chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4, HEP
Symptoms: Wrong product administered
Clinical narrative: 5 day old was given a flu shot, Fluzone instead of a Hepatitis B shot/no AE; 5 day old was given a flu shot, Fluzone instead of a Hepatitis B shot/no AE; Based on information previously received on 15-Oct-2019, the following information [classification "non-valid case" removed"] have been amended.  Initial information received on 15-Oct-2019 regarding an unsolicited non-valid non-serious case received from a physician.  This case involves a 5 days old male patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of HEPATITIS B VACCINE   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In October 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was of potential medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown whether adverse event was experienced or not.  Information on the batch number was requested.  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.  Addendum:  Based on information previously received on 15-Oct-2019, the following information [classification "non-valid case" removed"] have been amended.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Overdose
Clinical narrative: 21 adult patient received only the Fluzone Quadrivalent 1.0 ml dose, no adverse event; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 21 adult patients (age not reported) who were vaccinated with a 1.0 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number , Exp. Date, dose, route and site of administration not reported) on 22-Oct-2019.  The patient's medical history not reported and no patient received any other vaccine.  It was an actual medication error case due to overdose.  No adverse event reported at the time of reporting.  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.  Information on the batch number was requested.
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: had a doctor call in a prescription for Menactra and the patient is 70 years old, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old patient who was prescribed with vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was prescribed with vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported. The patient has not received Menactra yet. Patient who will be taking Solaris.  It was a case of medication error due to product prescribing error. It was reported that patient is 70 years old, and will therefore be receiving Menactra off label.   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: F
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction, Peripheral swelling
Clinical narrative: red swollen area on her arm; red swollen area on her arm; red swollen area on her arm; red swollen area on her arm/injection site reaction; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 73 years old female patient who experienced red swollen area on her arm (erythema)( swelling) and injection site reaction (vaccination site reaction) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  The patient developed a non-serious red swollen area on her arm (inflammation)  (erythema) (swelling) (Unknown latency) injection site reaction (vaccination site reaction) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was red swollen area on her arm.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for red swollen area on her arm, as Unknown for red swollen area on her arm, as Unknown for red swollen area on her arm and as Unknown for injection site reaction.  Information on batch number was requested.
Sex: U
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: vaccines were used in error as diluent/no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown demographics who only received diluent portion of received vaccines VARICELLA VACCINE, MMR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without active constituent.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to Active ingredient not added to diluent.  It was reported that there was no adverse event noted.  Information on the batch number was requested.  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: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ActHIB given with expired diluent, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received first 0.5 mL expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot: UI904AAA, expiry date: 19-SEP-2019 and Frequency = once) via intramuscular route in the left thigh) on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE).  It was a case of actual medication error due to Expired vaccine used. It was reported that ActHIB given with expired diluent.  At the time of reporting the patient had no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ActHIB Expired dose was administered/No AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE).  On 28-Oct-2019, the patient received first 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UI904AAA (Frequency = once) expiry date- 19-SEP-2019 via intramuscular route in the left thigh.  It was a case of actual medication error due to Expired vaccine used.  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.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired Flublok Quadrivalent, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked with 2019SA301057, 2019SA301296, 2019SA301298, 2019SA301297 (same reporter)  This case involves a 58 year old patient (gender not reported) who was inadvertently vaccinated with an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (frequency once) lot QFAA1827 via intramuscular route in the left deltoid on 26-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: rash on her arm; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves female patient of who experienced rash on her arm [Rash], while he/she received vaccine INFLUENZA VACCINE.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing allergic to Neomycin.   On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious rash on her arm (Rash) Unknown latency following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  Final diagnosis was rash on her arm.  Information on the batch number was requested.  Corrective treatment antibiotics was received.  The event outcome was reported as unknown for rash on her arm.
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy
Clinical narrative: Patienr received expired Fluzone Quad, no AE; Patient received Fluzone Quad while she was pregnant, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA301628 (same reporter).  This case involves a 32 years old female patient who was vaccinated with expired dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUZONE QUADRIVALENT while she was pregnant at 17 weeks of pregnancy, during second pregnancy trimester.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was reported as 03-Jul-2019.  The estimated due date is 08-Apr-2020.  The delivery type, birth type and fetal outcome were unknown.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE at a dose of 0.5 ml lot QFAA1816 via unknown route in unknown administration site.  Other relevant tests not reported.    The event outcome was reported as not applicable for both the events.  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.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: two-doses of Fluzone High-Dose 10-days apart; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that two-doses of Fluzone High-Dose 10-days apart (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for Immunisation.  On 28-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ287AA and expiry date: 28-May-2020 via intramuscular route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  It was unknown if the patient had any adverse event.  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: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic shock, Fluid retention, Headache, Lip swelling, Lymphadenopathy
Clinical narrative: anaphylaxis shock; swelling in her lip; swelling in her tongue; swelling in her glands; headache; fluid build up in her body; all her systems started to breakdown; Initial information received on 28-Oct-2019 regarding an unsolicited valid serious case received from a physician.   This case involves a 68 years old female patient who experienced headache (headache), anaphylaxis shock (anaphylactic shock), swelling in her lip (lip swelling), swelling in her tongue (swollen tongue), swelling in her glands (lymphadenopathy), fluid build up in her body (fluid retention) and and all her systems started to breakdown (multi-organ disorder), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ0288AA via unknown route in the arm.  On 26-Oct-2019, the patient developed a serious headache, anaphylaxis shock (anaphylactic shock), swelling in her lip (lip swelling), swelling in her tongue (swollen tongue), swelling in her glands (lymphadenopathy), fluid build up in her body (fluid retention) and all her systems started to breakdown (multi-organ disorder) two hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date: 80/50.   Final diagnosis was anaphylactic shock.  The patient was treated with Epinephrine (Epi pen) and was put on oxygen.  On an unknown date, the patient recovered from all the events.; Sender's Comments: This case concerns a 68 years old female patient who developed anaphylactic shock, headache, lip swelling, swollen tongue, lymphadenopathy, fluid retention and multi-organ disorder two hours after vaccination with FLUZONE QUADRIVALENT. The time to onset was compatible. However, patient's past history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Multi-organ disorder, Oxygen therapy, Swollen tongue
Clinical narrative: anaphylaxis shock; swelling in her lip; swelling in her tongue; swelling in her glands; headache; fluid build up in her body; all her systems started to breakdown; Initial information received on 28-Oct-2019 regarding an unsolicited valid serious case received from a physician.   This case involves a 68 years old female patient who experienced headache (headache), anaphylaxis shock (anaphylactic shock), swelling in her lip (lip swelling), swelling in her tongue (swollen tongue), swelling in her glands (lymphadenopathy), fluid build up in her body (fluid retention) and and all her systems started to breakdown (multi-organ disorder), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ0288AA via unknown route in the arm.  On 26-Oct-2019, the patient developed a serious headache, anaphylaxis shock (anaphylactic shock), swelling in her lip (lip swelling), swelling in her tongue (swollen tongue), swelling in her glands (lymphadenopathy), fluid build up in her body (fluid retention) and all her systems started to breakdown (multi-organ disorder) two hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events.  Relevant laboratory test results included: Blood pressure measurement - On an unknown date: 80/50.   Final diagnosis was anaphylactic shock.  The patient was treated with Epinephrine (Epi pen) and was put on oxygen.  On an unknown date, the patient recovered from all the events.; Sender's Comments: This case concerns a 68 years old female patient who developed anaphylactic shock, headache, lip swelling, swollen tongue, lymphadenopathy, fluid retention and multi-organ disorder two hours after vaccination with FLUZONE QUADRIVALENT. The time to onset was compatible. However, patient's past history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Fatigue, Influenza virus test negative, Injection site erythema, Injection site induration
Clinical narrative: Patient expressed swelling, redness, warmth at the site the next morning (11/3/19)as well as body aches, subjective fever, tired, dizziness. Patient denies any difficulty breathing, swallowing, or noted rash elsewhere. States symptoms have mildly improved compared to yesterday, and it doesn't appear to be as "hard" over the administration site. Recommended to closely monitor for signs of infection and continued improvement, and discussed possible association with Prevnar and strict ER precautions were discussed.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Patient expressed swelling, redness, warmth at the site the next morning (11/3/19)as well as body aches, subjective fever, tired, dizziness. Patient denies any difficulty breathing, swallowing, or noted rash elsewhere. States symptoms have mildly improved compared to yesterday, and it doesn't appear to be as "hard" over the administration site. Recommended to closely monitor for signs of infection and continued improvement, and discussed possible association with Prevnar and strict ER precautions were discussed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain in extremity
Clinical narrative: Shot was given very high in upper arm, just below the shoulder joint.  Tech went through the neck of my shirt, not a rolled up sleeve.  The shot hurt a little but nothing unusual. Within about 5 hours, my entire arm began to go numb and feel quite heavy.  By the time 8 hours had lapsed, my arm was paralized to the point that I could not lift it without using my other arm and hand to do so.  The pain was sharp in the shoulder joint the migrated down the length of my arm into my hand.   This severity level continued for four days. What sleep I got was sitting up. On October 24, I notified Dr. via message board. She called but offered no suggestions for pain relief or any ideas about regaining movement. Nor did she have any suggestions about how long the condition might persist.  By October 30, I was able to sleep in bed again and movement is pretty much back to normal although pain in the area below the injection site remains.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site
Clinical narrative: Shot was given very high in upper arm, just below the shoulder joint.  Tech went through the neck of my shirt, not a rolled up sleeve.  The shot hurt a little but nothing unusual. Within about 5 hours, my entire arm began to go numb and feel quite heavy.  By the time 8 hours had lapsed, my arm was paralized to the point that I could not lift it without using my other arm and hand to do so.  The pain was sharp in the shoulder joint the migrated down the length of my arm into my hand.   This severity level continued for four days. What sleep I got was sitting up. On October 24, I notified Dr. via message board. She called but offered no suggestions for pain relief or any ideas about regaining movement. Nor did she have any suggestions about how long the condition might persist.  By October 30, I was able to sleep in bed again and movement is pretty much back to normal although pain in the area below the injection site remains.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms: fever, chills, body aches.  (I know these are common side-effects.  I'm filling out form for more accurate statistical data on incidence.)
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, IPV, MENB, MMR, TD, VARCEL
Symptoms: Dizziness, Drooling, Dysphagia, Feeling abnormal, Throat irritation
Clinical narrative: After vaccines were administered the patient was given a juice box and escorted to front lobby to wait 10-15 before leaving the clinic. I noticed 14 mins after given the vaccine she was grabbing her throat and drooling from her mouth. She stated that " I don't feel right" and then said "Iam dizzy" she appeared to have troubles swallowing. She was quickly escorted back to exam room where she went unresponsive. B/p 70/62 P 98 R 9 O2 sat 68. EPI pen was administered and 911 called. Patient was transported to Local ER .
Age: 17.0
Sex: F
Vaccine: HEP, HPV9, IPV, MENB, MMR, TD, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: After vaccines were administered the patient was given a juice box and escorted to front lobby to wait 10-15 before leaving the clinic. I noticed 14 mins after given the vaccine she was grabbing her throat and drooling from her mouth. She stated that " I don't feel right" and then said "Iam dizzy" she appeared to have troubles swallowing. She was quickly escorted back to exam room where she went unresponsive. B/p 70/62 P 98 R 9 O2 sat 68. EPI pen was administered and 911 called. Patient was transported to Local ER .
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: PATIENT REPORTED THAT NEXT DAY SHE BROKE OUT IN RASH AND COMPLAINING ABOUT ITCHING ALL OVER THE BODY
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site mass, Pyrexia
Clinical narrative: Mom noticed a little spot on top of left thigh this past Friday, believes it is the location of injection of one of his 1 yr shots, stated there was a small bruise there after the injection, it went away and then in the same area a small red dot first appeared on 11/1/19. She didn't think anything about the red dot but then Fever started Sat evening. Fever was gone when waking up Sunday, fever came back Sunday evening at 103.1, and no fever since. Today there is a hard lump under the skin with a red mark that feels hard to the touch. No tenderness. Pt doesn't seem bothered by it. Pt received VVX on upper L thigh on 10/24/19.  This lesion is a little higher than I would have expect for the vaccination, but cannot guarantee where vaccine administration was done. I think fever is likely related to viral URI and not this area of redness, no evid of abcess, rec warm soaks 2x/d, allow him to play in warm tub supervised, call if increased redness or pain, will treat for possible infection in skin with abx. Will complete VAERS form. Phone f/u tomorrow.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Mom noticed a little spot on top of left thigh this past Friday, believes it is the location of injection of one of his 1 yr shots, stated there was a small bruise there after the injection, it went away and then in the same area a small red dot first appeared on 11/1/19. She didn't think anything about the red dot but then Fever started Sat evening. Fever was gone when waking up Sunday, fever came back Sunday evening at 103.1, and no fever since. Today there is a hard lump under the skin with a red mark that feels hard to the touch. No tenderness. Pt doesn't seem bothered by it. Pt received VVX on upper L thigh on 10/24/19.  This lesion is a little higher than I would have expect for the vaccination, but cannot guarantee where vaccine administration was done. I think fever is likely related to viral URI and not this area of redness, no evid of abcess, rec warm soaks 2x/d, allow him to play in warm tub supervised, call if increased redness or pain, will treat for possible infection in skin with abx. Will complete VAERS form. Phone f/u tomorrow.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: 80 year old female presents today with allergic reaction to Pneumovax 23.  She was given the vaccine on Friday at appt. She got her Pneumovax 23 in right deltoid and Flu vaccine in left deltoid.  She stated," Saturday she noticed her right arm starting with redness and swelling." She could hardly lift her arm. Examined right arm upper arm around injection site. No redness or swelling noted. There is Redness, swelling and warm to forearm down to her wrist. She also presents with a fine, red rash on her arms, neck, and trunk area. No rash on abdomen or legs. She denies any itching.  Dr examined arm and rash . He agrees it an allergic reaction to Pneumovax 23. Talked about starting her on a steroid pack but afraid it would cause more harm than just using OTC anti-histamines, cool wrap to arm and elevation. Patient and daughter agrees with Dr orders.  Instructed daughter to call if no signs of improvement. She and patient verbalized understanding.  Called director at Health Department and reported reaction. Also called Infection Disease. Completed reaction on care zone  and completed Vaccine Adverse Event Reporting System (VAERS) online .
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: 80 year old female presents today with allergic reaction to Pneumovax 23.  She was given the vaccine on Friday at appt. She got her Pneumovax 23 in right deltoid and Flu vaccine in left deltoid.  She stated," Saturday she noticed her right arm starting with redness and swelling." She could hardly lift her arm. Examined right arm upper arm around injection site. No redness or swelling noted. There is Redness, swelling and warm to forearm down to her wrist. She also presents with a fine, red rash on her arms, neck, and trunk area. No rash on abdomen or legs. She denies any itching.  Dr examined arm and rash . He agrees it an allergic reaction to Pneumovax 23. Talked about starting her on a steroid pack but afraid it would cause more harm than just using OTC anti-histamines, cool wrap to arm and elevation. Patient and daughter agrees with Dr orders.  Instructed daughter to call if no signs of improvement. She and patient verbalized understanding.  Called director at Health Department and reported reaction. Also called Infection Disease. Completed reaction on care zone  and completed Vaccine Adverse Event Reporting System (VAERS) online .
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm, unable to lift arm in front of body or to cross body, also can not lift arm to shoulder height.  Has been using ibuprofen, especially at bedtime to help with sleeping.  Patient does not report any swelling, hot-to-touch feeling or fever.  Patient contacted us for advice.  I recommended Tylenol and ice and to call the doctor.  Doctor's office advised her that this could last up to 6 weeks and also told her to use ice or heat and Tylenol or ibuprofen.  They thought probably tissue damage.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Patients states that the next day the patient felt pain and had redness and bruising from the vaccine. The patient reported it about 5 days after the vaccination and he states that its much better and he's not experiencing any pain. The bruising is also gone.
Age: 73.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At/around injection site was red and swollen per patient. It does not hurt.
Age: 3.0
Sex: F
Vaccine: MNQ, PNC13
Symptoms: Wrong product administered
Clinical narrative: Pt was administered Menatra in error instead of PCV13. The state nurse was contacted and advised that we proceed with administering the PCV13 today and no severe contraindication or adverse reaction was to be expected. She advised to report the incident on Vaers. The parents were informed of the error and given literature about both vaccines. They agreed to the PCV being administered and the PCV was administered without complications. Pt was discharged from our clinic with no issues.
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Seizure like phenomena
Clinical narrative: possible seizure around 45 min after vaccinations, patient was located in major electronics department with a lot of TVs and lights, caregiver pushing her in wheelchair, her eyes were closed. Paramedics were called to check patient out.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling hot, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: pt received flu shot at work, was given on the top of his left arm, shoulder, not in the deltoid area per pt and pt's wife who is a nurse, pt stated immediately had a warm sensation that went down left arm, pain immediately in shoulder, area became red, hot and at his appointment today 11-4-2019, states he is unable to raise arm up due to the pain in shoulder area
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site warmth, Product administered at inappropriate site
Clinical narrative: pt received flu shot at work, was given on the top of his left arm, shoulder, not in the deltoid area per pt and pt's wife who is a nurse, pt stated immediately had a warm sensation that went down left arm, pain immediately in shoulder, area became red, hot and at his appointment today 11-4-2019, states he is unable to raise arm up due to the pain in shoulder area
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness, swelling on injection site, body ache, headache, chills, fever.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: pain, redness, swelling on injection site, body ache, headache, chills, fever.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given off label meant for 4-6 years old and was given to a 9 months old. No symptoms or adverse reactions known at this time.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blood pressure decreased, Dizziness, Feeling cold, Immediate post-injection reaction
Clinical narrative: Patient instantly felt faint, dizzy, and cold upon administration. Blood pressure was taken immediately and had dropped to 65/47. Blood pressure taken a minute later with same result. We offered to call the ambulance for car and patient refused. Patient laid down on the pharmacy bench and started to feel better. Blood pressure was taken 5 minutes later and had risen to 95/67.  Patient sat down for 10 minutes and instantly felt better once she rest.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Patient was fine initially, he called back later that afternoon stating his tongue felt swollen and he felt his face was puffy. RN spoke to Dr. who asked that the patient come in to be evaluated. Patient was seen in clinic at 4:00PM on 10/23 and  given IM Benadryl. He was monitored for approximately 30 minutes following this injection.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Fatigue, Presyncope
Clinical narrative: patient was dizzy, feeling tired and almost fainted
Age: 85.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Adverse reaction started around 5pm.  the patient had been cutting firewood.  he had swelling all the way down his arm into his forearm and rash started later within 24 hours of vaccination
Age: 85.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site rash, Injection site swelling, Peripheral swelling
Clinical narrative: Adverse reaction started around 5pm.  the patient had been cutting firewood.  he had swelling all the way down his arm into his forearm and rash started later within 24 hours of vaccination
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Ocular hyperaemia, Periorbital swelling
Clinical narrative: patient described swollen, puffy, red left eye upon awakening on 11/3/2019.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Once injected in arm, my neck began to itch, then over the course of the next day red raised bumps started showing up across my chest, at injection site, left upper arm and across top of back. I called pharmacy on Saturday to see what to do. They advised Benadryl. Over the past couple of days I have developed itchy bumps on my toes and palms of hands I believe to be Dyshidrtic Eczema.
Age: 67.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash
Clinical narrative: Patient broke out in rash the next morning and saw prescriber 2 days later for cortisone shot and Benadryl. Patient still has rash on his chest and ankles. Patient had received flu shots in the past, it was his first time receiving  Fluad.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient got her flu shot at school around 1:30, has had multiple flu vaccines in past with no reactions or problems. Shortly after getting home from school that day, around 4:00 PM she started to develop hives and by the next morning had hives over her whole body essentially. No other symptoms reported at that time. Mom did take patient to her pediatrician (Dr.) on 10/29/2019 who said that he felt she was likely having a drug reaction rash from her Augmentin course she was just completing. He recommended mom to continue flu vaccines in the future. No other symptoms ever developed, hives had completely resolved within about two full days.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Cough, Fatigue, Injection site rash, Injection site swelling, Rash papular
Clinical narrative: Today the patient reported the following. Two days after receiving the vaccine (10/30/19) the injection site swelled up down to her elbow and had a bumpy rash around injection site. She also had a fever, cough and congestion and felt really weak and tired. Today 5 days after injection she said her arm is better and no longer swollen and the rash went a ways but she is still feeling tired and still congested and coughs.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Respiratory tract congestion
Clinical narrative: Today the patient reported the following. Two days after receiving the vaccine (10/30/19) the injection site swelled up down to her elbow and had a bumpy rash around injection site. She also had a fever, cough and congestion and felt really weak and tired. Today 5 days after injection she said her arm is better and no longer swollen and the rash went a ways but she is still feeling tired and still congested and coughs.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Grip strength decreased, Herpes zoster, Hyperaesthesia
Clinical narrative: 2 events. The day after (mildly) and the next 1.5 days, more intensely, I had significant flu like symptoms including skin sensitivity, reduced hand strength, shivering, general malaise and feeling horrible. This by itself would not have precipitated this report. The reason for this report is that I went to my doctor today for a 2-3 week significant and very itchy rash on my upper left thigh which he immediately diagnosed as shingles, not knowing ahead of time that I had received the Shingrix vaccination a month prior. So it would appear that within 2 weeks or so of receiving the vaccination, I developed shingles.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Rash pruritic
Clinical narrative: 2 events. The day after (mildly) and the next 1.5 days, more intensely, I had significant flu like symptoms including skin sensitivity, reduced hand strength, shivering, general malaise and feeling horrible. This by itself would not have precipitated this report. The reason for this report is that I went to my doctor today for a 2-3 week significant and very itchy rash on my upper left thigh which he immediately diagnosed as shingles, not knowing ahead of time that I had received the Shingrix vaccination a month prior. So it would appear that within 2 weeks or so of receiving the vaccination, I developed shingles.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Multiple small, itchy "chicken-pox-like" bumps on both hands. Occurred less than an hour after receiving vaccine.
Age: 52.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Chills, Erythema, Lip swelling, Lymph node pain
Clinical narrative: within 12 hours, severe body aches, chills as well as sore arm, joint pain,  within 32 hours, slight swelling above lip and on lip, within 42 hours swelling of face with tenderness, redness and swelling of lymph nodes
Age: 52.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Swelling face
Clinical narrative: within 12 hours, severe body aches, chills as well as sore arm, joint pain,  within 32 hours, slight swelling above lip and on lip, within 42 hours swelling of face with tenderness, redness and swelling of lymph nodes
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient complained of arm and shoulder pain (dull and sharp pains combined) that comes and goes. It is not a constant issue but certain movements do aggravate the area. The pain subsides after awhile.
Age: 80.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Peripheral swelling, Pruritus, Skin reaction
Clinical narrative: right arm is swollen, red, itchy. She states she is using warm compresses and benadryl
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around entire bicep and upper left arm. Patient mentioned  some soreness in the armpit/lymph node area.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site rash, Injection site warmth
Clinical narrative: Pt called @ 6:30pm 11/4/19 to let me know she was having some discoloration around the injection site almost like a rash, as well as it being warm to the touch. She states she had put some hydrocortisone and ice on it but it didn't help. She said she hadn't taken any benadryl yet as she didn't think it was that bad yet. She said she's having no trouble breathing and no swelling anywhere. I instructed her it wouldn't hurt to take benadryl if in fact the rash was an allergic rxn. i told her to go to express care or ER in case of worsening rash/hives/allergic reaction etc. She said the feeling was starting to affect a larger area of her arm. She states she had a sore arm with previous flu shots, but this felt worse. At that point, I told her it wouldn't hurt to go to express care and have them look at it since it's warm to the touch, just to make sure there was no infection. She said she did not have a fever.
Age: 93.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Mobility decreased, Muscle tightness
Clinical narrative: Received vaccine in September.  The day after started having sore joints; gradually getting worse.   Today took old Prednisone prescription she had because could hardly get out of bed.   Patient has not contacted pharmacy or PCP and doesn't plan to go over there.   Patient has been taking hot showers and applying stuff to skin hoping that muscles release.  Patient has never received a Pneumonia vaccine prior.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was seen on 10/23/19 for wellness visit and given flulaval; then, he returned on 11/1/19 for immunizations and got a second flu shot before the recommended 4 week break between the two doses
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Fatigue, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: Arm started getting sore within couple of hours.  Symptoms worsen by evening, patient was nauseous, had stomach upset (4 bowel movements)--she went in her pants while sleeping.    Arm was sore from shoulder to elbow and could not lift it.   Stomach symptoms started to alleviate after bowel movement. Patient took ginger and liquorice tablet to help with stomach.    Patient still somewhat sick to stomach and fatigue.  Arm still is sore but can actually use it now.   Called doctor but has not been able to speak to them yet.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: patient reported pain at injection site radiating up shoulder and down the arm, redness and swelling, and itching on the arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Skin warm
Clinical narrative: patient states she had a reaction that started 2 days after the immunization. Patient experienced arm redness, itchy, feverish arm, arm pain, and rash/hives as the reaction was resolving. All reactions were only on the arm that received the injection. she went to the md on day 3 for a cortisone shot and the reaction completely resolved after about 5 days. She is completely better now with no issues per patient.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: patient states she had a reaction that started 2 days after the immunization. Patient experienced arm redness, itchy, feverish arm, arm pain, and rash/hives as the reaction was resolving. All reactions were only on the arm that received the injection. she went to the md on day 3 for a cortisone shot and the reaction completely resolved after about 5 days. She is completely better now with no issues per patient.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Let the provider know that the wrong vaccine was given.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site starting hurting that evening.  Pharmacist suggested cold compresses.  Patient did so.  Arm got worse and the next day it started to swell past the elbow.  He continued cold compresses per pharmacist.  The next business day he called the pharmacy again and reported it was hot, very painful and still swollen.  Pharmacist had patient call his doctor to get it looked at right away.  Patient did go to doctor and found out it had become infected.  He got antibiotics.  Pharmacist called patient to check on him and told him to start them right away.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: cellulitis started early am on 11/3/19. raised red area not directly near the injection site. seen by physician and antibiotics given.
Age: 90.0
Sex: F
Vaccine: FLUA3, TDAP
Symptoms: Blood pressure decreased, Dizziness, Dyspnoea, Presyncope
Clinical narrative: PT FELT SO DIZZY AND STARTED BREATHING WITH DIFFUCLTY ALMOST FAINTED, CALLED 911, PT HAD A SEVERE DROP IN HER BLOOD PRESSURE AND WAS TRANSFERED TO ER TO HAVE SOME IV FLUIDS
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Muscular weakness
Clinical narrative: Patient received flu shot at pharmacy.  When walking out her legs gave out and she fell down.  She was coherent and breathing normally.  EMTs were contacted and she was taken to local ER.  Unknown status after leaving pharmacy.