chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired pen was administered to a patient and received vaccine which they believe was expired upon receipt. That dose was later given to a patient with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age patient who was vaccinated with an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH 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 unknown dose of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, (lot: UI871AB and expiry date: 11-May-2018) via unknown route used for prophylactic vaccination.  It was a case of expired vaccine used.  At the time of the report, no adverse event was reported.   Disclaimer: 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.  No further relevant information was reported.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was adminitered Pentacel vaccine which was exposed at below 30-32 F for one hour due to opening and closing of refrigerator door/No AE; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case is linked with cases 2020SA161184, 2020SA161064, 2020SA161181, 2020SA161182 and 2020SA161203 (same reporter).  This case involves a five months old female patient who was vaccinated with a 0.5ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door (lot number: UJ015AAA and expiry date 26-OCT-2020) via intramuscular route in the left thigh on 08-Jun-2020 for prophylactic vaccination  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, 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.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine exposed at below 30-32 F for one hour due to opening and closing of refrigerator door/no AE; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked with cases 2020SA161184, 2020SA161064, 2020SA161181, 2020SA161182 and 2020SA161203 (same reporter).  This case involves a 2 month old female patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was exposed at below 30-32 Fahrenheit for one hour due to opening and closing of refrigerator door (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 10-Jun-2020, the patient received first 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ015AAA and expiry date 26-OCT-2020) via unknown route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of reporting, 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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Pentacel was administered to 4 month old patient, no adverse event; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case from an other health professional  This case involves a 4 months old female patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE and ROTAVIRUS VACCINE for prophylactic vaccination.  On 18-Jun-2020, the patient received a 0.5 ml dose 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (diluent: Lot: UJ066ABA, ActHib Lot: UJ100AA) (expiry date 13-Jun-2020) via intramuscular route in the left thigh for prophylactic vaccination  It was a case of an actual medication error due to expired vaccine used  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received menactra which was already expired/no AE; Initial information was received on 23-Jun-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient (unknown demographics) who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE which was already expired (batch number and expiry date not reported) via an unknown route as an unknown administration site on an unknown date for prophylactic vaccination (expired product administered)  Medical history, concomitant therapy,  medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Ageusia, Chest discomfort, Cough, Dyspnoea, Pyrexia
Clinical narrative: On June 23, 2020, the donor called the center to report that he developed a fever, beginning the evening of June 17, 2020, that continued through June 21, 2020.  The donor had consulted his physician by phone and was advised that it could be a reaction to the vaccine.  When the donor also lost his sense of taste on June 21, he decided to get tested for COVID-19.  Donor received a positive test result on June 24.  On the June 23 call, the donor also disclosed, for the first time, that he had had a reaction that involved shortness of breath, chest tightness, and a mild cough after his first shot.  It is not clear whether the donor's symptoms are attributable to the vaccine or COVID-19.  Therefore, out of an abundance of caution, we are submitting this report.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: SARS-CoV-2 test positive
Clinical narrative: On June 23, 2020, the donor called the center to report that he developed a fever, beginning the evening of June 17, 2020, that continued through June 21, 2020.  The donor had consulted his physician by phone and was advised that it could be a reaction to the vaccine.  When the donor also lost his sense of taste on June 21, he decided to get tested for COVID-19.  Donor received a positive test result on June 24.  On the June 23 call, the donor also disclosed, for the first time, that he had had a reaction that involved shortness of breath, chest tightness, and a mild cough after his first shot.  It is not clear whether the donor's symptoms are attributable to the vaccine or COVID-19.  Therefore, out of an abundance of caution, we are submitting this report.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Bowel movement irregularity, Cold sweat, Headache, Hyperhidrosis
Clinical narrative: Clammy, nauseated, headache, low blood pressure, passed out, temperature, sweating, bowel movement
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Loss of consciousness, Nausea
Clinical narrative: Clammy, nauseated, headache, low blood pressure, passed out, temperature, sweating, bowel movement
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Rotator cuff syndrome
Clinical narrative: Left shoulder soreness following vaccine administration.  Patient continued to have pain for several weeks after vaccine.  She notified her PCP and they recommended rest and OTCs.  Pain continued x3 mo after vaccine.  She contacted her employer (who was responsible for providing vaccine) and they reached out to our clinic to have her evaluated.  She was evaluated at the clinic 6/10/2020 and suspected tendinitis of shoulder after vaccine administration.  She was given oral steroids and followed up 2 weeks later.  Pain still continues.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: Awaken at 5 am with severe shivering, entire body aching, & headache.  Lasted several hours.  On 3rd day symptoms had improved but felt very tired and short of breath.  Injection site ached for 3 to 4 days.  Had same adverse side affects with 1st vaccine given in February.  Discussed it with my doctor but said I should continue to take 2nd shot.  2nd shot symptoms were more severe than 1st vaccine taken.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Awaken at 5 am with severe shivering, entire body aching, & headache.  Lasted several hours.  On 3rd day symptoms had improved but felt very tired and short of breath.  Injection site ached for 3 to 4 days.  Had same adverse side affects with 1st vaccine given in February.  Discussed it with my doctor but said I should continue to take 2nd shot.  2nd shot symptoms were more severe than 1st vaccine taken.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Administration site pain, Administration site swelling, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Pt contacted  us c/o possible "allergic reaction" to Varicella vaccine received on 6/23/2020. Pt c/o pain, redness, itchiness, swelling and feeling a few blisters at administration site. Pt stated no fever was noted. Pt was instructed by Health Dept staff - LVN - to seek medical attention for her complaints.  This Nurse contacted patient to follow up with her. Pt stated she was currently at Hospital ER and was to be Rx'd steroid medication to apply to help with inflammation and itchiness. Pt stated she also received a steroid injection.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Pt contacted  us c/o possible "allergic reaction" to Varicella vaccine received on 6/23/2020. Pt c/o pain, redness, itchiness, swelling and feeling a few blisters at administration site. Pt stated no fever was noted. Pt was instructed by Health Dept staff - LVN - to seek medical attention for her complaints.  This Nurse contacted patient to follow up with her. Pt stated she was currently at Hospital ER and was to be Rx'd steroid medication to apply to help with inflammation and itchiness. Pt stated she also received a steroid injection.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Crying, Decreased appetite, Hypersomnia, Lethargy, Pyrexia
Clinical narrative: Week-long fevers, 101.7 highest. 6 days Fever All. Lethargic, sleeping and crying excessively. Vomited once, decreased appetite. Speech reduced. Physician was called several times,  no in-person visit.
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Speech disorder, Vomiting
Clinical narrative: Week-long fevers, 101.7 highest. 6 days Fever All. Lethargic, sleeping and crying excessively. Vomited once, decreased appetite. Speech reduced. Physician was called several times,  no in-person visit.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pyrexia, Rash, Rash erythematous
Clinical narrative: 10 days post vaccine low grade fever (100.2 F) 11 days post vaccine low grade fever and red bumps around injection site on left thigh appears 12 days post vaccine no fever raised red rash appears on trunk 13 days post vaccine no fever raised red rash spread over whole body 14 days post vaccine no fever raised red rash begins to fade 15 days post vaccine no fever, rash almost completely cleared
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: -4 year well check 2 days ago (6/17), received Kinrix (RD) and Proquad (LD) -R arm has been painful- now red, swollen and warm -No fevers  Skin: RUE with large area of erythema surrounding deltoid injection site, mild edema present   Physical findings demonstrated by parent/patient: area is warm, tender and mildly indurated per mom  Start Keflex. -Call for lack of improvement, spreading/streaking redness, worsening pain/swelling, or new fevers.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site warmth
Clinical narrative: -4 year well check 2 days ago (6/17), received Kinrix (RD) and Proquad (LD) -R arm has been painful- now red, swollen and warm -No fevers  Skin: RUE with large area of erythema surrounding deltoid injection site, mild edema present   Physical findings demonstrated by parent/patient: area is warm, tender and mildly indurated per mom  Start Keflex. -Call for lack of improvement, spreading/streaking redness, worsening pain/swelling, or new fevers.
Age: 40.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Headache, Pain, Pyrexia, Vision blurred
Clinical narrative: Blurry Vision, headache, mild fever (99.5F)  and soreness.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Oedema peripheral, Tenderness
Clinical narrative: under arms swollen and tender to touch, especially left arm as well as right front hip bone
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given a third dose of Menactra. This third dose was given less than 5 months after his booster dose.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: PT HAS SWELLING, AND STIFFNESS IN THE AREA WHERE THE TRUMENBA VACCINE WAS GIVEN WHICH WAS IN THE RIGHT DELTOID AREA. THE AREA FEELS HOT WITH ABOUT A 6X7 CENTIMETER OF REDNESS IN THE AREA. THE PATIENT ALSO EXPLAINED THAT IT'S PAINFUL FOR HER TO MOVE THE RIGHT SHOULDER COMPLETELY.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain
Clinical narrative: PT HAS SWELLING, AND STIFFNESS IN THE AREA WHERE THE TRUMENBA VACCINE WAS GIVEN WHICH WAS IN THE RIGHT DELTOID AREA. THE AREA FEELS HOT WITH ABOUT A 6X7 CENTIMETER OF REDNESS IN THE AREA. THE PATIENT ALSO EXPLAINED THAT IT'S PAINFUL FOR HER TO MOVE THE RIGHT SHOULDER COMPLETELY.
Age: 42.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given a Tdap on 1/23/2020.  He was given a Tdap on 6/25/2020 by mistake.  Patient has been notified.  He is not feeling any adverse effects to this vaccine.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache
Clinical narrative: headache chill
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular, Vaccination site erythema, Vaccination site rash, Vaccination site reaction
Clinical narrative: Pt developed a fever of 103 11 days after vaccination with a localized one inch area of papulovesicular red rash at site of vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Gait disturbance, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Vaccines to include DTAP and IPV given yesterday afternoon.  Started c/o leg/knee pain last night.  Woke up this morning refusing to get out of bed and c/o leg/knee pain.  Redness, swelling, no fever.  Redness and swell started and thigh and moved down toward knee.  Whole legs with redness and swelling.  Pt c/o knee pain, and limping.  Pt. sent to pediatrics orthopedics for further evaluation.  At this time pt is doing well.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Newborn was given the TDAP vaccination instead of the Hepatitis B vaccination. There were no signs or symptoms of an adverse reaction to the TDAP vaccination upon discharge from the hospital. The Hepatitis B vaccination was given on 6/25/2020 prior to discharge from the hospital and two days after the TDAP vaccination was given.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Pt developed rash on 6/18, rash became more painful, started spreading and vesicles were forming by 6/19/20 when pt was evaluated in office. Pt was prescribed a course of Valtrex.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: according to patient by night time her arm (site) was swollen and red and hot and was painful
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hallucination, Pain
Clinical narrative: Severe chills, hallucination, pain after 8 hours of second shot of Shingrix
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea, fever (99.9)
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Injection site pain, Pain
Clinical narrative: Patient tolerated first round without adverse events. Second administration he had flu-like symptoms the evening of administration. Symptoms described as aches and pains, fever, chills, shivering, pain in arm. He describes considering going to ER that he felt so bad. Injection site was painful. Had vaccine administered at local pharmacy. Symptoms resolved in 24 hours and were self-limited.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient tolerated first round without adverse events. Second administration he had flu-like symptoms the evening of administration. Symptoms described as aches and pains, fever, chills, shivering, pain in arm. He describes considering going to ER that he felt so bad. Injection site was painful. Had vaccine administered at local pharmacy. Symptoms resolved in 24 hours and were self-limited.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Significant soreness at injection site, fever, headache, body aches, tiredness.  Symptoms started approximately 6 hours after injection and worsened the second day.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Area around elbow/lower under arm area by elbow is red, swollen, and itchy but no reaction around injection site
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 4 in x 4 in area of induration and swelling right deltoid, warm to touch, no erythema
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Erythema, Rash
Clinical narrative: Patient developed Rash & Redness on the face, trunk, extremities 1-2 minutes after Rotateq given by mouth. Given 1 dose of Benadryl. Recheck in 30 minutes, Rash & Redness improved. VS stable - No other side effects.
Age: 0.08
Sex: F
Vaccine: RV1, RV1
Symptoms: Haematochezia
Clinical narrative: "Blood in stool"- hematochezia; This case was reported by a other health professional via call center representative and described the occurrence of hematochezia in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number PL9T9, expiry date 3rd September 2021) for prophylaxis.   On 12th June 2020, the patient received the 1st dose of Rotarix lyophilized formulation (oral). In June 2020, less than 2 weeks after receiving Rotarix lyophilized formulation, the patient experienced hematochezia (serious criteria GSK medically significant). On an unknown date, the outcome of the hematochezia was unknown.   It was unknown if the reporter considered the hematochezia to be related to Rotarix lyophilized formulation.  Additional details were provided as follows: It was reported that 2 month old patient who after receiving the first dose of Rotarix, experienced blood in stool. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Hives all over the body were discovered by the patient the next  day. Pharmacist recommended Benadryl and to call the physician who prescribed the vaccines. If there was any trouble breathing  the patient was advised to call the emergency room or call 911.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effect reported.; My daughter received the GARDASIL 9 shots at her wellness visits and not at the regular dosing schedule.; My daughter received the GARDASIL 9 shots at her wellness visits and not at the regular dosing schedule.; This spontaneous report was received from the patient's mother, referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date in June 2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, one dose as prophylaxis (strength, route of administration, anatomical site of injection, lot number and expiration date were not reported). On an unspecified date in 2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, one dose as prophylaxis (strength, route of administration, anatomical site of injection, lot number and expiration date were not reported) (inappropriate schedule of product administration). On an unspecified date in 2020, the patient was administered the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, one dose as prophylaxis (strength, route of administration, anatomical site of injection, lot number and expiration date were not reported) (inappropriate schedule of product administration). No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored dose of VARIVAX were administered to a patient; No adverse affects reported; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and previous medical history were not reported.  Information was extracted from data logger.  On an unknown date, the patient was vaccinated with one dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck)(VARIVAX) lot # S032355 and expiration date  14-OCT-2021 for prophylaxis  (strength and patient route of administration were not provided). The storage temperature was reported to be 7.1°F for a period of 30 minutes. No additional adverse effects were reported.   At the time of reporting, the outcome of product storage error was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: bad case of the shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's concurrent conditions and medical history were not provided.  On 26-NOV-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster).   On an unknown date (reported as "shortly after receiving vaccine"), the patient suffered a bad case of the shingles. It was reported that the patient's symptoms had resulted in physical limitations not present before used zoster vaccine live (ZOSTAVAX). Also, the patient sustained severe and permanent personal injuries. Further, the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.   At the time of the report, the outcome of shingles was reported as not recovered/not resolved.    Upon internal review, shingles were considered to be disabling due to severe and permanent personal injuries.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Dizziness, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: Her left arm was hurting a little; Numbness around neck and shoulders; Dizziness; Serious headaches; Arms tingling; Sudden pain at the injection site; Nausea without eating; This spontaneous report was received from a consumer concerning an 87 year old female patient. The patient's medical history included a hip replacement in 2012, which resulted in 2 blood clots in each lung. The patient had neither concomitant medications or drug reactions/allergies.  On 05-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) on an unspecified arm, frequency was reported as one/5years for "routine" (route of administration, lot number and expiration date were not reported). Since 16-JUN-2020, the patient experienced serious headaches, numbness around the neck and shoulders (hypoaesthesia) and arms tingling (paraesthesia); moreover, the patient also experienced pain at the injection site that reminded her of the vaccine, dizziness and nausea without eating. On 22-JUN-2020, the patient's arm was hurting a little while flexing the muscle to hold the phone (pain in extremity). The reporter stated that her health care professional gave her the prescription for vaccine, but reporter stated that she continued to put off getting the vaccination. On unknown dates, every 3 weeks international normalized ratio (INR) testings were carried out, as well as unspecified blood testing on unspecified dates. The patient did not seek medical attention and no treatment was given for the adverse events.  The outcome of headache, pain in extremity, nausea, dizziness, injection site pain, paraesthesia and hypoaesthesia was reported as not resolved. The casual relationship between therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was not provided.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: International normalised ratio, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Her left arm was hurting a little; Numbness around neck and shoulders; Dizziness; Serious headaches; Arms tingling; Sudden pain at the injection site; Nausea without eating; This spontaneous report was received from a consumer concerning an 87 year old female patient. The patient's medical history included a hip replacement in 2012, which resulted in 2 blood clots in each lung. The patient had neither concomitant medications or drug reactions/allergies.  On 05-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) on an unspecified arm, frequency was reported as one/5years for "routine" (route of administration, lot number and expiration date were not reported). Since 16-JUN-2020, the patient experienced serious headaches, numbness around the neck and shoulders (hypoaesthesia) and arms tingling (paraesthesia); moreover, the patient also experienced pain at the injection site that reminded her of the vaccine, dizziness and nausea without eating. On 22-JUN-2020, the patient's arm was hurting a little while flexing the muscle to hold the phone (pain in extremity). The reporter stated that her health care professional gave her the prescription for vaccine, but reporter stated that she continued to put off getting the vaccination. On unknown dates, every 3 weeks international normalized ratio (INR) testings were carried out, as well as unspecified blood testing on unspecified dates. The patient did not seek medical attention and no treatment was given for the adverse events.  The outcome of headache, pain in extremity, nausea, dizziness, injection site pain, paraesthesia and hypoaesthesia was reported as not resolved. The casual relationship between therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect; A patient was administered a dose of improperly stored GARDASIL 9; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.   On 23-JUN-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscular route, lot # 1621929, expiration date on 06-DEC-2021 as prophylaxis (strength, dose, frequency, and anatomical location were not reported). No additional adverse effect was reported.   The administered dose of vaccine experienced the temperature excursion below 36 degrees Fahrenheit (30.3 degrees Fahrenheit) for 15 minutes. The previous temperature excursion was above 47 degrees Fahrenheit (54.6 degrees Fahrenheit) for 1 hour. Data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pain at injection site with decreased range of motion of shoulder
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site rash, Musculoskeletal stiffness, Myalgia
Clinical narrative: rash around the injection site and very sore muscle. Next day (6 a.m.)  a 100.0 temperature with general stiffness and dizziness and headache. At 10:30 and  at 100.1
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Antinuclear antibody, Arthralgia, Blood culture negative, Haematology test, Immunology test
Clinical narrative: Symptoms: joint pain moving throughout the body, joint stiffness moving and settling in left shoulder, additional swelling  in left knee (initial injury site that led to vaccination) Time Course: swelling and pain began 2 hours post injection and worsened with time. Treatment with ABX and steroids improved symptoms slightly, but discontinuing steroids led to return of pain and stiffness.  Outcome: Vaccine given 6/16. Patient began ABX/steroids on 6/19 with pain/stiffness returning on 6/22. Patient was seen in emergency department on 6/24 due to worsening symptoms and inability to complete normal daily activities. Patient was admitted for observation and given IV steroids and pain medication and continued home ABX. Patient consulted on 6/26 noting pain is still present and left shoulder joint is frozen.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site joint movement impairment, Joint stiffness, Joint swelling, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Symptoms: joint pain moving throughout the body, joint stiffness moving and settling in left shoulder, additional swelling  in left knee (initial injury site that led to vaccination) Time Course: swelling and pain began 2 hours post injection and worsened with time. Treatment with ABX and steroids improved symptoms slightly, but discontinuing steroids led to return of pain and stiffness.  Outcome: Vaccine given 6/16. Patient began ABX/steroids on 6/19 with pain/stiffness returning on 6/22. Patient was seen in emergency department on 6/24 due to worsening symptoms and inability to complete normal daily activities. Patient was admitted for observation and given IV steroids and pain medication and continued home ABX. Patient consulted on 6/26 noting pain is still present and left shoulder joint is frozen.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Periarthritis, Rheumatoid factor, Streptococcus test
Clinical narrative: Symptoms: joint pain moving throughout the body, joint stiffness moving and settling in left shoulder, additional swelling  in left knee (initial injury site that led to vaccination) Time Course: swelling and pain began 2 hours post injection and worsened with time. Treatment with ABX and steroids improved symptoms slightly, but discontinuing steroids led to return of pain and stiffness.  Outcome: Vaccine given 6/16. Patient began ABX/steroids on 6/19 with pain/stiffness returning on 6/22. Patient was seen in emergency department on 6/24 due to worsening symptoms and inability to complete normal daily activities. Patient was admitted for observation and given IV steroids and pain medication and continued home ABX. Patient consulted on 6/26 noting pain is still present and left shoulder joint is frozen.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, erythema 3.5 inches pain
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: an unspecified number of patients were administered improperly stored Pedvaxhib and Rotateq; No additional adverse events; This non-valid spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On an unknown date the patients were vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R036177, expiration date 08-OCT-2021; lot number S016870, expiration date 26-FEB-2022; lot number S006470, expiration date 15-JAN-2022 and lot number S009234, expiration date 24-JAN-2022 (dose and route of administration were not provided) for prophylaxis. On an unknown date, the patients were also vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number S004400, expiration date 14-NOV-2020 (dose and route of administration were not provided) for prophylaxis. All the reported lot numbers were verified to be valid.   On an unknown date, the administered doses of vaccines experienced a temperature excursion of above 47 Fahrenheit (F) degrees (also reported as 64F and 47F) for 7 hours 30 minutes and for 3 hours respectively. The patients did not experience any additional adverse events. Digital Data Logger was not involved.  This is a non-valid report due to lack of patients' identifiers.
Sex: U
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 patient (pt) of unspecified age and unknown gender. Information about concurrent condition, concomitant medication or medical history was not provided. In 2018 the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a pharmacist for the long term prevention of shingles and/or zoster-related conditions. At the time of pt's vaccination, pt relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the pt to be vaccinated.  On an unspecified date (reported as subsequent to inoculation), the pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live(ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered as not recovered. The causality was assessed as related by the lawyer and patient.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms reported; and the fourth dose of GARDASIL 9 was administered; This spontaneous report was received from an administrator referring to an 18 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 05-NOV-2015, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # L025737, expiration date 31-JAN-2017; strength, dose and route were not reported) for prophylaxis. On 08-JAN-2016, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # L019297, expiration date 18-AUG-2017). On 12-MAY-2016, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M003659, expiration date 20-SEP-2017). On 15-JUN-2020, the patient was vaccinated with the forth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S028737, expiration date 03-APR-2022) (extra dose administered). No adverse symptoms were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028737; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 70.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Extensive swelling of vaccinated limb, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: area is blistering; the area was "swollen 3x the size and was hot to the touch"; the area was" swollen 3x the size and was hot to the touch; the patient was experiencing redness, swollen, and soreness at the injection site; the patient was experiencing redness, swollen, and soreness at the injection site; the patient was experiencing redness, swollen, and soreness at the injection site; the patient is also "extremely tired"; This spontaneous report as received from the patient's wife concerning to a 70 year old male.  The patient's pertinent medical history included stevens-johnson syndrome and penicillin allergy. The concomitant medications included unspecified medications for high blood pressure and cholesterol.  On 19-JUN-2020 at 11:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot # S033790 has been verified to be a valid lot number, expiration date 02-AUG-2021, in the right arm, for prophylaxis (dose and route of administration were not reported).  Later, on the same date at 23:00, the patient was experiencing redness (vaccination site erythema), swollen (vaccination site swelling), and soreness at the vaccination site (vaccination site pain). On 20-JUN-2020, reported as the next day, the area was swollen 3x the size (extensive swelling of vaccinated limb) and it was hot to the touch (vaccination site warmth). As of 22-JUN-2020 (reported as today), the area was blistering (vaccination site vesicles), but swelling was reduced, and it was no longer warm to the touch. Therefore, physician was contacted via telephone and it was recommended icing every few hours and taking ibuprofen, every 4 hours. As a result of this experience, the patient was also "extremely tired" (fatigue). The patient underwent quarterly unspecified lab tests and blood work. At the time of reporting, the patient was recovering from extensive swelling of vaccinated limb, vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site vesicles, the paharmacist also reported that the patient's arm was starting to heal. The outcome of vaccination site warmth was recovered. The outcome of fatigue was unknown.    The causality relatedness between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S033790; expirationdate: 02-AUG-2021; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 70.0
Sex: M
Vaccine: PPV, UNK
Symptoms: Vaccination site vesicles
Clinical narrative: area is blistering; the area was "swollen 3x the size and was hot to the touch"; the area was" swollen 3x the size and was hot to the touch; the patient was experiencing redness, swollen, and soreness at the injection site; the patient was experiencing redness, swollen, and soreness at the injection site; the patient was experiencing redness, swollen, and soreness at the injection site; the patient is also "extremely tired"; This spontaneous report as received from the patient's wife concerning to a 70 year old male.  The patient's pertinent medical history included stevens-johnson syndrome and penicillin allergy. The concomitant medications included unspecified medications for high blood pressure and cholesterol.  On 19-JUN-2020 at 11:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot # S033790 has been verified to be a valid lot number, expiration date 02-AUG-2021, in the right arm, for prophylaxis (dose and route of administration were not reported).  Later, on the same date at 23:00, the patient was experiencing redness (vaccination site erythema), swollen (vaccination site swelling), and soreness at the vaccination site (vaccination site pain). On 20-JUN-2020, reported as the next day, the area was swollen 3x the size (extensive swelling of vaccinated limb) and it was hot to the touch (vaccination site warmth). As of 22-JUN-2020 (reported as today), the area was blistering (vaccination site vesicles), but swelling was reduced, and it was no longer warm to the touch. Therefore, physician was contacted via telephone and it was recommended icing every few hours and taking ibuprofen, every 4 hours. As a result of this experience, the patient was also "extremely tired" (fatigue). The patient underwent quarterly unspecified lab tests and blood work. At the time of reporting, the patient was recovering from extensive swelling of vaccinated limb, vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site vesicles, the paharmacist also reported that the patient's arm was starting to heal. The outcome of vaccination site warmth was recovered. The outcome of fatigue was unknown.    The causality relatedness between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S033790; expirationdate: 02-AUG-2021; deviceage and unit: 0 ; operatorofdevice: Pharmacist; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or additional adverse effects reported; second dose in ROTATEQ immunization series was inadvertently administered past its expiry; Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication was not provided.      On 22-JUN-2020, the second dose in rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, lot # R025731, expiration date 14-JUN-2020; strength and dose were unknown) immunization series was inadvertently administered past its expiry (expired product administered). No symptoms or additional adverse effects was reported (no adverse event). The outcome of the events was unknown.