chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Burning sensation, Exposure via eye contact, Eye pain, Occupational exposure to product, Pruritus
Clinical narrative: have some stinging in my eye; having some slight itching and burning and some mild irritation; having some slight itching and burning and some mild irritation; having some slight itching and burning and some mild irritation; The vaccine squirted out from between where I attached the needle and the syringe; during administration of the vaccine to the patient, the vaccine squirted all over my face and got in my eyes and my mouth; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 34 years old male patient (reporter) who experienced have some stinging in my eye, having some slight itching and burning and some mild irritation during administration of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (injection suspension) )to the patient. the vaccine squirt in her mouth and eye during administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2019, the pharmacist was administering vaccine to the patient via unknown route and unknown administration site (lot number N1K811M exp date: 19-Oct-2019), and the vaccine squirted out from between where the needle and the syringe is attached. It squirted out while the needle was in the patient and while the pharmacist was pushing down on the plunger to administer the vaccine. The vaccine squirted all over the face and got in eyes and her mouth.   On an unknown date, the HCP had stinging in eye (eye pain) and having some slight itching and burning and some mild irritation (pruritus, skin irritation, skin burning sensation).   It is an actual medication error due to occupational exposure to product.  It is also a case of device issue due to syringe leak.  Lab test and corrective treatment not reported. HCP was advised to continue irrigating and washing the area and seek medical attention if necessary  Outcome of all the events was not reported.  Global PTC number was updated as: 100004481.  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.  Follow-up information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  Patient's gender was updated.  Follow-up information received on 20-May-2019 regarding an unsolicited valid non-serious case from a Quality department.  PTC number was updated and changes made in the field and narrative accordingly.  List of documents held by sender: none.
Sex: M
Vaccine: TYP
Symptoms: Skin irritation, Syringe issue
Clinical narrative: have some stinging in my eye; having some slight itching and burning and some mild irritation; having some slight itching and burning and some mild irritation; having some slight itching and burning and some mild irritation; The vaccine squirted out from between where I attached the needle and the syringe; during administration of the vaccine to the patient, the vaccine squirted all over my face and got in my eyes and my mouth; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 34 years old male patient (reporter) who experienced have some stinging in my eye, having some slight itching and burning and some mild irritation during administration of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (injection suspension) )to the patient. the vaccine squirt in her mouth and eye during administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-May-2019, the pharmacist was administering vaccine to the patient via unknown route and unknown administration site (lot number N1K811M exp date: 19-Oct-2019), and the vaccine squirted out from between where the needle and the syringe is attached. It squirted out while the needle was in the patient and while the pharmacist was pushing down on the plunger to administer the vaccine. The vaccine squirted all over the face and got in eyes and her mouth.   On an unknown date, the HCP had stinging in eye (eye pain) and having some slight itching and burning and some mild irritation (pruritus, skin irritation, skin burning sensation).   It is an actual medication error due to occupational exposure to product.  It is also a case of device issue due to syringe leak.  Lab test and corrective treatment not reported. HCP was advised to continue irrigating and washing the area and seek medical attention if necessary  Outcome of all the events was not reported.  Global PTC number was updated as: 100004481.  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.  Follow-up information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  Patient's gender was updated.  Follow-up information received on 20-May-2019 regarding an unsolicited valid non-serious case from a Quality department.  PTC number was updated and changes made in the field and narrative accordingly.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was inadvertently administered to a patient , no adverse event; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 24 months old female patient who was vaccinated with a 0.5 ml dose (fourth dose) of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5190AA and Exp. Date 24-Apr-2019) via intramuscular route in the right thigh on 17-May-2019.  The patient's medical history not reported and concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.  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.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired Daptacel vaccine (vaccine expired 3 days ago) was given to patient; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 year old female patient who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2019, the patient received a single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C526AA (expiry date: 15-May-2019)  via unknown route.  It was of actual medication error due to expired vaccine used.  It was not reported whether adverse event was experienced...  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: a patient was given the incorrect dose of IPOL,the patient was given 2cc instead of 0.5cc; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient of an unknown demographics who received vaccine IPV (VERO) [IPOL] and reported that a patient was given the incorrect dose of Ipol, the patient was given 2cc instead of 0.5cc.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of 2cc instead of 0.5cc suspect IPV (VERO) lot number not reported via unknown route in unknown administration site.  It was a case of overdose.  It was unknown if the patient had any adverse event.  List of documents held by sender: none.
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product dose omission
Clinical narrative: patient did not get the 3rd dose on day 21 or 28; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Adult patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] of 1st and 2nd dose nut missed the third dose.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect RABIES (HDC) VACCINE lot number not reported.  It was of actual medication error due to  missed dose.. patient received their first Imovax shot on April 10th, 2nd on April 17th, and now would like to receive the third injection. Caller would like to know if the patient can receive the third injection although it is off schedule.  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.  List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: child received the DTap/ IPV portion only of the Pentacel vaccine; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old patient who received 0.5 mL dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ123AAA, expiry date: 29-Sep-2020 via intramuscular route in the right thigh on 20-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  Office manager reports that today a child received the DTap/ IPV portion only of the Pentacel vaccine.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: ActHIb was reconstituted with sterile water and not the proper diluent; Initial and follow up information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (with unknown demographics) who received HIB (PRP/T) VACCINE [ACT-HIB] (lot number and Exp. Date not reported via unknown route in unknown administration site) that was reconstituted with sterile water and not with the 0.4 % NS diluent provided, 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 inappropriate reconstitution technique.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: On the same day, the patient received Pentacel and ActHIB vaccines; Initial information received on 20-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two months old female patient who received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On 29-Apr-2019, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UI9128A via intramuscular route in the left vastus lateralis.  On 29-Apr-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ066AB via intramuscular route in the right vastus lateralis.  It was a case of actual medication error due to Extra dose administered.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Injection site pruritus
Clinical narrative: Headache; chills/shivering; mild fever; muscle pain; pain/ itching/redness/swelling at injection site; diarrhea.   It felt like I was getting the flu, just like when I  had the first shot in March.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Headache; chills/shivering; mild fever; muscle pain; pain/ itching/redness/swelling at injection site; diarrhea.   It felt like I was getting the flu, just like when I  had the first shot in March.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Discomfort, Dyspnoea, Initial insomnia, Injection site pain
Clinical narrative: Patient received the Hepatitis B Vaccine after showing non-immunity to a post-series antibody. Titer was required for schooling purposes. Patient called the triage RN on 5/23/19 with complaints of right sided pain. Pain to the right upper arm and shoulder, right hip, and right knee. Triage advised patient to come to the clinic for evaluation which was completed. Patient reported to the MD that she had right upper arm and shoulder, right hip, and right knee pain. Arm and shoulder pain woke her up from sleep the evening after the vaccine, discomfort making it difficult to fall asleep. Difficulty using her right arm. Did try ibuprofen and Tylenol but was unsure of dosing at the time of appointment. Right thigh had mild discomfort, most achiness in joints. Patient did report subjective breathlessness the evening of 5/22, though also reported she was objectively breathing "fine". Denied fever, chills, rash, dizziness, parenthesis, difficulty with swallowing or breathing except as mentioned. Patient was advised to follow up in 5 days if no improvement or as needed. Was advised when to report to ED/UC.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Middle insomnia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Patient received the Hepatitis B Vaccine after showing non-immunity to a post-series antibody. Titer was required for schooling purposes. Patient called the triage RN on 5/23/19 with complaints of right sided pain. Pain to the right upper arm and shoulder, right hip, and right knee. Triage advised patient to come to the clinic for evaluation which was completed. Patient reported to the MD that she had right upper arm and shoulder, right hip, and right knee pain. Arm and shoulder pain woke her up from sleep the evening after the vaccine, discomfort making it difficult to fall asleep. Difficulty using her right arm. Did try ibuprofen and Tylenol but was unsure of dosing at the time of appointment. Right thigh had mild discomfort, most achiness in joints. Patient did report subjective breathlessness the evening of 5/22, though also reported she was objectively breathing "fine". Denied fever, chills, rash, dizziness, parenthesis, difficulty with swallowing or breathing except as mentioned. Patient was advised to follow up in 5 days if no improvement or as needed. Was advised when to report to ED/UC.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine should have been given subcutaneous and it was given intramuscular.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy, Mastitis, Vein disorder
Clinical narrative: a day after receiving dose, employee developed a localized mastitis to L nipple with engorged veins and swollen lymph nodes in axilla
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Herpes zoster oticus, Impaired work ability, Ophthalmic herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the pt was inoculated with ZOSTAVAX injection (lot number, vaccination site, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving ZOSTAVAX, on 16-JAN-2016, the pt developed a severe case of shingles on her left ear, left eye, and left side of her face. She was treated for months, inserted eye drops every two hours around the clock. At the reporting time, the pt had multiple, debilitating recurrences of viral episodes rendering her unable to work. The outcome of the events was reported as not recovered/not resolved. As a direct and proximate result of ZOSTAVAX, the pt's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The pt experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt also 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. Upon internal review, the events of severe case of shingles on her left ear and left eye was determined to be medically significant. The events of severe case of shingles on her left ear, left eye, and left side of her face were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Rash, Rash generalised
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 17-SEP-2010, the pt was inoculated with ZOSTAVAX injection (lot number, dosage, vaccination site and route of administration were not provided), as recommended for routine adult health maintenance for its intended purpose: the prevention of shingles. On 12-SEP-2016, the pt presented to the doctor with shingles, which caused a painful rash on his body. He was treated with acyclovir hydrocortisone cream, and gabapentin. The pt returned to the doctor several more times for help with neuropathic symptom concerns, reporting on 14-DEC-2016 "feels the shingles again and would like refill of acyclovir". The outcome of the events was not recovered. The pt suffered serious 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 pt had suffered and incurred damages, including medical expense and other economic and non-economic damages. Upon internal review, the event of neuropathic symptoms was determined to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cervix carcinoma, Endocervical curettage, Inappropriate schedule of product administration, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from an adult female patient referring on herself via company representative. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in February 2008, the patient was vaccinated with the first dose of GARDASIL (strength, lot number, anatomical location and expiration date were unknown) for prophylaxis when she was 13 years old. On an unknown date in September 2008 and in July 2009 the patient had received 2nd and 3rd doses of GARDASIL (strength, lot number, anatomical location and expiration date were unknown) (inappropriate schedule of product administration). On an unknown date, the patient was diagnosed with cervical cancer (cervix carcinoma) after receiving a CIN1 (Cervical intraepithelial neoplasia) during a pap smear test. On an unknown date in March 2019 a lead producer was performed to scrape out part of cervix. The patient sought medical attention and visited physician. The outcome of cervix carcinoma was reported as recovered. The causality assessment between the GARDASIL and cervix carcinoma was not reported. Upon internal review the event cervix carcinoma was considered as medically significant.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Hypersensitivity, Malaise
Clinical narrative: must be something I'm allergic to; breathing problems/severe respiratory problems; get very ill every; This case was reported by a consumer via interactive digital media and described the occurrence of allergy in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included asthma and allergy (allergic to lot of stuff).   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergy, difficulty breathing and unwell. On an unknown date, the outcome of the allergy, difficulty breathing and unwell were unknown.   It was unknown if the reporter considered the allergy, difficulty breathing and unwell to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that some sf the patients were intolerant to some vaccines. The patient gets very ill every time she had Flu vaccine so stopped having them and stated they were not suitable for everyone. The patient received couple of Flu vaccines. The patient was asthmatic and got breathing problems (severe respiratory problems) after vaccination and stated it must be something she was allergic to. The reporter reported that her brothers were given Penicillin in hospital and it nearly finished them off and both had allergic reaction. The reporter stated that it was great if the vaccines work but one should not assume that vaccines were right for everyone.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Incomplete course of vaccination
Clinical narrative: Bad reaction; This case was reported by a consumer via sales rep and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had Shingles vaccination 5 months ago and had a bad reaction to the first shot, so the patient did not go back for the second shot. The patient asking whether there was a problem with that to the doctor but doctor was not sure.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Bell's palsy in a 70-year-old female patient who received SHINGRIX (batch number 7M2KB, expiry date 30th March 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional details were provided as follows: In 2019, the patient received SHINGRIX. In 2019, the patient experienced Bell's palsy.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX (batch number 47JA3, expiry date 12th May 2020) and (batch number 72AA3, expiry date 10th October 2021) for prophylaxis. On 29th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 30th April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain (serious criteria clinically significant/intervention required) and injected limb mobility decreased (serious criteria clinically significant/intervention required). The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the left arm. The batch number (72AA3) and expiry date (10th October 2021) for adjuvant. The patient was complaining of injection site arm soreness. It was lasted for 3 to 4 days but had continued intermittently off and on since then. The patient treated with TYLENOL, but had no relief. The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Product preparation issue
Clinical narrative: the Vaccines were mixed in the same syringe and given at one site,
Age: 4.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent reported quarter sized red bump on right arm at injection site. No fever, redness or streaking
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Rash, Rash pruritic, Urticaria
Clinical narrative: rash over both arms, sore throat, raspy voice after 2nd shingrix.  itching n areas with rash.  hives /welts, no vessicles.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Fainting
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Significant swelling & redness of left upper arm from elbow to shoulder, warm to touch > 24 hrs after vaccine. Started on Keflex.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Patient reports headache,total body neuralgia and "toothache pain" down arm-symptoms resolved in 24 hours
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Developed red, spotty rash around his thigh where the injection was given. Lasted a few days.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Developed a hard nodule close to the injection site almost immediately. Lasted a couple of days.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain
Clinical narrative: next morning after shingrix #2, body aches, no fever, very sore arm lasted one week
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: On 5/16/19, approximately 48 hours after administration of vaccine, the client reported area of redness where Varicella vaccine was administered approximately 1 inch in diameter.
Age: 43.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects.; Patient was administered the 1st dose on 19-OCT-2014. Patient was administered the 2nd dose of VAQTA 30-APR-2019.; This spontaneous report was received from a pharmacist referring to an approximately 48 year-old patient of unknown gender.   The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant medications were unot reported.  On 19-OCT-2014, the patient was vaccinated with the first dose of  hepatitis a vaccine, inactivated (VAQTA) (strength, route of administration, anatomical location, lot number and expiration date were not provided). On 30-APR-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) (strength, route of administration and anatomical location were not provided), lot number S001485 and expiration date 12-MAY-2020; as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; The patient was administered PNEUMOVAX 23 who was improperly stored; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 15-MAY-2019, the patient was administered Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (lot # R031812, expire date reported as 26-SEP-2020) (strength, dose, frequency and route were not reported) who was improperly stored. No adverse effects have been reported.   It was reported that the dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) underwent temperature excursions of 9 degrees Celsius (8.88 °C) for a time frame of 20 minutes, which was called by the digital data logger. There were no previous temperature excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Depression, Dysstasia, Gait disturbance
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately September 2017 (reported as "fall of 2017"), the pt was vaccinated with ZOSTAVAX for routine adult health maintenance and for its intended purpose: for the prevention of shingles (herpes zoster) (strength, dose, route, lot number and expiration date were not provided). In May of 2018, the pt developed shingles and she was subsequently hospitalized in June of 2018 for 4 days. The shingles had affected her neurologically by causing numbness in her feet and legs causing her to trip often. She was also having pain in her midriff area down her back to the point where she cannot sit, stand, walk, drive or work. The patient, a self-professed workaholic, has been unable to work. On an unknown date, the pt became clinically depressed and had to have eye movement desensitization and reprocessing (EMDR) treatments for the depression. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using The Company's product. The patient also experienced mental and emotional distress due to the resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, 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 also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles, numbness in her feet and legs causing her to trip often, and depression was not recovered. The reporter considered the events to be related to ZOSTAVAX. Shingles, numbness in feet and legs causing her to trip often, and depression were considered disabling due to permanent personal injuries and because the patient was unable to work. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Herpes zoster, Hypoaesthesia, Impaired driving ability, Impaired work ability
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In approximately September 2017 (reported as "fall of 2017"), the pt was vaccinated with ZOSTAVAX for routine adult health maintenance and for its intended purpose: for the prevention of shingles (herpes zoster) (strength, dose, route, lot number and expiration date were not provided). In May of 2018, the pt developed shingles and she was subsequently hospitalized in June of 2018 for 4 days. The shingles had affected her neurologically by causing numbness in her feet and legs causing her to trip often. She was also having pain in her midriff area down her back to the point where she cannot sit, stand, walk, drive or work. The patient, a self-professed workaholic, has been unable to work. On an unknown date, the pt became clinically depressed and had to have eye movement desensitization and reprocessing (EMDR) treatments for the depression. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using The Company's product. The patient also experienced mental and emotional distress due to the resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, 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 also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles, numbness in her feet and legs causing her to trip often, and depression was not recovered. The reporter considered the events to be related to ZOSTAVAX. Shingles, numbness in feet and legs causing her to trip often, and depression were considered disabling due to permanent personal injuries and because the patient was unable to work. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Several months after zoster vaccine live (ZOSTAVAX) vaccine was administered, on 01-OCT-2018, the patient presented to a hospital and was diagnosed with shingles. On 03-OCT-2018, he presented to his primary care doctor who told him that the vaccine likely caused his shingles outbreak. He was prescribed gabapentin and acyclovir. As a result of vaccination the patient sustained personal injuries. Further, as a tragic consequence of vaccination the patient suffered serious 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 the zoster vaccine live (ZOSTAVAX) vaccine, the patient has suffered and incurred damages, including medical expense and other economic and non-economic damages. The outcome of shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 23-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for the shingles.  The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter had a patient that reported a high grade fever with the dose of the Shingrix vaccine. The reporter would like to know if it was safe for the patient to administer the 2nd dose. Also, the reporter had some specific questions about Shingrix vaccine. The reporter was a pharmacist and had a patient that received the rabies vaccine in the past and was told to always inform that he got this vaccine rabies before getting any other vaccine because for some vaccines he could be at risk of a serious reaction.  The reporter would like to know if it was safe for the patient to administer the Shingrix vaccine.      Lab Comments: lab test performed on unknown date
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: vaccination site pain; injected limb mobility decreased; Cannot hold anything; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and muscle weakness. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and muscle weakness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 63 years old at the time of reporting. The patient received Shingrix on left arm. The patient experienced pain at the injection site for the past months since he was vaccinated. The pain was intense enough that he could not raise his arm up to his shoulder and could not hold anything in his left hand without dropping it. For tolerance of 2nd dose of Shingrix refer case US2019GSK081895.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: body pain; headache; sore arm; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 29th December 2018, refer case US2019GSK093712).   On 3rd May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced general body pain, headache and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, headache and pain in arm were unknown.   It was unknown if the reporter considered the general body pain, headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and was better but had a little headache, whole body feel moderately sore and arm was very sore or when moving for a couple of days then just sore to touch for a few days.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: vaccination site pain; Fever; This case was reported by a other health professional via sales rep and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in December 2018 and experienced injected site pain refer case US2019AMR071499).   In February 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 63 years old at the time of reporting. It was reported that 2 months after receiving the 1st dose of Shingrix the patient received 2nd dose of Shingrix on right arm. The patient experienced pain and fever for two days. The reporter wondered what treatment the patient could get to overcome the pain.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: body pain; Muscles hurt; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced general body pain and muscle pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the general body pain and muscle pain were recovered/resolved.   It was unknown if the reporter considered the general body pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and whole body hurt, muscles hurt and it was better the next day.  The patient took chewable Benadryl before going to bed. For tolerances of 2nd dose of Shingrix, refer case US2019AMR092823.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Headache, Influenza like illness
Clinical narrative: severe headache; flu-like symptoms; This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the arm from an unspecified date at SINGLE DOSE for immunisation, meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration in the arm on an unspecified date at SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. Patient complained of severe headache and flu-like symptoms. Lasted 24-48 hours. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Right arm numbness and tingling.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: None @ appt for immunizations symptoms developed in the evening Friday with swelling/redness LT & hurts to touch.