chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 91 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that he had a friend who received the first dose of Shingrix a little over 6 months or so, and developed a case of shingles about 3 months after receiving the dose. The patient was fully recovered and also did not have any post-herpetic neuralgia.  Till the time of report the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was inquiring if she should receive the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: tired; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (in right side).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's husband. The reporter couldn't recall which arm she received the vaccine in, however, the patient had a history of breast cancer in her right side, so he believed she received the Shingrix in the left arm.   The patient experienced a slight fever and tiredness after receiving the first dose of Shingrix. The patient felt fine the first day and the next day her symptoms hit. It was reported that within 24 hours the fever resolved.  The reporter did not consent to follow-up. For tolerance to next dose, refer case US2019GSK080269.
Age: 52.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Alopecia
Clinical narrative: Alopecia; This case was reported by a other health professional via call center representative and described the occurrence of alopecia in a 52-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis, Typhoid vaccine for prophylaxis and diphtheria toxoid + pertussis toxoid acellular + tetanus toxoid (Tdap) for prophylaxis.   Concomitant products included HBV (Engerix B).   On 25th February 2019, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received Hepatitis A vaccine at an unknown dose, Typhoid vaccine at an unknown dose and Tdap at an unknown dose and frequency. In March 2019, 14 days after receiving Engerix B and unknown after receiving Hepatitis A vaccine and Typhoid vaccine, the patient experienced alopecia. The patient was treated with medication unknown (Unspecified Medication). On an unknown date, the outcome of the alopecia was unknown.   The reporter considered the alopecia to be possibly related to Engerix B. It was unknown if the reporter considered the alopecia to be related to Hepatitis A vaccine and Typhoid vaccine.  Additional details were provided as follows: On 21st January 2019, the patent received the 1st dose of Engerix-B.  The healthcare professional noted the patient received Hep B, Hep A, TDap and typhoid vaccines when at the office. Brand name of the Hep A, TDap, and typhoid vaccines were not provided at the time of this call. About two weeks after receiving his 2nd dose of Engerix-B, the patient reported the alopecia.  The patient was upset because he was having alopecia. The patient had started a very expensive medication to treat it (medication not otherwise specified).  The healthcare professional stated the patient was threatening to sue the clinic for not stating that alopecia was a side effect.  The patient believed the Engerix-B caused the alopecia. It was unknown if the reporter considered the alopecia to be related to TDap vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a 63-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (3 to 4 outbreaks per year) and painful rash (large and painful rash on legs). In March 2018, the patient received the 1st dose of SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and painful rash were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and painful rash to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. Since getting the vaccine, she had got a shingles outbreak a few months before the date of reporting and another outbreak in the night of 1st May 2019. The rash appeared on her legs. The rash was not as large and painful as it was prior to getting the SHINGRIX vaccinations. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Extraocular muscle paresis, Eye pain, Ocular vascular disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of eye muscle weakness in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received at age of 60). On 14th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced eye muscle weakness (serious criteria GSK medically significant), ocular vascular disorder, double vision and eye pain. On an unknown date, the outcome of the eye muscle weakness, ocular vascular disorder, double vision and eye pain were not recovered/not resolved. It was unknown if the reporter considered the eye muscle weakness, ocular vascular disorder, double vision and eye pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. Two weeks later, the patient experienced double vision and pain in his right eye. The patient states that the muscle in his right eye became weak. The patient visited an ophthalmologist 3 times and the physician informed him that these symptoms were a result of a loss of blood flow in the right eye.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Gait disturbance, Headache, Pain, Pyrexia
Clinical narrative: Woke up at 3 AM next day - was so cold - went to bathroom could hardly walk - back to sleep - 7 AM got up - ached terribly all over - walking difficult - had fever, headache very scary. Took hot shower for relief. Read side effects - sure enough - the shot. Call pharmacy + Dr. office - they verified the reaction Slept off + on all day.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Fever ranging from 101-102 started on 4/30/19, after vaccine was administered.  Mylagia, localized swelling around injection site.  Child evaluated in our office on 5/3/19,  all symptoms at the time of this visit were resolved except for swelling of the right deltoid area.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Headache, Injection site macule
Clinical narrative: Severe dizziness Headache  Pea size red spot near injection site, flat no oozing Diminished appetite
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Dysphemia, Speech disorder
Clinical narrative: Stuttering and speaking less
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: REACTION AROUND INJECTION SITE
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration at injection site starting 7-8 days after injection
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis at injection site
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Discomfort, Dizziness, Fatigue, Lip pain
Clinical narrative: patient is here with concerns about swollen lip and discomfort. Patient received Trumenba vaccine 2 days ago on 5/7/19. Patient states that she felt feverish, body aches and fatigue that day. The next day she developed loose watery stools and fatigue, dizziness and body aches continued. Last night patient noticed that her lower lip seemed to have uneven bump on it and when she woke up this morning there was significant swelling. There was some drainage noticed as well. patient has cleaned it with peroxide. The lip in tender on pressure but otherwise not painful.  Patient states that she had body aches and diarrhea with fatigue with her first dose of trumenba as well but no lip swelling.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Lip swelling, Pain, Pyrexia, Secretion discharge
Clinical narrative: patient is here with concerns about swollen lip and discomfort. Patient received Trumenba vaccine 2 days ago on 5/7/19. Patient states that she felt feverish, body aches and fatigue that day. The next day she developed loose watery stools and fatigue, dizziness and body aches continued. Last night patient noticed that her lower lip seemed to have uneven bump on it and when she woke up this morning there was significant swelling. There was some drainage noticed as well. patient has cleaned it with peroxide. The lip in tender on pressure but otherwise not painful.  Patient states that she had body aches and diarrhea with fatigue with her first dose of trumenba as well but no lip swelling.
Age: 68.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Body temperature, Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient had sore arm and temperature evening of 5-7-19.  On 5-9-19, inside arm was red and swollen from elbow upward for about 6 inches and tender to touch. Patient's cardiologist advised him to show injection site to pharmacy and to let his doctor look at his arm.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Burning sensation, Pain, Paraesthesia, Skin irritation
Clinical narrative: Within 10 minutes of leaving pharmacy, patient experienced tingling/burning/irritation near right breast.  Patient thought it was an underwire in her bra and dismissed it.  By the next day, the irritation was way worse and felt like it was "on fire".  Even clothes touching the spot was extremely painful.  There was no rash at the time and no rash ever appeared.  She also experienced increased temperature for a few days.  She says the pain is still present but is less than it was the first few days.  Patient spoke with doctor by phone but she  did not have a rash and didn't see point of going in.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Get another vaccine
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Localize swollen, redness and warmth measuring 2.5 X 2.5 inches Treatment-Prednisone 20mg 1po BID x 10 days
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Limb discomfort
Clinical narrative: Very sore tender left arm x5 days. ..Relegated to full bed rest x3 days. Flu like symptoms including low grade fever, significant chills and shivering, nausea, complete lack of appetite and thirst, muscle aches, fatigue.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Thirst decreased
Clinical narrative: Very sore tender left arm x5 days. ..Relegated to full bed rest x3 days. Flu like symptoms including low grade fever, significant chills and shivering, nausea, complete lack of appetite and thirst, muscle aches, fatigue.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood pressure increased, Chest pain, Cough
Clinical narrative: Patient notified me he thought he might be having an adverse reaction to the vaccine. He complained of chest pain/back pain, and was coughing. 911 was called, and patient was sat down and his blood pressure was taken twice about 5 minutes apart (both high results). Paramedics arrived and took the patient to the hospital.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong shot given pcv 23 not prevnir 13. no reaction
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect reported; one patient "who already has positive measles, mumps, and rubella titers" accidentally received a dose of M-M-R II; one patient "who already has positive measles, mumps, and rubella titers" accidentally received a dose of M-M-R II; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.      The nurse reported that one patient who already had positive measles, mumps, and rubella titers; on 01-MAY-2019, accidentally received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered) subcutaneously (strength and dose were not reported; lot # R036582 and expiration date 17-DEC-2020), as prophylaxis instead of varicella virus vaccine live (Oka/Merck)(VARIVAX) (wrong product administered). No adverse effect reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effect; adult patient was inadverently administered a pediatric dose of recombivax; This spontaneous report was received from a nurse regarding an adult patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On an unknown date in 2019 (last week), the patient was inadvertently vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route, lot# and expiry date) for prophylaxis (incorrect dose administered). No adverse effects reported (no adverse event). Product quality complaint was not involved.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 7 days after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The patient enquired regarding symtoms of fever and shivering would show up within 1 day or later. The patient refered symtoms of fever and shivering related to vaccine, but did not experinced it. About a week or so later the patient had fever and aches.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Rash, Wheezing
Clinical narrative: itching; rash/ rash in her hand; wheezing; Allergic reaction; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a 37-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included latex allergy.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus, rash, wheezing and allergic reaction. On an unknown date, the outcome of the pruritus, rash, wheezing and allergic reaction were unknown.   It was unknown if the reporter considered the pruritus, rash, wheezing and allergic reaction to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter was a medical assistant at a physician's office.  The reporter said that another employee (Shingrix administrator) at their office administered Shingrix vaccine to a patient.  The administrator had developed itching and rash in her hands and also experienced some wheezing. The administrator was allergic to latex and they were suspicious that the administrator might develop those symptoms from having allergic reaction to the elastitag that comes with the vaccine.  The administrator was holding the elastitag in her hands. That elastitag had a number on it, which was 826-310.  The reporter couldn't clarify when the administrator administered the vaccine to the patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pain
Clinical narrative: sore at injection site; left arm warm to touch; burning sensation left arm; redness left arm; fever; nausea; headache; swelling on her left arm from the shoulder to the elbow/ swelling left arm; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   On 4th April 2019, the patient received the 1st dose of Shingrix. On 5th April 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, injection site erythema, fever, nausea and headache. The patient was treated with dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, fever, nausea and headache were recovered/resolved and the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, injection site erythema, fever, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The next day after vaccination, the patient experienced a fever of 101 degree Fahrenheit.  The patient experienced redness and swelling on her left arm from the shoulder to the elbow after receiving the vaccine. The swelling lasted 2 weeks and the redness had decreased, however there was a little redness still there. Patient also experienced a burning sensation on her left arm. The patient put a cool wet rag on her arm but that did not help with the burning sensation. Patient used cream on her arm to relieve the burning. The burning sensation felt the same as when the patient has had shingles in the past. Patient did not plan to get the 2nd dose of Shingrix. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: sore at injection site; left arm warm to touch; burning sensation left arm; redness left arm; fever; nausea; headache; swelling on her left arm from the shoulder to the elbow/ swelling left arm; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included adalimumab (Humira).   On 4th April 2019, the patient received the 1st dose of Shingrix. On 5th April 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, injection site erythema, fever, nausea and headache. The patient was treated with dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, fever, nausea and headache were recovered/resolved and the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth, burning sensation, injection site erythema, fever, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The next day after vaccination, the patient experienced a fever of 101 degree Fahrenheit.  The patient experienced redness and swelling on her left arm from the shoulder to the elbow after receiving the vaccine. The swelling lasted 2 weeks and the redness had decreased, however there was a little redness still there. Patient also experienced a burning sensation on her left arm. The patient put a cool wet rag on her arm but that did not help with the burning sensation. Patient used cream on her arm to relieve the burning. The burning sensation felt the same as when the patient has had shingles in the past. Patient did not plan to get the 2nd dose of Shingrix. The reporter consented to follow up.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster, Immunodeficiency, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of stroke in a 49-year-old female patient who received SHINGRIX (batch number K2ZY4, expiry date 21st April 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 7th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced stroke (serious criteria GSK medically significant), immunodeficiency (serious criteria GSK medically significant) and product supply issue. On an unknown date, the outcome of the stroke, immunodeficiency, shingles and product supply issue were unknown. It was unknown if the reporter considered the stroke, immunodeficiency and shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient developed an episode of Shingles after receiving the first dose of SHINGRIX. The patient was diagnosed with Shingles in February 2019. The patient then reported that at some unspecified time after the shot that had a stroke. Vaccine supply, possible off-schedule dose and the patient was reporting to be immune suppressed was reported. No additional details were provided.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to pt <4yrs of age; no problems reported
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered for pt <4yrs of age; no problems reported
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: L leg swelling and rash with induration
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site discomfort, Muscle spasms
Clinical narrative: Injection site soreness, chills, slight fever, aching joints and muscles, leg cramps and headache.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Injection site soreness, chills, slight fever, aching joints and muscles, leg cramps and headache.
Age: 1.25
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Client received 0.5 ml of Typhim Vi in the Right thigh 05/07/19. Client is 15 months old. Minimum age for Typhim Vi is 2 years. Notified mother of child that dose was given in error as this vaccine is not licensed for children under age 2 years. Mother reports that client had no adverse reactions to the vaccine.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion, Viral infection, Viral test negative
Clinical narrative: Febrile seizure without any other viral symptoms
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Lip swelling, Neck pain, Swelling face
Clinical narrative: Patient returned with mother 20 minutes later due to patient's lip becoming swollen, continued to increase until Zyrtec was given.  It was able to stop the increase in swelling but not decrease.  Patient also stated that the back of her neck was hurting a little. Due to swelling on face we sent her to the ER.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Patient had large red swollen area on left arm from shoulder to elbow, rash, blisters, itching, nodular under surface of skin.  Was seen in clinic by her primary care provider.  No treatment but was advised by her provider to not get 2nd dose.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin mass
Clinical narrative: Patient had large red swollen area on left arm from shoulder to elbow, rash, blisters, itching, nodular under surface of skin.  Was seen in clinic by her primary care provider.  No treatment but was advised by her provider to not get 2nd dose.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Had Prevnar 13 on 4/26/2018 no problem   After receiving vaccination patient's arm start selling from left deltoid to elbow arm became re, hot to the touch and  painfull and started itching. medical Doctor put patient on 2 antibiotics Doxycycline and Keflex. Patient has recovered fully.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Culture negative, Joint fluid drainage, Mobility decreased, Swelling
Clinical narrative: The patient called 2 days after getting the injection that he had excess shoulder swelling and was unable to lift his arm above parallel to the ground. He went to orthopedics and they drained his shoulder and tested the fluid for infection. After the culture came back negative for infection he was given a cortisone shot (which he gets regularly) to help with the inflammation. I called him 2 days later and he reported his symptoms have improved greatly. He did request that his second dose be given in a different muscle, which we plan to accommodate.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: The patient called 2 days after getting the injection that he had excess shoulder swelling and was unable to lift his arm above parallel to the ground. He went to orthopedics and they drained his shoulder and tested the fluid for infection. After the culture came back negative for infection he was given a cortisone shot (which he gets regularly) to help with the inflammation. I called him 2 days later and he reported his symptoms have improved greatly. He did request that his second dose be given in a different muscle, which we plan to accommodate.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Client called HD on 04-05-2019 to complain of Left arm pain with movement. Client received a Tdap vaccine on 04/03/2019. Client was advised to see PCP for evaluation. Follow up calls were made to client and client was not able to see PCP.  Client was informed that a VAERS report would be completed by HD.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia, Rash
Clinical narrative: Pt stated that within a day after receiving the vaccination she experienced a rash that covered her entire face, fever, muscle aches and pains, and fatigue.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: The morning after pt experience pain though out body, joint pain, headache, fever and fatigue
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Peripheral swelling
Clinical narrative: Patient came to pharmacy at 7pm 05/09/19, with a swollen raised bump near her right arm elbow. In our system, patient was administered Shingrix on 05/07/19. Shingrix is for IM administration while the site looks like the vaccine was given  subcutaneously.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depressed mood
Clinical narrative: Per patient's phone call 5/9/19 she felt depressed after the shot and the depressed mood lasted 5 weeks.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depression, Food poisoning, Malaise
Clinical narrative: Per patient's phone call 5/9/19 she felt depressed after the shot and the depressed mood lasted 5 weeks.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt came to the pharmacy where she  received the vaccine with red and  swollen arm. She went to the hospital previously where she was prescribed with benadryl and azithromycin.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pyrexia, Tremor
Clinical narrative: About 3 hours after receiving the Shingles vaccine, I devrloped a 101 degree fever and felt weak and shaky and had chills. These symptoms lasted about 36 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Hypoaesthesia, Myalgia
Clinical narrative: Arm pain with numbness, tingling to fingers and burning to palm of hand of injection site. Light sensitivity next morning. Redness, swelling the next day. Fatique. Nausea. General Myalgia. Headache. Tingling to face where light sensitivity was.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Paraesthesia, Photophobia, Swelling
Clinical narrative: Arm pain with numbness, tingling to fingers and burning to palm of hand of injection site. Light sensitivity next morning. Redness, swelling the next day. Fatique. Nausea. General Myalgia. Headache. Tingling to face where light sensitivity was.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Headache, Paraesthesia
Clinical narrative: 15 year old had first dose of HPV vaccine and walking out of clinic she felt faint, nurse saw it and made her lay down. She had ringing in the ears, tingling and clammy hands, headache and has impaired vision and felt like she was going to die. The next day she still has headache and vision issues.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Tinnitus, Visual impairment
Clinical narrative: 15 year old had first dose of HPV vaccine and walking out of clinic she felt faint, nurse saw it and made her lay down. She had ringing in the ears, tingling and clammy hands, headache and has impaired vision and felt like she was going to die. The next day she still has headache and vision issues.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Haematochezia, Muscle spasms, Pain in extremity
Clinical narrative: SHINGRIX 50mcg inj first shot. I never had a reaction to any shot before. My arm was very sore and is still hurting, 4 days later. I think the diarrhea was like nothing I have ever experienced. It started with terrible cramps. Then like pure water for over 90 minutes and every 5 hours later. The second day I saw bright red blood in my stool. I was concerned the printout I was given listed this over 1/2 way down. When it started without a warning on the third day I was not home and it started once and again after 45 minutes and then after 30 minutes the first spill.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient experienced redness and swelling at site of injection and directly adjacent to it on the arm. She also mentioned feeling "flu-like" symptoms (more severe than her 1st dose), but has gone away. She was complaining of a spreading rash.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Headache
Clinical narrative: Patient mom states patient had a headache and high temp.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: Patient came into pharmacy on 5/8 in the morning stating that she had received a pneumonia vaccine on 5/6 and that she had a bad reaction to it.She proceeded to show me her arm which was red to the elbow.She also showed me photos on her phone with what looked like her arm swollen at the injection site.She asked me to call her physician and let him know that she had a bad reaction to the vaccine, which I did. The MD office sent in a prescription for cehpahlexin for her.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure normal, Dizziness, Heart rate normal, Respiratory rate, Syncope
Clinical narrative: Patient fainted as she was walking out at exam, felt dizzy, pale, no loss of consciousness within 15 min after vaccination. Threw up chocolate later that am. BP & HR & breathing nml
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Patient fainted as she was walking out at exam, felt dizzy, pale, no loss of consciousness within 15 min after vaccination. Threw up chocolate later that am. BP & HR & breathing nml
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient developed a itchy, painful rash on her back on May 4th. May 5th she was given a cortisone injection and prescribed Triamcinolone cream 1% and benadryl.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Differential white blood cell count, Full blood count, Hypoaesthesia
Clinical narrative: 36 AFTER INJECTION - LEFT SIdE OF body NUMb - Including NOSE AND CHEEK. CALLED DR. 12 HOURS LATER - SAId TO go TO EMERGENCY ROOM
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypoaesthesia, Influenza like illness, Injection site pain
Clinical narrative: 36 AFTER INJECTION - LEFT SIdE OF body NUMb - Including NOSE AND CHEEK. CALLED DR. 12 HOURS LATER - SAId TO go TO EMERGENCY ROOM
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Tinnitus
Clinical narrative: ON 5/9/19 PATIENT CALLED PHARMACY TO REPORT SWOLLEN ARM AT INJECTION SITE AND EAR RINGING
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Throat irritation
Clinical narrative: Pt received Bexsero in left deltoid on 5/8/19 at 11:30 AM. On 5/8/19 at 5 PM pt started experiencing moderate to severe pain at injection site. redness, and swelling about the size of a half dollar. Pt also complains of itchy throat and itchy arms (bilateral). Pt received Benadryl and prednisone in the office. Pt was sent home with Rx of prednisone and hydroxyzine.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted; This report was identified from a line listing obtained on request by the Company from the Food and drug administration (FDA) under the Freedom of Information Act (VAERS# 743077) a healthcare professional refers to a 15-year-old male patient. The patient's historical condition included asthma. The patient was not taking any medication and there was no known allergy (NK). The patient's current illness and prior vaccinations was not reported. On 04-APR-2018, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) dose 5 (lot# N021872, expiry date was not reported) via subcutaneous route in left arm for prophylaxis. On 04-APR-2018, the patient fainted (syncope). The patient was given juice and waited 10-15 mins. The patient's lab test was reported as none. It was reported that the patient felt better and headed home. The recovery of the event was unknown. Causality assessment was not reported.   Follow-up information was received from healthcare professional on 15-APR-2019.  The patient's ethnicity was reported. The patient's allergies to medications, food, or other products was reported as none. On 04-APR-2018 at 09:30, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On the same day at 09:50, the patient fainted. The patient visited doctor's or healthcare professional office and clinic.   Follow-up information was received from healthcare professional on 01-MAY-2019. It was reported that there was no event of syncope on 04-APR-2018 (discrepant information).
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Secretion discharge, Urticaria
Clinical narrative: Patient spoke with nursing after hours:  I received a shingles vaccine last week, 2 days later I developed hives on my right thigh area. States he has area of hives left thigh, itches, some spots have broken open and are draining - no urticaria elsewhere. States injection site right arm looks great.   Patient didn't return phone call for follow up  When presented for second injection - stated the hives with drainage lasted for 4 days. All cleared up at this presentation. No injection given then as uncertain if ok to give or not. UrticariaPruritus
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: pain at injection site; knot on arm at injection site; hot at injection site; chills; headache; nausea; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site lump, injection site warmth, chills, headache, nausea and fever. On 19th April 2019, the outcome of the injection site warmth, chills, headache, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, chills, headache, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient planned to follow-up with her physician on an unknown date. The reporter had consented to follow up.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Chills, Headache, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: pain at injection site; knot on arm at injection site; hot at injection site; chills; headache; nausea; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site lump, injection site warmth, chills, headache, nausea and fever. On 19th April 2019, the outcome of the injection site warmth, chills, headache, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, chills, headache, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient planned to follow-up with her physician on an unknown date. The reporter had consented to follow up.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: pain at injection site; knot on arm at injection site; hot at injection site; chills; headache; nausea; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site lump, injection site warmth, chills, headache, nausea and fever. On 19th April 2019, the outcome of the injection site warmth, chills, headache, nausea and fever were recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site warmth, chills, headache, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient planned to follow-up with her physician on an unknown date. The reporter had consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: injection site swollen; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 495D3, expiry date 24th November 2020) for prophylaxis.   On 15th February 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 15th February 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting Shingrix was given to the patient subcutaneously, which led to intramuscular formulation administered by other route. The patient came in for their 2nd dose on 30th April 2019, and asked why it was given different this time, that was how the pharmacist became aware.  The patient did had more of a site reaction, they stated it kind of bubbled up.  The patient stated it was more than what she would normally had with like a flu shot, it was not anything that went anywhere and it stayed localized. This case has been linked with case US2019GSK083750, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site swelling
Clinical narrative: injection site swollen; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 495D3, expiry date 24th November 2020) for prophylaxis.   On 15th February 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 15th February 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reporting Shingrix was given to the patient subcutaneously, which led to intramuscular formulation administered by other route. The patient came in for their 2nd dose on 30th April 2019, and asked why it was given different this time, that was how the pharmacist became aware.  The patient did had more of a site reaction, they stated it kind of bubbled up.  The patient stated it was more than what she would normally had with like a flu shot, it was not anything that went anywhere and it stayed localized. This case has been linked with case US2019GSK083750, reported by the same reporter.
Age: 54.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Joint stiffness, Muscle spasms, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Stiffness/stiffness in left and right hand/muscle stiffness; Muscle cramping; arm pain/feet pain; arm pain/pain in finger joints in left and right hand/Joint pain; joint stiffness in upper extremities and both feet; This case was reported by a nurse via call center representative and described the occurrence of limbs stiffness in a 54-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33CA7, expiry date 30th January 2020) for prophylaxis.   On 15th April 2019, the patient received Boostrix (intramuscular) .5 ml. On 18th April 2019, 3 days after receiving Boostrix, the patient experienced limbs stiffness, muscle cramp, pain in arm, pain in joint involving hand and stiff joint. On an unknown date, the outcome of the limbs stiffness, muscle cramp, pain in arm, pain in joint involving hand and stiff joint were unknown.   It was unknown if the reporter considered the limbs stiffness, muscle cramp, pain in arm, pain in joint involving hand and stiff joint to be related to Boostrix.  Additional details were provided as follows: The patient was administered Boostrix vaccine. Three days post vaccination patient was experiencing stiffness in left and right hand, muscle cramping, pain in finger joints in left and right hand, joint and muscle stiffness in upper extremities and both feet. No further details were provided. The nurse stated she had faxed a form to report the event to VAERS.