chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Myalgia upper extremities / muscle pain in arm; Pain in joint involving shoulder region; This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced myalgia and joint pain. On an unknown date, the outcome of the myalgia and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the myalgia and joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix in left arm. The patient had muscle and joint pain in the both the shoulders and arms. Additional information was not provided.  The reporter consented to follow up. This case has been linked with case US2019215234, reported by same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Caller stated that vaccine leaked while injecting the patient with pre-filled 0.5mL syringe/No AE; Patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe; Initial information regarding an unsolicited valid non-serious case received from a consumer and transmitted to Sanofi on 25-Oct-2019.  This case involves an unknown age adult patient who experienced caller stated that vaccine leaked while injecting the patient with pre-filled 0.5ml syringe/no ae (syringe issue) and patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe (underdose), while received vaccine influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a single dose of suspect influenza quadrival a-b vaccine lot UJ212AB expiration date: 30-Jun-2020 via unknown route in the arm nos for prophylactic vaccination.  On an unknown date, it was reported that vaccine leaked while injecting the patient with pre-filled 0.5ml syringe/no ae (syringe issue) and patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe (underdose).  It was not reported if the patient received a corrective treatment.  Event outcome was not applicable for both events.
Age: 55.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Wrong product administered
Clinical narrative: patient was supposed to receive Fluzone Quadrivalent, but instead the nurse accidentally administered Tubersol, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 55 years old female patient who was supposed to receive vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] but instead the nurse accidentally administered TUBERCULIN TEST [TUBERSOL] (lot C5563AB, Exp. Date 14-Mar-2021) via intramuscular route in left deltoid, on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse reactions were 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.
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Quadracel in the left thigh instead of the intended vaccine which was Pentacel with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot: UTR, expiry date: unknown), via unknown route in the left thigh, on 11-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the wrong product administered. It was reported that the quadracel in the left thigh instead of the intended vaccine which was pentacel with no ae (wrong product administered).  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: 26 patients received Fluzone Quadrivalent vaccines of 1ml during a flu shot clinic with no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a Consumer (Office Staff).  This case involves 26 patients with unknown demographics, who were vaccinated with a 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (Batch number: UJ255AA, expiration date: 30-Jun-2020, dose, route and site of administration was not reported) on 11-Oct-2019.   Medical history and concomitant medications were not reported.  It was a case of overdose.  At the time of reporting, 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.
Sex: M
Vaccine: FLUX, UNK
Symptoms: Wrong product administered
Clinical narrative: received Tubersol injection by accident instead of the ordered influenza vaccine / no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA296272.  This case involves Adult male patient who received vaccine TUBERCULIN TEST [TUBERSOL] instead of INFLUENZA VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  It was reported that received Tubersol injection by accident instead of the ordered influenza vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: M
Vaccine: FLUX, UNK
Symptoms: Wrong product administered
Clinical narrative: received Tubersol injection by accident instead of the ordered influenza vaccine / no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA296269.  This case involves Adult male patient who received vaccine TUBERCULIN TEST [TUBERSOL] instead of INFLUENZA VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong product administered.  It was reported that received Tubersol injection by accident instead of the ordered influenza vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD administered to 4 year-old boy, no AE; Fluzone HD administered to 4 year-old boy, no AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a health-care professional (nurse) via phone.  This case is linked with 2019SA307288.   This case involves a 4-years male patient, who was vaccinated with a dose of INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE), (Batch number: UJ287AA and expiration date: 28-MAY-2020 at a dose of 0.5 ml via Intramuscular in Left Vastus Lateralis on 01-Nov-2019.  The patient medical history and concomitant medications were not reported.  It was the case of inappropriate age at vaccine administration and overdose.  At the time of reporting, 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: something with the needle or barrel was wrong so a good portion of the dose sprayed back at me with no AE; something with the needle or barrel was wrong so a good portion of the dose sprayed back at me with no AE; Initial information received on 21-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA293075 (for patient).  This case involved a female patient (administering pharmacist) for whom it was reported that something with the needle or barrel was wrong (Syringe issue), a good portion of the dose sprayed back at Pharmacist (Occupational exposure to product and needle issue) and were reported, while she was administering vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (FLUZONE HIGH DOSE) to the patient.  Medical history, treatment, past vaccinations and concomitant medication were not reported.  On 18-Oct-2019, the patient was administering a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Lot number- UJ285AB) via intramuscular route in the right arm .  It was a case of actual medication error due to Occupational exposure to product and needle issue.  It was reported that something with the needle or barrel was wrong so a good portion of the dose sprayed back at me and dribbled down the patient's arm. The patient is fine, but most of the dose was lost through the end of the plunger. The Pharmacist reported that a consumer did not receive their full dose of Fluzone High-Dose due to the vaccine sprayed from the end of the plunger.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye discharge, Eye pruritus, Feeling abnormal, Nasopharyngitis
Clinical narrative: scratchy throat; itchy eyes; drainage from eyes; chills; slight fever; felt like she had a severe head cold; had been hit by a truck; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 73 years old female patient who experienced throat (throat irritation), itchy eyes (eye pruritus), drainage from eyes (eye discharge), felt like she had a severe head cold (nasopharyngitis), chills (chills), slight fever (pyrexia) and feeling like she "had been hit by a truck " (unevaluable event), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination and family history were not provided.  On 12-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left deltoid.  On 12-Nov-2019, the patient developed a non-serious head cold (nasopharyngitis) and feeling like she "had been hit by a truck " (unevaluable event) 6 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date patient developed a non-serious scratchy throat (throat irritation), itchy eyes (eye pruritus), drainage from eyes (eye discharge), chills (chills), slight fever (pyrexia) 36 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  Other relevant tests were not reported.  Final diagnosis was slight fever, chills, throat irritation, eye pruritus, eye discharge, nasopharyngitis and unevaluable event.  The patient was treated with ibuprofen (ADVIL).  The event outcome was reported as recovered for all the events.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: scratchy throat; itchy eyes; drainage from eyes; chills; slight fever; felt like she had a severe head cold; had been hit by a truck; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 73 years old female patient who experienced throat (throat irritation), itchy eyes (eye pruritus), drainage from eyes (eye discharge), felt like she had a severe head cold (nasopharyngitis), chills (chills), slight fever (pyrexia) and feeling like she "had been hit by a truck " (unevaluable event), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination and family history were not provided.  On 12-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left deltoid.  On 12-Nov-2019, the patient developed a non-serious head cold (nasopharyngitis) and feeling like she "had been hit by a truck " (unevaluable event) 6 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date patient developed a non-serious scratchy throat (throat irritation), itchy eyes (eye pruritus), drainage from eyes (eye discharge), chills (chills), slight fever (pyrexia) 36 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE  Other relevant tests were not reported.  Final diagnosis was slight fever, chills, throat irritation, eye pruritus, eye discharge, nasopharyngitis and unevaluable event.  The patient was treated with ibuprofen (ADVIL).  The event outcome was reported as recovered for all the events.  Information on the batch number was requested.
Sex: M
Vaccine: FLU4, PNC
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 3 month old male received Fluzone Quadrivalent 0.5 mL on 27Nov2019 in error and the consumer was to get the Prevnar vaccine instead; a 3 month old male received Fluzone Quadrivalent 0.5 mL on 27Nov2019 in error and the consumer was to get the Prevnar vaccine instead; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.   This case involves a 3 months old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of PREVNAR and reported that a 3 month old male received Fluzone QUADRIVALENT 0.5 ml on 27nov2019 in error and the consumer was to get the Prevnar vaccine instead (wrong product administered) and (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Nov-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE (lot UT6656NA and expiry date: 30-Jun-2020) via intramuscular route in the left thigh.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product dose omission
Clinical narrative: child had missed Ipol dose between the age of 4-6, no adverse event; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a child patient (age and gender not reported) who missed a dose of vaccine IPV (VERO) [IPOL], which the child was supposed to get at age of 4 to 6 (month or year not specified).  This was a potential medication error case due to missed dose.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: I received my flu shot on Nov 14th and developed a bruise a little larger than a quarter at the injection site. I rolled up the sleeve on my dress to receive the shot in my left deltoid, but the sleeve was a bit tight and my failure to mention this to the nurse might have resulted in the bruise. The nurse did remark that I bled more than expected, which I suspect could have also been the result of the tight sleeve. I was not sure if this was of clinical significance but I thought it would be better to give more information than not at all.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Uncontrollable shivering for 2 hours, starting about 12 hours after injection.  Body, mainly hands and legs, where cold. Headache, muscle aches everywhere. Injection site very painful and developed a swelling which subsided after 24 hours, but still very tender and difficult to move.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Uncontrollable shivering for 2 hours, starting about 12 hours after injection.  Body, mainly hands and legs, where cold. Headache, muscle aches everywhere. Injection site very painful and developed a swelling which subsided after 24 hours, but still very tender and difficult to move.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site discomfort, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Note I sent to Dr. about a week after:  "From: Patient  Sent: 9/28/2019 4:04 PM  To: MD Subject: RE: Non-Urgent Medical Question  Received a flu shot little more than a week ago. Initially had sore shoulder in general and more acutely in my shoulder joint toward the front. It is painful to lift my arm last 90. It is painful to put on a coat ( swinging to the rear motion). Buckling seat belt motion is painful. I'm concerned something isn't right. The injection felt "bubbly" toward the end."  The shot didn't feel right. The Pharmacist did not pinch the muscle and the shot felt high in the arm. At the end of the injection before he removed the needle I felt a "burst, or bubbling" sensation in my shoulder joint immediately followed by the pain that I still have today. I've had several flu shots in the past and I'm familiar with the soreness that comes on after the shot and lingers for about a day. I had that pain as well, but it came and went like it usually does.  I always bleed after an injection and there was no blood this time.  Wife commented about how high the bandaid was on my shoulder. Do not remember seeing a bruise.  Today, December 6th, 2019, I am still experiencing pain. Pain lifting or lowering the weight of a milk jug or more past horizontal. Pushing down to lift my weight. Cross body motions like coats or robes. Sometimes feels like the arm is weaker, like I cannot lift my coat to swing it on.   The pain feels sharp, comes on quick and goes away quick. Though sometimes if I lift an object that causes the pain, it will be sustained.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Note I sent to Dr. about a week after:  "From: Patient  Sent: 9/28/2019 4:04 PM  To: MD Subject: RE: Non-Urgent Medical Question  Received a flu shot little more than a week ago. Initially had sore shoulder in general and more acutely in my shoulder joint toward the front. It is painful to lift my arm last 90. It is painful to put on a coat ( swinging to the rear motion). Buckling seat belt motion is painful. I'm concerned something isn't right. The injection felt "bubbly" toward the end."  The shot didn't feel right. The Pharmacist did not pinch the muscle and the shot felt high in the arm. At the end of the injection before he removed the needle I felt a "burst, or bubbling" sensation in my shoulder joint immediately followed by the pain that I still have today. I've had several flu shots in the past and I'm familiar with the soreness that comes on after the shot and lingers for about a day. I had that pain as well, but it came and went like it usually does.  I always bleed after an injection and there was no blood this time.  Wife commented about how high the bandaid was on my shoulder. Do not remember seeing a bruise.  Today, December 6th, 2019, I am still experiencing pain. Pain lifting or lowering the weight of a milk jug or more past horizontal. Pushing down to lift my weight. Cross body motions like coats or robes. Sometimes feels like the arm is weaker, like I cannot lift my coat to swing it on.   The pain feels sharp, comes on quick and goes away quick. Though sometimes if I lift an object that causes the pain, it will be sustained.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient reported having  hives over most parts of the body after 1 hour of receiving the vaccine.  It lasted for up to 3 days.  Patient took diphenhydramin OTC tablets and applied Benadryl cream to the reactions sites.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Patient came in to report an adverse reaction to the flu vaccine she received on 10/11/19.  She said she feels the vaccine was administered too high and it has caused bursitis.  She said there was pain immediately when the shot was put in her arm, but the vaccine was still given.  She said in 1 to 2hours her arm was stiff and painful in a strange way.  She said the pain stopped after a couple of days, but then it returned.  She said she can't sleep on her arm and she has limited range of motion.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient came in to report an adverse reaction to the flu vaccine she received on 10/11/19.  She said she feels the vaccine was administered too high and it has caused bursitis.  She said there was pain immediately when the shot was put in her arm, but the vaccine was still given.  She said in 1 to 2hours her arm was stiff and painful in a strange way.  She said the pain stopped after a couple of days, but then it returned.  She said she can't sleep on her arm and she has limited range of motion.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Balance disorder, Blood test, Eating disorder
Clinical narrative: She started to have stomach pain when eating on 08/05. She got to the point where eating any food made her stomach worse so her weight declined very fast.  To date, he has lost 18+ lbs.  She is very weak.  on 08/28 the school called the ambulance because her jaw was clenched shut, and her hands wouldn't work, she had numbness and tingling in her feet, and legs.  She was very unstable and weak and we had to carry her in.  She is still in abdominal pain and weak.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Gastric emptying study, Hypoaesthesia, Magnetic resonance imaging abdominal, Musculoskeletal disorder, Paraesthesia
Clinical narrative: She started to have stomach pain when eating on 08/05. She got to the point where eating any food made her stomach worse so her weight declined very fast.  To date, he has lost 18+ lbs.  She is very weak.  on 08/28 the school called the ambulance because her jaw was clenched shut, and her hands wouldn't work, she had numbness and tingling in her feet, and legs.  She was very unstable and weak and we had to carry her in.  She is still in abdominal pain and weak.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Trismus, Ultrasound abdomen, Weight decreased
Clinical narrative: She started to have stomach pain when eating on 08/05. She got to the point where eating any food made her stomach worse so her weight declined very fast.  To date, he has lost 18+ lbs.  She is very weak.  on 08/28 the school called the ambulance because her jaw was clenched shut, and her hands wouldn't work, she had numbness and tingling in her feet, and legs.  She was very unstable and weak and we had to carry her in.  She is still in abdominal pain and weak.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA beginning < 24 hours after vaccination and lasting > 6 weeks
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient developed urticaria on the night of 12/5/19 (48 hrs after receiving first dose of HPV)and was seen by ED where she was evaluated and treated with Benadryl. No signs of anaphylaxis. Spoke with mother on 12/6/19 and patient still had hives and was continuing with Benadryl 50 mg every 4-6 hrs.  Patient will follow up next week for allergy testing to rule out other possible cause for hives.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Patient c/o high fever and chills.  Inflammation/redness at site of injection from top of arm to elbow.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Upper left arm swelling; upper arm Erythema; skin warm; This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and skin warm. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the swelling arm, erythema of extremities and skin warm were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided, but it could be 59 to 60 years. The patient experienced upper left arm swelling, with redness and warmth that improved after steroid administration.   No further details available. The reporter was unable to provide business address or phone number for reporter.   The reporter prefers email contact.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: feel pain at the left deltoid, which was the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date 17th December 2021) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 5 days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The health care professional reported that the patient received Shingrix and 5 days later started to feel pain at the left deltoid, which was the injection site, the pain continues at the time of reporting and was increasing The reporter did not consent to follow up.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling, Rash papular
Clinical narrative: After the patient received the influenza vaccine the site has swelling followed by a papular rash
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: PAIN IN SHOULDER, DECREASED MOVEMENT
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Influenza like illness, Pyrexia, Syncope
Clinical narrative: Patient reports having flu-like symptoms of fever and chills resolving 12/4, patient woke on 12/5 feeling weak and then experienced syncopal event with little warning. Patient reports feeling a little weak but otherwise is recovered,
Age: 11.0
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Local reaction at injection site of 2" started 24 hours after injection. Face became bright red with whelps on both cheeks 2h hours after shot. Face is pruritic.
Age: 16.0
Sex: M
Vaccine: HEP, TD, UNK
Symptoms: Body temperature increased, Chills
Clinical narrative: 12/5/19 client received Td - LA + Hep B - RA. 12/6/19 mother notified PHN that son had C/O chills during night; temp not taken at that time. Temp taken in 12/6/19 morning 101-102. Started giving Tylenol & alternating with Ibuphren. Denies C/O of pain, redness, swelling @ other injection sites. Instructed to contact private MD for confirmation of Adverse reaction. Go to E.R if Temps High. 12/6/19 PHN recommended that mother contact private provider & report vaccine adverse reaction for confirmation of reaction. PHN stated would need something in written that private provider believes safe to continue with vaccines for future. Client just started to received vaccines this year - had and Religious exemption before.
Age: 16.0
Sex: M
Vaccine: HEP, TD, UNK
Symptoms: Chills, Pyrexia
Clinical narrative: 12/5/19 client received Td - LA + Hep B - RA. 12/6/19 mother notified PHN that son had C/O chills during night; temp not taken at that time. Temp taken in 12/6/19 morning 101-102. Started giving Tylenol & alternating with Ibuphren. Denies C/O of pain, redness, swelling @ other injection sites. Instructed to contact private MD for confirmation of Adverse reaction. Go to E.R if Temps High. 12/6/19 PHN recommended that mother contact private provider & report vaccine adverse reaction for confirmation of reaction. PHN stated would need something in written that private provider believes safe to continue with vaccines for future. Client just started to received vaccines this year - had and Religious exemption before.
Age: 16.0
Sex: M
Vaccine: HEP, TD, UNK
Symptoms: Body temperature increased, Chills
Clinical narrative: High fever and chills on and off from 12/6/19 around 2am to present, 12/6/19, 2:49. No other symptoms, Treating with tylenol and ibuprofen  Unknown was chosen for type of vaccine because the form given to us from the health dept. only stated HEPB-PED and Td, no other identifying info was given.
Age: 16.0
Sex: M
Vaccine: HEP, TD, UNK
Symptoms: Chills, Pyrexia
Clinical narrative: High fever and chills on and off from 12/6/19 around 2am to present, 12/6/19, 2:49. No other symptoms, Treating with tylenol and ibuprofen  Unknown was chosen for type of vaccine because the form given to us from the health dept. only stated HEPB-PED and Td, no other identifying info was given.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: ARM PAIN @ POINT OF INSERTION, MOSTLY SORE IN THE MORNING. BUT DOES COME AND GO DURING THE DAY. DOES NOT AFFECT MY ABUILITY TO DO THINGS, BUT IS PAINFUL @ TIMES. STILL HURT OVER 2 MONTH LATER
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Accidently administered 1 dose of the shingrix adjuvant by itself. Realized the mistake and readministered the adjuvant  suspension with the  antigen component. The dose was administered on 11/29/2019. Called patient on 12/3/2019 to check up on him, he said he is not experiencing any adverse side effects, he is feeling fine.
Age: 84.0
Sex: M
Vaccine: FLUR4
Symptoms: Muscular weakness, Paralysis, Respiratory failure
Clinical narrative: Muscle weakness which led to paralysis and now respiratory failure
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Influenza like illness, Malaise, Myalgia, Nausea
Clinical narrative: Became significantly ill with influenza-like symptoms the day following #1 vaccination.    So ill that had I been required to work,  I would have been unable to do so.    But the real problem that causes me to report this vaccine is that following the #2 shot in the series,  I have had unexplained "generalized muscle pain"  and a significant increase in "ringing in the ears"   ( note:  I do have mild tinnitus of long standing).    I also feel at times as if I could become nauseated.    And this has been occurring DAYS since the #2 vaccination that was performed at another pharmacy on 11/21/2019.   Lot code for the #2 dose was the same:   58160-0823-11
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Became significantly ill with influenza-like symptoms the day following #1 vaccination.    So ill that had I been required to work,  I would have been unable to do so.    But the real problem that causes me to report this vaccine is that following the #2 shot in the series,  I have had unexplained "generalized muscle pain"  and a significant increase in "ringing in the ears"   ( note:  I do have mild tinnitus of long standing).    I also feel at times as if I could become nauseated.    And this has been occurring DAYS since the #2 vaccination that was performed at another pharmacy on 11/21/2019.   Lot code for the #2 dose was the same:   58160-0823-11
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypoaesthesia, Pain in extremity
Clinical narrative: Pain and numbness in left arm, profuse sweating, hospitalized for 2 days
Age: 53.0
Sex: F
Vaccine: FLUC4, PNC13, TDAP, VARZOS
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Patient presented to the Pharmacist on 11/25/19 with a swollen right hand in pain. She returned on 12/3/19 complaining of loss of arm strength in her right arm.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Lymph node pain, Oropharyngeal pain
Clinical narrative: Sore throat, headache, fatigue, gland ache
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Dyspnoea, Injection site swelling, Nausea
Clinical narrative: chills; nausea; aches; shortness of breath; weakness; swelling at the injection site; This spontaneous report was received from a nurse referring to herself, a 80 years old female patient. Concomitant therapies included pravastatin, digoxin, ibuprofen and furosemide (LASIX). The patient was allergic to hydromorphone hydrochloride (DILAUDID), cefaclor (CECLOR) and codeine. There was no pertinent medical history.  On 06-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (left arm; lot number: S018405; expiration date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021; strength and dose were not provided), intramuscularly for vaccination. On the same date, after the administration of the vaccine, the patient experienced chills, nausea, aches, shortness of breath, weakness and swelling at the injection site on the left arm. The patient received ibuprofen 200mg to treat the events. There was no lab diagnostics or studies performed. The patient spoke to the physician to seek medical attention. At the time of the report, the outcome of the events was recovering. The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: chills; nausea; aches; shortness of breath; weakness; swelling at the injection site; This spontaneous report was received from a nurse referring to herself, a 80 years old female patient. Concomitant therapies included pravastatin, digoxin, ibuprofen and furosemide (LASIX). The patient was allergic to hydromorphone hydrochloride (DILAUDID), cefaclor (CECLOR) and codeine. There was no pertinent medical history.  On 06-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (left arm; lot number: S018405; expiration date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021; strength and dose were not provided), intramuscularly for vaccination. On the same date, after the administration of the vaccine, the patient experienced chills, nausea, aches, shortness of breath, weakness and swelling at the injection site on the left arm. The patient received ibuprofen 200mg to treat the events. There was no lab diagnostics or studies performed. The patient spoke to the physician to seek medical attention. At the time of the report, the outcome of the events was recovering. The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 03-NOV-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, pt suffered shingles lesions on the right side of face, arm, neck and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of defendants' conduct, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the shingles was reported as not recovered. The causality assessment was related.  The event of shingles lesions on the right side of face, arm, neck, diagnosed as herpes zoster was considered to be disabling.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects were reported; patient received and expired dose of PEDVAX HIB; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 03-DEC-2019, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 0.5 milliliter, once, lot # R034340 and expiration date 23-NOV-2019 was an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (route and anatomical location were not provided) for prophylaxis. No additional adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: the patient was administered a properly stored but expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-DEC-2019, the patient was vaccinated with the first dose of a properly stored but expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N001533 and expiration date 16-OCT-2019 (dose, frequency, route and anatomical location were not provided) for prophylaxis.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: arm pain / Right arm so sore; I could not raise arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm a day before reporting. Everybody had told the patient how painful the shot was, but patient not feeling any discomfort. The patient's right arm was so sore and could not raise it for two days. The patient did not want to be that big bad wolf. The follow up was not required.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: fever night of vaccines.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Chest pain, Headache, Oropharyngeal pain, Pain, Photophobia
Clinical narrative: Woke up @ 2AM (12/3/19) with body aches, frontal headache, photophobia, some chest pain, throat pain. Initially tachycardic with WBC 16.6 -ceftriaxone 1 gm given with Imitrex. All other tests were normal. Symptoms more likely related to elevated immune response secondary multiple IZs.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Spinal X-ray normal, Tachycardia, White blood cell count increased
Clinical narrative: Woke up @ 2AM (12/3/19) with body aches, frontal headache, photophobia, some chest pain, throat pain. Initially tachycardic with WBC 16.6 -ceftriaxone 1 gm given with Imitrex. All other tests were normal. Symptoms more likely related to elevated immune response secondary multiple IZs.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Approximately two weeks after vaccination, he developed a red, bumpy rash at the injection site. The rash persisted for approximately 2 weeks after initial appearance. It did not appear to bother him, no itching or other discomfort.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Syncope
Clinical narrative: approx. 5 minutes after receiving vaccination, patient was leaving the store (walking with brother, sister, and father) and he fainted.  When he fainted, he hit the floor.  911 was called.  The fire crew showed up first and evaluated the patient and then the Ambulance showed up to transport patient to the E.R. to further evaluate the patient.  Patient's mom called the next day to say all was okay and the patient's dad called 2 days after to confirm that all was okay.
Age: 29.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dysaesthesia, Full blood count abnormal, Gram stain negative
Clinical narrative: Patient reported to medical on 04Nov19 with complaint of dysesthesia, numbness, and tingling of extremities. Patient evaluated and instructed to RTC if Sx worsen or do not improve. Patient RTC 07Nov19 with complaint of worsening Sx, sent to Neuro for urgent consult. Seen by Neuro 11Nov19 and referred to hospital for possible Dx of GBS. Patient treated with IVIG and extensive physical therapy while hospitalized. Transferred to Rehab Facility to finish physical therapy.