chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Electrocardiogram ambulatory abnormal, Heart rate increased, Palpitations
Clinical narrative: palpitation; extra beats; This case was reported by a consumer and described the occurrence of palpitation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced palpitation and heartbeats increased. On an unknown date, the outcome of the palpitation and heartbeats increased were unknown.   It was unknown if the reporter considered the palpitation and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient began to experiencing palpitations and was evaluated by her physician and cardiologist including a 72 hours holter monitor which showed episodes of extra beats. The reporter did not provide additional information other than that she did call the event in to the GSK Consumer line and also that her physician was provided forms to report the event if he so chose.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Injection site pain, Lethargy, Scab
Clinical narrative: lethargy; hand blisters/ oval spots on left hand; arm  soreness; headache; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a day after receiving Shingrix, the patient experienced shingles. On 16th May 2019, the patient experienced injection site pain and headache. On 19th May 2019, the patient experienced blister. On 22nd May 2019, the patient experienced lethargy. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and blister were recovering/resolving and the outcome of the injection site pain was recovered/resolved and the outcome of the lethargy and headache were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blister, injection site pain, lethargy and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for herself. On 16th May 2019, the patient received 1st dose of Shingrix in the left arm, via an unspecified route, from an unspecified batch number and reported soreness in the left arm , which resolved. The patient also reported headaches on the same day and it comes and goes. On 19th May 2019, 3 days after receiving a dose of Shingrix, the patient reported oval shaped spots on the left hand between the index finger and middle finger and went to see a doctor and on 22nd May 2019, was diagnosed with shingles and started on acyclovir 800 mg, 35 pills, 5 pills per day. At the time of this report, the shingles were currently healing and in the bloody and scabby stage. On 22nd May 2019, 6 days after receiving a dose of Shingrix, the patient also reported lethargy which was ongoing. The reporter gave consent to follow up and to contact the pharmacy and provided contact details for the same.
Sex: M
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: theraphy non-responder; Hepatitis B antibody negative; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix, the 2nd dose of Twinrix and the 3rd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, Twinrix and Twinrix, the patient experienced therapy non-responder and hepatitis b antibody negative. On an unknown date, the outcome of the therapy non-responder and hepatitis b antibody negative were unknown.   It was unknown if the reporter considered the therapy non-responder and hepatitis b antibody negative to be related to Twinrix, Twinrix and Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received all 3 doses of Twinrix about 2.5 years ago. The patient recently had titers done and it shows he was not immune to hepatitis B.      Lab Comments: Lab test performed on an unknown date
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: muscles aching; soreness around the injection site; joints were on fire; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received the 2nd dose of Shingrix. On 3rd May 2019, 2 hrs after receiving Shingrix, the patient experienced muscle pain, injection site pain and burning sensation in joints. The patient was treated with intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the muscle pain, injection site pain and burning sensation in joints were recovered/resolved.   It was unknown if the reporter considered the muscle pain, injection site pain and burning sensation in joints to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for herself. The patient got a dose of Shingrix injection in the right deltoid, and that she had a violent reaction. Two hours after the injection the patient experienced the normal soreness around the injection site, but it got worse and then all of her muscles were aching. The patient stated it felt like her joints were on fire.  The patient went to Emergency Room and the physician was able to reverse the reaction with intravenous (IV) fluid (patient not sure what medications she was given) and the pain dissipated over the next 3 hours.  The patient went home after 5 hours in the emergency room feeling no pain and fully recovered. The patient did not have the opportunity to tell her primary care physician below yet.  The reporter gave consent to follow up, and to contact the physician and provided contact details for the same. The reporter did not have record of lot or expiration date.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye infection viral
Clinical narrative: bilateral viral eye infection; This case was reported by a nurse via call center representative and described the occurrence of eye infection viral in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included MEASLES VIRUS VACCINE LIVE ATTENUATED (MEASLES VACCINE).   On 21st May 2019, the patient received the 2nd dose of Shingrix .5 ml. On 28th May 2019, 7 days after receiving Shingrix, the patient experienced eye infection viral (serious criteria clinically significant/intervention required). The patient was treated with Eye Drops (Nos). On an unknown date, the outcome of the eye infection viral was not recovered/not resolved.   It was unknown if the reporter considered the eye infection viral to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid and developed bilateral viral eye infections. She went to her optometrist and was being treated with prescription eye drops. She did not have vaccine information for this adverse event  She had a measles vaccine a week before the Shingrix dose 2, administered subcutaneous. Emergency visit was required. The reporter was consented to follow up
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Muscular weakness
Clinical narrative: He has had limited use of right arm and can barely lift it over his head; Extreme weakness on right arm; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration on 12Feb2018 13:30 at a single dose for Vaccination/pneumonia inoculation. Medical history included osteoarthritis from 1993 and ongoing, and Digestive upsets (constipation uses Colace and senna for life). Concomitant medication included docusate sodium (COLACE), and sennoside a+b; both for constipation, to ensure proper passage of intestinal waste. The patient was also taking some pain killers and Benzodiazepines.The patient received the product pneumococcal 13-val conj vac (dipht crm197 protein) for pneumonia inoculation along with vaccines for shingles and 3 others on the same day and the patient had extreme weakness on right arm since then. The patient added that ever since the inoculation, he had limited use of right arm and can barely lift it over his head. The outcome of the event 'extreme weakness on right arm' was not recovered while 'limited use of right arm' was unknown.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Pneumonia; This is a spontaneous report from a contactable physician via Pfizer sales representative who reported same event for two different patients. This was the 2nd of 2 reports.  An elderly male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), and pneumococcal vaccine polysacch 23v (PNEUMOVAX), both at single dose via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown. The patient was hospitalized due to the event. Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-2019241946 same reporter, different patient, same product and event
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: pneumonia; pneumonia; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar event for two patients. This is the first of two reports.  An elderly male patient of unspecified age but over 65, received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose and pneumococcal vaccine polysacch 23v (PNEUMOVAX), via an unspecified route of administration on an unspecified date at unknown does, both for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced pneumonia on an unspecified date and was hospitalized. The outcome of the event was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results are needed for full medical assessment.,Linked Report(s) : US-PFIZER INC-2019241924 same reporter, different patient, same product and event
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Slight swelling and redness and injection site, body aches, fever, chills
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Patient states redness and swelling started yesterday (6/6/19), one day after vaccine. This morning she came into the pharmacy to ask about the reaction. She said the redness was spreading and it had swollen a little more. I advised the patient to take OTC ibuprofen and use an ice pack to help with swelling and inflammation and to check back in with us if it doesn't improve over the weekend.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Diffuse itchy erythematous  urticaria, onset ~3 hours after administration of vaccine. Improved with PO Benadryl, topical Calamine. Recommended pt be treated with continued Benadryl or Zyrtec until fully resolved.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: On 6/6/2019 I administered Proquad which is MMR and varicella combined and a varicella. I was supposed to administer MMR and varicella separately. Mother was notified immediately and so were the nurses, I spoke to the provider and he stated the patient would be fine. I also contacted Merck to double check the patient would not be at risk.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema, warmth, tenderness, swelling at injection site
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash stared on the right side of back at the waistline,  has no traveled to the front right side
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Client developed redness, warmth, pain, and hardness to site of vaccine which resolved without incident.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: PARENT CALLED ON 06/03/2019 TO REPORT A LOCAL REACTION THAT WAS BOTHERING THE CLIENT.  PARENT DESCRIBED THE REACTION  AROUND THE  IMMUNIZATION SITE  AS RED, SWOLLEN, WARM WITH A HARD, PAINFUL "BUMP"  AT THE INJECTION SITE, WHICH DEVELOPED AFTER RECEIVING THE IMMUNIZATION  FIVE (5) DAYS AGO. . THEY HAD TRIED OTC ANALGESICS AND COOL/WARM COMPRESSES TO THE SITE WITHOUT RELIEF.. JUNE 7,2019- PARENT CONTACTED FOR UPDATE. THEY TRIED BENADRYL AS WELL.REDNESS IS GONE, PAIN HAS SUBSIDED AND THERE IS STILL A SMALL HARD "KNOT" AT THE SITE OF INJECTION.  NO FORMAL MEDICAL TREATMENT WAS NEEDED.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site warmth, Local reaction
Clinical narrative: PARENT CALLED ON 06/03/2019 TO REPORT A LOCAL REACTION THAT WAS BOTHERING THE CLIENT.  PARENT DESCRIBED THE REACTION  AROUND THE  IMMUNIZATION SITE  AS RED, SWOLLEN, WARM WITH A HARD, PAINFUL "BUMP"  AT THE INJECTION SITE, WHICH DEVELOPED AFTER RECEIVING THE IMMUNIZATION  FIVE (5) DAYS AGO. . THEY HAD TRIED OTC ANALGESICS AND COOL/WARM COMPRESSES TO THE SITE WITHOUT RELIEF.. JUNE 7,2019- PARENT CONTACTED FOR UPDATE. THEY TRIED BENADRYL AS WELL.REDNESS IS GONE, PAIN HAS SUBSIDED AND THERE IS STILL A SMALL HARD "KNOT" AT THE SITE OF INJECTION.  NO FORMAL MEDICAL TREATMENT WAS NEEDED.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Peripheral swelling, Skin irritation, Vaccination site warmth
Clinical narrative: Red, warm to touch area below the vaccination site.  Patient states this started the evening she received the vaccine and she experienced some swelling in the arm the following day but now the irritation seems to be lessening.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea
Clinical narrative: nausea, headache, soreness and redness at injection site.  Suggested cold compress and either tylenol or ibuprofen
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling of upper arm, warm to touch and sore
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Lethargy, Pain in extremity
Clinical narrative: Pain in arm and general joint pain of all major joints and lethargy
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Fever 101, malaise, nausea and vomiting, sore arm starting the next morning, about 12 hours after administration, and lasting about 24 hours.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: 6-5-2019 Student came to clinic and asked if he could take to the nurse He said he got his 1st Hep b on 5-7 Tues .   He said he also had blood titers and a health Screen that night.  He had just got over a bout with the flu but was feeling ok that night.  He said about 2 days after the shot he started having some numbness in his feet and abdominal area.   He went to the Dr. But they cannot figure out the cause. He just wanted to let us know in case we had ever heard of something like that.  He thought it might be also from the flu .   I sent him a message today with all the info about his shot ( lot number ECT).  In case he should need that.  He said he is feeling much better this week and the numbness in his abdomen is gone and he only has a little in his feet now.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In or about 2008, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) administered by a healthcare provider for the long-term prevention of herpes zoster or shingles. On an unknown date, the pt was treated at a physician's office for shingles or herpes zoster. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, he had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the event was not recovered. The event of shingles or herpes zoster was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: MMR, UNK
Symptoms: Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: PCR testing which was positive for strain found in MMR II; had fever; rash; This spontaneous report was received from the employee from the office and refers to a 1-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(dose, frequency, route of administration, lot# and expiry date were not specified) for prophylaxis. Other suspect therapies included sterile diluent (Merck Sharp & Dohme). On an unknown date (also reported as "two of the patients were female and one of the patients was male", "4, 6 and 12 days respectively, after measles, mumps, and rubella (wistar ra 27-3; virus vaccine, live (M-M-R II) was administered"), the patient experienced fever and rash. Additionally, on an unknown date, the patient had polymerase chain reaction (PCR) testing which was positive for strain found in measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005218:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles/shingles are painful; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient had a Family History of shingles (mother suffered with shingles).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and low grade fever. On an unknown date, the outcome of the vaccination failure and low grade fever were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and low grade fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 3 years before the date of reporting. The patient experienced shingles every year since the time of receiving Shingrix. The patient was happy with the Shingrix vaccine when it was released newly in the market. At the time of reporting, the patient again suffered shingles for the third time and stated that it always broke out shortly on back the right leg after a bout of low grade fever.  The patient felt to be compensated and reported that the GSK's research department should pay to study why Shingrix could not protect the patient from shingles, but the patient experienced shingles inspite of receiving Shingrix. The reporter could be contacted by phone. This case was considered as suspected vaccination failure as the details regarding vaccination schedule was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at injection site; injection site big right away; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The patient reported that  when she got the flu shot that the injection site usually gets red and big right away. This case was linked to case US2019098274 reporter for same patient , different vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: pain at site of injection/ arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (For tolerance of 1st dose refer link case US2019098197).   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 29th May 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The Shingrix vaccine was administred on left deltoid. The patient arm was really hurt after receiving Shingrix vaccine.  The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain in extremity, Pyrexia
Clinical narrative: chills; feverish; weak; arm  soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 28th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th May 2019, the patient experienced chills, fever and weakness. On an unknown date, the outcome of the pain in arm, chills, fever and weakness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills, fever and weakness to be related to Shingrix.  Additional details were reported as follows: In the evening, the patient received a dose of Shingrix. Later that evening the patient's arm started feeling sore.  On the date of reporting in morning, 1 day after vaccination, the patient woke up feeling chills, feverish and weak. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: headache; very achy; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 29th May 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and pain. On 30th May 2019, the patient experienced headache. On an unknown date, the outcome of the influenza-like symptoms, headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller reported that she received Shingrix the day before reporting and same evening she started feeling achy after dinner and on the date of reporting she has a headache and was very achy. The patient felt like she has the flu.  The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Sick with flu-like symptoms; Sick with flu-like symptoms; pain at site of injection/ arm hurt; Wrong route of administration; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th March 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, sickness, pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the influenza-like symptoms, sickness, pain in arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the influenza-like symptoms, sickness and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient got Shingrix vaccine in the fatty part of the on left deltoid, which led to vaccine administered at inappropriate site.  After that shot the patient got sick with flu-like symptoms and her arm really hurt.  For tolerance of 2nd dose refer link case US2019GSK103044.  The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Exposure via skin contact, Injection site extravasation, Pain in extremity, Tenderness
Clinical narrative: redness at injection site; injection site pain/ arm tendernes; underdose; Inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On 15th May 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On 16th May 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities and pain in arm. On 17th May 2019, the outcome of the erythema of extremities and pain in arm were recovered/resolved. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in her left deltoid. On 15th May 2019, the pharmacist was going to get a bandaid to cover the injection site, she noticed that some of the injection was coming out of the back of her arm and dripping off her elbow, which led to accidental underdoes, inadvertent exposure to vaccine and exposure via skin contact. The pharmacist stated that perhaps she had the syringe filled to high. The patient asked if she received enough of a dose or if she was okay to get second dose in 2-6 months.  The pharmacist did follow up with someone from their company and her pharmacist was told the injection would still be effective.   The patient did not feel the fluid going into her arm during the injection but that her husband said that he felt it going into his arm when he got it.  The patient  reported that her arm was red and painful, and tender to the touch starting the next night and it lasted for a day. The patient reported that  when she got the flu shot that the injection site usually gets red and big right away.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: redness at injection site; injection site pain/ arm tendernes; underdose; Inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On 15th May 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On 16th May 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities and pain in arm. On 17th May 2019, the outcome of the erythema of extremities and pain in arm were recovered/resolved. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in her left deltoid. On 15th May 2019, the pharmacist was going to get a bandaid to cover the injection site, she noticed that some of the injection was coming out of the back of her arm and dripping off her elbow, which led to accidental underdoes, inadvertent exposure to vaccine and exposure via skin contact. The pharmacist stated that perhaps she had the syringe filled to high. The patient asked if she received enough of a dose or if she was okay to get second dose in 2-6 months.  The pharmacist did follow up with someone from their company and her pharmacist was told the injection would still be effective.   The patient did not feel the fluid going into her arm during the injection but that her husband said that he felt it going into his arm when he got it.  The patient  reported that her arm was red and painful, and tender to the touch starting the next night and it lasted for a day. The patient reported that  when she got the flu shot that the injection site usually gets red and big right away.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: muscle aches; fatigue; fever; swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number D7797, expiry date 9th July 2021) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th May 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling. On 22nd May 2019, the patient experienced fever. On 29th May 2019, the patient experienced muscle pain and fatigue. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the fever, muscle pain and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, fever, muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The Shingrix  batch number was reported as 07297, however based on a batch number review, the batch number was corrected to D7797. The pharmacist reported that a patient had swelling at the injection site after receiving the first dose of Shingrix which started the same day and then resolved.  Five days after vaccination the patient experienced a fever. On 29th May 2019, 12 days after vaccination the patient experienced muscle pain and fatigue. The reporter had consented to follow up.  The onset date of fever was reported as 22nd May 2019 in core and source document. But in narrative it was reported that the patient experienced a fever on last night on 29th May 2019. The onset date of fever was captured as per core and source document.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: pain at injection site.; knot in muscle; pain in muscle; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number JE45P, expiry date unknown) for prophylaxis.   On 21st March 2019, the patient received the 1st dose of Shingrix. In March 2019, less than a month after receiving Shingrix, the patient experienced injection site pain, nodule and muscle pain. On an unknown date, the outcome of the injection site pain, nodule and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, nodule and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain and a knot in muscle for 2 months since receiving the dose of Shingrix.  It was reported that the provided lot number, stated expiration date documented was not correct.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: muscle pain; headache; fever; upset stomach; tiredness; Shoulder pain; shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 27RS1 ?, expiry date 12th July 2021) for prophylaxis.   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2019, 11 hrs after receiving Shingrix, the patient experienced shivering and shoulder pain. On 30th May 2019, the patient experienced muscle pain, headache, fever, upset stomach and tiredness. On an unknown date, the outcome of the shivering, muscle pain, headache, fever, upset stomach and tiredness were not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shivering, muscle pain, headache, fever, upset stomach, tiredness and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix around 2 pm.  He woke up at around 1 am with shivering.  On 30th May 2019, 1 day after ereciving Shingrix, the patient woke up with muscle pain, headache, fever, upset stomach, and tiredness.  The patient also said that his shoulder where he got the injection hurts.  The reporter did not had the patient with her at the time of the call and was unable to clarify further the events. The reporetd batch number 27RS1 was not available in sales data sheet so captured as 27RS1 ?
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Pyrexia
Clinical narrative: muscle pain; headache; fever; upset stomach; tiredness; Shoulder pain; shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 27RS1 ?, expiry date 12th July 2021) for prophylaxis.   On 29th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2019, 11 hrs after receiving Shingrix, the patient experienced shivering and shoulder pain. On 30th May 2019, the patient experienced muscle pain, headache, fever, upset stomach and tiredness. On an unknown date, the outcome of the shivering, muscle pain, headache, fever, upset stomach and tiredness were not recovered/not resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shivering, muscle pain, headache, fever, upset stomach, tiredness and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix around 2 pm.  He woke up at around 1 am with shivering.  On 30th May 2019, 1 day after ereciving Shingrix, the patient woke up with muscle pain, headache, fever, upset stomach, and tiredness.  The patient also said that his shoulder where he got the injection hurts.  The reporter did not had the patient with her at the time of the call and was unable to clarify further the events. The reporetd batch number 27RS1 was not available in sales data sheet so captured as 27RS1 ?
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Pain at the injection site; redness at the injection site; knot in arm; Pain in arm; Arm redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 58160082311 ?, expiry date 16th May 2020) for prophylaxis.   On 17th May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a month after receiving Shingrix, the patient experienced local swelling, pain in arm and erythema of extremities. On 17th May 2019, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the local swelling, pain in arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, local swelling, pain in arm and erythema of extremities to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix on the left deltiod. The reporter stated that the patient experienced pain and redness at the injection site after injection which was resolved but states the pain, redness moved down to the left forearm and also had a knot which was unresolved. The reported batch number 58160082311 did not available in the sales date sheet so captured as 58160082311 ?
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Electromyogram abnormal, Hypoaesthesia, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: presented to emergency room on 4/17/18 with sudden onset of numbness and weakness progressing over several hours
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Diarrhoea, Faeces discoloured, Rash
Clinical narrative: The day after receiving the Polio IPV vaccine, my son was biting his hands in frustration and had diarrhea.  At 11:30am on 5/17/19 his daycare called to say he had three diarrhea diapers in an hour. It was very excessive for him.  My son had no fever.  On 5/18/19 my son developed a rash on his  right lower leg.  I am not sure how long it was there, as I discovered it while he was napping.  Patient has had several  diarrhea  episodes that have  resulted in a  green, jello like substance. He has also had many extremely watery poops. No blood has been observed in his stools.  He has been averaging anywhere from 1-5 diarrhea diapers a day. This is not his normal poop routine.  We have taken him to the doctors several times and we were told to wait two weeks before we did any testing. We are now going to test for Lyme disease as well as getting his stool tested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: pt reports received first shingrix dose 5/20/19 in morning. That afternoon developed fever, chills, body aches, resolved after 24 hours. 16 days later same exact symptoms happened and resolved again in 24 hours.  No other vaccines given that day pt reports.
Age: 42.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: patient woke up 6 days post injection, with pain in calves, and over past 24 hours, it  has spread into her joints, knees, arms, hands.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Neck pain, Peripheral swelling, Tenderness
Clinical narrative: PATIENT CAME IN AND SAID HE COULD BARELY LIFT HIS ARM THE NEXT DAY AFTER GETTING THE SHOT.  VERY TENDER/SORE TO THE TOUCH.  UNDER THE ARM WAS SWOLLEN AND RED.  HE ALSO STATED HIS LOWER ARM VEINS HURT AND ALSO BY HIS NECK.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Vascular pain
Clinical narrative: PATIENT CAME IN AND SAID HE COULD BARELY LIFT HIS ARM THE NEXT DAY AFTER GETTING THE SHOT.  VERY TENDER/SORE TO THE TOUCH.  UNDER THE ARM WAS SWOLLEN AND RED.  HE ALSO STATED HIS LOWER ARM VEINS HURT AND ALSO BY HIS NECK.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site induration, Local reaction, Malaise, Peripheral swelling
Clinical narrative: Localized reaction, arm swelling injection site hard to touch. Patient developed fever chills. Stated she was sick in bed for 3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Localized reaction, arm swelling injection site hard to touch. Patient developed fever chills. Stated she was sick in bed for 3 days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site induration, Injection site swelling, Pain, Pyrexia
Clinical narrative: Localized reaction, arm swelling injection site hard to touch. Patient developed fever chills. Stated she was sick in bed for 3 days.
Age: 1.75
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Grandmother called to notify me that child had a temperature 1 hour after getting today's vaccinations.  Grandma gave Tylenol at 11am and infant took a nap.  At 4pm, Grandma said child's temperature is 103.1 and had not received pain reliver since 11 am.    Encouraged to given Tylenol and Ibuprofen per bottle directions and give luke warm bath.  Is to contact physician office or ER number if fever gets higher.   Next day, grandma said pain reliver and bath helped bring fever "way" down.  No hospital visit.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 5/7/19 at 1800, report from parent the L upper thigh was swollen, red and warm to touch.  Benadryl and Ibuprofen given.  On visit on 5/8/19 at 8:20am, report was lesions 5cm x 4.5 cm oblong erythematous with hardened center . 3cm round ; non tender and no drainage.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: On 5/7/19 at 1800, report from parent the L upper thigh was swollen, red and warm to touch.  Benadryl and Ibuprofen given.  On visit on 5/8/19 at 8:20am, report was lesions 5cm x 4.5 cm oblong erythematous with hardened center . 3cm round ; non tender and no drainage.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Developed fatigue, body aches on 4/19/19. Had dry cough and one loose stool and headache. On 4/22/19 developed maculopapular rash across chest, arms and legs, back and feet. Had fever 101 on 2/18/19.  referred to dermatology who did biopsy which showed urticurial-allergic eruption. He had also taken codeine for cough night before erupton occurred.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Developed fatigue, body aches on 4/19/19. Had dry cough and one loose stool and headache. On 4/22/19 developed maculopapular rash across chest, arms and legs, back and feet. Had fever 101 on 2/18/19.  referred to dermatology who did biopsy which showed urticurial-allergic eruption. He had also taken codeine for cough night before erupton occurred.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Developed fatigue, body aches on 4/19/19. Had dry cough and one loose stool and headache. On 4/22/19 developed maculopapular rash across chest, arms and legs, back and feet. Had fever 101 on 2/18/19.  referred to dermatology who did biopsy which showed urticurial-allergic eruption. He had also taken codeine for cough night before erupton occurred.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient assumes vaccine was given too low, had a rash, and has experienced pain 25 days past injection date
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash, Scab, Skin lesion
Clinical narrative: Often, about 3 days after the onset of a viral illness, I develop a fine rash on my chest and upper abdomen.  it eventually disappears.  In this case, the fine rash appeared and then transitioned into a series of raised, red lesions, about 5 mm in diameter and very itchy.  I didn't really see any vesicles but the lesions eventually developed scabs.  that is the current status.  they are still very itchy but seem to be slowly subsiding.  I have not used anything orally or topically for the itchiness.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: Often, about 3 days after the onset of a viral illness, I develop a fine rash on my chest and upper abdomen.  it eventually disappears.  In this case, the fine rash appeared and then transitioned into a series of raised, red lesions, about 5 mm in diameter and very itchy.  I didn't really see any vesicles but the lesions eventually developed scabs.  that is the current status.  they are still very itchy but seem to be slowly subsiding.  I have not used anything orally or topically for the itchiness.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: Patient stated that her symptoms started the evening she received the vaccination and was in extreme pain all over her body. This lasted for a good 2 days and still does not feel right almost a week later.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cold sweat, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Syncopal episode, low blood pressure, clammy/sweaty, lasted approximately 30 minutes