol, then was able to sleep for 3 hours. When I woke up my symptoms were much better, though I still had mild fatigue and achiness.   Day 3:  I was mildly fatigued but otherwise felt good.   Day 4: I awoke with a series of small rashes on my torso (front, back, and sides), as well as my inner arm. They were red, flat, not raised, and mildly itchy, One was around my umbilicus, a few under my breasts, and other splotched in random other places on my torso. My inner ears were also mildly itchy. I put generic rash cream on the rashes on my torso and arms, and the itchiness subsided. The redness decreased throughout the day, though they were all still visible by evening.    Day 5: I awoke and my entire torso was bright red *except* the places where the rashes had been the day before, which were normal skin color. Ears are itchy again, and skin is very mildly itchy. Other than that, no other symptoms. No trouble breathing, good energy.   I have never had rashes or an allergic reaction like this before. I assume it's an allergic reaction, due to the itchy inner ears and skin.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Day 1: 7 hours after the vaccine shot, I experienced mild fatigue and chills. Overnight, I had night sweats and insomnia. (Night sweats are a symptom that started after the first vaccine shot, and had dwindled until the second brought them up again).   Day 2: The next morning, I experienced intense fatigue, dizziness, chills, fever, headache with light and sound sensitivity, nausea, and intense fatigue. I was unable to get out of bed most of the day. I could not sit up without intense effort to even drink water. At approximately 11am, I took 600mg Tylenol, then was able to sleep for 3 hours. When I woke up my symptoms were much better, though I still had mild fatigue and achiness.   Day 3:  I was mildly fatigued but otherwise felt good.   Day 4: I awoke with a series of small rashes on my torso (front, back, and sides), as well as my inner arm. They were red, flat, not raised, and mildly itchy, One was around my umbilicus, a few under my breasts, and other splotched in random other places on my torso. My inner ears were also mildly itchy. I put generic rash cream on the rashes on my torso and arms, and the itchiness subsided. The redness decreased throughout the day, though they were all still visible by evening.    Day 5: I awoke and my entire torso was bright red *except* the places where the rashes had been the day before, which were normal skin color. Ears are itchy again, and skin is very mildly itchy. Other than that, no other symptoms. No trouble breathing, good energy.   I have never had rashes or an allergic reaction like this before. I assume it's an allergic reaction, due to the itchy inner ears and skin.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: fever, chills, headache, nausea, fatigue, body aches Tylenol and fluids 48 hours
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever, chills, headache, nausea, fatigue, body aches Tylenol and fluids 48 hours
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: At 11:25 am client states she's having shortness of breath and has heart racing.  Vital signs obtained by EMS:  BP 150/78, Pulse 75, O2 sat 99%.  At 11:30 am client states she feels better.  EMS discharge client home.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Vomiting
Clinical narrative: Chills, fatigue,  nausea/ actively throwing up for 24 hours. Stomach flu like symptoms
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy Rash on both arms that changes in location day to day. Today I have a 4 inch by 6 inch rash in left antecubital that appears will be spreading down my entire arm and 2 by 2 in right antecubital. Have applying hydrating cream to arms. This morning applied steroid cream.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: 11:30 after receiving vaccine client states he is feeling foggy.  Vital signs obtained by EMS:  BP 150/83, Pulse 74, O2 sat 97%.  11:30 am client states he if feeling better.  Client discharged home by EMS.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration
Clinical narrative: Asymmetrical skin discoloration at site of injection
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itch
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: I woke up Friday with a fever. I suffered from being cold and could not get warm. The fever broke Friday night. Saturday I had severe body ache and tiredness. Sunday I woke up with the most terrible headache. The headache lasted 6 hours and was very intense. Monday the chills returned as I could not get warm and I still feel fatigued easily.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I woke up Friday with a fever. I suffered from being cold and could not get warm. The fever broke Friday night. Saturday I had severe body ache and tiredness. Sunday I woke up with the most terrible headache. The headache lasted 6 hours and was very intense. Monday the chills returned as I could not get warm and I still feel fatigued easily.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: 9 days after shot my arm starting itching and became red and feverish
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: generalized pain in my joints for about 3 days  pain went away and all is fine
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Impaired work ability, Somnolence
Clinical narrative: pronounced fatigue which is impacting her work/ excessive tiredness/nodding off at work; This spontaneous report as received from nurses regarding a non-pregnant 36-year-old female patient. The patient's concurrent conditions included polycystic ovarian syndrome (PCOS), endometriosis, rheumatoid arthritis, anxiety, seasonal allergy and coeliac disease. The patient had drug reactions included nausea due to erythromycin, and brain zaps due to duloxetine. The patient's concomitant therapies included elagolix sodium (ORILISSA), phenylpropanolamine hydrochloride (reported as norephedrine), lisdexamfetamine dimesylate (VYVANSE) (reported as VIVANCE), pantoprazole sodium (PROTONIX), montelukast sodium (SINGULAIR), duloxetine hydrochloride (CYMBALTA), fluticasone propionate (+) salmeterol xinafoate (ADVAIR), albuterol sulfate (manufacturer unknown), abatacept, alprazolam (XANAX) and fluticasone propionate (FLONASE).     On 11-JAN-2021 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milligram (anatomical location of administration not reported; lot number 1687292 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) with expiration date 25-AUG-2022) intramuscularly once for prophylaxis.    On 12-JAN-2021 (conflicting information: also reported as 11-JAN-2021), the patient experienced pronounced fatigue which was impacting her work. The patient had excessive tiredness and nodding off at work. The patient had not sought medical attention. No treatment or additional exam had been performed by the reporting time. The outcome was reported as not recovered. The patient was inquiring that how long this side effect would last.     The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: caller mentioned she is allergic to Pneomovax; This report was received from Pfizer and was assigned manufacturer report number 2021070603 for PFIZER-BIONTECH COVID-19 VACCINE. This was originally reported by a female consumer of unknown age regarding herself.  There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (allergy to vaccine).  At the time of the report, the outcome of the event was unknown.  The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: she experienced a minor adverse reaction when she got her dose; This spontaneous report as received from a representative from the physician's office via a company representative and refers to a non-pregnant female patient of unknown age. The patient's concurrent condition, concomitant medication and medical history were not provided.    On an unknown date in December 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in December 2020 (reported as when she got her dose), the patient experienced minor adverse reaction. It was unknown what adverse reaction she had experienced. The outcome of adverse reaction was unknown.        The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Visual impairment
Clinical narrative: hearing loss; vision issues; On or about 2009, Patient was administered the ZOSTAVAX vaccine; Information has been received regarding a case in litigation from a lawyer referring to a 55 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a Family Practice for the long-term prevention of shingles and zoster-related conditions (Inappropriate schedule of product administration). Subsequently, the patient was treated by providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: hearing loss and vision issues. The outcome of the events hearing loss and vision issues was unknown.  Upon internal review, hearing loss was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: Could hair loss be a side effect / alopecia; This case was reported by a consumer and described the occurrence of alopecia in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was not recovered/not resolved.   It was unknown if the reporter considered the alopecia to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had inquired if alopecia could be a side effect of Shingrix. The patient had already made an appointment with a dermatologist. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Experienced a reaction / felt the "Face little puffy"; This case was reported by a pharmacist and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows:  The age at the vaccination was not reported. After receiving dose of Shingrix, the experienced a reaction and felt the face a little puffy. The HCP did not have any other information about the vaccine or the reaction. The reporter consent to follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Nausea, Swelling face
Clinical narrative: The patient experienced a temp of 101, Ha/N, and her face was swollen
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain, Myalgia
Clinical narrative: Muscle soreness, L axillary lymph nodes and Left lateral breast pain.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngeal hypoaesthesia
Clinical narrative: Client attended by onsite EMT complained of sore throat, numbness to the throat.  Client had stopped Methotrasate 2 weeks earlier. BP 144/78, HR 72, O2 sat 96.  Client stated he felt better and was released home.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Erythema, Headache, Induration
Clinical narrative: Red, hot, swollen , hard lump with pain and itching about 12 hrs after vaccine Very swollen lymph nodes in axilla of that arm 36 hrs after vaccine Body aches, headache, chills, GI upset About 12-26 hrs after vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mass, Pain, Pruritus, Skin warm
Clinical narrative: Red, hot, swollen , hard lump with pain and itching about 12 hrs after vaccine Very swollen lymph nodes in axilla of that arm 36 hrs after vaccine Body aches, headache, chills, GI upset About 12-26 hrs after vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Red, hot, swollen , hard lump with pain and itching about 12 hrs after vaccine Very swollen lymph nodes in axilla of that arm 36 hrs after vaccine Body aches, headache, chills, GI upset About 12-26 hrs after vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Ear pain, Fatigue, Headache, Pain
Clinical narrative: Temperature of 102.2 (afternoon of 2/6/2021) Headache (11:30 am 2/6/2021 - am of 2/7/2021) Ear ache (11:30 am 2/6/2021 - am of 2/7/2021) Fatigue (11:30 am 2/6/2021 - pm of 2/7/2021) Body aches (11:30 am 2/6/2021 - pm of 2/7/2021) Felt like my body temperature had trouble regulating (pm of 2/7/2021 until am of 2/9/2021)
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Injection site pain, Lethargy
Clinical narrative: Within 5 minutes of getting the shot on 2/6 I felt pain in the upper arm that moved down to forearm into left pinky. At approximately 3 pm arm started to hurt at the injection site. Iced for the next 36 hours until the swelling went down.  On 2/7/21 at 10 pm started feeling like sickness was starting. On 2/8/21 was lethargic with body aches, headache, dry cough, and temperature up to 101.5 degrees F.  Took 325 mg of Tylenol every 6 hrs. 2/9/21 up dose of Tylenol to 500 mg every 6 hrs as fever increased. Experienced night sweating and severe joint pain in hips, lower back, and along the upper spine. Fever broke at approximately 7 pm 2/9/21. Joint pain continues through 2/10/21