chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: allergic reaction / continues to worsen; red; itchy; blotches on his skin; painful blotches on his skin; blisters on his legs and feet; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced allergic reaction, erythema, pruritus, itchy rash, skin pain and blistery rash. On an unknown date, the outcome of the allergic reaction, erythema and pruritus were not recovered/not resolved and the outcome of the itchy rash, skin pain and blistery rash were unknown.   It was unknown if the reporter considered the allergic reaction, erythema, pruritus, itchy rash, skin pain and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated he has what seems to be an allergic reaction and it continues to worsen.  He reported red itchy painful blotches on his skin. He also reported blisters on his legs and feet.  He has seen a dermatologist and is taking a steroid cream. He reported that he was allergic to a lot of things" so he was unsure if this is related to the Shingrix or not. He declined to provide any information beyond that.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR178479:same patient
Age: 71.0
Sex: M
Vaccine: FLUA4, VARZOS
Symptoms: Chills, Cough, Hyperhidrosis, Insomnia, Musculoskeletal stiffness
Clinical narrative: Pleurisy; coughing as if throat needed to be cleared; dripping sweat; Chills; unable to get muscles to relax and unclench; fever; patient woke up at 2 AM; This case was reported by a consumer via call center representative and described the occurrence of pleurisy in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date unknown) for prophylaxis.   Co-suspect products included QUADRIVALENT INFLUENZA VACCINES (FLUAD QUADRIVALENT) for prophylaxis.   The patient's past medical history included lung operation (at an unspecified date) and pleurisy. Previously administered products included Shingles with an associated reaction of ill-defined disorder (received on unknown date).   On 27th August 2020, the patient received the 1st dose of Shingrix and FLUAD QUADRIVALENT. On 27th August 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 28th August 2020, the patient experienced sweating, chills, muscle stiffness and fever. On 30th August 2020, the patient experienced pleurisy and cough. On an unknown date, the outcome of the pleurisy was not recovered/not resolved and the outcome of the cough, sweating, chills, muscle stiffness, insomnia and fever were unknown.   It was unknown if the reporter considered the pleurisy, cough, sweating, chills, muscle stiffness, insomnia and fever to be related to Shingrix.  Additional details were provided as follows: The reporter husband is the patient. The patient received 1st dose Shingrix in left arm and Fluad Quadravalent  flu vaccine in right  arm.  During bedtime that night, caller reports patient woke up at 2 AM putting on quilts and unable to get muscles to relax and unclench. Patient was dripping sweat yet still had chills and a fever.  The patient reported her husband did not have a headache. On Saturday, patient reportedly up and moving doing some activities. On Sunday, patient started coughing as if throat needed to be cleared. Coughing became worse and patient noticed cough inability to rid cough.  The patient reported patient developed pleurisy after having a lung surgery at an unspecified date and assumes he has pleurisy again. The patient reported this has not been confirmed by a  physician. Caller reports her husband went up for a 3 to 4 mile hike and noticed pleurisy became worse. Caller reports her husband had the previous shingles vaccine, and that after lung surgery he had shingles in March or April 2020.  The reporter consent to follow up. This case has been linked with case US2020176972 and US2020AMR177786 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176972:same reporter US-GLAXOSMITHKLINE-US2020AMR177786:same reporter
Age: 71.0
Sex: M
Vaccine: FLUA4, VARZOS
Symptoms: Pleurisy, Pyrexia
Clinical narrative: Pleurisy; coughing as if throat needed to be cleared; dripping sweat; Chills; unable to get muscles to relax and unclench; fever; patient woke up at 2 AM; This case was reported by a consumer via call center representative and described the occurrence of pleurisy in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number ZR979, expiry date unknown) for prophylaxis.   Co-suspect products included QUADRIVALENT INFLUENZA VACCINES (FLUAD QUADRIVALENT) for prophylaxis.   The patient's past medical history included lung operation (at an unspecified date) and pleurisy. Previously administered products included Shingles with an associated reaction of ill-defined disorder (received on unknown date).   On 27th August 2020, the patient received the 1st dose of Shingrix and FLUAD QUADRIVALENT. On 27th August 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 28th August 2020, the patient experienced sweating, chills, muscle stiffness and fever. On 30th August 2020, the patient experienced pleurisy and cough. On an unknown date, the outcome of the pleurisy was not recovered/not resolved and the outcome of the cough, sweating, chills, muscle stiffness, insomnia and fever were unknown.   It was unknown if the reporter considered the pleurisy, cough, sweating, chills, muscle stiffness, insomnia and fever to be related to Shingrix.  Additional details were provided as follows: The reporter husband is the patient. The patient received 1st dose Shingrix in left arm and Fluad Quadravalent  flu vaccine in right  arm.  During bedtime that night, caller reports patient woke up at 2 AM putting on quilts and unable to get muscles to relax and unclench. Patient was dripping sweat yet still had chills and a fever.  The patient reported her husband did not have a headache. On Saturday, patient reportedly up and moving doing some activities. On Sunday, patient started coughing as if throat needed to be cleared. Coughing became worse and patient noticed cough inability to rid cough.  The patient reported patient developed pleurisy after having a lung surgery at an unspecified date and assumes he has pleurisy again. The patient reported this has not been confirmed by a  physician. Caller reports her husband went up for a 3 to 4 mile hike and noticed pleurisy became worse. Caller reports her husband had the previous shingles vaccine, and that after lung surgery he had shingles in March or April 2020.  The reporter consent to follow up. This case has been linked with case US2020176972 and US2020AMR177786 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176972:same reporter US-GLAXOSMITHKLINE-US2020AMR177786:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Inappropriate schedule of product administration, Injection site pain, Pain, Pyrexia
Clinical narrative: burning during urination; aching in body; fever of 100 degrees; soreness around the injection site,; received first dose of Shingrix 2/11/20 (Inappropriate schedule of vaccine); This case was reported by a consumer via call center representative and described the occurrence of micturition burning in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Chickenpox and Shingrix with an associated reaction of injection site erythema (1st dose received in 2nd November 2019, Please refer the case US2020AMR178503.).   On 2nd September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd September 2020, less than a day after receiving Shingrix, the patient experienced micturition burning, general body pain, fever, injection site pain and drug dose administration interval too long. On an unknown date, the outcome of the micturition burning and injection site pain were not recovered/not resolved and the outcome of the general body pain, fever and drug dose administration interval too long were recovered/resolved.   It was unknown if the reporter considered the micturition burning, general body pain, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix vaccine in the left arm intramuscularly. The patient reported after receiving the 2nd dose had soreness around the injection site, fever of 100 degrees, and aching in body. The patient reported the aching in body and fever have subsided but the soreness around the injection site is still ongoing currently. The patient reported burning during urination that began this morning and was still ongoing currently.  2nd November 2019, the patient received 1st dose and 2nd dose on 2nd September 2020, which led to lengthening of the vaccination schedule. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR178503:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: zoster rash erupting on back; acute zoster / Zoster reaction; This case was reported by a physician via sales rep and described the occurrence of rash zosteriform in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia.   On 1st September 2020, the patient received Shingrix. In September 2020, less than a day after receiving Shingrix, the patient experienced rash zosteriform and herpes zoster. The patient was treated with antivirals nos. On an unknown date, the outcome of the rash zosteriform and herpes zoster were unknown.   It was unknown if the reporter considered the rash zosteriform and herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Shingrix and inside of 12 hours had zoster rash erupting on back and had acute zoster. The patient was started on antivirals.  No further details were provided.  The reporter consent to follow up. This case has been linked with case US2020178099 and US2020178096 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178096:same reporter US-GLAXOSMITHKLINE-US2020178099:same reporter
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: arm was sore; first dose of Shingrix around November 22, 2019 but has not received second dose yet; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-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 an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Next day after receiving the 1st dose of Shingrix the patient experienced arm was sore and soreness was resolved approximately four to five days later. The patient not received second dose yet although it has been longer than 6 months. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked with case US2020178098 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178098:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: pain and redness at site of injection; redness and pain at injection site; gave injection subcutaneously; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had his first injection of Shingrix last week but pharmacist gave injection subcutaneously near his tricep and not intramuscularly in his deltoid.  The patient experienced redness and pain at injection site. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Crying, Erythema, Immediate post-injection reaction, Urticaria
Clinical narrative: Crying; welts; Patient turned red; Initial information received on 31-Aug-2020 regarding an unsolicited valid non-serious case from a nurse..  This case involves child patient who experienced crying, welts (urticaria) and turned red (erythema), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ220AA) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious crying, welts (urticaria) and turned red (erythema) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired dose of Fluzone quadrivalent was administered to the patient, no AE; Initial information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a patient (gender unspecified) who was given an expired dose of QUADRIVALENT INFLUENZA VACCINE (INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED) (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. The patient received no other vaccines.   On 28-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number not reported, expiry date: 30-06- 2020) once via intramuscular route in the arm NOS for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, the patient had no adverse event.  Lab data, corrective treatment and outcome: not applicable.  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 lot number.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: a patient was administered doses of Pentacel and Fluzone Quadrivalent before finding out the products were not viable/ No AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant).  This case is linked to cases 2020SA238410 (same reporter).  This case involves a six months old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] before finding out the products were not viable (poor quality product administered) on 01-Sep-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) for prophylactic vaccination and CEFTRIAXONE SODIUM ([CEFTRIAXONE SODIUM]) for an unknown indication.  On 01-Sep-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ146AAA and expiry date 14-Feb-2021) via intramuscular route in the left thigh and also received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number an expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination respectively.  Case details: Medical assistant called to report that two doses of Pentacel and Fluzone Quadrivalent were administered before administered before finding out the products were not viable.  It was an actual medication error due to poor quality vaccine administered.  No adverse event symptoms.  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 on the lot number for this case (for suspect Fluzone Quadrivalent)
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; Initial information received on 02-Sep-2020 regarding an unsolicited valid serious case received from a consumer (patient).  This case involves male patient of an unknown age who experienced anaphylactic reaction, while he received INFLUENZA VACCINE.  Medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing medical history of allergic to eggs (food allergy) and Chronic obstructive pulmonary disease (COPD).  Concomitant medication was not reported.  On an unknown date (reported that 20 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was also reported that the consumer also inquired besides injection site tenderness, were there any other side effects. The consumer also reported he has Chronic obstructive pulmonary and wanted to know if FLUBLOK is recommended and if we have any vendor/pharmacy information on where he can get the FLUBLOK vaccine, as he doesn't want to have to worry about the flu and coronavirus disease (COVID 19).  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event anaphylactic reaction was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a male patient who presented with anaphylactic reaction after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Patient had medical history of being allergic to eggs, and chronic obstructive pulmonary disease at time of vaccination. Additional information on patient's concomitant medication and investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 55.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Contusion, Peripheral swelling
Clinical narrative: Swelling, blue/bruised.  Patient received vaccines 9/9/20 and reported symptoms 09/13/20 (Unable to get in touch with patient to clarify exactly when symptoms started so just put 09/09/20) Patient stated at time she is fine.  On 09/13/20 arm looked blue/bruised, Slight swelling if any.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: Patient was administered Hepatitis A and HPV-9 vaccines in the office today.  Before administration of vaccines Mother stated that patient has a history of fainting and vomiting after receiving vaccines. Patient was offered apple juice and a sucker before receiving the vaccines but declined.  Within 1-2 minutes following administration of the Hepatitis A and HPV-9 vaccines patient had a syncopal episode and vomited.  He was laid down on exam table, given a cool compress for his forehead, offered sucker and apple juice but he declined, vitals were taken and  Nurse Practitioner spoke to patient too. After laying on exam table for about 20 minutes, when he felt better, Mother moved him to sit up in the chair.  He sat up in a chair in the exam room for a few more minutes before leaving the office with Mother.
Age: 1.25
Sex: F
Vaccine: FLUN4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under 2 years of age given FluMist. The patient did not show any symptoms
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Had flu shot at approximately 3:30 pm on 9/12/20 and broke out in hives at approximately 6:30 pm on 9/12/20
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness 45mm across by 60mm up and down, swelling, warm to the touch
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Chills, Night sweats, Pyrexia
Clinical narrative: Chills, fever, pain in lower back. Fever occured during sleep, broke a sweat. Next morning no adverse affects and none since
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Eye pain, Hyperhidrosis, Loss of consciousness, Mobility decreased, Pain in extremity
Clinical narrative: Patient reported arm soreness, pain, and inability to move arm. She also experienced excessive sweating, eye pain, and a brief loss of consciousness (fainted). She said she did not have a fever or excessive redness or swelling at the injection site. She called her doctor and they told her to contact the pharmacy. They did not ask her to come in and be seen. I told her to try taking an over the counter anti-inflammatory and use a cold compress to help with the sweating and eye pain.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Patient reported arm soreness, pain, and inability to move arm. She also experienced excessive sweating, eye pain, and a brief loss of consciousness (fainted). She said she did not have a fever or excessive redness or swelling at the injection site. She called her doctor and they told her to contact the pharmacy. They did not ask her to come in and be seen. I told her to try taking an over the counter anti-inflammatory and use a cold compress to help with the sweating and eye pain.
Age: 21.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction noted.  Vaccine was given outside of the approved age ranges.
Age: 29.0
Sex: F
Vaccine: HEP, HEP, HEPA, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered two hepatitis B vaccines at same time; 1 in the right art and 1 in the left arm both IM. Patient was notified immediately. Called patient next day; denies any adverse/side effects. Regional Nurse Manager was also notified immediately after event occurred.
Age: 70.0
Sex: U
Vaccine: FLU4, HEPA, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Vomiting
Clinical narrative: Became very dizzy and fatigued, vomited until bile was present, symptoms persisted until Saturday. Sunday morning took Motrin for headache. Tired, but not exhausted. No symptoms on Monday.
Age: 72.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Severe arm and shoulder pain.  Unable to raise arm.  Better now but lasted over 2 weeks.  Abnormal pain
Age: 75.0
Sex: M
Vaccine: FLUA4, PNC13
Symptoms: Dizziness, Seizure, Skin laceration
Clinical narrative: Patent woke up the next morning after receiving the shots and got out of bed and was dizzy and ran into the wall and cut his forehead. He was convulsing for about an 1.5 hours and his wife took him to the ER. By the time he got to the ER, the convulsions had stopped. The ER fixed the cut on his forehead.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Vaccine given and was expired. Call placed to Merck and verified that vaccine counts and does not need to be repeated.
Age: 73.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Flushing, Loss of consciousness
Clinical narrative: patient stated she felt faint and was going to go "out". Patient went unconscious continued to breath, flushed on arms and chest ems called patient awoke EMT arrived and spoke with patient taking blood pressure and oxygen level. Patient stated she did not want to go to hospital and EMTs escorted her to her car and she was driven home
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: chills, fever, arthralgia, myalgia, mild nausea , decreased appetite, headache   36-48 hours
Age: 67.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Pyrexia
Clinical narrative: chills, fever, arthralgia, myalgia, mild nausea , decreased appetite, headache   36-48 hours
Age: 72.0
Sex: F
Vaccine: FLUA4, FLUA3
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Within one hour of receiving the 11AM injection, my left shoulder became excruciating painful, with pain continuing down the arm.  Due to the pain I had little to no range of motion.  Neither aspirin nor NSAIDS had any effect on the pain.  By the following morning, most of the pain had gone, and it disappeared completely by mid-day.
Age: 72.0
Sex: F
Vaccine: FLUA4, FLUA3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Within one hour of receiving the 11AM injection, my left shoulder became excruciating painful, with pain continuing down the arm.  Due to the pain I had little to no range of motion.  Neither aspirin nor NSAIDS had any effect on the pain.  By the following morning, most of the pain had gone, and it disappeared completely by mid-day.
Age: 72.0
Sex: F
Vaccine: FLUA4, FLUA3
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: SEREVE PAIN FROM LEFT SHOULDER RADIATING DOWN HER LEFT ARM FOR 1 WEEK
Age: 72.0
Sex: F
Vaccine: FLUA4, FLUA3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: SEREVE PAIN FROM LEFT SHOULDER RADIATING DOWN HER LEFT ARM FOR 1 WEEK
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: the night of the injection flu-like symptoms, body aches, slight nausea, chills, loss of appetite, headache, very sore at injection sight include red spot approximately 1" in diameter around the injection sight. Symptoms  continued all day on Sunday (took two 500mg acetaminophen around 12 noon on Sunday - gave some relief of symptoms for about 8 hours). Today, Monday 9/14 feeling a lot better, a little sweaty at times but almost back to normal after 48 hours.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: the night of the injection flu-like symptoms, body aches, slight nausea, chills, loss of appetite, headache, very sore at injection sight include red spot approximately 1" in diameter around the injection sight. Symptoms  continued all day on Sunday (took two 500mg acetaminophen around 12 noon on Sunday - gave some relief of symptoms for about 8 hours). Today, Monday 9/14 feeling a lot better, a little sweaty at times but almost back to normal after 48 hours.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Dizziness postural, Hyperhidrosis, Pallor, Visual impairment
Clinical narrative: During car ride home after vaccines administered vision became black for a few seconds, diaphoresis & dizziness & pallor. Ate crackers & drank lemonade & felt better. Color returned. Throughout the afternoon & evening was dizzy whenever stood up. Felt fine, asymptomatic 8/25 when awoke. No further symptoms
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE reported; The nurse stated the expired product was given to a patient today; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant therapies, drugs reactions or allergies were not provided.  On 27-AUG-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella virus vaccine live (PROQUAD)( lot # S000622, expiration date: 06-JUL-2020)(dose, strength, route of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # S005088, expiration date: 27-SEP-2021) (dose, strength, route of administration were not provided). The measles, mumps, rubella and varicella virus vaccine live (PROQUAD) had no temperature excursions in the past. There was no other adverse event reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no further AE information reported; administration of improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 27-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella virus vaccine live rHA (recombinant human albumin) (PROQUAD) lot # S021326 was verified to be valid, expiration date reported and established as 05-JAN-2021 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. There was also a previous temperature excursion of 6 to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. Digital Data Logger was involved.  The patient did not experience any additional adverse reactions.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: S031881, expiration date: 07-APR-2021, route of administration was not provided) 0.5 ml diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number: S031881, expiration date: 07-APR-2021, route of administration was not provided) 0.5 ml diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Gave expired MMR to patient; This spontaneous report was received from a specific reporter, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.     On 02-SEP-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route were not provided; lot # R024907, expiration date 30-AUG-2020) for prophylaxis. The outcome of expired product administered was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a heath care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient 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 the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sex: U
Vaccine: HEP
Symptoms: Immunisation, No adverse event, Underdose
Clinical narrative: No additional AE/PQC; staff nurse administered a pediatric dose of RECOMBIVAX to an adult patient on 10-AUG-2020 and 12-AUG-2020; pediatric vaccine (0.5mL) 10-AUG-2020 and 12-AUG-2020; This spontaneous report has received from an office employee, referring to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 10-AUG-2020, the patient was vaccinated by a nurse, with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), at 0.5 milliliter (mL) (route of administration, scheme vaccine and anatomical location were not provided; lot number 9794C was an invalid lot number for hepatitis b vaccine (recombinant), expiration date was reported on 13-JUN-2020), as prophylaxis. On 12-AUG-2020, the patient received, by a nurse, another pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), at a dose of 0.5 mL (route of administration, scheme vaccine, anatomical location, lot number and expiration date were not reported), as prophylaxis.  The reporter stated that the nurse assumed that giving the additional dose of the pediatric vaccine (0.5mL) to the patient, to equal one adult dose (1.0 mL), would be sufficient (product administered to patient of inappropriate age and incorrect dose administered). No additional adverse event (AE) were reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error, Single component of a two-component product administered
Clinical narrative: a nurse forgot to mix the sterile diluent with the "shingles" vaccine and administered only the sterile diluent to a patient today; a nurse forgot to mix the sterile diluent with the "shingles" vaccine and administered only the sterile diluent to a patient today; patient did not receive complete dose from initial attempt.; This spontaneous report has received from a medical assistant, referring to a 56 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.  On 09-SEP-2020, the reporter stated that a nurse forgot to mix the sterile diluent (manufacture unknown) (1 dose, strength, route, indication, lot number and expiration date were unknown) with the shingles vaccine and administered only the sterile diluent (manufacture unknown) to the patient (single component of a two-component product administered and product preparation error), instead of the vaccine itself. Upon probing, the reporter was referring to zoster vaccine live (ZOSTAVAX) (1 dose, strength, route, lot number and expiration date were unknown) vaccine for prophylaxis, and today was meant to be first shot of shingles vaccine. The reporter would like to know if it was okay to administer zoster vaccine live (ZOSTAVAX) since patient did not receive complete dose from initial attempt (accidental underdose).
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain
Clinical narrative: nausea; dizziness; aching all over the body; headache; fatigue.; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th September 2020, couple of hours after receiving Shingrix, the patient experienced pain in arm. On 7th September 2020, the patient experienced nausea, dizziness, general body pain, headache and fatigue. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the nausea, dizziness, general body pain, headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, nausea, dizziness, general body pain, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm a few hours after the injection.  Three days after receiving vaccination, the patient experienced nausea, dizziness, aching all over the body, headache, and fatigue.   The patient shared that his sister's husband had unspecified adverse reactions and shared that his nurse reported unspecified adverse reactions to Shingrix as well.   There were no other details provided. The reporter consented to follow up. This case linked with US2020AMR181580 and US2020AMR181581, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR181580:same reporter (borther´s in law case) US-GLAXOSMITHKLINE-US2020AMR181581:same reporter (nurse case)
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: nausea; dizziness; aching all over the body; headache; fatigue.; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th September 2020, couple of hours after receiving Shingrix, the patient experienced pain in arm. On 7th September 2020, the patient experienced nausea, dizziness, general body pain, headache and fatigue. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the nausea, dizziness, general body pain, headache and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, nausea, dizziness, general body pain, headache and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm a few hours after the injection.  Three days after receiving vaccination, the patient experienced nausea, dizziness, aching all over the body, headache, and fatigue.   The patient shared that his sister's husband had unspecified adverse reactions and shared that his nurse reported unspecified adverse reactions to Shingrix as well.   There were no other details provided. The reporter consented to follow up. This case linked with US2020AMR181580 and US2020AMR181581, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR181580:same reporter (borther´s in law case) US-GLAXOSMITHKLINE-US2020AMR181581:same reporter (nurse case)
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: injection site rash; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had injection site rash.
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Serology test, Therapeutic response decreased
Clinical narrative: Titers were low; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, 3 weeks after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The age at vaccination was not reported. After had completed the Hepatitis B vaccine series, had the titers drawn, and the titers were low. It was 3 weeks since the date of reporting since he completed the series. The patient wanted to get revaccinated with Hepatitis B vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Rash, Swelling
Clinical narrative: Rash that started as two spots /  the rash had become larger; Pain; Swelling; has had to remain on her couch since the injection; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 1st September 2020, immediately after receiving Shingrix, the patient experienced pain, swelling and mobility decreased. On 4th September 2020, the patient experienced rash. On an unknown date, the outcome of the pain and swelling were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the pain, swelling, mobility decreased and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine in the left arm and experienced pain and swelling that was so severe that she had to remain on her couch since the injection. The patient noticed a rash that started as two spots that were the size of a nickle and rash had became larger and she continued to have pain and swelling. The pain and swelling had improved. All information was not available. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, Eye irritation, Occupational exposure to product
Clinical narrative: it burned a little bit.; when withdrawing Shingrix out of the vial, the vaccine shot in his/her eye; when withdrawing Shingrix out of the vial, the vaccine shot in his/her eye; when withdrawing Shingrix out of the vial, the vaccine shot in his/her eye; This case was reported by a other health professional via call center representative and described the occurrence of burning sensation in eye in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation in eye, inadvertent exposure to vaccine, exposure via eye contact and occupational exposure to product via eye. On an unknown date, the outcome of the burning sensation in eye, inadvertent exposure to vaccine, exposure via eye contact and occupational exposure to product via eye were unknown.   It was unknown if the reporter considered the burning sensation in eye to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The health care provider reported that when withdrawing Shingrix out of the vial, the vaccine shot in his/her eye and it burned a little bit which led to  inadvertent exposure to vaccine, exposure via eye contact and occupational exposure to product via eye. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling
Clinical narrative: pain and swelling at injection site; pain and swelling at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix. On 2nd September 2020, immediately after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had pain and swelling at injection site.  The adverse reactions appeared right away, and still not recovered.  No other information was provided. The reporter consented to follow up. Address and Email were confirmed.