chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: PATIENT REPORTED THEY HAD A RAISED RASH ON 8/21 THAT WAS AROUND THE INJECTION SITE.  THEY WENT TO URGENT CARE THE FOLLOWING DAY AND THE RED AREA WAS OUTLINED AND ABOUT THE SIZE OF A HALF DOLLAR BUT WASN'T RAISED ANYMORE.  PATIENT WAS ADVISED TO MONITOR AND IT SEEMED TO BE IMPROVING.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Localised infection, Peripheral swelling, Tenderness
Clinical narrative: red tendeR swollen extended past elbow W/I 24 infect inner arm
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise, Nausea
Clinical narrative: erythema, tenderness to (R) shoulder below injection site. Having nausea and body malaise
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Gait disturbance, Influenza, Injection site pain
Clinical narrative: Shot 10am 8/4-by 8:30pm that eve, abdominal pains-(R) side. Woke up 11:30pm same nite - pains so fierce thought I may have to go to ER. Severe flu symptoms - vomiting / diahrea 11:30 to 3:30am with abdominal pains, subsided by 4am very week Weds 8/5 & thurs 86 also, difficulty walking Also, severe pain @ injection site 8/4 until Fri pm 8/7/20. - No fever/no headache Note: I received Zoztovax vaccine 2011 no adverse reactions
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Shot 10am 8/4-by 8:30pm that eve, abdominal pains-(R) side. Woke up 11:30pm same nite - pains so fierce thought I may have to go to ER. Severe flu symptoms - vomiting / diahrea 11:30 to 3:30am with abdominal pains, subsided by 4am very week Weds 8/5 & thurs 86 also, difficulty walking Also, severe pain @ injection site 8/4 until Fri pm 8/7/20. - No fever/no headache Note: I received Zoztovax vaccine 2011 no adverse reactions
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Headache, Pyrexia
Clinical narrative: Patient experienced elevated blood pressure, headache, and fever. Seeked hospital treatment
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt began with itching at 8pm on 8-20-2020 - no rash was noted. Dad gave pt Benadryl 1 tab. Pt woke at 8 AM 8-21-2020 with hives all over body - described as raised pink spots with pale centers. Dad reports the ones on her belly and ribs are large like the size of his hand. Pt c/o itching. Dad gave Benadryl 1 tab and put pt. in Oatmeal Bath. Denied difficulty breathing/swallowing, drooling or swollen tongue. Denies fever/sx of illness. Denies redness, swelling or tenderness to injection sites. Denies prior reactions to immunizations. Denies eating any new foods. Pt. happy and active splashing in tub just itchy. Dr advised Benadryl q 6-8 hours PRN itch, monitor clinically and call back with update this afternoon
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Hyperhidrosis, Tremor, Vomiting
Clinical narrative: Three hours after administration. Tremors, Body Shakes, Sweating, Vomiting, back pain
Age: 70.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: left Bicep red, swollen, inflamed, warm to Touch. Pt went to see MD. Pt given augmentin 875 mg and Mobic 15 mg by MD.
Age: 66.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Lethargy, Loss of consciousness, Pollakiuria, Pyrexia
Clinical narrative: Fever of 102 degrees for about 12 hours, frequent urination, Sunday 8/23 about 4 AM passed out in bathroom, lethargy, extremely tired for rest of 8/22, and 8/23, still tired 8/24
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Developed varicella-like rash (2 pox) 7 days after vaccine administration on 8/20/2020 Papulovesicular rash on (L) arm, (R) hand, otherwise well
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: fever, tylenol
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Pain in the arm when raises her arm - little swelling - No redness
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Back pain, Fatigue, Nausea
Clinical narrative: redness and swelling at the injection-site; redness and swelling at the injection-site; Fatigue filling wiped out/extreme fatigue; Nausea that is severe and constant / extreme nausea; Back pain; muscle pain/extreme muscle pain; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   Concomitant products included ondansetron (Zofran), promethazine (Phenergan), metoclopramide hydrochloride (Reglan) and prochlorperazine (Compazine).   On 30th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th July 2020, 1 days after receiving Shingrix, the patient experienced nausea. On 31st July 2020, the patient experienced injection site redness, injection site swelling, fatigue, back pain, muscle pain and feeling sick. On an unknown date, the outcome of the injection site redness and injection site swelling were recovered/resolved and the outcome of the fatigue, nausea, back pain, muscle pain and feeling sick were not recovered/not resolved.   It was unknown if the reporter considered the injection site redness, injection site swelling, muscle pain and feeling sick to be related to Shingrix. The reporter considered the fatigue, nausea and back pain to be related to Shingrix.  Additional information was received as follows: The patient experienced extreme nausea, fatigue, muscle pain, feeling sick, redness and swelling at the injection-site. The patient was unsure if the adverse events occurred that night after getting the shot, but noticed them by the next morning. She reported going to the ER the day before the report to seek treatment. She was discharged from the ER on the same day. The redness and swelling at the injection-site had since resolved.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: redness and swelling at the injection-site; redness and swelling at the injection-site; Fatigue filling wiped out/extreme fatigue; Nausea that is severe and constant / extreme nausea; Back pain; muscle pain/extreme muscle pain; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   Concomitant products included ondansetron (Zofran), promethazine (Phenergan), metoclopramide hydrochloride (Reglan) and prochlorperazine (Compazine).   On 30th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th July 2020, 1 days after receiving Shingrix, the patient experienced nausea. On 31st July 2020, the patient experienced injection site redness, injection site swelling, fatigue, back pain, muscle pain and feeling sick. On an unknown date, the outcome of the injection site redness and injection site swelling were recovered/resolved and the outcome of the fatigue, nausea, back pain, muscle pain and feeling sick were not recovered/not resolved.   It was unknown if the reporter considered the injection site redness, injection site swelling, muscle pain and feeling sick to be related to Shingrix. The reporter considered the fatigue, nausea and back pain to be related to Shingrix.  Additional information was received as follows: The patient experienced extreme nausea, fatigue, muscle pain, feeling sick, redness and swelling at the injection-site. The patient was unsure if the adverse events occurred that night after getting the shot, but noticed them by the next morning. She reported going to the ER the day before the report to seek treatment. She was discharged from the ER on the same day. The redness and swelling at the injection-site had since resolved.  The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: redness and swelling at the injection-site; redness and swelling at the injection-site; Fatigue filling wiped out/extreme fatigue; Nausea that is severe and constant / extreme nausea; Back pain; muscle pain/extreme muscle pain; feeling sick; This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   Concomitant products included ondansetron (Zofran), promethazine (Phenergan), metoclopramide hydrochloride (Reglan) and prochlorperazine (Compazine).   On 30th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th July 2020, 1 days after receiving Shingrix, the patient experienced nausea. On 31st July 2020, the patient experienced injection site redness, injection site swelling, fatigue, back pain, muscle pain and feeling sick. On an unknown date, the outcome of the injection site redness and injection site swelling were recovered/resolved and the outcome of the fatigue, nausea, back pain, muscle pain and feeling sick were not recovered/not resolved.   It was unknown if the reporter considered the injection site redness, injection site swelling, muscle pain and feeling sick to be related to Shingrix. The reporter considered the fatigue, nausea and back pain to be related to Shingrix.  Additional information was received as follows: The patient experienced extreme nausea, fatigue, muscle pain, feeling sick, redness and swelling at the injection-site. The patient was unsure if the adverse events occurred that night after getting the shot, but noticed them by the next morning. She reported going to the ER the day before the report to seek treatment. She was discharged from the ER on the same day. The redness and swelling at the injection-site had since resolved.  The reporter consented to follow up.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Blood electrolytes normal, CSF culture negative, Computerised tomogram head normal, Culture urine negative
Clinical narrative: 3 seizures no fever
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Enterovirus test negative, Herpes simplex test negative, Magnetic resonance imaging brain normal, Polymerase chain reaction, Respiratory viral panel
Clinical narrative: 3 seizures no fever
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: SARS-CoV-2 test negative, Seizure like phenomena
Clinical narrative: 3 seizures no fever
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Gene mutation identification test negative, Lumbar puncture normal, Magnetic resonance imaging normal
Clinical narrative: 3 seizures no fever
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Seizure
Clinical narrative: 3 seizures no fever
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: I've had the flu shot for the past 10 yrs. no side effects ever. The pharmarcist  suggested the pneumoccal 23 vaccination.  I rec it around 9;30am and by 8;30pm is when i started to have a fever, nauseous,chills,shaking  swelling redness inflamed hot swelling in my right arm. it spread by the next day to half around my right arm.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Skin warm
Clinical narrative: I've had the flu shot for the past 10 yrs. no side effects ever. The pharmarcist  suggested the pneumoccal 23 vaccination.  I rec it around 9;30am and by 8;30pm is when i started to have a fever, nauseous,chills,shaking  swelling redness inflamed hot swelling in my right arm. it spread by the next day to half around my right arm.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Anger, Chills, Confusional state, Erythema, Inflammation
Clinical narrative: I've had the flu shot for the past 10 yrs. no side effects ever. The pharmarcist  suggested the pneumoccal 23 vaccination.  I rec it around 9;30am and by 8;30pm is when i started to have a fever, nauseous,chills,shaking  swelling redness inflamed hot swelling in my right arm. it spread by the next day to half around my right arm.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Nausea, Peripheral swelling, Pyrexia, Skin warm, Swelling
Clinical narrative: I've had the flu shot for the past 10 yrs. no side effects ever. The pharmarcist  suggested the pneumoccal 23 vaccination.  I rec it around 9;30am and by 8;30pm is when i started to have a fever, nauseous,chills,shaking  swelling redness inflamed hot swelling in my right arm. it spread by the next day to half around my right arm.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Tremor
Clinical narrative: I've had the flu shot for the past 10 yrs. no side effects ever. The pharmarcist  suggested the pneumoccal 23 vaccination.  I rec it around 9;30am and by 8;30pm is when i started to have a fever, nauseous,chills,shaking  swelling redness inflamed hot swelling in my right arm. it spread by the next day to half around my right arm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nephropathy
Clinical narrative: Shingles rash, with itching, burning and pustules appeared on July 5, 2020. Began 7 day course of Valtrex on July 6, 2020.Rash subsided, but itching and burning remained. In late July, post-herpetic neuropathy began, affecting  right side of face, jaw, throat, neck, and right shoulder. PCP prescribed Gabapentin 300 mg, along with ibuprofen, as needed. On August 17,2020,I reported back to PCP that pain was still significant, and he prescribed,in addition to Gabapentin, Tramadol 50 mg and Prednisone.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Post herpetic neuralgia, Pruritus, Pustule
Clinical narrative: Shingles rash, with itching, burning and pustules appeared on July 5, 2020. Began 7 day course of Valtrex on July 6, 2020.Rash subsided, but itching and burning remained. In late July, post-herpetic neuropathy began, affecting  right side of face, jaw, throat, neck, and right shoulder. PCP prescribed Gabapentin 300 mg, along with ibuprofen, as needed. On August 17,2020,I reported back to PCP that pain was still significant, and he prescribed,in addition to Gabapentin, Tramadol 50 mg and Prednisone.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Shingles rash, with itching, burning and pustules appeared on July 5, 2020. Began 7 day course of Valtrex on July 6, 2020.Rash subsided, but itching and burning remained. In late July, post-herpetic neuropathy began, affecting  right side of face, jaw, throat, neck, and right shoulder. PCP prescribed Gabapentin 300 mg, along with ibuprofen, as needed. On August 17,2020,I reported back to PCP that pain was still significant, and he prescribed,in addition to Gabapentin, Tramadol 50 mg and Prednisone.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient had redness. heat, swelling, and pain not at injection site, but down his arm in elbow area.  Say it was improving on 8/24/2020 and had not contacted doctor.
Age: 65.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Erythema, Joint swelling, Skin warm
Clinical narrative: Patient had redness. heat, swelling, and pain not at injection site, but down his arm in elbow area.  Say it was improving on 8/24/2020 and had not contacted doctor.
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Headache, Myalgia
Clinical narrative: Diarrhea, muscle aches, headace
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Diet refusal, Fatigue, Irritability
Clinical narrative: After arriving home from the doctor patient was fussy and tired. She refused to eat anything and was lethargic. Around 5:00pm she felt warm, so I took her temperature. Her fever was 100.6°. She suddenly started throwing up profusely and having diarrhea at the same time. I thought she was done and got everything out of her system when she started to throw up more. By now it was 6:00pm and she couldn?t keep her eyes open. She normally goes to sleep around 7:30pm, so it was early for her to be so tired. I put her to sleep in her crib. Around 9:30pm she is woke up screaming and throwing  up in her crib and also had diarrhea in her diaper. I took her temperature and it was 101.6. I gave her children?s Tylenol for the fever and she went back to bed 90 minutes later. The next morning she had  an 100° temperature and had diarrhea throughout the day, no appetite, and was lethargic.  We monitored her temperature all day and it stayed around 99.5°, but jumped to 101.1° around 6:00pm.  Around 7:00pm she threw up again. The next day she still had diarrhea and her temp was around 99.9°.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Lethargy, Pyrexia, Screaming, Skin warm, Somnolence
Clinical narrative: After arriving home from the doctor patient was fussy and tired. She refused to eat anything and was lethargic. Around 5:00pm she felt warm, so I took her temperature. Her fever was 100.6°. She suddenly started throwing up profusely and having diarrhea at the same time. I thought she was done and got everything out of her system when she started to throw up more. By now it was 6:00pm and she couldn?t keep her eyes open. She normally goes to sleep around 7:30pm, so it was early for her to be so tired. I put her to sleep in her crib. Around 9:30pm she is woke up screaming and throwing  up in her crib and also had diarrhea in her diaper. I took her temperature and it was 101.6. I gave her children?s Tylenol for the fever and she went back to bed 90 minutes later. The next morning she had  an 100° temperature and had diarrhea throughout the day, no appetite, and was lethargic.  We monitored her temperature all day and it stayed around 99.5°, but jumped to 101.1° around 6:00pm.  Around 7:00pm she threw up again. The next day she still had diarrhea and her temp was around 99.9°.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Vomiting
Clinical narrative: After arriving home from the doctor patient was fussy and tired. She refused to eat anything and was lethargic. Around 5:00pm she felt warm, so I took her temperature. Her fever was 100.6°. She suddenly started throwing up profusely and having diarrhea at the same time. I thought she was done and got everything out of her system when she started to throw up more. By now it was 6:00pm and she couldn?t keep her eyes open. She normally goes to sleep around 7:30pm, so it was early for her to be so tired. I put her to sleep in her crib. Around 9:30pm she is woke up screaming and throwing  up in her crib and also had diarrhea in her diaper. I took her temperature and it was 101.6. I gave her children?s Tylenol for the fever and she went back to bed 90 minutes later. The next morning she had  an 100° temperature and had diarrhea throughout the day, no appetite, and was lethargic.  We monitored her temperature all day and it stayed around 99.5°, but jumped to 101.1° around 6:00pm.  Around 7:00pm she threw up again. The next day she still had diarrhea and her temp was around 99.9°.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chicken Pox on arms , legs, and abdomen
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No further AE/PQC reported; Pneumovax23 being administered 4 days after expiration; This spontaneous report has been received from a physician referring to an unspecified patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 06-AUG-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with expiration date of 02-AUG-2020 (strength, indication, dose, route, frequency, anatomical location, and lot # were not provided) for prophylaxis.  This is a non-valid case due to the lack of patient's identifiers.
Age: 46.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: wilhout any adverse symptoms; A patient in their office today received a dose of PROQUAD and MMRII instead of just PROQUAD.; A patient in their office today received a dose of PROQUAD and MMRII instead of just PROQUAD.; This spontaneous report was received from a medical assistant, referring to a 46 year old female patient. The information regarding patient's medical history, concurrent conditions, concomitant medications were not provided.  On 12-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose 0.5ml, lot # S015428 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 20-MAY-2021, albumin status rHA (recombinant Human albumin), concentration, frequency and route were unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose 0.5ml, lot #S021619 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 09-JAN-2021, albumin status rHA (recombinant Human albumin), concentration, frequency and route were unknown) instead of just measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (inappropriate schedule of product administration and product administered to patient of inappropriate age). The patient was without any adverse symptoms as of now per the medical assistant.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 27-MAR-2020, the patient was vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot# S030206, expiration date on 24-MAR-2021 at a dose of 0.5 milliter, subcutaneously on the right tight.   There was no adverse effects reported.  Administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion between -14 and -10 degrees Celsius (-11.2C) for 3 hour and 42 minutes. Digital data logger was involved. There were no previous temperature excursions reported.   This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008875: US-009507513-2008USA008885: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008877: US-009507513-2008USA008879: US-009507513-2008USA008883: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008876: US-009507513-2008USA008917: US-009507513-2008USA008904: US-009507513-2008USA008933: US-009507513-2008USA008932: US-009507513-2008USA008903: US-009507513-2008USA008901: US-009507513-2008USA008931: US-009507513-2008USA008930: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008928: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008926: US-009507513-2008USA008925: US-009507513-2008USA008896:
Age: 0.17
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 month old patient accidentally vaccinated with PNEUMOVAX23; No adverse event; This spontaneous report was received from a physician assistant, who is also the patient's mother, reporting about a 2-month-old male patient. The patient's concurrent conditions and medcial history, as well as concomitant medications, were not reported.  On an unknown date, the patient was accidentally vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided). No adverse events were reported.
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: GARDASIL 9 underwent a temperature excursion 8/6/2020 and was administered on 8/11/2020.; No additional AE reported; This spontaneous report has been received from a vaccine coordinator, regarding to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 06-AUG-2020, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection vaccine underwent a temperature excursion (product storage error), and was administered to the patient on 11-AUG-2020, at a dose of 5 milliliter (mL) (route of administration, vaccine scheme and anatomical location were not provided; lot number was S005524 and expiration date was on 29-SEP-2021), as prophylaxis. No additional adverse event (AE) was reported.  There was a temperature of 14.5 degree Celsius (C), with a time frame of 45 minutes. There was not a previous temperature excursion. In addition, a digital 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. ; devicelotnumber: S005524; expirationdate: 29-SEP-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: 62.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No aditional adverse effect reported; The patient was inadvertently administered with a dose of expired but properly stored VAQTA; This spontaneous report has been received from a pharmacist referring to a 62-year-old patient of unknown gender. There was no information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history.  On 13-AUG-2020, the patient was inadvertently vaccinated with a dose of expired but properly stored hepatitis A vaccine, inactivated (VAQTA) injection, vial, strength: 50/1.0 U/ml, 1 dosage form, lot # S018419, expiration reported and validated as 12-JUL-2020, as prophylaxis (dosage schedule, route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported) (expired product administered). No additional adverse effects were reported (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of the GARDSIL 9 series on an unspecified date in 2/2020 and the second dose of the series on 8/10/2020; This spontaneous report was received from a pharmacist, concerning an adult male patient in his mid 20's. Information regarding concomitant medications, pertinent medical history and drug reactions/allergies was not reported.   On an unspecified day in February 2020, 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) for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported= On 10-AUG-2020, the patient received the second dose of the series (Inappropriate schedule of product administration).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No further AE/PQC reported; she received the first and second shot but I did not received the 3rd; This spontaneous report was received from a consumer on behalf of her daughter, referring to her daughter, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  In approximately 2018 (also reported as a couple of years ago), the patient was vaccinated the first and second dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, anatomical site of injection, lot number and expiration date were not reported) as prophylaxis, but she did not received the third dose. It had been 2 years since the patient received the last dose (inappropriate schedule of product administration). No further adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD vaccine administered to patient after temperature excursion; no adverse effect; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.    On 02-AUG-2020, registered a temperature excursion of 35.2 Fahrenheit degrees between 4-5 hours, for a measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) doses. On 07-AUG-2020, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was administered to the patient once per subcutaneous route, lot # T001188 expiration date 11-JUL-2021, for prophylaxis. Vaccines were evaluated for stability on 18-AUG-2020 and were supported.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse events reported.; patient received VARIVAX on 8/13/2020 using a short needle (exact size unknown at time of call) on the  top of thigh.  Due to the location this is being reported as possibly administered into the muscle; possibly administered in to the muscle/it might have hit muscle; Information has been received from a registered nurse, referring to an 18 months old male patient. The patient's medical history, concurrent condition and concomitant medication was not provided.     On 13-AUG-2020, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, lot # and expiration date were unknown) using a short needle (exact size unknown at time of call) on the top of thigh. Due to the location this was being reported as possibly administered into the muscle (incorrect route of product administration). The reporter reported they used a subcutaneous size needle and the baby was described as "chubby" but since location was closer to hip, concerned it might have hit muscle (circumstance or information capable of leading to medication error). No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Haemorrhage, Skin laceration, Syringe issue
Clinical narrative: Syringe issue; Wound bleeding; Finger injury; Accidental exposure while administering drug; This spontaneous report was received from a nurse referring to another nurse, who was a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 18-AUG-2020 (also reported as "yesterday"), the patient was preparing the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S022599 (expiration date: 25-FEB-2022) for a patient administration. Then, when she was gently rolling the syringe, the bottom portion of the syringe broke off in "full circle" and it cut the nurse's finger. She experienced bleeding which was managed with placing an gauze pad and a BANDAID. The bleeding stopped after an hour. Upon probing, the entire round base came off the barrel of the syringe. The round base remained intact as it broke of the barrel, but the base remained hanging on the plunger of the syringe. This occurred before the needle was placed on the syringe. The patient did not miss the dose as replacement dose was provided.  No causality assessment was provided. 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: S022599; expirationdate: 25-FEB-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 suggest a causal association with the device or device constituent
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Pain in extremity, Skin warm
Clinical narrative: Site of injection became inflamed; Entire L arm was painful; Hot to the touch; This case was reported by a consumer via patient support programs and described the occurrence of injection site inflammation in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site inflammation, pain in arm and skin warm. On an unknown date, the outcome of the injection site inflammation, pain in arm and skin warm were unknown.   The reporter considered the injection site inflammation, pain in arm and skin warm to be possibly related to Shingrix.  Additional information was received as follows: Patient had a reaction to the Shingrix Vaccine. Site of injection became inflamed, entire L arm  was painful for 24 hours. It was also painful and hot to the touch. Pharmasist told patient that this was a normal reaction. No other information provided.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dry skin, Eczema, Rash pruritic
Clinical narrative: Dry itchy rash; Looked like Eczema; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included poison ivy rash (almost recovered).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and Boostrix (intramuscular). On an unknown date, immediately after receiving Shingrix and Boostrix, the patient experienced itchy rash and eczema. On an unknown date, the outcome of the itchy rash and eczema were unknown.   It was unknown if the reporter considered the itchy rash and eczema to be related to Shingrix and Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she had poison ivy prior to receiving vaccines, but it had almost disappeared. The patient developed rash after receiving the 2nd Shingrix vaccine and Boostrix vaccine on the same day.  This occurred approximately two months ago from the date of report. She reported that shortly after receiving vaccines, she developed a dry itchy rash on her lower legs, hands, and feet.  Her doctor stated that it looked like Eczema. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Tiredness; Headache; Shivering; Fever; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 69-year-old 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 tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the tiredness, headache, shivering, fever and upset stomach were unknown.   The reporter considered the tiredness, headache, shivering, fever and upset stomach to be possibly related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported. The patient reported experiencing tiredness, headache, shivering, fever, and upset stomach after receiving their 1st dose of the Shingrix vaccine. He stated he thiought he got "all" of the side effects from the vaccine. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: did not received the second dose; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 14th August 2020, less than a year after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of the Shingrix vaccine about one year ago and did not receive the second dose, which led to incomplete course of vaccination. On 14th September 2020, the patient was diagnosed with shingles and was started on Valacyclovir.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles breakout; . This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 7th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than 2 weeks after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir (Aciclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was taken as an adult as per vaccine indication. Reporter called in to request information of how to proceed during a shingles breakout for a patient that had the first dose of Shingrix and just recently had a Shingles breakout. Patient normally treats the condition with aciclovir and was wondering if this was alright, given the recent vaccination. Reporter mentioned to 2nd line agent that patient had experienced shingles breakouts for the past 20 years. Reporter did not have any patient or vaccine information due to "patients just come here to buy the products". Agent did not pursue for more information. The reorter did not consent to follow-up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Urticaria, Vertigo
Clinical narrative: Vertigo; Nausea; Dizziness; Headache; Hives all over his body; This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In August 2020, the patient received the 2nd dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced vertigo, nausea, dizziness, headache and hives. The patient was treated with meclozine hydrochloride (Meclizine) and prednisone. On an unknown date, the outcome of the vertigo, nausea, dizziness and hives were not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the vertigo, nausea, dizziness, headache and hives to be related to Shingrix.  Additional details were provided as follows: The patient reported that he had received both doses of the Shingrix vaccine but he was not sure of the amount of time in between the doses. He stated it had only been a month, but then said he did not remember. The patient recieved 2nd dose of Shingrix approximately 2 weeks before the date of reporting and shortly after receiving the injection, he began to have hives all over his body, intermittent dizziness while sitting and lying down, intermittent vertigo when standing, and random times of where he experienced nausea. The patient scheduled an appointment with his HCP and was given Prednisone for the hives and Meclizine for nausea. The reporter consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Severe Vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe vomiting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: shivering/chills; pain; fever; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a female 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 shivering, pain and fever. On an unknown date, the outcome of the shivering, pain and fever were unknown.   It was unknown if the reporter considered the shivering, pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever, pain, chills, and shivering that her niece reported to the pharmacist.   The pharmacist had no other details of the aunt's experience at time of report. The reporter consented to follow up. This case linked with US2020AMR167887 and US2020167477, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR167887:same reporter US-GLAXOSMITHKLINE-US2020167477:same reporter
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, body aches, sore and red arm where the vaccine wAs given
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Feeling hot, Injection site bruising, Injection site erythema, Injection site reaction
Clinical narrative: normal local site reactions at first- redness and bruising not of concern; two days after vaccine administration severe pain along spinal cord and tingling/burning feeling in the extremities and feeling hot (no fever); this has been intermittent ; it comes and goes, not always present each day but can interrupt sleep
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Local reaction, Paraesthesia, Sleep disorder, Spinal pain
Clinical narrative: normal local site reactions at first- redness and bruising not of concern; two days after vaccine administration severe pain along spinal cord and tingling/burning feeling in the extremities and feeling hot (no fever); this has been intermittent ; it comes and goes, not always present each day but can interrupt sleep
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction, hives. I'm still in hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Rash erythematous
Clinical narrative: large raised red rash on left arm. appeared in ~24 hours, lasted for ~4 days
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain
Clinical narrative: Later that night, the patient had symptoms of myalgia on both of her arms; "it went from one arm to the other."; The patient had "upper body pain above her belly button".; This spontaneous report was received from a pharmacist and refers to a 57-year-old female patient. The patient concurrent conditions included COVID-19. She had "a ton" of an unspecified allergies. The patient had no concomitant medications. No information regarding the patient's medical history was provided.  On 25-JUL-2020, the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml, intramuscularly(anatomical location was not reported) (lot# S024808 with expiration date 02-JUN-2021). A reason for vaccination was that "the patient had COVID-19 and her doctor wanted her to get the vaccine for breathing and pneumonia" (prophylaxis).  On the same day at night, she began to have symptoms of myalgia on both of her arms, reported as "it went from one arm to the other". On that day (25-JUL-2020, reported as "then"), the patient had "upper body pain above her belly button". She did not sought any medical attention. The patient took a diphenhydramine (BENADRYL) but it was not prescribed treatment for her symptoms. No laboratory tests were performed. The outcome of the events was reported as recovering.  The relatedness between the aforementioned events and PNEUMOVAX 23 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: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; 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