chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I feel not so good; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2020, the patient received Shingrix. On 10th October 2020, 1 days after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad 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 felt not so good.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigue; fever; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue 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 fatigue and fever. On an unknown date, the outcome of the fatigue and fever were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix.  Additional details were provided as follows:  The case reported by patient herself. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient experienced fever and fatigue after shingrix dose.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: Extreme tiredness; Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced tiredness and dizziness. On an unknown date, the outcome of the tiredness and dizziness were unknown.   It was unknown if the reporter considered the tiredness and dizziness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but selected as an adult as per vaccine indication. The patient inquired that was it normal to had extreme tiredness and dizziness 4 days after the Shingles shot. No other information was available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Inappropriate schedule of product administration, Injected limb mobility decreased
Clinical narrative: Pain at the shoulder; Swelling at the shoulder; 1st dose March 10, 2020 and 2nd dose on October 1, 2020; Limitied range of motion at shoulder; Injection site Pain; Swelling; Hardness (Induration); Hot temperature (at injection site); Diarrhea; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th March 2020).   On 1st October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue and mobility decreased. On an unknown date, the patient experienced shoulder pain, swollen joints and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, injection site swelling, fatigue and mobility decreased were not recovered/not resolved and the outcome of the injection site induration, injection site warmth, diarrhea and drug dose administration interval too long were recovered/resolved and the outcome of the shoulder pain and swollen joints were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue, shoulder pain, swollen joints and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist was reporting numerous adverse events that were reported by the patient.  The patient received Shingrix and experienced, injection site pain, swelling, induration and hot temperature at injection site.  The pharmacist reported that the patient experienced diarrhea 6 hours after vaccine administration which has resolved.  The pharmacist added, the patient continues to complain of fatigue, pain and swelling at the shoulder as well as limited range of motion of the shoulder.  Additionally, the pharmacist noted the patient has been to her doctor and they have ordered an MRI of her shoulder.  The patient received 2nd dose late, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Pain at the shoulder; Swelling at the shoulder; 1st dose March 10, 2020 and 2nd dose on October 1, 2020; Limitied range of motion at shoulder; Injection site Pain; Swelling; Hardness (Induration); Hot temperature (at injection site); Diarrhea; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th March 2020).   On 1st October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue and mobility decreased. On an unknown date, the patient experienced shoulder pain, swollen joints and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, injection site swelling, fatigue and mobility decreased were not recovered/not resolved and the outcome of the injection site induration, injection site warmth, diarrhea and drug dose administration interval too long were recovered/resolved and the outcome of the shoulder pain and swollen joints were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue, shoulder pain, swollen joints and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist was reporting numerous adverse events that were reported by the patient.  The patient received Shingrix and experienced, injection site pain, swelling, induration and hot temperature at injection site.  The pharmacist reported that the patient experienced diarrhea 6 hours after vaccine administration which has resolved.  The pharmacist added, the patient continues to complain of fatigue, pain and swelling at the shoulder as well as limited range of motion of the shoulder.  Additionally, the pharmacist noted the patient has been to her doctor and they have ordered an MRI of her shoulder.  The patient received 2nd dose late, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: Pain at the shoulder; Swelling at the shoulder; 1st dose March 10, 2020 and 2nd dose on October 1, 2020; Limitied range of motion at shoulder; Injection site Pain; Swelling; Hardness (Induration); Hot temperature (at injection site); Diarrhea; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th March 2020).   On 1st October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue and mobility decreased. On an unknown date, the patient experienced shoulder pain, swollen joints and drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, injection site swelling, fatigue and mobility decreased were not recovered/not resolved and the outcome of the injection site induration, injection site warmth, diarrhea and drug dose administration interval too long were recovered/resolved and the outcome of the shoulder pain and swollen joints were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration, injection site warmth, diarrhea, fatigue, shoulder pain, swollen joints and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The pharmacist was reporting numerous adverse events that were reported by the patient.  The patient received Shingrix and experienced, injection site pain, swelling, induration and hot temperature at injection site.  The pharmacist reported that the patient experienced diarrhea 6 hours after vaccine administration which has resolved.  The pharmacist added, the patient continues to complain of fatigue, pain and swelling at the shoulder as well as limited range of motion of the shoulder.  Additionally, the pharmacist noted the patient has been to her doctor and they have ordered an MRI of her shoulder.  The patient received 2nd dose late, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Tenderness
Clinical narrative: arm achiness; Tenderness; fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included drug allergy.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, several hours after receiving Shingrix, the patient experienced pain in arm, tenderness and fatigue. On an unknown date, the outcome of the pain in arm, tenderness and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tenderness and fatigue to be related to Shingrix.  Additional information was provided as follows: The patient experienced arm achiness, tenderness and fatigue after receiving the 1st dose of Shingrix. The events became worse the following day and the next day and then, were resolved after 3-4 days. For the tolerance of 2nd dose, refer the case- US2020AMR202084. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202084:Same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling hot, Migraine, Pain in extremity, Pyrexia
Clinical narrative: throwing up; Being hot all night; Feeling out of it; Sore Arm; Fever; Migraine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, migraine, feeling hot and feeling abnormal. On 11th July 2020, the patient experienced vomiting. On 12th July 2020, the outcome of the pain in arm, fever, migraine, vomiting, feeling hot and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the pain in arm, vomiting, feeling hot and feeling abnormal to be related to Shingrix. The reporter considered the fever and migraine to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine and later that night she developed symptoms of sore arm, fever, migraine, throwing up, being hot all night and feeling out of it.   This case has been linked with case US2020AMR202822, reported by same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202822:husband's case
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: throwing up; Being hot all night; Feeling out of it; Sore Arm; Fever; Migraine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, migraine, feeling hot and feeling abnormal. On 11th July 2020, the patient experienced vomiting. On 12th July 2020, the outcome of the pain in arm, fever, migraine, vomiting, feeling hot and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the pain in arm, vomiting, feeling hot and feeling abnormal to be related to Shingrix. The reporter considered the fever and migraine to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine and later that night she developed symptoms of sore arm, fever, migraine, throwing up, being hot all night and feeling out of it.   This case has been linked with case US2020AMR202822, reported by same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202822:husband's case
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore and painful/arm painful; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 2nd October 2020, less than a day 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 details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm on October and the arm was sore and painful.   The reporter wanted to know if that amount of time would had to be in pain if he received the second injection.   The reporter also wanted to know how much time should wait before receiving a flu injection and if there was some financial assistance available to assist in paying for the Shingrix.    The reporter provided the caller with the Medical Disclaimer and gave the number to our MI department.   The reporter was also given information from content in consumer FAQs and call was transferred to our Patient Assistance Program. The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Transient global amnesia
Clinical narrative: experienced TGA (Transient global amnesia); This case was reported by a nurse via call center representative and described the occurrence of transient global amnesia in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 93JN5, expiry date 19th September 2022) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix. On 28th July 2020, 5 days after receiving Shingrix, the patient experienced transient global amnesia. On an unknown date, the outcome of the transient global amnesia was unknown.   It was unknown if the reporter considered the transient global amnesia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had experienced Transient global amnesia. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore arms; Chills; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of 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 pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were unknown.   It was unknown if the reporter considered the pain in arm, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist stated that after receiving Shingrix patients often report sore arms, chills, and fever. She stated when patients return for the second dose they ask patients how they did after dose 1, and patients often report arm soreness, localized, nothing major, though it was more sore than getting a flu shot. The reporter consented to follow up. The case had been linked with US2020AMR204634 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR204634:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: got sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from the patient.  This case involves an unknown demographics patient who got sick (malaise), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient got sick (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on the batch number for this case.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Colitis microscopic, Defaecation urgency, Diarrhoea, Feeding disorder
Clinical narrative: Sept 7th - diarrhea starts, in 3 days becomes violent and immediate (unable to hold more than 20 seconds from onset)  Sept 18th & 26th - follow-up visits with Doctor, having 12-16 bowel movements per day, lost 17lbs to this point,   Doctor has no idea what is wrong, can barely eat soft food at this point, perscribed antibiotic and sent to   hospital for fluids and testing, hospital mis-diagnosed and perscribed even stronger antibiotic Sept 29th - called Doctor's office 8:30am, ask to come in for fluids, extremely weak, still having severe diarrhea, cannot   stomach any food, was told by nurse to go to ER, they did not have time to give me fluid - they were closing at noon  (in Doctor's defense, he never received my request, the nurse acted on her own) he would have given me fluid Oct 2nd - appointment with Dr., lost 27lbs to this point, cannot eat anything, takes all I have just to walk between   the bed and toilet, sent to hospital for colonoscopy and endoscopy, hospital admitted me Oct 4th - diagnosed with Lymphocytic Colitis and discharged, put on Budesonide by Dr.  Oct 17th -  follow-up with Dr., stay on Budesonide for next 6 months  Continuous side effect to present day
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Frequent bowel movements, Weight decreased
Clinical narrative: Sept 7th - diarrhea starts, in 3 days becomes violent and immediate (unable to hold more than 20 seconds from onset)  Sept 18th & 26th - follow-up visits with Doctor, having 12-16 bowel movements per day, lost 17lbs to this point,   Doctor has no idea what is wrong, can barely eat soft food at this point, perscribed antibiotic and sent to   hospital for fluids and testing, hospital mis-diagnosed and perscribed even stronger antibiotic Sept 29th - called Doctor's office 8:30am, ask to come in for fluids, extremely weak, still having severe diarrhea, cannot   stomach any food, was told by nurse to go to ER, they did not have time to give me fluid - they were closing at noon  (in Doctor's defense, he never received my request, the nurse acted on her own) he would have given me fluid Oct 2nd - appointment with Dr., lost 27lbs to this point, cannot eat anything, takes all I have just to walk between   the bed and toilet, sent to hospital for colonoscopy and endoscopy, hospital admitted me Oct 4th - diagnosed with Lymphocytic Colitis and discharged, put on Budesonide by Dr.  Oct 17th -  follow-up with Dr., stay on Budesonide for next 6 months  Continuous side effect to present day
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Influenza like illness, Muscular weakness
Clinical narrative: Patient reported that she became very dizzy and actually fell down, she felt flu-like and her legs had no strength.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: REDNESS AND HARDNESS AT INJECTION SITE FOR OVER TWO WEEKS  FOLLOWING INJECTION. PAIN,  SORENESS AND HARNESS LASTED FOR OVER ONE MONTH AT THE INJECTION SITE
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: numbness, tingly sensation, swelling, redness, and warmth to the area of injection
Age: 1.75
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient was given Menactra instead of MMR.  Vaccine is licensed to give 9 months to 55 years.  Contacted the LHD and was told there may be swelling at the injection site.  Recommended to ice the site.  Chief Medical Officer called and spoke with Mother.  Mother will follow up in the near future to receive the MMR vaccine.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, X-ray
Clinical narrative: Patient reported a pain level of 10/10 within 24 hours of receiving the vaccination.  Patient also reported a lack of full range of motion in the left arm where the vaccine was administered.  Patient allowed 7 days for the symptoms to dissipate with no relief at which point she seeked medical attention and received an xray. Extensive details of that X-ray were not shared.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pruritus, Skin warm, Swelling
Clinical narrative: pt presented back to office on 10-16-20 with quite large local reaction with redness, warmth, and local itching, but no tenderness, no fever, no systemic s/s of allergic reaction, I placed pt on hydroxyzine as needed for itching and a 3 day course of oral steroid for swelling, advised family to apply cool compress as tolerated and monitor for worsening s/s, advised family that this looks to be a local reaction and not an allergic reaction to the vaccine, antibiotic is not indicated at this time, family to call if worsening or concerns
Age: 7.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Wrong product administered
Clinical narrative: Patient was given Menactra instead of MMR.  Vaccine is licensed to give 9 months to 55 years.  Contacted the LHD and was told there may be swelling at the injection site.  Recommended to ice the site.  Chief Medical Officer called and spoke with Mother.  Mother will follow up in the near future to receive the MMR vaccine.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Injected limb mobility decreased, Myalgia, Nausea
Clinical narrative: REPORTS EXPERIENCING EXCESSIVE FATIGUE, SEVERE MUSCLE ACHES, RESTRICTION TO MOVEMENT TO LEFT ARM, NAUSEA, DIZZINESS, BLURRED VISION.  REPORTS TAKING SOME OTC TYLENOL 800MG PO TO ALLEVIATE ACHES AND EATING SOMETHING  (BANANA AND ORANGE JUICE) .
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: REPORTS EXPERIENCING EXCESSIVE FATIGUE, SEVERE MUSCLE ACHES, RESTRICTION TO MOVEMENT TO LEFT ARM, NAUSEA, DIZZINESS, BLURRED VISION.  REPORTS TAKING SOME OTC TYLENOL 800MG PO TO ALLEVIATE ACHES AND EATING SOMETHING  (BANANA AND ORANGE JUICE) .
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia
Clinical narrative: Patient complains of constant nerve like pain that has not subsided.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Dyskinesia, Immediate post-injection reaction, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Initially, I noticed injection was given very high on the left shoulder. Upon injection, my left arm had an involuntary reflexive jerk, leading me to believe a nerve/ligament/tendon was hit. In the days to follow, I had typical muscle soreness like any other flu shot. Since then, I have been experiencing a deeper ache to sharp pain in my shoulder joint, to elbow, and down to my wrist. This has woken me up several nights up to today's date. I contacted my VA primary care team nurse on 10/13/2020 regarding the issue. Physical Therapy was ordered by my VA doctor. I received a phone call from VA Physical Therapy on 10/15/2020. via telephone video conference to start the physical therapy intake. My first appointment with Physical Therapy will be some time during the week of 10/19/2020.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Initially, I noticed injection was given very high on the left shoulder. Upon injection, my left arm had an involuntary reflexive jerk, leading me to believe a nerve/ligament/tendon was hit. In the days to follow, I had typical muscle soreness like any other flu shot. Since then, I have been experiencing a deeper ache to sharp pain in my shoulder joint, to elbow, and down to my wrist. This has woken me up several nights up to today's date. I contacted my VA primary care team nurse on 10/13/2020 regarding the issue. Physical Therapy was ordered by my VA doctor. I received a phone call from VA Physical Therapy on 10/15/2020. via telephone video conference to start the physical therapy intake. My first appointment with Physical Therapy will be some time during the week of 10/19/2020.
Age: 68.0
Sex: M
Vaccine: FLUA4, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Tinnitus
Clinical narrative: Tiredness, muscle pain, headache, dizziness when I laid down, or laying down turned my head.  Ringing  in ears
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site bruising, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: After receiving the vaccine in the morning, redness and soreness started in the same arm the dose was administered.  She tried Tylenol and Ibuprofen, but it kept getting worse.  After 2 days, she came back to the pharmacy to ask advice.  She had a red spot around the injection site that was about 4 inches in diameter with bruising.  Her arm was sore and slightly swollen.  She was referred to her Dr for consultation/examination.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Patient said it has been a couple years since she had the flu shot, never had any issues in the past, stated the day after the shot she started having a low grade temperature and whole body aches and thought this was unusual for her, she is going to go to dr office to verify nothing else is going on.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Swelling, Swelling face
Clinical narrative: Patient stated the day after the immunization his toes started to tingle and his arm was sore. The tingling in his toes lasted on and off for the next week. Then on 10-15-20 he reports his face and toes were puffy.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: pt had swelling in both arms  reddened  hot touch
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash to all four extremities and face, patient c/o itching. Patient stated she took Claritin and that she does not think it has spread to anywhere else on her body.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Patient received her first high dose flu vaccine 10/13/2020 at a flu clinic run by Health District. The next day patient reported her arm was sore, "hot" and red. Also complained of swelling from left shoulder to elbow. Came to health district office 10/15 and left arm was pink, with swelling noted as stated, not warm to touch. Encouraged patient to call her PCP or her GI doctor as she stated she is on medication for Crohn's disease.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Night sweats, Pain, Pyrexia
Clinical narrative: fever body aches chills night sweats
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Insomnia, Pyrexia
Clinical narrative: Fever, chills, insomnia  No sleep entire night
Age: 5.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to recieve FluZone due to his age. He recieved FluBlok. There was no reaction. Mother was informed.
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Contusion, Erythema
Clinical narrative: redness, bruising
Age: 78.0
Sex: M
Vaccine: FLUA4, PNC13
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient reported pain in Right arm that started the day after his injection.  He states it starts at his shoulder and sometimes causes tingling/numbness that radiates down his arm.
Age: 7.0
Sex: F
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to recieve Fluzone due to age. Patient recieved Flublok. Mom was notified.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: I am unsure of the dose number in the series or the manufacturer of the vaccine.  I am also no t sure which flu vaccine I received.      I have a 2 inch diameter welt on my arm where the vaccine was given and soreness to the area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Condition aggravated, Headache, Hypoaesthesia, Mental impairment
Clinical narrative: One week after my injection, my multiple sclerosis symptoms were exacerbated.  I was very numb,   severe headaches, mental fog and balance issues. These symptoms were intense and continued throughout  the summer. On September 23, 2020, I scheduled an appointment with my doctor.  We discussed the events from the vaccine and debated the choices for receiving the second injection.  We decided on a wait and see option to be reassessed before December.  We also decided to make contact with my neurologist for a consultation.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Multiple sclerosis
Clinical narrative: One week after my injection, my multiple sclerosis symptoms were exacerbated.  I was very numb,   severe headaches, mental fog and balance issues. These symptoms were intense and continued throughout  the summer. On September 23, 2020, I scheduled an appointment with my doctor.  We discussed the events from the vaccine and debated the choices for receiving the second injection.  We decided on a wait and see option to be reassessed before December.  We also decided to make contact with my neurologist for a consultation.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, itching (at times), warm to the touch - Applied ice for the swelling, took Benadryl for the itching, took Tylenol for the discomfort
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Pain of skin
Clinical narrative: It was the shingles vaccine, but I don't know which one they gave me.  After a few days, I noticed increased sensitivity on my abdomen and back, in one wide band a little below my rib cage on the front.  In addition I got a rash about one inch in diameter on my abdomen within that band.  It is sore, red, bumpy, has little vesicles in it.  My doctor (nurse practitioner) confirms that it seems to be shingles itself.  It is quite painful from back to front on the skin, and sometimes deeper in my abdomen.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Sensitive skin, Swelling
Clinical narrative: It was the shingles vaccine, but I don't know which one they gave me.  After a few days, I noticed increased sensitivity on my abdomen and back, in one wide band a little below my rib cage on the front.  In addition I got a rash about one inch in diameter on my abdomen within that band.  It is sore, red, bumpy, has little vesicles in it.  My doctor (nurse practitioner) confirms that it seems to be shingles itself.  It is quite painful from back to front on the skin, and sometimes deeper in my abdomen.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Burning sensation
Clinical narrative: Intense burning and extreme soreness in both upper armpits. It feels like I have painful shingles in my armpits. I have never experienced this before (nothing even close, my armpits have never bothered me in anyway)  and got it within 13 hours (possibly sooner, as I was asleep and awoke to the pain) after having the vaccine.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: a temperature excursion for multiple vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 08-OCT-2020, the patient was vaccinated with an improperly stored temperature excursion hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date: 06-SEP-2022; dose and route were not reported) for prophylaxis (product storage error). Product was supported with temperature stability data.   The administered dose of the vaccine experienced a temperature excursion 50 Fahrenheit (F) for 9 hours time frame. There was no previous temperature excursion. The digital data logger was involved. There was no adverse effect reported. Device was not available for evaluation (obtain was false). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: her arm was "quite painful."; muscle ache, swelling; her arm having "a certain heat to it"; her arm was swollen from her elbow to her shoulder; muscle ache; This spontaneous report was received from a 66 years old female patient referring to herself. The patient had no concomitant medication. The patient's current condition included arthritis. The patient had none drug reactions/ allergies.  In September 2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (second dose, lot # T020638, expiration date 26-FEB-2020; dose and route were not reported) for prophylaxis (reported as scheduled vaccine).    The patient reported that a few hours after she received her 2nd administration of the vaccine, her arm was quite painful. She reported that, overnight, the pain ramped up and her arm was swollen from her elbow to her shoulder in the morning. She reported having significant muscle ache, swelling, and her arm having a certain heat to it for 72 hours, which slowly dissipated after 48 hours. She inquired if these kinds of reactions were normal to experience with the vaccine. None lab diagnostics/studies performed. Device was not available for evaluation (obtain was false). The outcome of the events was recovered.     The causal relationship between the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: She said the patient is asymptomatic.; patient was accidently given 2 doses of PNEUMOVAX23.; This spontaneous report was received from a physician concerning a 79-year-old male patient. No information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history, or drug reactions/allergies was provided.  On 01-JUN-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number, and expiration date were not reported) as prophylaxis.  On 23-SEP-2020, the patient was accidentally given a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, with lot number T010293 which was confirmed as valid for pneumococcal vaccine, polyvalent (23-valent) and with expiration date reported and validated as 30-AUG-2021 (dose, route of administration, and anatomical location were not provided) for prophylaxis (extra dose administered). The reporter noted that the patient was asymptomatic (no adverse event). No product quality complaint was reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: improperly sotred PNEUMOVAX was administered; This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-SEP-2020, the patient was vaccinated with an improperly stored dose of   pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S029542, expiring on 10-JUN-2021, for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of 48F for 106 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  No additional information was provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: several patients were administered doses of Hepatitis A vaccine less than 6 months apart; Information has been received from a physician assistant via a company representative, referring to several children patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with hepatitis a vaccine, inactivated(manufacturer unknown) (trade name, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis.       On an unspecified date, less than 6 months apart the unspecified patients were vaccinated with another dose of hepatitis a vaccine, inactivated(manufacturer unknown) (trade name, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: experienced a syncopal episode; This spontaneous report was received from a healthcare professional (HCP) via a company representative referring to a 12-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date in August 2020, reported as "2 months ago", the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Then, she experienced syncopal episode. It was reported that the patient did not experience any other side effects, did not have any injury associated with the event and recovered while at the office (on an unknown date in August 2020). She she did not seek medical attention and no treatment was given for the adverse event.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE/PQC.; received VAQTA at 2 months and 2 days old. The child was supposed to receive PEDVAX HlB instead; received VAQTA at 2 months and 2 days old. The child was supposed to receive PEDVAX HlB instead; This spontaneous report as received from a medical assistant refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2020 the patient was supposed to receive haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. However, the patient was mistakenly vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 milliliter, frequency reported as once, lot # S037576 has been verified to be a valid lot number, expiration date 10-APR-2021 (anatomical location and route of administration were not provided) for prophylaxis. Therefore, the vaccine was administered to patient of inappropriate age. No adverse event was reported. The outcome of the events was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 13-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 13-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083: