chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of patient. The age at vaccination was not reported. The patient got shingles 4 days after the SHINGRIX was administered. The reporter asked could SHINGRIX cause shingles.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pruritus and incomplete course of vaccination. On an unknown date, the outcome of the pruritus and incomplete course of vaccination were unknown. It was unknown if the reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced arm itching and back itching after receiving a dose of SHINGRIX. On 19th March 2019 the patient was going to the her physician and she told that she will mention this to her physician. In March 2018, the patient got the first shot of SHINGRIX and forgot to go back for the next shot, which led to incomplete course of vaccination.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Rash, Sensation of foreign body
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old male patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 7th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash, lump feeling in throat and swallowing difficult. On an unknown date, the outcome of the rash, lump feeling in throat and swallowing difficult were recovered/resolved. It was unknown if the reporter considered the rash, lump feeling in throat and swallowing difficult to be related to SHINGRIX. Additional details were provided as follows: The patient had no reported allergies. The patient received SHINGRIX vaccine in the left deltoid. The patient experienced a neck rash, lump feeling in throat and difficulty swallowing after receiving SHINGRIX and did not seek medical treatment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of welts in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 15th March 2019, the patient received SHINGRIX. On 16th March 2019, 1 days after receiving SHINGRIX, the patient experienced welts and skin red. On an unknown date, the outcome of the welts and skin red were not recovered/not resolved. It was unknown if the reporter considered the welts and skin red to be related to SHINGRIX. Additional information were reported as follows: This case is reported by the nurse for herself. The patient developed a big red hard welp. At the time of reporting, the event was ongoing. Lot number and expiry date was unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 68-year-old female patient who received SHINGRIX (batch number 9349T, expiry date 7th September 2021) for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient developed a rash after receiving SHINGRIX. The healthcare professional noted that the patient has been seeing a dermatologist for the rash.
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Based on information received on 18-Mar-2019, the report previously considered as non-valid became valid as patient involved was specified. Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves unknown age male patient who was vaccinated with injection of IPOL (batch number, expiry date, route and site of administration were not reported for both vaccines) on unknown date. The patient's past medical history, medical treatments and family history were not provided. It was an actual medication error case due to product storage error. In this case a temp excursion occurred with vaccines unopened ADACEL, MENACTRA, ACT-HIB, TENIVAC, DAPTACEL and with unopened and opened IPOL. It was reported that patient received IPOL that was in a temp excursion. The patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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. Follow up information was received on 18-Mar-2019 from other healthcare professional. Case becomes valid, patient information updated. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2019SA077334 (same reporter). This case involves a 11 years old male patient received a first 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6217AA and Exp. Date 21-Mar-2021) via unknown route in the right deltoid on 18-Mar-2019 at around 4:00 pm, that may have been frozen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE for Immunisation. It was an actual medication error case due to Incorrect product storage. No adverse reactions 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.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2019SA077321 (same reporter). This case involves a 11 years old male patient received a first 0.5 ml dose of ADACEL (lot U6217AA and Exp. Date 21-Mar-2021) via unknown route in the left deltoid on 18-Mar-2019 at around 3:00 pm, that may have been frozen. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE for Immunisation. It was an actual medication error case due to incorrect product storage. No adverse reactions 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: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 20-Mar-2019 and additional information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a six years old patient (gender unknown) who received a 0.25ml dose of FLUZONE QUADRIVALENT lot number and expiration date not reported via unknown route in unknown administration site on 04-Feb-2019. 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 vaccine underdose. A 6 year old patient received a 0.25 mL dose of FLUZONE QUADRIVALENT instead of 0.50ml. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: 34.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Vaccination site inflammation
Clinical narrative: Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 34 years old female patient who experienced redness, swelling and severe pain at the injection site and a little bit of dizziness, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Mar-2019, the patient received a first 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6207AA and Exp. Date 25-May-2020) via unknown route in the right deltoid. On 17-Mar-2019, the patient developed a non-serious redness, swelling and severe pain at the injection site and a little bit of dizziness three days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 18-Mar-2019, the patient was admitted to the emergency room because the pain was so bad. Other relevant tests not reported. Final diagnosis was dizziness and vaccination site inflammation. The patient was treated with CLINDAMYCIN (x 3 days) and IBUPROFEN. The patient outcome was not reported for dizziness and vaccination site inflammation. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old female patient who received 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number not reported and expiry date 16-Mar-2019) via unknown route in the upper arm side unknown on 18-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Mar-2019, the patient received a Dose  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the arm NOS. It was a case of actual medication error due to expired vaccine used, inappropriate age at vaccine administration and overdose. 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 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: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 57 years old female patient who received 0.5 mL booster dose of vaccine ADACEL lot U5563AA, expiry date-28/02/2019 via unknown route in the left deltoid on 11-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines were given. It was a case of actual medication error due to Expired vaccine used. No side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via phone. This case is linked to cases 2019SA082205, 2019SA082208, 2019SA082210 and 2019SA082211 (same reporter). This case involves a 6 months old female patient who experienced redness and swelling on left thigh from vaccine injections, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL PREVENAR 13 and ROTATEQ on an unknown date. On 13-Mar-2019, the patient received a 0.5 ml dose of suspect PENTACEL (lot number: UJ095AA, expiry date, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious redness and swelling on left thigh from vaccine injections (vaccination site inflammation) following the administration of PENTACEL. No lab data was reported. Final diagnosis was redness and swelling on left thigh from vaccine injections. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for redness and swelling on left thigh from vaccine injections. Documents held by the sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician by phone. This case is linked to cases 2019SA082205, 2019SA082208, 2019SA082209 and 2019SA082211 (same reporter). This case involves a 2 months old female patient who experienced red swollen thigh, painful to touch, site reaction, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 and ROTATEQ on an unknown date. On 15-Mar-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AA. On an unknown date, the patient developed a non-serious red swollen thigh, painful to touch, site reaction following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. No lab data was reported. Final diagnosis was red swollen thigh, painful to touch, site reaction. 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: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a five years old male patient who received a 0.5ml dose of DAPTACEL lot C5169AA, Expiration Date: 16-Mar-2019 via unknown route in the left thigh on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines concomitantly. It was an actual medication error due to expired vaccine used. A patient received a DAPTACEL vaccine that was expired on 16-Mar-2019. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 39 years old female patient who received a 0.5ml dose of MENACTRA lot U6220AA, expiration date: 30-Apr-2019 via unknown route in unknown administration site on 22-Mar-2019 and HEPATITIS A VACCINE, HEPATITIS B VACCINE lot number and expiration date not reported 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. Concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. A patient was inadvertently received MENACTRA instead of Hepatitis A and B vaccines. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute kidney injury, Condition aggravated, Haemolysis, Paroxysmal nocturnal haemoglobinuria, Transaminases increased
Clinical narrative: Flare of chronic PNH with complications including hemolysis, AKI and transaminitis.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Purulent discharge, Rash erythematous, Rash pustular
Clinical narrative: Patient came into our pharmacy on Wednesday, March 20, 2019 to show the pharmacist (me)  several spots only on  her right arm; eventhough she received the vaccine in her left arm. One of the spots and the worst of them were a cluster of 3 puss filled pustles and a few other red spots on her right arm. I advised her to check with her primary care physician (PCP) to get a diagnosis. She returned to the pharmacy a little later with a diagnosis of shingles and  a prescription for Valacyclovir 1 Gm. Tabs. #30  Sig: Take 1 tablet by mouth 3 times daily. Dr also advised her NOT to get the 2nd dose of SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site erythema
Clinical narrative: Approximately 48 hours after injection, patient developed redness at the injections site spanning 2 inches in diameter. She also developed aching in several joints and what she described as "flu like" symptoms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Later that night arm was sore and soreness did not go away. Patient did not take any medication or called the doctor. In late October, soreness continued and mentioned to doctor during an scheduled visit; no treatment recommended. Overtime, soreness has worsen to the point that patient can't lift arm over head without holding it with other hand. Soreness is centered at injection site and can't sleep on the right side at all. Patient has not been to the doctor or done anything at home to take care of it.  Patient reports she has received Flu shots in the past with no problem and nothing else has been done to the arm except for the vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site swelling
Clinical narrative: Deltoid was cleaned and palpated, injection given with 1 inch needle. After withdrawl of needle from muscle, a small bleed occurred and ran down arm. This was cleaned then it was noticed that there was bruising and swelling underneath the injection site. The bleeding had stopped but a quarter-size bruise was under the skin. Patient was urged to ice the site and go to the doctor if it got any worse.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Immediate pain at site of injection as well as throughout shoulder. Pain still present about 6 weeks after vaccine was given, description of pain and exam consistent with rotator cuff tendinitis.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure inadequately controlled, Blood pressure increased
Clinical narrative: Potentially increased blood pressure and was hard to get under control.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain
Clinical narrative: Extensive LUE cellulitis, pain.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Administration site infection, Administration site swelling, Injection site erythema
Clinical narrative: Went to ER. Red and swollen at site of administration. Dr. at ER said infected. Primary care physician said received in Sept 2018.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer via Pfizer and refers to a patient of unknown age with a history of lymphoma. On an unknown date in 2003, the patient was vaccinated with a dose of PNEUMOVAX 23 injection. On an unknown date, the patient experienced an unspecified adverse event, reported as "a bad reaction" after the second dose. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported.
Sex: M
Vaccine: MMRV
Symptoms: Chemotherapy, Neoplasm malignant
Clinical narrative: Information has been received from a nurse, referring to a male patient of unknown age. Information about medical history, concurrent condition and concomitant therapy was unknown. On an unknown date, the patient was vaccinated with childhood dose of PROQUAD (dose, strength, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced an unspecified cancer. The patient had sought medical attention and received unspecified chemotherapy for his cancer. On an unknown date, at the age of 16 year old, the patient received another dose of PROQUAD. The outcome of the cancer was unknown. The causality assessment was not provided by the reporter. Upon internal review, the cancer determined to be medically significant.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Pain in extremity, Rash macular
Clinical narrative: Two days following SHINGRIX vaccine, first dose, developed severe Shingles outbreak. Person had chicken pox as child, shingles in late teen, and ZOSTAVAX on 07/15/2013. Red splotch on hip, pain from hip down whole left side, even to foot.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received SHINGRIX (batch number G2ZF2, expiry date 22nd March 2021) for prophylaxis. Co-suspect products included PREVNAR 13 for prophylaxis. The patient's past medical history included shingles. On 1st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and PREVNAR 13. On 2nd October 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated that the patient received SHINGRIX on left deltoid. On the same day, the patient also received the PREVENAR 13 in her right arm. The next day, the patient broke out with Shingles blisters on her nose and on her hand. At the time of reporting, the patient had now recovered. No further details were provided at time of reporting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (experienced severe case of Shingles in the throat in August 2018 that had cleared). On 9th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The batch number or expiry date for SHINGRIX was not provided. The patient experienced throat shingles in late February or in Early March, but not as severe as first one.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Encephalitis, Laboratory test abnormal, Meningitis viral, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of encephalitis in a 69-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. On 18th March 2019, 7 days after receiving SHINGRIX, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), viral meningitis (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization) and aphasia (serious criteria hospitalization). The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the encephalitis, viral meningitis, fever and aphasia were unknown. It was unknown if the reporter considered the encephalitis, viral meningitis, fever and aphasia to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX vaccine one week prior to being hospitalized. The patient presented with fever and aphasia and was hospitalized. After doing some test work, results suggested that the patient had encephalitis and or viral meningitis. No further details were provided. Lab Comments: In March 2019, after doing some test work, results suggested encephalitis and/or viral meningitis.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pruritus
Clinical narrative: Received SHINGRIX IM in LD. The resulting severe muscle soreness (with mild to moderate itching) lasted 4 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Peripheral swelling
Clinical narrative: Pain for 2 days. Oblong area around shot site 3" wide and 5-6 inches long, red raised and tender to touch with arm swelling. Hx 3-28-19 no raised red welt. Swelling decreased.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Cough, Decreased appetite, Headache
Clinical narrative: Began with dry cough. Progressed next morning to weakness, nausea, wretching, loss of appetite, myalgias, headache, chills, diaphoresis X 1. Lost 4 pounds in 4 days. Cancelled all activities for 4 days. This is day #6;  feeling almost normal except some lingering weakness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Loss of personal independence in daily activities, Myalgia, Nausea, Retching
Clinical narrative: Began with dry cough. Progressed next morning to weakness, nausea, wretching, loss of appetite, myalgias, headache, chills, diaphoresis X 1. Lost 4 pounds in 4 days. Cancelled all activities for 4 days. This is day #6;  feeling almost normal except some lingering weakness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: Began with dry cough. Progressed next morning to weakness, nausea, wretching, loss of appetite, myalgias, headache, chills, diaphoresis X 1. Lost 4 pounds in 4 days. Cancelled all activities for 4 days. This is day #6;  feeling almost normal except some lingering weakness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: PT REPORT HAVING SHINGLES LESIONS ON LEFT SIDE OF HER BODY AS WELL AS A SORE ARM. PT CALLED HER PROVIDER HOWEVER ELECTED TO NOT SEEK ANY TREATMENT AT THIS TIME. SHE IS GOING TO WAIT AND SEE IF THE LESIONS SELF-RESOLVE.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pt is experiencing pain at site of SHINGRIX. Pt states pain is from neck down to finger tips. She states she is having some difficulty lifting her arm. No systemic sx- no rash or redness at site of injection.No oral or airway issues- breathing comfortably.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count, Hypoaesthesia, Joint range of motion decreased, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Pt is experiencing pain at site of SHINGRIX. Pt states pain is from neck down to finger tips. She states she is having some difficulty lifting her arm. No systemic sx- no rash or redness at site of injection.No oral or airway issues- breathing comfortably.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt is experiencing pain at site of SHINGRIX. Pt states pain is from neck down to finger tips. She states she is having some difficulty lifting her arm. No systemic sx- no rash or redness at site of injection.No oral or airway issues- breathing comfortably.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Fever, chills, severe redness and swelling to elbow. Joint pain and limitation in movement fatigue and headache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Mobility decreased, Pyrexia
Clinical narrative: Fever, chills, severe redness and swelling to elbow. Joint pain and limitation in movement fatigue and headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Severe headache - Excedrin Migraine - no relief - 11 hours; Nausea - no treatment - 9 hours; Exhaustion - rest and sleep - 14 hours; Soreness at injection site - 40+ still ongoing.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Patients mother came in 3/28/2019 to explain reaction experienced 2/21/2019- hives on both arms, abdomen and legs. Hives lasted approx. 3-4 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Pain, Pyrexia
Clinical narrative: Severe backache, mild headache, mild body aches, mild fever - took 4 ibuprofen first day, oxycodone 2nd day - symptoms mostly gone in 36 hrs.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Experienced stomach pain, nausea, and vomiting after taking first dose.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Inflammation, Muscle spasms, Pain, Pain in extremity
Clinical narrative: RADIATING PAIN STARTING FROM LEFT LOWER BACK TRAVELLING DOWN TO LEFT LEG. PATIENT WENT TO SEE DOCTOR ON 3/28/19 AND WAS PRESCRIBED CYLCOBENZAPRINE FOR MUSCLE SPASM, HYDROCODONE W/APAP FOR PAIN, AND METHYLPREDNISOLONE DOSE PAK FOR INFLAMMATON.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Fibromyalgia, Headache, Pain, Pyrexia
Clinical narrative: Woke up with severe shakes, fever grew to 103, up every hour, freezing, headache, and Fibromialgia hurting everywhere.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Woke up with severe shakes, fever grew to 103, up every hour, freezing, headache, and Fibromialgia hurting everywhere.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Left arm turned red, swollen, red, hot and itchy; the area extended to elbow.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Client stated she was having sever pain on her right arm, that she could not move arm and arm was swollen. Pain was going up to her neck.
Age: 12.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received PEDVAXHIB instead of MENACTRA; no symptoms of a reaction seen at time of administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Vaccine was given and within 1-2 minutes of receiving it patient reported itching on her legs. Leg was rechecked and redness and a small hive was noted so Provider was asked to come see the reaction and advise further. Ice pack was placed on the reaction site and reaction was monitored for 15 minutes to confirm there was no worsening or anaphylactic reaction. After this time patient reported the itching had stopped and she was stable to return home. Mom instructed on what to watch for and asked to return for any worsening symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus
Clinical narrative: Vaccine was given and within 1-2 minutes of receiving it patient reported itching on her legs. Leg was rechecked and redness and a small hive was noted so Provider was asked to come see the reaction and advise further. Ice pack was placed on the reaction site and reaction was monitored for 15 minutes to confirm there was no worsening or anaphylactic reaction. After this time patient reported the itching had stopped and she was stable to return home. Mom instructed on what to watch for and asked to return for any worsening symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 28-SEP-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than one week after receiving the ZOSTAVAX, the patient suffered from herpes zoster and post herpetic neuralgia. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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 ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the herpes zoster and post herpetic neuralgia was considered to be not recovered. Herpes zoster and post herpetic neuralgia was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Neuropathy peripheral
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. In or around 01-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX vaccine (date not reported), the patient suffered Peripheral neuropathy and Chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient experienced 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. Treatment and outcome of events was unknown. Upon internal review, Peripheral neuropathy and Chronic inflammatory demyelinating polyneuritis were determined to be medically significant events. Peripheral neuropathy and Chronic inflammatory demyelinating polyneuritis were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of indication not provided). The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date [reported as shortly after receiving the ZOSTAVAX], the patient developed a painful rash accompanied by persistent pain. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. At a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the events was considered to be not recovered. ZOSTAVAX did not prevent shingles and persistent strain of herpes zoster were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 15 year old patient. On an unknown date the patient was vaccinated with VAQTA, 1 milliliter for prophylaxis. On an unknown date the patient experienced incorrect dose administered and no adverse event. The outcome of incorrect dose administered and no adverse event is unknown. The reporter considered incorrect dose administered and no adverse event to be not assessed to VAQTA.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an 18 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 27-MAR-2019, the patient was vaccinated with an expired dose of VAQTA, intramuscular, R010369, expiration date 25-MAR-2019 for prophylaxis (dose was not reported) (expired product administered). No adverse effects were reported. The outcome of the event expired product administered was not reported.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Caesarean section, Expired product administered, Exposure during pregnancy, Placenta praevia, Ultrasound antenatal screen abnormal
Clinical narrative: This 36-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX on 24th September 2018, for prophylaxis. The subject's estimated date of delivery was 28th February 2019. The subject received BOOSTRIX at week 20 of the pregnancy and during the second trimester of pregnancy. On an unknown date, unknown after receiving BOOSTRIX, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The patient received BOOSTRIX (batch number: 33T42, expiry date 1st February 2021). The patient might had given another dose at 28 weeks but the reporter had only information for dose given at 20 weeks. There was some uncertainty about the patient actually receiving another dose at 28 weeks. The reporter consented to follow-up. Follow up information was received from health care professional on 18th March 2019: The reporter's contact details were updated. The patient's demographic details were updated. The patient's past medical history included normal birth (5) and spontaneous abortion (1 spontaneous abortion). Concurrent medical conditions included hypothyroidism, anxiety and LE varicosities. The patient's last menstrual period was on 24th September 2018 and estimated date of delivery was 28th February 2019. The patient received concomitant products such as salbutamol sulphate (Ventolin Hfa), minerals nos + vitamins nos (Prenatal Vitamins). The patient also received expired Xanax and Prozac at 25 weeks gestation. The patient received another dose of BOOSTRIX on 7th December 2018 at 28 weeks gestation. After 137 days, the patient gave birth to a neonate via cesarean delivery. On 18th October 2018, 24 days after 1st dose, the patient experienced placenta previa. On 7th December 2018, less than a day after 2nd dose, the patient experienced placenta previa. On 1st February 2019, 56 days after 2nd dose, the patient experienced placenta previa. Ultrasound performed on 24th September was normal and it confirmed estimated date of delivery. Ultrasound performed on 18th October 2018, 7th December 2018 and 1st February 2019 was abnormal and confirmed placenta previa. It was unknown if the reporter considered the placenta previa to be related to BOOSTRIX.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry skin, Erythema, Pain, Pruritus
Clinical narrative: All over body rash and hives. Body aches and shivering, low grade fever initially. All over body hives were solid red and I experienced five pounds watch weight gain. All resolved except for itchy post hive dry skin in four days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash generalised, Urticaria, Weight increased
Clinical narrative: All over body rash and hives. Body aches and shivering, low grade fever initially. All over body hives were solid red and I experienced five pounds watch weight gain. All resolved except for itchy post hive dry skin in four days.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Hypersensitivity, Rubber sensitivity, Swelling
Clinical narrative: PATIENT HAD ALLERGIC REACTION TO LATEX. RIGHT NOW PATIENT HAS BIG BUMP AND TAKING BENADRYL BUT IF IT GET WORSE THEN WILL SEE DOCTOR.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site induration, Injection site pain, Limb discomfort
Clinical narrative: Pain, tenderness, induration to injection site on left upper extremity. Left upper extremity also with intermittent numbness/tingling as well as slightly decreased range of motion due to discomfort.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: Pain, tenderness, induration to injection site on left upper extremity. Left upper extremity also with intermittent numbness/tingling as well as slightly decreased range of motion due to discomfort.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, mild swelling in upper arm, redness from shoulder to elbow, and flu like symptoms. Treated with Tylenol and cold compress.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pruritus, Injection site rash, Rash macular, Rash pruritic
Clinical narrative: Chills and itchy rash at injection site the day after administration (resolved within 24 hours). Reports that after vaccination, started getting itchy splotches across entire upper body that disappear with application of Cetaphil then reappear as 2-3 blotches at a time. Also started experiencing bad pain in opposite (left) shoulder since vaccination.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms leading to disruption of work schedule. Treated with Tylenol, Excedrin.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Swelling, Swelling face, Swelling of eyelid
Clinical narrative: 03/06/2019 Reaction started around 2000,  Rt side of neck, cheek, and eye lid got swollen. No difficultly breathing at that time. 03/07/2019 continued with swollen neck, cheek and eye lid, around 1313 had difficulty breathing.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Pt received duplicate immunization. She had received Influenza FLUZONE QUAD vaccine on 10/31/19. Lot UI998AC.