chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five-year-old female patient who was vaccinated with an expired 0.5 mL dose of DAPTACEL (fifth dose in series) frequency once lot C5117AA, 19 Jan 2019 via unknown route in the left deltoid on 04-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE INACT (IPV) for Immunisation; MMR for Immunisation; and VARICELLA ZOSTER VACCINE for Immunisation. It is an actual medication error case due to expired vaccine used. No adverse event 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult (unknown demographic patient) patient who administered an expired 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 received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported. It was an actual medication error due to expired vaccine used. It was not reported 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. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 16 years old male patient who received 0.5 ml vaccines FLUBLOK QIV (lot number: QPAA1803 , expiry date: 31-May-2019) instead of INFLUENZA VACCINE via intramuscular route in right deltoid on 31-Dec-2018 since there were out of stock of the regular flu shot. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown demograpgic patient who was vaccinated with a dose of vaccine PENTACEL which had been left outside of refrigeration for one week (lot UJ082AAA) Exp. Date, route and administration site not reported. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. It was unknown whether the patient experienced 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. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a nine-weeks-old female patient who received 0.5 mL dose of vaccine PENTACEL lot C5516AA, expiry 15-Sep-2019 Administered via unknown route in the left deltoid On 31-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccinations included ROTATEQ for Immunisation; PREVNAR 13 for Immunisation; and HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that child was administered the DTaP-IPV component of PENTACEL ( 0.5ml dose), without reconstitution of the HIB component. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.08
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 5 weeks old male patient who received vaccines MENACTRA instead of HEPATITIS B VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Feb-2019, the patient received a 0.5 mL dose of suspect MENACTRA lot U5833AA via unknown route in the thigh NOS. It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. It was unknown if any adverse event was occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 12 years old female patient who received 0.5 ml MENACTRA, once on an unknown date of Sep-2018 (lot number not reported) and again on 07-Feb-2019 (lot U6207AB) via unknown route in unknown administration site) in an interval of 5 months. In the same interval on an unknown date of Sep-2018, the patient received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Tdap) (produced by unknown manufacturer lot number not reported) and on 07-Feb-2019, 0.5 ml ADACEL (lot C5585BA) both via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported 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 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. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 57 years old female patient who was vaccinated with a 0.5 ml dose of vaccine MENACTRA (lot U6151AB and Exp. Date 16-MAR-2019) via unknown route in the arm NOS instead of vaccine TENIVAC on an unspecified date. The patient's medical history was not reported and concomitant medications included PNEUMOCOCCAL PNEUMOVAX 23 given in arm for Immunisation. It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered. It was unknown whether the patient experienced 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. It was linked to 2019SA038790.  This case involves a 11 years old male patient who received 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 received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number U61552AA.  No other vaccines were given.  It was a case of actual medication error due to Inappropriate age at vaccine administration. Patient received first Menactra at age 11 and then a booster at age 15 year.  It was unknown whether patient experience 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: 82.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 82 years old male patient who received a 0.5ml booster dose of TENIVAC batch number not reported via unknown route in unknown administration site on 17-Jan-2019. The patients past vaccination(s) included first dose of TENIVAC on 02-NOV-2009. The patients past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old male patient who only received the diluent instead of the ACT-HIB portion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; and DAPTACEL for Immunisation received on 21-Jan-2019. On 21-Jan-2019, the patient received a 0.5 ml dose of suspect ACT-HIB lot U6054BA via unknown route in unknown administration site. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves 10 patients who was administered vaccine ADACEL that was out of temperature range. 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 ADACEL lot U6043BA via unknown route. It was a case of actual medication error due to incorrect product storage. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Localised infection
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves 36-year-old male patient who received vaccine IMOVAX RABIES. The patients past medical history, concomitant medication and family history were not provided. On 04-Feb-2019, the patient received injection of first dose of suspect IMOVAX RABIES lot number not reported via unknown route in unknown administration site. It was an actual medication error due to Inappropriate schedule of vaccine administered. It was reported that patient was bitten on the tip of his finger by a stray cat several days before the first dose but given but he did not think anything about it until the finger started to get infected. First dose given 04-Feb-2019, but the product was not available to give the dose for day 3 but will be given today. IMOGAM was not administered but they plan on giving it today. It was unknown whether patients experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old male patient received vaccine MENACTRA instead of MENINGOCOCCAL VACCINE B. The patients past medical history, concomitant medication and family history were not provided. On unknown date in May 2014, the patient received a first dose of suspect MENACTRA lot number not reported via unknown route in unknown administration site. On 17-May-2018 he also received a second Booster dose of the same vaccine with an unknown batch number via unknown route in unknown administration site and On 05-Feb-2019 patient also received a third dose 0.5ml of the same vaccine lot U6179AA, expiry 29-Mar-2020 via unknown route in the right deltoid instead of suspect MENINGOCOCCAL VACCINE B not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was an actual medication error due to wrong vaccine administered and extra dose administered. It was reported that order was documented as meningitis immunization and nurse did not realize patient had been scheduled for meningitis B vaccine instead patient receiving a third MENACTRA vaccine. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 13.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA040917, 2019SA040918 and 2019SA040916 same reporter. This case involves a 13 years old female patient who received first dose 0.5 mL vaccine IPV (VERO) [IPOL] lot P1A242M, expiry date- 26-Apr-2020 via intramuscular route in the left deltoid on 05-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ADACEL for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to Incorrect product storage. It was reported that after the vaccine had a temp excursion on 04 Feb 2019 and 4 children got the IPOL on 5th Feb 2019. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA040917, 2019SA040918 and 2019SA040495 same reporter. This case involves a 11 years old female patient who received vaccine IPOL lot P1A242M, expiry date- 26-Apr-2020 via intramuscular route in the left deltoid on 05-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation; ADACEL for Immunisation; and VARICELLA ZOSTER VACCINE for Immunisation. It was a case of actual medication error due to Incorrect product storage. It was reported that after the vaccine had a temp excursion on 04 Feb 2019 and 4 children got the IPOL on 5th Feb 2019. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: HEP, IPV, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked with case 2019SA040495, 2019SA040916 and 2019SA040918 (same reporter). This case involves 10 year old male patient was vaccinated with IPV (VERO) [IPOL] (lot: P1A242M, expiry date: 26-Apr-2020) via intramuscular route in the left deltoid, on 05-FEB-2019 which had a temp excursion on 04 Feb 2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); ADACEL; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was an actual medication error due to incorrect product storage as after the vaccine had a temp excursion on 04 Feb 2019, patient received IPOL.. Vaccine stored at temperature outside the recommended range 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. List of document held by sender: none.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 08-year-old male patient was vaccinated with second dose of IPOL (lot: P1A242M, expiry date: 26-Apr-2020) via intramuscular route in the left deltoid, which had a temp excursion on 04-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; ADACEL; MMR and VARICELLA ZOSTER VACCINE Immunisation. It is an actual medication error case due to incorrect product storage. It was reported that the vaccine stored at temperature outside the recommended range. 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 and Module VI of the Good Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of document held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 11-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a four months old female patient who received third Primary dose of vaccine PENTACEL batch number C5408AB (expiry date 05-Oct-2019) via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). It was a case of actual medication error due to inappropriate reconstitution technique. (It was reported that there is a child who obtained the DTap/IPV separately without the ActHiB.) It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia
Clinical narrative: Joint pain (all joints) pain 7 out of 10, chills, muscle ache. Lasting 24 hours. Second day mostly muscle ache 4 out of 10 pain. Third day only pain at injection site when touched.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills, fever of 109 degrees, and muscle aches all over the body.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever, 101.2 (by oral thermometer). Lasted about 12 hours. Fever broke and I felt fine. I also have some soreness in the shoulder, around the site of the injection.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Malaise, Pallor
Clinical narrative: Patient stated she did not feel well after receiving vaccines then passed out. Was only out a few seconds and came to. Patient was dizzy and pale. Orange juice and ice pop given no other treatment need, Dr. was in to see patient after the event.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Blindness transient, Dizziness, Dizziness postural, Nervousness
Clinical narrative: Patient had dizziness and was lightheaded when standing, which increased with walking. She became weak, momentarily lost vision and collapsed. Symptoms appeared to be that of fainting. After sitting/laying back for 5+ minutes, symptoms faded. Haylie was given water to drink and then had a small cookie. She felt shaky afterwards, but otherwise normal.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient had dizziness and was lightheaded when standing, which increased with walking. She became weak, momentarily lost vision and collapsed. Symptoms appeared to be that of fainting. After sitting/laying back for 5+ minutes, symptoms faded. Haylie was given water to drink and then had a small cookie. She felt shaky afterwards, but otherwise normal.
Age: 1.17
Sex: F
Vaccine: FLU4, HEPA, MMRV, PNC13
Symptoms: Blood glucose normal, Febrile convulsion, Influenza virus test negative
Clinical narrative: Febrile Seizures X 2 on 2/15/2019.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness at injection site and swelling. Patient states pain in the area and that swelling has gotten worse throughout the day.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: I received the shot on Tuesday afternoon. I had a stronger reaction to it than to other vaccines (Flu, pneumonia) --  felt achey, tired, but took ibuprofen that night and an Aleve on Wednesday. It was too sore to sleep on that side both Tuesday and Wednesday nights, but it wasn't until thursday morning that I realized the soreness was beyond the injection site, and saw in the mirror that there was a red, slightly inflamed, spot on my arm about 3 inches wide and 6 inches long. It was hot and sore to the touch. I went to the local urgent care clinic. They were puzzled by the reaction, but diagnosed cellulitis and gave me a prescription for Cephalexin (500 mg, 3Xday) and told me to discuss it with my regular physician and report it to the CDC. I see my regular doctor next Tuesday and will discuss it with her.  Just started the antibiotics, so don't know if they will clear it not. I am not sure when this started, but given the size of the patch on my arm, I would guess it started as soon as I got the injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Insomnia, Pain
Clinical narrative: I received the shot on Tuesday afternoon. I had a stronger reaction to it than to other vaccines (Flu, pneumonia) --  felt achey, tired, but took ibuprofen that night and an Aleve on Wednesday. It was too sore to sleep on that side both Tuesday and Wednesday nights, but it wasn't until thursday morning that I realized the soreness was beyond the injection site, and saw in the mirror that there was a red, slightly inflamed, spot on my arm about 3 inches wide and 6 inches long. It was hot and sore to the touch. I went to the local urgent care clinic. They were puzzled by the reaction, but diagnosed cellulitis and gave me a prescription for Cephalexin (500 mg, 3Xday) and told me to discuss it with my regular physician and report it to the CDC. I see my regular doctor next Tuesday and will discuss it with her.  Just started the antibiotics, so don't know if they will clear it not. I am not sure when this started, but given the size of the patch on my arm, I would guess it started as soon as I got the injection.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure X 1 on 01/18/2019.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Diarrhoea, Fatigue
Clinical narrative: Beginning the day after the vaccine I experienced the following for the next 36 hours: Sore arm, painful to movement and to touch,at site of injection, chills, fever, body aches, fatigue, stomach pain, abdominal discomfort diarrhea. Seventy-two hours after the vaccine, all symptoms except the diarrhea had resolved with the diarrhea resolving on 2/17/2019.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Beginning the day after the vaccine I experienced the following for the next 36 hours: Sore arm, painful to movement and to touch,at site of injection, chills, fever, body aches, fatigue, stomach pain, abdominal discomfort diarrhea. Seventy-two hours after the vaccine, all symptoms except the diarrhea had resolved with the diarrhea resolving on 2/17/2019.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient called the pharmacy and stated that they were fine the night of the receiving the shot, however upon awakening the patient stated that they had severe pain in one foot as well as swelling. The patient then stated that the pain and swelling seemed to be spreading up the leg. The patient was referred the the emergency room with pending outcome.
Age: 43.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Asthenia, Blood test, Cellulitis, Chills, Headache
Clinical narrative: Within 8 hours of injection, body aches all over and soreness and stiffness near injection. Fever and chills, weakness and headache developing within 12 hours of injection. Fever reached 103 degrees within 24 hours of injection. Pain and weakness worsened. Went to clinic then ER 26 hours after vaccine.
Age: 43.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Immunisation reaction, Injection site pain, Injection site reaction, Local reaction, Musculoskeletal stiffness
Clinical narrative: Within 8 hours of injection, body aches all over and soreness and stiffness near injection. Fever and chills, weakness and headache developing within 12 hours of injection. Fever reached 103 degrees within 24 hours of injection. Pain and weakness worsened. Went to clinic then ER 26 hours after vaccine.
Age: 43.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Pain, Pyrexia, White blood cell count increased
Clinical narrative: Within 8 hours of injection, body aches all over and soreness and stiffness near injection. Fever and chills, weakness and headache developing within 12 hours of injection. Fever reached 103 degrees within 24 hours of injection. Pain and weakness worsened. Went to clinic then ER 26 hours after vaccine.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Chest X-ray normal, Chest pain, Cough, Dizziness, Electrocardiogram normal
Clinical narrative: Very shortly after getting the vaccine (within an hour) I developed chest pain on my right side. It was persistent for 22 hours. After 3.5 hours I contacted the provider who gave me the vaccine. She assessed my symptoms over the phone and instructed me to go to an urgent care to have an EKG. I was seen at urgent care promptly after getting off the phone with the provider. At urgent care (arrived at 5:10 pm) I had a physical exam, an EKG and a chest x-ray to rule out other reasons for the chest pain. Both tests were negative for signs or heart issues and for lung infection. During the visit I developed tinnitus. It is still happening at the time if this report- so over 24 hours later. At the end of the visit the provider gave me a ZPAK for a lingering cough. I took the first ZPAK dose before bed that evening. I awoke at 5:00 am too dizzy to sit up. I have never had that reaction to ZPAK ever and I have been on it many times. After a half hour I tried to walk and kept veering left. I got to the bathroom and took a bath. With effort I was able to walk straight. I am intermittently dizzy and feel unwell. Never have felt like this from azithromycin, much less a single dose. This is the vaccine.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Gait disturbance, Malaise, Tinnitus
Clinical narrative: Very shortly after getting the vaccine (within an hour) I developed chest pain on my right side. It was persistent for 22 hours. After 3.5 hours I contacted the provider who gave me the vaccine. She assessed my symptoms over the phone and instructed me to go to an urgent care to have an EKG. I was seen at urgent care promptly after getting off the phone with the provider. At urgent care (arrived at 5:10 pm) I had a physical exam, an EKG and a chest x-ray to rule out other reasons for the chest pain. Both tests were negative for signs or heart issues and for lung infection. During the visit I developed tinnitus. It is still happening at the time if this report- so over 24 hours later. At the end of the visit the provider gave me a ZPAK for a lingering cough. I took the first ZPAK dose before bed that evening. I awoke at 5:00 am too dizzy to sit up. I have never had that reaction to ZPAK ever and I have been on it many times. After a half hour I tried to walk and kept veering left. I got to the bathroom and took a bath. With effort I was able to walk straight. I am intermittently dizzy and feel unwell. Never have felt like this from azithromycin, much less a single dose. This is the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: Developed shingles 5 days later in mouth, lips, chin, ear, gums, down the throat, fever.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Headache, chills, very achy joints and tiredness.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient experiencing what we consider to be a local site reaction (severe). 6 inch diameter swelling and tenderness over 48 hours post-injection. Little redness or warmth.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Body pain in joints and muscle; injection site pain; Headache; Fatigue; Chills.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Body pain in joints and muscle; injection site pain; Headache; Fatigue; Chills.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypertension, Lymphadenopathy
Clinical narrative: BLOOD PRESSURE HAS BEEN HIGH SINCE GETTING VACCINE (190/HIGH 80'S), SWOLLEN GLANDS, AND PT SAID "I FELT LIKE I WAS GOING TO DIE". HER DOCTOR IS MONITORING HER BUT NO TREATMENT.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Hypersensitivity, Mouth swelling
Clinical narrative: PATIENT RECEIVED SHOT ON 2/20/19 AROUND 6 PM AND STARTED DEVELOPING ALLERGIC REACTION THAT NIGHT AROUND 1 AM. PT REPORTED SWELLING IN MOUTH, SHIVERING AND TROUBLE BREATHING. PT TOOK BENADRYL AROUND 3 AM AND SYMPTOMS IMPROVED THEREAFTER. ADVISED PT TO CONTACT MD IF SYMPTOMS CONTINUE OR GET WORSE. PT REPORTS NO PREVIOUS REACTIONS TO FLU SHOTS.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Loss of personal independence in daily activities, Myalgia, Neck pain, Pain, Quality of life decreased
Clinical narrative: Patient reported soreness, has been occurring since the shot which has been over a month.  Patient reports no redness or swelling. Muscle pain and soreness getting worse. It has now been a month after the shot, patient went to the doctor. Patient will get xrays and see the orthopedist in March. The pain is now radiating up into the neck. Pain is affecting patients function and quality of life.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Patient reported soreness, has been occurring since the shot which has been over a month.  Patient reports no redness or swelling. Muscle pain and soreness getting worse. It has now been a month after the shot, patient went to the doctor. Patient will get xrays and see the orthopedist in March. The pain is now radiating up into the neck. Pain is affecting patients function and quality of life.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain, X-ray
Clinical narrative: Patient reported soreness, has been occurring since the shot which has been over a month.  Patient reports no redness or swelling. Muscle pain and soreness getting worse. It has now been a month after the shot, patient went to the doctor. Patient will get xrays and see the orthopedist in March. The pain is now radiating up into the neck. Pain is affecting patients function and quality of life.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient had swelling, redness and heat at the site of injection. She went to a physicians office where they made the diagnosis of cellulitis at the site of injection.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Rash
Clinical narrative: Patient started experiencing  fatigue and developed rash within 24 hours. Rash has persisted on chest for several days (5 days and counting). Patient has contacted PCP and was told to return to pharmacy in order to issue VAERS.
Age: 54.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: Shingles- face.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Skin warm, Tenderness
Clinical narrative: Localized site reaction to (R) arm. 6 x 4 cm warm to touch, pain with palpation.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Injection area became red and swollen to size of golf ball. Patient has a fever going on 3rd day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Pain and redness at injection site. Redness warmth and induration around the arm/deltoid area. Patient "feels fine" but the arm just hurts.
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On Saturday Feb. 16, 2019 patient was seen by provider. Provider ordered a flu vaccine for ages 6 months-35 months in which I accidentally grabbed a 4yr old and above flu vaccine and administered to child. After logging into database I realized the age/dosage was the wrong one in which I then immediately informed the providers. I also informed the mother by phone of the higher dosage and if patient had any symptoms or side effects to return to clinic or go to ER. Patient was contacted again by clinic manager on Tuesday 2/19/19 to follow up on the baby and mother stated that the baby was fine and has had no reaction nor fever.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Patient came to pharmacy with red patches that were swollen and irritated on upper left deltoid and wrapping around arm.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness at site of injection which has continued on and off after several weeks.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle spasms, Nausea
Clinical narrative: Spasm shoulder muscles bilateral. Nausea.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right arm swollen and red, pt given 40mg single vial of DEPO MEDROL in clinic, Cephalexin 500mg oral capsule.
Age: 51.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a other health professional and described the occurrence of fever in a 51-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020) for prophylaxis. Co-suspect products included PREVNAR 13 (batch number S58704, expiry date 31st October 2019) for prophylaxis. On 13th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and the 1st dose of PREVNAR 13 (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, headache and muscle pain. The patient was treated with ADVIL and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the fever, injection site pain, headache and muscle pain were unknown. It was unknown if the reporter considered the fever, injection site pain, headache and muscle pain to be related to SHINGRIX. Additional details were provided as follows: Concomitant products, other medical conditions was not available. Around 13:00, the patient was administered SHINGRIX in the right deltoid and PREVNAR in the left deltoid and she had some significant soreness in arms at injections site, the left arm was worse than the right arm. The patient had a fever of 102 degrees Fahrenheit overnight, a bad headache and muscle aches. She was working from home today. The patient took ADVIL and put ice on it. It was unknown if the reporter considered the fever, injection site pain, headache and muscle pain to be related to PREVNAR 13.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Catheterisation cardiac normal, Chest pain, Discomfort, Electrocardiogram, Pericarditis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a 62-year-old male patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) for prophylaxis. On 28th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain and fever. On 30th January 2019, the patient experienced pericarditis (serious criteria GSK medically significant) and chest pain. On an unknown date, the outcome of the pericarditis and chest pain were not recovered/not resolved and the outcome of the pain and fever were recovered/resolved. It was unknown if the reporter considered the pericarditis, pain, fever and chest pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. On the same day of vaccination in later evening, the patient developed a fever and aches. By Wednesday the patient was starting to feel better. On 30th January 2019, Wednesday night, 2 days after receiving SHINGRIX, the patient developed chest pains. On 31st January 2019 next morning, the patient went to see his doctor and they took him to the hospital.  The patient under went a heart catheterization and there were no major blockages or problems. The patient also got a electrocardiogram and heart sonogram and he was diagnosed with pericarditis.  The patient was still undergoing treatment for the condition and still gets some chest pains from time to time.