chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; patient was administered GARDASIL 9 two years ago/The second dose was administered today; This spontaneous report was received from a nurse prescriber, referring to a 15 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  In September 2017 (reported as "two years ago"), 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 (strength, dose, route, frequency, lot# and expiration date were not reported).  On 10-SEP-2019 (reported as "today"),  the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot# R029512, expiration date 08-JUL-2021, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported.
Age: 9.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received improperly stored PROQUAD; No adverse effect; This spontaneous report was received from a medical assistant, referring to a 9 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 05-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot# S002494, expiration date 23-JUL-2020, for prophylaxis (strength, dose, route and frequency were not reported). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)was reconstituted with a properly sterile diluent (MERCK STERILE DILUENT).   The temperature excursion was of 6 fahrenheit degrees (°F) to 14 °F (102°F), during 50 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Age: 65.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Body temperature increased, Influenza like illness, Vomiting
Clinical narrative: Severe flu-like ague,vomiting starting 4-5 hours after innoculations. Temp went up to 101. symptoms lasted 6-8 hours.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: On 09/15/19 patient developed large red circle on upper shoulder area, next to the site of administration. Patient presented to the pharmacy 09/16/19 concerned about the area and complained that it hurt to touch as well. I told the patient to take Benadryl to help ease the reaction and to follow up with her PCP.
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Erythema, Headache, Nausea, Pruritus, Pyrexia
Clinical narrative: headache, nausea followed by fever the rest of the 14th. Rash around neck that night, woke up Sunday 15th with rash down chest. Itching down torso. Went to medical office for steroid shot and medrol pack. Monday 16th now. Not as red still see rash up skin, itch is still there and down back.  Do I get second shot??
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Rash
Clinical narrative: headache, nausea followed by fever the rest of the 14th. Rash around neck that night, woke up Sunday 15th with rash down chest. Itching down torso. Went to medical office for steroid shot and medrol pack. Monday 16th now. Not as red still see rash up skin, itch is still there and down back.  Do I get second shot??
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: SHINGLES LEFT ARM, AND CHIN APPEARED 9/14/19 3 DAYS AFTER SHOT. VERY MILD CASE LASTED 2 DAYS. NO PAIN. ITCHING, AND BLISTERS ONLY.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Child received DTP/IPV for wrong series.  No adverse reaction noted.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Patient blacked out, nausea, vomiting and headache
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She had her vaccine late evening on September 11th.  The next morning when she woke up she said her leg hurt and it hurt to walk. I just told her she would be fine.  Then I looked at her leg  when I got her dressed. It was a little swollen (which I expected) a little red and warm to the touch. She had a slight fever of 99.8.  She went to school and I picked her up at 11:30.  Her leg looked much worse. I called the dr office and they told me to put cold compress on the site and give her motrin.  I went back to work and an hour later I received a call that my daughter is really hurting. She is saying her head hurts and is not herself at all.  I called back the dr and got an apt to go in.  I saw a nurse for about 2 mins max. She looked at her leg and just said it was normal. No vitals were taken.  On the way home I stopped to pick up motrin from the store and gave it to her in the parking lot.  I picked up my son and we went home. When I got home I took her temp again (after I gave her motrin).  It was almost 103.  By that evening (5:00pm) Her whole upper thigh was huge.  Over the size of a baseball.  It was very red and very hot to the touch.  The next morning 9/13 there was no change in her leg.  Her fever was down to the upper 100's with no Motrin given.  She still said her leg hurt to walk.  On 9/14 the swelling went down slightly but was still very red and hot to the touch.  She no longer had a fever.  That evening she developed diarrhea.  9/15 she still had diarrhea that morning. Her leg was still red and  hot to the touch.  The swelling did go down a little more.  9/16 No diarrhea. The swelling continues to go down along with the redness.  It is no longer hot to the touch.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: She had her vaccine late evening on September 11th.  The next morning when she woke up she said her leg hurt and it hurt to walk. I just told her she would be fine.  Then I looked at her leg  when I got her dressed. It was a little swollen (which I expected) a little red and warm to the touch. She had a slight fever of 99.8.  She went to school and I picked her up at 11:30.  Her leg looked much worse. I called the dr office and they told me to put cold compress on the site and give her motrin.  I went back to work and an hour later I received a call that my daughter is really hurting. She is saying her head hurts and is not herself at all.  I called back the dr and got an apt to go in.  I saw a nurse for about 2 mins max. She looked at her leg and just said it was normal. No vitals were taken.  On the way home I stopped to pick up motrin from the store and gave it to her in the parking lot.  I picked up my son and we went home. When I got home I took her temp again (after I gave her motrin).  It was almost 103.  By that evening (5:00pm) Her whole upper thigh was huge.  Over the size of a baseball.  It was very red and very hot to the touch.  The next morning 9/13 there was no change in her leg.  Her fever was down to the upper 100's with no Motrin given.  She still said her leg hurt to walk.  On 9/14 the swelling went down slightly but was still very red and hot to the touch.  She no longer had a fever.  That evening she developed diarrhea.  9/15 she still had diarrhea that morning. Her leg was still red and  hot to the touch.  The swelling did go down a little more.  9/16 No diarrhea. The swelling continues to go down along with the redness.  It is no longer hot to the touch.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain, Skin warm
Clinical narrative: Patient reported local pain which subsided over following days, but starting 09/13/2019 area began to be red, inflamed and warm to touch. Patient presented to pharmacy on 09/16/2019 with area red, inflamed and warm to touch. Patient denied any issues with breathing or swallowing. Patient advised to contact MD.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Patient experienced soreness after injection then the pain around her shoulder gotten worse over time.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient had an annual visit with PCP and MD placed an order for a Influenza vaccine. I explained vaccine side effects, contraindications and CDC recommendations for vaccine. Patient given VIS. Patient reported never taken the influenza vaccine before. Patient reports allergies to Nuts only. Patient denies allergies to eggs, gelatin. Patient also denied history of Guiliam Barre Syndrome. I administered Afluria flu vaccine as per MD ordered on the left deltoid. Patient tolerated well no complains right after given vaccine. As Medical Assistant drew blood from patient approximately 10 minutes after patient reported red spots appeared on bilateral forearms. I immediately inform MD, and RN of reaction. Patient denied SOB, itchiness, neither swelling of face. MD assess patient lung sounds- negative wheezing. MD ordered PO Diphenhydramine. RN administered Diphenhydramine 25 mg as per MD ordered. Patient was observed for an hour after administration of medication. Patient denied any new symptoms, patient was informed to call office if new symptoms arise, also a prescription was sent to pharmacy. At time patient left no more concerns or questions. RN left voicemail to patient the following day. I called back patient as well to find out how he was feeling. Spoke with patient. Patient reported feeling well. Red spots are still there looked the same. Patient denies SOB, itchiness, or swelling. Patient informed no new spots appeared. Patient only felt a tight lower back later Wednesday. MD was made aware of this.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Rash erythematous
Clinical narrative: RED RASH ON ARMS AND LEGS APPEARED THE DAY AFTER THE VACCINATION
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Client given pediatric dose of Hepatitis A vaccine. Follow pc made x2 on 9/16/19, Messages left. Client was informed Hep A dose given on 9/12/19 is invalid and needs to be repeated. Encouraged to call if has further questions or concerns. Given contact information to return pc. No return contact made.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccine at age 7 when vaccine recommended for ages 6 and under. No adverse reaction reported.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called in complaining of pain in the arm where shot was given, also redness and slight swelling around injection site.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles in which he had to go to doctor for treatment
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: FROM 8/31 UNTIL 9/4/2019 HE EXPERIENCED PAIN IN HIS LEFT ARM AND HE COULDNT PUT HIS ARM OVER HIS HEAD THE ENTIRE TIME. HE SAID " IT HURT LIKE THE DICKENS" BUT IT CLEARED UP ON THE DAY HE REPORTED ON 09/04/2019 AT 11:44AM
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: patient received MMR 11/28/2018 instead of MMR-V as ordered. Patient not immunized with Varicella vaccine  on this date. Varicella was given 5/22/19 as a catch up dose. No Varicella outbreak during lack of coverage.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: Soreness, pt stated that he was unable to bend and it just ached for over 2 weeks now
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Chills, Erythema, Pyrexia
Clinical narrative: this was  the second shot - joints ached fever, chills, redness on left forearm which then developed into painful rash and blisters. As of today the 16th of September blisters have popped and pain  is less but still  present. On  Sept 13 doctor prescribed Valacyclovir 1 gram 3 x day for 10 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: this was  the second shot - joints ached fever, chills, redness on left forearm which then developed into painful rash and blisters. As of today the 16th of September blisters have popped and pain  is less but still  present. On  Sept 13 doctor prescribed Valacyclovir 1 gram 3 x day for 10 days
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pustular
Clinical narrative: PATIENT REPORTED A "POX-LIKE" RASH ON ARMS AND LEGS WHICH LASTED FOR 3 DAYS. PATIENT TOOK BENADRYL (ORAL) WHILE EXPERIENCING RASH)
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Erythema, Hyperhidrosis, Infection, Peripheral swelling, Skin warm
Clinical narrative: woke up morning after immunization with swollen and warm red upper arm. patient complained of sweats. patient went to doctor and was told she had an infection. she received a prescription for doxycycline.
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: woke up morning after immunization with swollen and warm red upper arm. patient complained of sweats. patient went to doctor and was told she had an infection. she received a prescription for doxycycline.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: patient received MMR on 10/4/2018 instead of MMR-V as ordered. Patient was not immunized with Varicella on this date. Varicella was given on 7/10/2019 as a catch up dose. No varicella outbreak during lack of coverage.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash started on left arm, then in back on buttocks and hands. Hard time breathing
Age: 60.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Cold sweat, Diarrhoea
Clinical narrative: Received a flu vaccine and Shingrix vaccine at the same time. By evening had joint/muscle pain and shivering. Got up feeling fatigued and weak, slight nausea. At approximately 8:00 a.m., felt dizzy and clammy, then passed out and hit forehead on marble floor. No further dizziness after that event. Fatigue and joint/muscle pain continued throughout that day but subsided by evening. On 09/16/2019 (four days after the shot), experienced nausea and diarrhea. Have never had an adverse reaction to a flu shot.
Age: 60.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Dizziness, Fatigue, Head injury, Loss of consciousness, Myalgia
Clinical narrative: Received a flu vaccine and Shingrix vaccine at the same time. By evening had joint/muscle pain and shivering. Got up feeling fatigued and weak, slight nausea. At approximately 8:00 a.m., felt dizzy and clammy, then passed out and hit forehead on marble floor. No further dizziness after that event. Fatigue and joint/muscle pain continued throughout that day but subsided by evening. On 09/16/2019 (four days after the shot), experienced nausea and diarrhea. Have never had an adverse reaction to a flu shot.
Age: 60.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Nausea
Clinical narrative: Received a flu vaccine and Shingrix vaccine at the same time. By evening had joint/muscle pain and shivering. Got up feeling fatigued and weak, slight nausea. At approximately 8:00 a.m., felt dizzy and clammy, then passed out and hit forehead on marble floor. No further dizziness after that event. Fatigue and joint/muscle pain continued throughout that day but subsided by evening. On 09/16/2019 (four days after the shot), experienced nausea and diarrhea. Have never had an adverse reaction to a flu shot.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: (L) arm inflammation  9.5 by 10.5 cm, red raised area on LA Deltoid
Age: 48.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's wife called to stated pt. had "bad reaction right arm is swollen red & hot w/a red ring on the whole arm."
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored PROQUAD; 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 pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # S002494, expiration date: 23-JUL-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.2 degrees Fahrenheit, multiple) for 50 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; one dose of an improperly stored vaccine, VARIVAX, was administered to one patient; VARIVAX / assistant confirmed route of administration was "intramuscular"; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 11-SEP-2019, the patient was vaccinated with improperly stored vaccine of varicella virus vaccine live (oka/merck)(VARIVAX)0.5 ml, once, intramuscularly, lot # S002877, expiration date 29-JAN-2021, for prophylaxis (strength, lot#, expiration date were not reported). VARIVAX was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT), possible lot # S000130 expiration date reported as 23-AUG-2021.  The temperature excursion was of 8.1 Fahrenheit degrees (°F), for 20 minutes. However, a previous temperature excursion of 8.1 °F for 17 minutes, and 9.5°F for 21 minutes were also reported. A digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful; Wrong Injection Technique; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain and wrong injection technique. On an unknown date, the outcome of the pain and wrong injection technique were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter administered the 1st dose of Shingrix injection in the deltoid muscle and the patient asked why the injection was given in the deltoid muscle. The reported stated she was researching this further and was not sure whether the Shingrix was given subcutaneously, which led to wrong injection technique. The pharmacist was not in the pharmacy at the time of this call, so limited details were available. The reporter consented to follow up. This case had been linked to the case US2019162812, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Asthenia, Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Feeling of weakness; feeling of overall fever; Site of injection is very hot; Injection site red; Injection site a little tough to the touch; Side Effects; This case was reported by a consumer and described the occurrence of feeling hot in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On 3rd September 2019, less than a day after receiving Shingrix, the patient experienced feeling hot and adverse drug reaction. On 4th September 2019, the patient experienced feelings of weakness. In September 2019, the patient experienced injection site warmth, injection site erythema and injection site induration. The patient was treated with paracetamol (Tylenol). On 4th September 2019, the outcome of the feeling hot was recovered/resolved. On an unknown date, the outcome of the feelings of weakness was unknown and the outcome of the injection site warmth, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the feeling hot, feelings of weakness, injection site warmth, injection site erythema, injection site induration and adverse drug reaction to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. On Tuesday evening, the patient had feeling of overall fever (but no high temperature was registered on thermometer) until midday on Wednesday. The next day morning, the patient had feeling of weakness.  The patient stated, till the time of reporting, the site of injection was very hot, red and a little tough to the touch (60 plus hours post injection). The other side effects were gone about 30 hours post injection. The patient had been taking extra strength Tylenol to help and was icing the injection site.  The patient asked if these were typical reaction occurs after vaccination and also asked if GlaxoSmithKline have any suggestions for it.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Feeling of weakness; feeling of overall fever; Site of injection is very hot; Injection site red; Injection site a little tough to the touch; Side Effects; This case was reported by a consumer and described the occurrence of feeling hot in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix. On 3rd September 2019, less than a day after receiving Shingrix, the patient experienced feeling hot and adverse drug reaction. On 4th September 2019, the patient experienced feelings of weakness. In September 2019, the patient experienced injection site warmth, injection site erythema and injection site induration. The patient was treated with paracetamol (Tylenol). On 4th September 2019, the outcome of the feeling hot was recovered/resolved. On an unknown date, the outcome of the feelings of weakness was unknown and the outcome of the injection site warmth, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the adverse drug reaction was recovered/resolved.   It was unknown if the reporter considered the feeling hot, feelings of weakness, injection site warmth, injection site erythema, injection site induration and adverse drug reaction to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. On Tuesday evening, the patient had feeling of overall fever (but no high temperature was registered on thermometer) until midday on Wednesday. The next day morning, the patient had feeling of weakness.  The patient stated, till the time of reporting, the site of injection was very hot, red and a little tough to the touch (60 plus hours post injection). The other side effects were gone about 30 hours post injection. The patient had been taking extra strength Tylenol to help and was icing the injection site.  The patient asked if these were typical reaction occurs after vaccination and also asked if GlaxoSmithKline have any suggestions for it.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm ached; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient reported for himself. About 2 months and 1 week before the reporting date, the patient got his 1st dose of Shingrix in an unknown arm. Afterwards his arm ached quite a bit for about 1 week before resolving.  The patient consented to follow up. This case has been linked to US2019162791, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: Feel very achy; Feel tired; Fell just not up to par; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingles vaccine. In September 2019, less than a week after receiving Shingles vaccine, the patient experienced pain, tiredness and feeling abnormal. On an unknown date, the outcome of the pain, tiredness and feeling abnormal were unknown.   It was unknown if the reporter considered the pain, tiredness and feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient felt very achy, tired, and just not up to par after receiving vaccine. The patient realized that these are common side-effects of the drug. The patient asked when they go away and when should I worry.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Nausea, Pain
Clinical narrative: lightheaded / dizzy; achy; queasy; This case was reported by a nurse via sales rep and described the occurrence of light headedness in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, 3 hrs after receiving Bexsero, the patient experienced light headedness, pain and queasy. On an unknown date, the outcome of the light headedness, pain and queasy were unknown.   It was unknown if the reporter considered the light headedness, pain and queasy to be related to Bexsero.  Additional case details were provided as follows: The patient's mother narrated the adverse events to the nurse and she reported to GlaxoSmithKline. About 3 hours after receiving the Bexsero vaccine, the patient started feeling lightheaded, dizzy, achy and queasy. The patient however did not faint. The reporter consented to follow up and provided her details.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Myalgia, Pyrexia
Clinical narrative: Severe Muscle Pain; Injection Site Pain; Fever; Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th September 2019, the patient received the 1st dose of Shingrix. On 6th September 2019, 2 days after receiving Shingrix, the patient experienced muscle pain, injection site pain, fever and malaise. On an unknown date, the outcome of the muscle pain, injection site pain, fever and malaise were unknown.   It was unknown if the reporter considered the muscle pain, injection site pain, fever and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient vaccinated with Shingrix and was experiencing severe muscle pain, injection site pain, fever and malaise. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site induration, Injection site nodule
Clinical narrative: Developed a hard knot at the site of injection and it is blackish-blue in color; Developed a hard knot at the site of injection and it is blackish-blue in color; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site induration and injection site discoloration. On an unknown date, the outcome of the injection site induration and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site induration and injection site discoloration to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient got her first Shingrix shot two or three days ago.  She developed a hard knot at the site of injection and it was blackish-blue in color. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Vertigo; This case was reported by a pharmacist via call center representative and described the occurrence of vertigo 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, less than a week after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was recovering/resolving.   It was unknown if the reporter considered the vertigo to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient returned to the pharmacy to discuss vertigo which started after Shingrix administration. The reporter then spoke with the patient 1 week after her dose and the symptoms were subsiding. The reporter had no further details, they were not in the pharmacy at the time of reporting. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extensive swelling of vaccinated limb; Irregular shaped redness; Pain; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 1-year-old male patient who received DTPa (Infanrix) (batch number T753J, expiry date 1st February 2021) for prophylaxis.   On 23rd August 2019, the patient received Infanrix. On an unknown date, less than 2 weeks after receiving Infanrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site pain to be related to Infanrix.  Additional case details were reported as follows: The patient received vaccine in left thigh. The patient developed an injection site reaction, left lateral thigh swelling approximately 18cm, pain & irregular shaped redness. No additional details or resolution of symptoms were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Loss of consciousness, Oral herpes, Pain in extremity
Clinical narrative: cold sore; sore arm; felt bad; passed out; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date, received 1st dose).   In July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced cold sores (serious criteria hospitalization), pain in arm (serious criteria hospitalization), feeling bad (serious criteria hospitalization) and passed out (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the pain in arm, feeling bad and passed out were recovered/resolved.   It was unknown if the reporter considered the cold sores, pain in arm, feeling bad and passed out to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 80 or 81 years. The patient received Shingrix about 2 months before the date of reporting on right arm. The patient experienced sore arm. The day after receiving Shingrix, the patient felt bad, sat down and passed out. The patient was admitted to the hospital overnight for observation and was released the next day. The reporter consented to follow up. This case has been linked with cases US2019163766 and US2019163768 reported by the same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: muscular pain; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced muscle pain and injection site pain. On an unknown date, the outcome of the muscle pain and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscular pain in and around the injection site.  The patient told that, the muscular pain in the whole arm that he noticed once he moves his arm. It was noticeable pain.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Induration, Product administered at inappropriate site, Skin warm
Clinical narrative: CELLULITIS; INDURATION; WARM TO TOUCH; Vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 3-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2018-2019 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of FluLaval Quadrivalent 2018-2019 season (intramuscular) .5 ml. On 26th August 2019, unknown after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced vaccine administered at inappropriate site. On 28th August 2019, the patient experienced cellulitis (serious criteria GSK medically significant), induration and skin warm. The patient was treated with cephalexin (Keflex) and mupirocin (Bactroban (Mupirocin)). On an unknown date, the outcome of the cellulitis, induration, skin warm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis, induration and skin warm to be related to FluLaval Quadrivalent 2018-2019 season.  Additional details were provided as follows: The patient received FluLaval Quadrivalent 2018-2019 season on right thigh, which led to vaccine administered at inappropriate site. The patient had not received any other vaccines while receiving FluLaval Quadrivalent 2018-2019 season. The patient experienced cellulitis, induration and was warm to touch. The patient was treated with Keflex and Bactroban. It was not necessary for the reporter to follow-up. This case has been linked with case US2019AMR164419 reported by the same reporter. Clarification has been raised to confirm the time to onset of event, as of now it was considered as 2 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized rx at time of injection on 9/9/19 and then on 9/14/19 noted inc in pain,swelling,redness,heat and firm tissue to Rt arm from shoulder to elbow. Presented to wlc on 9/16/19 with ongoing pain although decreased some,swelling, redness and heat with firm tissue from rt deltoid to elbow.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Localized rx at time of injection on 9/9/19 and then on 9/14/19 noted inc in pain,swelling,redness,heat and firm tissue to Rt arm from shoulder to elbow. Presented to wlc on 9/16/19 with ongoing pain although decreased some,swelling, redness and heat with firm tissue from rt deltoid to elbow.
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: CLIENT GIVEN FIRST DOSE OF HEPATITIS A UNEVENTFULLY AROUND 10:20. CLIENT CALLED CLINIC AROUND 1520 COMPLAINING OF HAVING HIVES ALL OVER HER BODY WHEN SHE RETURNED HOME. INSTRUCTED TO TAKE BENADRYL, CALL PCP FOR FURTHER RECOMMENDATIONS, AND GO TO ER IF SYMPTOMS PROGRESS OF INVOLVE THE RESPIRTORY SYSTEM. F/U PC MADE 9/9/19 CLIENT REPORTS DID F/U WITH PCP VIA PC. NO FURTHER RECOMMENDATIONS WERE MADE. CLIENT WAS USING BENADRYL PO & TOPICALLY FOR 36 HOURS. REPORTS HIVES ARE STILL PRESENT BUT HAVE DECREASED IN SIZE AND SEVERITY. GIVEN CLINIC PH # TO CALL IF HAS FURTHER ?S OR CONCERNS.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Headache
Clinical narrative: Pt. reported feeling dizzy for 3-4 days after the immunization and having headache. Pt. stated she normally has vertigo but this dizziness was different from her usual symptoms and she also had headache. Pt. fully recovered as of today (6 days post immunization).
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: The patient's arm was bleeding upon removing the needle (more than a couple drops) and the patient's arm immediately began swelling after the injection.  The patient did not seem to be in any distress, and stated she was having no pain.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary pain, Chills, Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: fever, chills, weakness pain numbness in bilateral lower extremities, pain right axilla, left upper arm tingling
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: fever, chills, weakness pain numbness in bilateral lower extremities, pain right axilla, left upper arm tingling
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Uveitis
Clinical narrative: 4 weks after vaccination I was foud to have uveitis, initially in the right eye and then in both
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Headache, Nausea, Neck pain
Clinical narrative: nausea for 7 days, headache, backache and neck pain for 7 days -no treatment requested, advised if it continues past today to report to the doctor
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site warmth
Clinical narrative: LVL=8.25cm x 8.89 red, warm to touch, & itchy, irritated RVL= 1.9cm x 1.27 red, irritated
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Patient bled initially, then immediately after removing the inject-safe bandage to replace with clean/dry bandage, the patient's arm puffed up right at injection site. Probably 1.5-2inches in diameter, obvious swelling and bruising under the skin. Reached out to patient 5 hours after administration, she said swelling has mostly gone down but there is a semi-hard bump where injection took place
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Child died.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint stiffness, Product administered at inappropriate site
Clinical narrative: Injection was placed on the tip of my shoulder, in the joint space. With a couple hours, severe pain, joint stiffness. Still trouble rotating my shoulder without pain today.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site paraesthesia
Clinical narrative: TINGLING SENSATION AT INJECTION SITE
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: After 1 day, patient noticed redness / rash at the injection site. Patient contacted us at the pharmacy to report that the rash/redness had moved down her upper arm and is now above and on her elbow.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Rash
Clinical narrative: Localized reaction to first Menveo vaccine on 8/5/19. Swelling, pain, redness to arm at site of injection. Size of baseball. Viewed picture of patient arm with reaction on MOC phone today. Reaction started same day, but by the next day was worse. Associated blotchy rash to face, neck, and arm. No anaphylaxis. Patient/family did seek care at urgent care and was treated with prednisone. Improvement within 24 hours and resolved within a few days of treatment.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash macular
Clinical narrative: Localized reaction to first Menveo vaccine on 8/5/19. Swelling, pain, redness to arm at site of injection. Size of baseball. Viewed picture of patient arm with reaction on MOC phone today. Reaction started same day, but by the next day was worse. Associated blotchy rash to face, neck, and arm. No anaphylaxis. Patient/family did seek care at urgent care and was treated with prednisone. Improvement within 24 hours and resolved within a few days of treatment.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported 9/10 that Right Arm was warm at injection site. starting to swell by the 13th was still swollen and red warm to the touch redness and swelling gone by 9/15/2019
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: Vaccination at 11:30 am on 9/11/19.  By 1 pm headache was noted then body aches.  Chills began at 7 pm leading to an early bedtime at 8 pm.  The next morning at 6:30 am (9/12/19) she had dizziness.  She continued to feel dizzy and passed out.  Her husband was present.  She had no memory of passing out.  She went to the ER and received fluids, toradol,  and Zofran.  She was released from the ER around 10:30 am and slept at home the rest of the day.  She also did not work the next day (9/13/19) and napped off and on all day.  She was tired the following day but felt better.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Pain, Somnolence
Clinical narrative: Vaccination at 11:30 am on 9/11/19.  By 1 pm headache was noted then body aches.  Chills began at 7 pm leading to an early bedtime at 8 pm.  The next morning at 6:30 am (9/12/19) she had dizziness.  She continued to feel dizzy and passed out.  Her husband was present.  She had no memory of passing out.  She went to the ER and received fluids, toradol,  and Zofran.  She was released from the ER around 10:30 am and slept at home the rest of the day.  She also did not work the next day (9/13/19) and napped off and on all day.  She was tired the following day but felt better.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: RED RASH ON RIGHT INNER DELTOID (NOT AT INJECTION SITE). RASH IS WARM TO TOUCH. PATIENT FEELS TIRED AND RUN DOWN.
Age: 63.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient started developing a large, red, sore arm at shot location the following day. Very painful to touch and very warm to touch. Counseled patient via phone to take tylenol if needed and to apply ice as needed. Started getting better by Monday 9/16/19.
Age: 25.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: The next morning, the patient noticed swelling, redness, and a welt at the site of injection. Reported itchiness and warmth at site.
Age: 0.92
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event, Wrong schedule
Clinical narrative: Patient did not have a reaction - Immunizations given too soon against ACIP guidelines
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid function disorder, Facial paralysis
Clinical narrative: Employee Health office received word from the employee's manager that the employee was taken to the Emergency Room with facial drooping and inability to blink approximately 24 hrs after receiving flu vaccine. Manager verbalized the employee was diagnosed with having Bell's Palsy. Manager disclosed that employee has been complaining of ringing in the ears for past couple weeks and had an MRI already scheduled with her PCP prior to onset of Bell's Palsy symptoms. Manager reports the ED physician does not think the incident is vaccine related, rather coincidental.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Urticaria
Clinical narrative: Headache, fatigue, hives No treatment, just rest Doing well, this lasted a few days
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Injection site pain, Pyrexia
Clinical narrative: Patient received the flu shot in her right arm and is complaining of right shoulder pain, fever, sweating, chills, and a numbness in her fingers. She presented to urgent care and they said they were not concerned unless the fever lasted more than 48 hours. Patient presented to her pediatrician who stated the shot may have been injected into her bursa space (shoulder joint) and she needs to present back to the MD for an MRI if it continues after 7 days. Patient is still experiencing pain and will seek more medical attention this week.
Age: 45.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized swelling, warmth, redness, pain at left anterolateral arm injection site.  Began day after vaccination and was reported to be persisting on day 5
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Chills, fever, headache, body aches, fatigue, flu like symptoms
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, fever, headache, body aches, fatigue, flu like symptoms
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After vaccination patient developed an active shingles infection
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; A patient was inadvertently administered an expired dose of VARIVAX (N021314 8/7/2019) on 8/23/2019.; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions or allergies were provided. Concomitant therapies included sterile diluent.  On 23-AUG-2019, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N021314 with an expiration date on 07-AUG-2019) for prophylaxis (dosage schedule, route and anatomical location). No adverse effects were reported. No temperature excursions were present.