chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient of unknown demography who was supposed receive the doses 8 weeks apart but received the second unknown dose 5 weeks apart of vaccine MENACTRA (lot U5916BA and expiry date 20-Jul-2019) via unknown route in the left deltoid on 06-Nov-2018. The patient's past medical history included Asplenia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administration. 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 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.
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (consumer) via phone. This case is linked to case 2019SA087191 (same reporter). This case involves a male patient (age not reported) who experienced burning throughout their bodies, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unspecified date of Feb-2019, the patient received a dose of suspect FLUZONE QUADRIVALENT (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious burning throughout their bodies (burning sensation) following the administration of FLUZONE QUADRIVALENT. No Lab data was reported. Final diagnosis was burning throughout their bodies. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by the sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Induration, Injection site pain, Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from Health Authorities under reference-745497. This case involves a 37 years old male patient who experienced arthus reaction, warmth, induration and consisting of pain, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 11-Apr-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 13-Apr-2018, 2 days (also reported as 12 hours) after the vaccination the patient experienced arthus reaction (type iii immune complex mediated reaction), feeling hot, induration and pain. Arthus reaction was assessed as medically significant. (Other relevant tests included no lab data.) Final diagnosis was arthus reaction, feeling hot, induration and pain. It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as unknown for all events. List of documents held by sender: none. Amendment: 01-Apr-2019 Upon second medical examination of the case during internal review, a significant correction was performed on 01-Apr-2019 to correct the case seriousness which was upgraded due to IME convention (type III immune complex mediated reaction); Sender's Comments: This case involves a 37 years old patient who developed Arthus reaction consisting of pain, warmth, and induration 12 hours post vaccination with ADACEL Time to onset is compatible with the role of vaccine. More details regarding patient's condition at the time of vaccination, immune status, previous vaccination history, etiological workup and investigation reports to identify alternative etiology particularly infectious are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Administration site erythema, Administration site induration, Administration site warmth, Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from Health Authorities under reference- 745501. This case involves a 46 years old male patient who experienced arthus reaction, erythema, induration and warmth surrounding the administration site, while he received vaccine ADACEL. The patient's past medical history and medical treatment(s), vaccination(s) concomitant medication(s) and family history was reported as none. On 21-Apr-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 22-Apr-2018, also reported as 10 hours after the vaccination the patient experienced arthus reaction (type iii immune complex mediated reaction), administration site erythema, administration site induration and administration site warmth. Arthus reaction was assessed as medically significant. No lab data was reported. Final diagnosis was arthus reaction, administration site erythema, administration site induration and administration site warmth. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.; Sender's Comments: Patient experienced arthus reaction, administration site erythema, administration site induration and administration site warmth after vaccination. Arthus reaction was assessed as medically significant. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Type III immune complex mediated reaction, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from Other health care professional via Health Authorities under reference 575268. This case involves a 11 years old male patient who experienced likely arthus reaction, redness and swelling at vaccination site, while he received vaccines ADACEL and GARDASIL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Apr-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site. On 20-Apr-2015, the patient received a dose of suspect GARDASIL (lot number and Expiry date unknown) via unknown route in unknown administration site. On 22-Apr-2015, the patient developed a serious likely arthus reaction (type iii immune complex mediated reaction) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and GARDASIL. This event was assessed as medically significant. On 22-Apr-2015, the patient developed a non-serious swelling at vaccination site (vaccination site swelling) and redness at vaccination site (injection site erythema) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and GARDASIL. (Other relevant tests included no lab data.) Final diagnosis was redness and swelling at vaccination site and likely arthus reaction. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.; Sender's Comments: This case involves a 11 years old male patient who experienced likely arthus reaction and redness and swelling at vaccination site, while he received ADACEL and GARDASIL VACCINE. Time to onset is compatible with the role of vaccine. However, further information including concomitant medications excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 0.5
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 6 months 22 days old female patient who was vaccinated with a 0.5 ml dose of expired vaccine ADACEL (lot number not reported)(Exp. Date 23-MAR-2019) via unknown route in the left thigh on 27-Mar-2019. The patient's medical history not reported and No concomitant vaccines were given. It was an actual medication error case due to expired vaccine used. No side effects reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a three years old patient who was vaccinated with QUADRACEL (lot: C5248AA, expiry date: 21-Aug-2019) via unknown route in the right arm, on 14-Jun-2018. It was reported that patient received QUADRACEL immunization, 4 days prior to fourth birthday. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. No adverse events 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. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product storage error, Wrong technique in product usage process
Clinical narrative: Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 months old female patient received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13, HEPATITIS B VACCINE and ROTAVIRUS VACCINE on 27-Mar-2019. On 27-Mar-2016, the patient received a third dose 0.5ml of suspect PENTACEL lot C5590AA, expiry date 18-Oct-2019 via intramuscular route in the left arm. It was an actual medication error due to incorrect product storage and wrong technique in product usage process. It was reported that patient received an invalid PENTACEL which was reconstituted on 26-Mar-2019 and given on 27-Mar-2019. 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.
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: No adverse event, Product storage error, Wrong technique in product usage process
Clinical narrative: Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 months old female patient who was vaccinated PENTACEL lot C5590A Expiration Date 18-Oct-2019 via intramuscular route in the left thigh, on 27-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13, HEPATITIS B VACCINE and ROTAVIRUS VACCINE. It was an actual medication case error due wrong technique in product usage process and incorrect product storage. It was reported that PENTACEL was reconstituted on 26Mar2019 and given on 27Mar2019, (DTaP/IPV Lot C5447AA, Expiration Date: 18Oct2019. Hib Vial Lot C5590A, Expiration Date: 18Oct2019). It was reported that, no adverse reaction observed. 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: 2.0
Sex: U
Vaccine: DTAP, HEP, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case is linked to cases 2019SA089010 and 2019SA089011 same reporter. This case involves a 2 years old patient who received 0.5 mL dose of vaccine DAPTACEL lot C5171AA, expiry date- 23-Mar-2019 via unknown route in unknown administration site on 24-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and HEPATITIS B VACCINE. It was a case of actual medication error due to Expired vaccine used. 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: 1.83
Sex: M
Vaccine: DTAP, HEP, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is related to case- 2019SA089330, 2019SA089331, same reporter. This case involves a 22 months old male patient who received an expired DAPTACEL vaccine. The patient's past medical history and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and HEPATITIS B VACCINE on 24-Mar-2019. On 24-Mar-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C517AA, expiry date 23-Mar-2019 via intramuscular route in the thigh nos. It was an actual medication error due to expired vaccine used. 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 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.
Sex: U
Vaccine: DTAP, HEP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff). This case is linked to cases 2019SA088988 and 2019SA089011, same reporter. This case involves a 24 months old patient who received vaccine DAPTACEL. The patients past medical history and family history were not provided. Concomitant medications included HEPATITIS B VACCINE on 27-Mar-2019. On 27-Mar-2019, the patient received a 0.5ml dose of suspect DAPTACEL lot C5171AA, expiry date 23-Mar-2019 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that patient received expired dose of DAPTACEL vaccine on 27-Mar-2019 which got expired on 23-Mar-2019. It was unknown whether patient 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.
Sex: U
Vaccine: DTAP, HEP, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a non-HCP (Office Staff). This case is linked to cases 2019SA089010 and 2019SA088988 (same reporter). This case involves a 24 months old patient who received 0.5 mL dose of vaccine DAPTACEL (lot C5171AA, Exp. Date- 23-Mar-2019) via unknown route in unknown administration site on 24-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR and HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse reactions. 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic patient who was vaccinated with PENTACEL lot number not reported via intramuscular route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. It is an actual medication error case due to Inappropriate reconstitution technique. It was reported that the patient received just the diluent of DTaP/IPV from the PENTACEL and not the HIB. It was not reported that the patient had adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 28-Mar-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old female patient who was vaccinated with an expired dose of FLUZONE HIGH DOSE (lot UI993AA, expiry date: 18-Mar-2019, via intramuscular route in the left deltoid) on 28-Mar-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. It was unknown whether the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.17
Sex: M
Vaccine: DTAP, HEP, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is related to case- 2019SA088989 and 2019SA089331 (same reporter). This case involves a 19 months old male patient (second patient) who received an expired 0.5 ml single dose DAPTACEL vaccine on 24-Mar-2019 (lot C517AA, expiry date 23-Mar-2019 via intramuscular route). The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13; and HEPATITIS B VACCINE on 24-Mar-2019. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a two-months-old male patient who was vaccinated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ100AA via unknown route in the left thigh, on 27-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ, PREVNAR 13 and HEPATITIS B VACCINE. It was an actual medication case error due Inappropriate reconstitution technique. It was reported that the patient only received the diluent portion of the PENTACEL vaccine without the ACTHIB (lypholized powder). No side effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Day 3 post injection employee stated she had welts and then a rash down her left arm beneath the injection site. This was proceeded the day before with pain down the left arm the entire day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Tiredness, very sore arm (upper left) possible low fever, muscle soreness.
Age: 1.83
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Child was given expired Hep B vaccine twice. First date was 6/23/04 and second time this occured was 8/4/04. Pt did not have any adverse reactions.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza like illness, Pain, Pain in extremity, Pneumonia
Clinical narrative: Headache 20 mins after injection. The next 2 days my entire body ached, and my headache continued. Very sore arm. Felt like i had the flu. Then i got pneumonia for almost 3 months.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient came into pharmacy 3-31-2019 and showed me a rash around her waist and across her back that she said started to appear about a week after her first SHINGRIX vaccine on 3-16-2019. Outside of a sore arm for a few days she had no problems around the injection site.
Age: 1.58
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Irritability, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Low grade fever, fatigue, irritability and all over body rash of raised red spots.
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Injection site has red lump, warm to touch, painful. No new chills or fever. Tried warm/cold compress, ibuprofen, TYLENOL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left leg area measured 2.5 inches in diameter today in the office. Site erythematous, hard, hot to touch. Treated with KEFLEX.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Approximately 11:30 PM, Wednesday, 3/27/2019, I awoke and began 6 hours of simultaneous vomiting and diarrhea. It finally stopped after 5:00 AM Thursday, 3/28/2019. I slept all day Thursday and late that afternoon ate 1 saltine cracker. Friday I began feeling better, but still did not want to eat until Saturday except for small occasional portions of bland food. This was the most violent vomiting combined with diarrhea I have ever experienced. And almost 50 years ago, I had a case of Amoebic Dysentery. This was worse. I realize that vomiting and diarrhea are symptoms of the SHINGRIX vaccine, but I did not expect those two to occur together at the same time. I am a small woman, about 90 pounds and I wonder if this vaccine should be given in a lower dose for smaller people. Not everyone weighs 150 pounds! Please consider that. My doctor has advised me to wait 6 months before taking the 2nd vaccine.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Maculopapular rash on truck, UE, and LE sparing palms and soles, face and muscosal membrances. Itchy.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea, Tinnitus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling, redness, pain at vaccination site. Nausea, vomiting and tinnitus started that night. Tinnitus still present one week later.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Swelling, redness, pain at vaccination site. Nausea, vomiting and tinnitus started that night. Tinnitus still present one week later.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Incredibly painful burn and itch following by recurring rash.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient had a reaction on his left arm that measured 2 in by 3 in. Area is red, warm to touch, hard and painful. Treated with KEFLEX.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient called, stating that the area around her arm was red and itching. I advised her to monitor the rash and take BENADRYL. I also advised her to seek medical attention if the rash spreads, gets worse, or if she experiences trouble breathing. Patient will be contacting doctor Monday morning (4/2/19).
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient stated he received the vaccine and did not have any signs/symptoms of a reaction until about 6 hours later. Donor then had itchy hives on the left forearm that resolved within 2 days. Donor took BENADRYL until resolved.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 2 month old patient of unknown gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On 12-MAR-2019, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # N021308 and expiration date: 05-MAR-2019) orally for prophylaxis. No adverse effects reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a 19 weeks old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 14-MAR-2019, the patient was vaccinated with the first dose of ROTATEQ orally for prophylaxis (lot # R034700, expiration date: 16-JUN-2020) (dose was not reported). No adverse effect was reported.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous, Haematocrit decreased, Herpes zoster disseminated, Lethargy, Polymerase chain reaction positive
Clinical narrative: Pt reported rash on left shoulder 3/11/2019, then was admitted to the hospital on 3/13/2019 with worsening rash extending to left face, and back, and lesions developed at other metastatic sites on body. Seen by ID and dermatology and rash diagnosed as disseminated Zoster.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised, Rash vesicular, Skin lesion, Varicella virus test positive
Clinical narrative: Pt reported rash on left shoulder 3/11/2019, then was admitted to the hospital on 3/13/2019 with worsening rash extending to left face, and back, and lesions developed at other metastatic sites on body. Seen by ID and dermatology and rash diagnosed as disseminated Zoster.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Nausea, Vertigo
Clinical narrative: Started Thursday after vaccination on Tuesday: Extreme fatigue. Head felt "full" "foggy". Nausea. Sweats. But worse was vertigo at night when turning over in bed. Lasted for 4-5 days.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyskinesia, Feeling hot, Hyperhidrosis, Lethargy
Clinical narrative: While we were talking, within 5 minutes of FLUZONE given IM, Patient noticed to become lethargic, diaphoresis, pale looking, warm to touch, and very drowsy. She noticed to have a one second long of generalized jerky movement of upper/lower extremities while sitting in the chair. Vital signs as followed: 107/69 (right upper arm), 97% on room air, 72bpm HR. Radial pulses: 2+ palpable bilateral. Reposition Patient to the floor/flat position, cold towel applied to forehead/neck areas, verbal stimulation provided by myself and her mother. Patient opened eyes and verbalized feeling hot/dizziness, no further jerky movement noticed but she remained lethargic. No rash/no SOB noticed. Rapid Response and 911 called, teams arrived within 5 minutes. By then Patient already recovered, alert, awake, responsive, no resp. distress. Vital signs: 109/79, HR 66, 97% on room air. Since Patient is now better, no S/S of allergic reaction, can stand up, and ambulate. No residual of what happened, able to communicate well with paramedic, mother and staff, and drink water. Mother declined ER visit. Total time of event: approximate 30min.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Skin warm, Somnolence
Clinical narrative: While we were talking, within 5 minutes of FLUZONE given IM, Patient noticed to become lethargic, diaphoresis, pale looking, warm to touch, and very drowsy. She noticed to have a one second long of generalized jerky movement of upper/lower extremities while sitting in the chair. Vital signs as followed: 107/69 (right upper arm), 97% on room air, 72bpm HR. Radial pulses: 2+ palpable bilateral. Reposition Patient to the floor/flat position, cold towel applied to forehead/neck areas, verbal stimulation provided by myself and her mother. Patient opened eyes and verbalized feeling hot/dizziness, no further jerky movement noticed but she remained lethargic. No rash/no SOB noticed. Rapid Response and 911 called, teams arrived within 5 minutes. By then Patient already recovered, alert, awake, responsive, no resp. distress. Vital signs: 109/79, HR 66, 97% on room air. Since Patient is now better, no S/S of allergic reaction, can stand up, and ambulate. No residual of what happened, able to communicate well with paramedic, mother and staff, and drink water. Mother declined ER visit. Total time of event: approximate 30min.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Nausea
Clinical narrative: The evening I received the shot I noticed that I was a little dizzy depending on the way I moved my head. I had suffered from vertigo in prior years but when I get vertigo I am in bed and can not getup and walk for at least a week at an episode. At this point I have been dizzy since the shot. I can getup and walk and drive but if I move my head quickly I get dizzy and have to sit down. I used to get the Flu vaccine but that seemed to bring on the severe vertigo. I have never had this what I call mild vertigo but it is troubling and is quite scary. I am so afraid that it is going to trigger a more intense episode. I feel nauseous most of the time and can not stoop down to pick-up anything fear of falling over.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Heart rate increased, Injection site swelling, Myalgia, Nausea
Clinical narrative: Fever,feeling nauseous,chills,muscle sore,high heart rate and redness and swelling of the shot area.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever,feeling nauseous,chills,muscle sore,high heart rate and redness and swelling of the shot area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Fatigue, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Shoulder was very sore immediately after the shot and a bruise formed. Over the course of the evening, shoulder became even more sore and was painful to move. I took naproxen before bed. By the next morning, had significant body aches, arm very sore, headache, nausea but no vomiting. Felt like the flu. I took more naproxen, which helped. The following day still had some arm pain and some fatigue, but overall felt much better. By the 3rd day, still had minor shoulder pain but mostly back to normal. My husband had the shot at the same time and had very similar symptoms.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain, Pain in extremity
Clinical narrative: Shoulder was very sore immediately after the shot and a bruise formed. Over the course of the evening, shoulder became even more sore and was painful to move. I took naproxen before bed. By the next morning, had significant body aches, arm very sore, headache, nausea but no vomiting. Felt like the flu. I took more naproxen, which helped. The following day still had some arm pain and some fatigue, but overall felt much better. By the 3rd day, still had minor shoulder pain but mostly back to normal. My husband had the shot at the same time and had very similar symptoms.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Diarrhoea, Erythema, Headache, Lymphadenopathy
Clinical narrative: Started with swelling, redness and heat of entire deltoid on day of followed by lymphadenopathy on the left neck and supraclavicular and headache, temp of 100°, diarrhea 9-10 days following injection.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm, Swelling
Clinical narrative: Started with swelling, redness and heat of entire deltoid on day of followed by lymphadenopathy on the left neck and supraclavicular and headache, temp of 100°, diarrhea 9-10 days following injection.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Erythema, Pruritus, Skin warm, Vaccination site erythema, Vaccination site oedema
Clinical narrative: Erythema, warmth and itching began yesterday. Patient marked site with a pen. He reported that today the erythema had progressed. He had erythema, edema, and warmth from site of vaccination to his elbow.
Age: 35.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Vaccination site warmth
Clinical narrative: Erythema, warmth and itching began yesterday. Patient marked site with a pen. He reported that today the erythema had progressed. He had erythema, edema, and warmth from site of vaccination to his elbow.
Age: 77.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Confusional state, Culture negative, Fall, Limb discomfort
Clinical narrative: Patient reported a sore upper arm, with itchy warm rash. A fever of 103 degrees F, with confusion and falling. Stated these progressed over a couple days and went to E.R. where they admitted him to inpatient for two nights and treated him for cellulitis. A culture came back inconclusive but the patient's condition improved with care including antibiotics.
Age: 77.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash pruritic, Skin warm
Clinical narrative: Patient reported a sore upper arm, with itchy warm rash. A fever of 103 degrees F, with confusion and falling. Stated these progressed over a couple days and went to E.R. where they admitted him to inpatient for two nights and treated him for cellulitis. A culture came back inconclusive but the patient's condition improved with care including antibiotics.
Age: 1.83
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Per Public Health, no adverse effects. At the time of this report, I had not notified patient caregiver.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Suspected cellulitis on arm, extended from acromion process on right arm to elbow. Red, splotchy, hot to touch. When I saw pt. at pharmacy on Saturday, 3/30/19, I advised she go to urgent care.  Have yet to heard back from pt. regarding follow up.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Electrocardiogram, Generalised tonic-clonic seizure
Clinical narrative: Tonic Clonic Seizure.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bladder disorder, Chills, Cold sweat, Fatigue
Clinical narrative: I WAS SO SICK THAT NIGHT I ALMOST CALLED 911. I HAD CONSTANT SHIVERING UP AND DOWN MY WHOLE BODY, FATIGUE, NAUSEA (WHICH I HAD TO TAKE MEDICINE FOR), MUSCLE PAIN, SORE ARM, BLADDER PRESSURE (LIKE I HAD TO KEEP URINATING, EVEN THOUGH I DIDN'T), AND A MIGRANE SO BAD I THOUGHT I WAS HAVING A STROKE ( I COULDN'T TOLERATE ANY LIGHT). I DIDN'T HAVE A FEVER, BUT ABOUT 24 HOURS LATER I BROKE INTO A COLD SWEAT. I HAD THE SHOT THURSDAY AND COULD NOT GET OUT OF BED FRIDAY OR SATURDAY. SUNDAY I STARTED MOVING AROUND BUT WAS STILL WEAK.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Migraine, Myalgia, Nausea, Pain in extremity
Clinical narrative: I WAS SO SICK THAT NIGHT I ALMOST CALLED 911. I HAD CONSTANT SHIVERING UP AND DOWN MY WHOLE BODY, FATIGUE, NAUSEA (WHICH I HAD TO TAKE MEDICINE FOR), MUSCLE PAIN, SORE ARM, BLADDER PRESSURE (LIKE I HAD TO KEEP URINATING, EVEN THOUGH I DIDN'T), AND A MIGRANE SO BAD I THOUGHT I WAS HAVING A STROKE ( I COULDN'T TOLERATE ANY LIGHT). I DIDN'T HAVE A FEVER, BUT ABOUT 24 HOURS LATER I BROKE INTO A COLD SWEAT. I HAD THE SHOT THURSDAY AND COULD NOT GET OUT OF BED FRIDAY OR SATURDAY. SUNDAY I STARTED MOVING AROUND BUT WAS STILL WEAK.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia
Clinical narrative: I WAS SO SICK THAT NIGHT I ALMOST CALLED 911. I HAD CONSTANT SHIVERING UP AND DOWN MY WHOLE BODY, FATIGUE, NAUSEA (WHICH I HAD TO TAKE MEDICINE FOR), MUSCLE PAIN, SORE ARM, BLADDER PRESSURE (LIKE I HAD TO KEEP URINATING, EVEN THOUGH I DIDN'T), AND A MIGRANE SO BAD I THOUGHT I WAS HAVING A STROKE ( I COULDN'T TOLERATE ANY LIGHT). I DIDN'T HAVE A FEVER, BUT ABOUT 24 HOURS LATER I BROKE INTO A COLD SWEAT. I HAD THE SHOT THURSDAY AND COULD NOT GET OUT OF BED FRIDAY OR SATURDAY. SUNDAY I STARTED MOVING AROUND BUT WAS STILL WEAK.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Rash macular
Clinical narrative: Arm swollen up red and splotchy.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: After about 3 hours the injection site started to swell, get painful and feverish. By 10pm I had a difficult time raising my left arm. The pain kept me awake almost the whole night. At 7am I could not raise my arm any. My arm swelled to the point that I could not remove my wedding band. This went on until I saw my doctor 7 days later. He ascertained that it was not skeletal and gave me CELESTONE and TORADOL injections along with a prescription of Prednisone. My doctor referred me to a Physical Therapist which I am currently going to. My range of movement and level of pain has improved some but it still painful enough to wake me up at night and limit my motion. Also, it hurts when I use my left arm to drive.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Middle insomnia, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: After about 3 hours the injection site started to swell, get painful and feverish. By 10pm I had a difficult time raising my left arm. The pain kept me awake almost the whole night. At 7am I could not raise my arm any. My arm swelled to the point that I could not remove my wedding band. This went on until I saw my doctor 7 days later. He ascertained that it was not skeletal and gave me CELESTONE and TORADOL injections along with a prescription of Prednisone. My doctor referred me to a Physical Therapist which I am currently going to. My range of movement and level of pain has improved some but it still painful enough to wake me up at night and limit my motion. Also, it hurts when I use my left arm to drive.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Discomfort, Injection site pain, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: After about 3 hours the injection site started to swell, get painful and feverish. By 10pm I had a difficult time raising my left arm. The pain kept me awake almost the whole night. At 7am I could not raise my arm any. My arm swelled to the point that I could not remove my wedding band. This went on until I saw my doctor 7 days later. He ascertained that it was not skeletal and gave me CELESTONE and TORADOL injections along with a prescription of Prednisone. My doctor referred me to a Physical Therapist which I am currently going to. My range of movement and level of pain has improved some but it still painful enough to wake me up at night and limit my motion. Also, it hurts when I use my left arm to drive.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Hypoacusis, Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: Shingrix #1 effect: 10/20/18 at bedtime developed ringing in left ear for 2 min, followed by greatly diminished hearing in left ear. Left ear continues to have ringing and continued noticeable diminished hearing loss. Hearing test performed 3/25/2019 at audiology clinic. Result is extremely noticeable hearing deficit and now referred to ENT provider for follow up. Shingrix #2 effect: Acute onset severe pain to injection site three hours after vaccine administered. Pain involved left shoulder and forearm. No relief with TYLENOL or topical ice/heat to area. Unable to use left arm/hand at all for next 48 hours post injection. Missed one day of work due to extreme left arm pain. Continue to have limited range of motion to left shoulder and pain to left shoulder if sleeping on left side.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Shingrix #1 effect: 10/20/18 at bedtime developed ringing in left ear for 2 min, followed by greatly diminished hearing in left ear. Left ear continues to have ringing and continued noticeable diminished hearing loss. Hearing test performed 3/25/2019 at audiology clinic. Result is extremely noticeable hearing deficit and now referred to ENT provider for follow up. Shingrix #2 effect: Acute onset severe pain to injection site three hours after vaccine administered. Pain involved left shoulder and forearm. No relief with TYLENOL or topical ice/heat to area. Unable to use left arm/hand at all for next 48 hours post injection. Missed one day of work due to extreme left arm pain. Continue to have limited range of motion to left shoulder and pain to left shoulder if sleeping on left side.