chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Immunoglobulin therapy
Clinical narrative: Unknown disorder; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. The patient was treated with immunoglobulin human normal, immunoglobulin human normal (Gammaglobulin). On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The pharmacist stated that after receiving the 1st dose of Shingrix, the patient was diagnosed with a new disorder (precise diagnosis unknown to pharmacist) and was started on Gammaglobulin infusions. The pharmacist became notably frustrated when specialist attempted to collect more details for the adverse event.  The pharmacist stated that she did not know what the diagnosis was, only that the patient was not diagnosed with this disorder prior to receiving the first dose of Shingrix.  The pharmacist was transferred to second line specialist for further discussion regarding her inquiry. The specialist neglected to ask whether safety had permission to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness on arm bigger than half dollar size; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 16th July 2019, the patient received Shingrix. In July 2019, less than 2 weeks after receiving Shingrix, 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 recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional information received were as follows: The pharmacist called in to question that any information on the reaction lasting this long.  The pharmacist stated that the patient received the 2nd dose of Shingrix on left arm. The patient initially had swelling but swelling had gone down and still had redness on arm bigger than a half dollar size.  The adverse event was collected. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: fatigue; pain at injection site; swelling at the injection site; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 1st dose of Shingrix. In July 2019, 6 hrs after receiving Shingrix, the patient experienced fatigue, injection site pain, injection site swelling and headache. On an unknown date, the outcome of the fatigue, injection site pain, injection site swelling and headache were recovering/resolving.   It was unknown if the reporter considered the fatigue, injection site pain, injection site swelling and headache to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received his 1st dose of Shingrix in the left arm. In the middle of the night, around 6-8 hours after receiving Shingrix, the patient experienced a reaction which included fatigue, swelling and pain at the injection site and a headache.  The patient claimed that his symptoms were improving but they were the worst on Saturday 27th July 2019. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: hard lump under the skin/ Injection site induration; This case was reported by a other health professional via call center representative and described the occurrence of injection site induration in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   On 26th July 2019, the patient received Shingrix. On 26th July 2019, less than a day after receiving Shingrix, the patient experienced injection site induration. On an unknown date, the outcome of the injection site induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix Vaccination and had a hard lump under the skin. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Influenza like illness, Injection site pain
Clinical narrative: herpes simplex; soreness at the injection site; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   The patient's past medical history included shingles.   On 30th April 2019, the patient received the 1st dose of Shingrix .5 ml. On 1st May 2019, 1 days after receiving Shingrix, the patient experienced injection site pain and influenza-like symptoms. On 4th May 2019, the patient experienced herpes simplex. On an unknown date, the outcome of the injection site pain, influenza-like symptoms and herpes simplex were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms and herpes simplex to be related to Shingrix.  Additional information was provided as follows: The patient experienced typical soreness at the injection site. Four days after vaccination, the patient had herpes simplex on left side on her nose. She had not had that before. She took one medication and it went away. The reporter consented for follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fall, Fatigue
Clinical narrative: Fatigue; Joint pain; Dizziness; Fell a couple times; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 19th June 2019, the patient received Shingrix (intramuscular). In June 2019, less than 2 weeks after receiving Shingrix, the patient experienced fatigue, joint pain, dizziness and fall. On an unknown date, the outcome of the fatigue, joint pain, dizziness and fall were unknown.   It was unknown if the reporter considered the fatigue, joint pain, dizziness and fall to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received Shingrix. Three or four days after the injection, the pharmacist followed up and the patient did not report any symptoms at that time.  On 27th June 2019 the patient's husband called the pharmacy to report the patient was experiencing fatigue, joint pain, dizziness, and she had fallen a couple times due to the dizziness.  The patient's husband denied fever and denied rash. The reporter consented to follow up. The pharmacist states he filed a VAERS report and he consents to follow up from safety.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, TD, VARZOS
Symptoms: Computerised tomogram head normal, Fall, Head injury, Headache, Syncope
Clinical narrative: After receiving 4 vaccinations, patient stood up and started to walk out of exam room.  She suffered syncopal episode which caused her to fall and hit back of her head on the floor.  EMS was activated and she transported to the hospital for evaluation.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Computerised tomogram normal, Decreased appetite, Discomfort, Irritability, Rash
Clinical narrative: bump on for head X 1 week, rash all over body X 1 day, loss of appetite, fussy X 6 days as per 07/22/2019 office visit.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Swelling, Tenderness
Clinical narrative: bump on for head X 1 week, rash all over body X 1 day, loss of appetite, fussy X 6 days as per 07/22/2019 office visit.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Asthenia, Dizziness, Feeling abnormal, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: 7/15/19 office visit: - Numbness/tingling of her L shoulder about 1 hr after receiving the HPV and Menactra vaccines at her WCC on 6/13 - The numbness has gotten progressively worse such that it has spread to her other shoulder, her neck and diffusely down her spine - The numbness is constant, she is experiencing pain in her muscles as well - She thinks that she has also felt more foggy since the vaccine where her brain and mouth don't feel connected. Will say things that don't make sense sometimes, her sister corroborates this - She feels dizzy on occasion without LOC - She feels more weak as well, she has dropped things a couple of times after this started 7/24/19 office visit: Pt in the clinic with her mom for follow up of reaction to HPV vaccine, vaccine was given on 6/13/19 in left deltoid, she almost immediately had numbness in her arm, neck and spine. She now notices a lump on her spin on her neck. Pt also notices some numbness in legs as well. Pt tearful in the office. She was seen in UC was given prednisone/muscle relaxer, she has not tried either, she does have a referral to Pediatric Neurology. Pt has been sick in the past, She also has severe anxiety. Pt states she has been having nausea with movement of her head and neck.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site paraesthesia, Myalgia, Neck mass, Speech disorder, Tearfulness
Clinical narrative: 7/15/19 office visit: - Numbness/tingling of her L shoulder about 1 hr after receiving the HPV and Menactra vaccines at her WCC on 6/13 - The numbness has gotten progressively worse such that it has spread to her other shoulder, her neck and diffusely down her spine - The numbness is constant, she is experiencing pain in her muscles as well - She thinks that she has also felt more foggy since the vaccine where her brain and mouth don't feel connected. Will say things that don't make sense sometimes, her sister corroborates this - She feels dizzy on occasion without LOC - She feels more weak as well, she has dropped things a couple of times after this started 7/24/19 office visit: Pt in the clinic with her mom for follow up of reaction to HPV vaccine, vaccine was given on 6/13/19 in left deltoid, she almost immediately had numbness in her arm, neck and spine. She now notices a lump on her spin on her neck. Pt also notices some numbness in legs as well. Pt tearful in the office. She was seen in UC was given prednisone/muscle relaxer, she has not tried either, she does have a referral to Pediatric Neurology. Pt has been sick in the past, She also has severe anxiety. Pt states she has been having nausea with movement of her head and neck.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle pain, nausea, shivering, tiredness, unsteady feeling
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Headache, muscle pain, nausea, shivering, tiredness, unsteady feeling
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Constipation, Fatigue, Lethargy, Nasal congestion, Pyrexia
Clinical narrative: Significant rash to face and trhink-raised red popular exanthem highly concentrated to face; sporadic on extremiter. Mild nasal congestion; fatigue/lethargy, constipation all started with rash. 8/3/19 when constipation started, 8/4/19 when fatigue started with low grade fever. 8/5/19 when rash started
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash papular
Clinical narrative: Significant rash to face and trhink-raised red popular exanthem highly concentrated to face; sporadic on extremiter. Mild nasal congestion; fatigue/lethargy, constipation all started with rash. 8/3/19 when constipation started, 8/4/19 when fatigue started with low grade fever. 8/5/19 when rash started
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Developed large hives to right leg, thigh, and buttox the morning after shots
Age: 60.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse symptoms reported; was vaccinated with both an adult and pediatric dose of VAQTA; Information has been received from a medical assistant referring to a 60 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided.  On 16-JUL-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (an adult dose and a pediatric dose; strength, frequency, route, batch/lot number and expiration date were not provided) for prophylaxis. The patient was supposed to receive an adult dose of hepatitis a vaccine, inactivated (VAQTA) instead of the pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (Inappropriate dose of vaccine administered). No adverse symptoms were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: unilateral, vesicular rash on the front of her right leg that spread to the top of her back and did not cross the midline; unspecified physician thought it was shingles; This spontaneous report was received from a registered nurse (patient's mother) regarding a 3 years old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in October 2016, the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage schedule, lot# and expiry date were not reported) for prophylaxis. On 02-AUG-2019, the patient developed a unilateral, vesicular rash on the front of her right leg that spread to the top of her back and did not cross the midline (Rash vesicular). The mother reported that an unspecified physician had sent a sample of vesicular rash for analysis (results unknown). The mother reported that the unspecified physician thought it was shingles (Herpes zoster). The patient had sought medical attention and the physician had prescribed oral acyclovir and an unspecified topical steroid lotion. No product quality complaint (PQC) was present. Outcome of the events Rash vesicular and Herpes zoster was not recovered. Causality assessment for the events was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Ocular shingles; Shingles on face; This case was reported by a physician via sales rep and described the occurrence of ophthalmic herpes zoster in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date unknown) for prophylaxis.   On 16th July 2019, the patient received Shingrix. On 31st July 2019, 15 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.  Additional details were received as follows: The patient was diagnosed with shingles on face and ocular shingles. The patient was referred to ophthalmologist. The reporter consented to follow up. The batch number of Shingrix was reported as 5227X, which was corrected to 52R7X as per sales data sheet.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: injection site is warm, red and spreading / Reporter stated outcome as between persisting and worsening; injection site is warm, red and spreading; injection site is warm, red and spreading; This is a spontaneous report from a contactable Pharmacist. A 65-year-old female patient started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot#: X39675, NDC number: 0005197102, Expiry Date: Jul2020), via an unspecified route of administration on 18Jul2019 at single dose for routine vaccination. Medical history included allergic to adhesive. There were no concomitant medications. The patient experienced injection site is warm, red and spreading on 20Jul2019 with outcome of not recovered, reporter stated outcome as between persisting and worsening on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red area of the arm at the injection site; Warmth at the injection site; This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number not reported), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced large red area of the arm at the injection site and warmth at the injection site, with no pain on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Limb mass, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: also has redness on her arm; arm swelled really bad the next day; lump in her arm; arm is very sore and hard to move; arm is very sore and hard to move; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 46-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) with unknown lot number and expiration date, via an unspecified route of administration on the arm on 11Jul2019 at a single dose for prevention. The patient's medical history included rheumatoid arthritis, and post-traumatic stress disorder (PTSD) from 2011 and ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2012 and ongoing for PTSD, and ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) that the patient has taken since age 23 which she takes out of habit because was recommended by her mother, and adalimumab (HUMIRA) rheumatoid arthritis and it suppresses her immune system. The patient reported that she received a dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Her arm swelled really bad the next day (12Jul2019). She still has a lump in her arm (started on 12Jul2019) and the doctor doesn't know what to do at this point. The patient was asking how long she should expect the lump to be in her arm. She also has redness on her arm  on 13Jul2019. Her arm was very sore and hard to move. She ended up going to the ER. The outcome of the events "arm swelled really bad the next day" and redness on her arm was recovering. The outcome of the event lump in her arm was not recovered. And the outcome of the event "arm is very sore and hard to move" was unknown.  Information on the batch number has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Fatigue, sweating, severe muscle aches, headache.
Age: 26.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient called saying that one day ago, she woke up with redness and swelling at her injection site that was hot to the touch. She was not running a fever.
Age: 32.0
Sex: F
Vaccine: TDAP, UNK, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Computers were down a ProQuad  MMRV was pulled and given instead of a regular MMR  The mistake was noted when putting lot number information from paper chart into computer
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient had a large warm red swollen area on arm below where vaccination occurred.  Pharmacist circled with pen and instructed patient to report to urgent care if red area grows or she develops symptoms such as fever.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old patient of unspecified gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 01-SEP-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Pt was treated by a physician for the following injury resulting from zoster vaccine live (ZOSTAVAX) use: Bell's Pallsy. Pt claimed damages as a result of: injury to themselves, loss of consortium, loss of services, economic losses.  Upon internal review, the event of facial paralysis was considered to be medically significant.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Pain of skin
Clinical narrative: Hurt at injection; big pale pink rectangular area with a red dot; big bright red spot; Shower stung; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on April 2019 in left arm and experienced injection site tenderness, injection site coloration and nonspecific reaction, refer case US2019137560.).   On 26th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site coloration, injection site erythema and stinging skin. On an unknown date, the outcome of the injection site pain, injection site coloration, injection site erythema and stinging skin were unknown.   It was unknown if the reporter considered the injection site pain, injection site coloration, injection site erythema and stinging skin to be related to Shingrix.  Additional case details were reported as follows: The patient hurt at injection. The patient had the same reaction with a big pink rectangular area approximately 2-3 inches at the injection site that was pinkish and hurt to the touch with a red dot. The patient took a shower and the shower stung and she noticed there was now a big red spot that was bright red. The reporter gave permission to follow up. This case has been linked with US2019137560, reported by the same reporter for the same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Rash, Rash generalised
Clinical narrative: Painful rash; painful rash about the arms, upper arms, neck, upper chest, and top of scalp; This case was reported by a pharmacist via call center representative and described the occurrence of painful rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on 24th May 2019 (batch number CF9K4, expiry date 11th September 2021), in right arm developed rash, refer case US2019137612.).   On 23rd July 2019, the patient received the 2nd dose of Shingrix. On 27th July 2019, 4 days after receiving Shingrix, the patient experienced painful rash and generalized rash. On an unknown date, the outcome of the painful rash and generalized rash were unknown.   It was unknown if the reporter considered the painful rash and generalized rash to be related to Shingrix.  Additional case details were reported as follows: On 23rd July 2019, the patient received vaccine in unknown arm which led to inappropriate schedule of vaccine administered. The 4 days after vaccination, the patient reported that she developed a painful rash about the arms, upper arms, neck, upper chest, and top of scalp. At time of reporting it was not known what the status of the events were. The reporter also reported that the husband of the patient also reported and event, which would be submitted as a clone to this report. The reporter gave permission to follow up. This case had been linked to the case US2019137612, reported for same patient. This was a medication error with harm.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; post herpetic neuralgia; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had both doses of the Shingrix series completed. The patient experienced post herpetic neuralgia. The patient did not exhibit any rash or visible indication of shingles. The patient noted that, the patient must have had shingles based on the post herpetic neuralgia. The patient did not wish to participate in a safety report and provide to her demographics. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Blood pressure inadequately controlled, Cardiac fibrillation, Cardioversion, Condition aggravated
Clinical narrative: Fibrilation; low blood pressure; heart rate not controlled; Injection site pain; achy all over; This case was reported by a consumer via call center representative and described the occurrence of fibrillation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibrillation. Previously administered products included Shingrix with an associated reaction of pain (1st dose received 2 to 3 months before the time of reporting, refer case US2019AMR141015).   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, 14 hrs after receiving Shingrix, the patient experienced general body pain. On 30th July 2019, the patient experienced injection site pain. On 31st July 2019, the patient experienced fibrillation (serious criteria GSK medically significant), low blood pressure and heart rate irregular. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular were unknown.   It was unknown if the reporter considered the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular to be related to Shingrix.  Additional case details were reported as follows: The patient a dose of Shingrix on the right arm at the pharmacy. Immediately after vaccination, the patient experienced injection site pain. The next day, 14 hours after vaccination, the patient experienced achiness all over.  On the same day, around 2 PM, the patient noted she was experiencing fibrillation and low blood pressure of about 70/50.   The patient went to the emergency room and the blood pressure and heart rate could not be controlled.   The patient had cardioversion.   The patient was discharged. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate irregular, Hypotension, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Fibrilation; low blood pressure; heart rate not controlled; Injection site pain; achy all over; This case was reported by a consumer via call center representative and described the occurrence of fibrillation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibrillation. Previously administered products included Shingrix with an associated reaction of pain (1st dose received 2 to 3 months before the time of reporting, refer case US2019AMR141015).   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, 14 hrs after receiving Shingrix, the patient experienced general body pain. On 30th July 2019, the patient experienced injection site pain. On 31st July 2019, the patient experienced fibrillation (serious criteria GSK medically significant), low blood pressure and heart rate irregular. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular were unknown.   It was unknown if the reporter considered the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular to be related to Shingrix.  Additional case details were reported as follows: The patient a dose of Shingrix on the right arm at the pharmacy. Immediately after vaccination, the patient experienced injection site pain. The next day, 14 hours after vaccination, the patient experienced achiness all over.  On the same day, around 2 PM, the patient noted she was experiencing fibrillation and low blood pressure of about 70/50.   The patient went to the emergency room and the blood pressure and heart rate could not be controlled.   The patient had cardioversion.   The patient was discharged. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Fibrilation; low blood pressure; heart rate not controlled; Injection site pain; achy all over; This case was reported by a consumer via call center representative and described the occurrence of fibrillation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibrillation. Previously administered products included Shingrix with an associated reaction of pain (1st dose received 2 to 3 months before the time of reporting, refer case US2019AMR141015).   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). In July 2019, 14 hrs after receiving Shingrix, the patient experienced general body pain. On 30th July 2019, the patient experienced injection site pain. On 31st July 2019, the patient experienced fibrillation (serious criteria GSK medically significant), low blood pressure and heart rate irregular. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular were unknown.   It was unknown if the reporter considered the fibrillation, general body pain, injection site pain, low blood pressure and heart rate irregular to be related to Shingrix.  Additional case details were reported as follows: The patient a dose of Shingrix on the right arm at the pharmacy. Immediately after vaccination, the patient experienced injection site pain. The next day, 14 hours after vaccination, the patient experienced achiness all over.  On the same day, around 2 PM, the patient noted she was experiencing fibrillation and low blood pressure of about 70/50.   The patient went to the emergency room and the blood pressure and heart rate could not be controlled.   The patient had cardioversion.   The patient was discharged. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a other health professional via sales rep and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Medical assistant reported a couple of patients didn't want to return for second dose due to the pain with the 1st dose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Vaccination failure
Clinical narrative: Suspetcted vaccination failure; neuropathy; shingles on the lower left dermatome, wrapping around the patient's back; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a 70-year-old 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 .5 ml. On 29th July 2019, less than a year after receiving Shingrix and 183 days after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, neuropathy and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, neuropathy and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: This case was reported by the patient's neighbor, who was nurse practitioner. The age at vaccination was not reported. The patient developed shingles 6 months after getting the 2nd dose of Shingrix.  The shingles was on the lower left dermatome and wrapping around the patient's back.  The patient had developed neuropathy due to the shingles. The field representative was only able to provide the reporter's home address, but did not know her office address. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Inappropriate schedule of product administration
Clinical narrative: stomach cramps; first dose on 30Mar2019/was supposed to get her second dose two months after however received it on 12Jul2019; This is a spontaneous report from a Pfizer sponsored program IVR and LIve Operator Support for 1-844 TRUMENBA Customer Service Line, received from a contactable consumer. A 20-year-old female patient received second dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the left arm on 12Jul2019 at a single dose as school suggested to get meningitis B. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of meningococcal group b rlp2086 on 30Mar2019 for immunization. On 12Jul2019, the patient experienced inappropriate schedule of vaccine administered. The patient reported that she got her got first dose on 30Mar2019 and was supposed to get her second dose two months after however received it on 12Jul2019. The patient reported that she received the vaccine on 14:45 (also reported as 16:45). The patient additionally reported that she had stomach cramps on unspecified date; took advil for it and stated that it was not due to the vaccine. The outcome of the event stomach cramps was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: There is not a reasonable possibility that the reported event stomach cramps is related to the suspect product
Sex: F
Vaccine: PNC13
Symptoms: Feeling cold, Headache, Rash
Clinical narrative: rash in her leg/ she has one big patch and smaller patches of this rash; has had a headache; she also feels very cold; This is a spontaneous report from a contactable consumer. A 68-year-old female patient started to receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported she was experiencing a rash in her leg, she also feels very cold and has had a headache. She said that her physician didn't consider the rash serious and recommended applying either calamine or a hydrocortisone cream, and that the rash hasn't moved to other parts of her body although she has one big patch and smaller patches of this rash. Patient wanted to know if rash is a common side effect with Prevnar 13 and if it resolves eventually. Outcome of the events was unknown.  Information on the batch number has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Nausea, Peripheral swelling, Vaccination site swelling
Clinical narrative: the arm that the Trumenba was administered in was puffy.; headache; nausea; chills; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) for immunization. It was reported that on 29Jul2019, the patient was administered meningococcal group b rlp2086 in one arm and was administered  meningococcal vaccine a/c/y/w conj (dip tox) in the other arm and the arm that the meningococcal group b rlp2086 was administered in was puffy and within 6 hours of administration of the vaccine, the patient complained of headache, nausea and chills and on the next day, the patient came in with her siblings and was seeing the HCP and was still complaining that her arm was puffy and still had a headache. The outcome of the events vaccination site swelling and headache was not recovered while the outcome of the events nausea and chills was unknown.  Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of redness at the injection site and warm  to the touch.; Large area of redness at the injection site and warm  to the touch.; This is a spontaneous report from a contactable other healthcare professional via a sales representative. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had large area of redness at the injection site and warm to the touch on an unspecified date. No pain reported. Event took place after use of product. Outcome of the events was unknown.    No follow- up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site nodule, Rash
Clinical narrative: Allergies: Pneumococcal 13-valent conjugate; Rash; Nodule at site of injection; This is a spontaneous report from a contactable physician. A 63-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), rash, and nodule at site of injection on an unspecified date. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Limb mass, Pain
Clinical narrative: Painful lump on her arm; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported that a female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  Caller mentioned that she got Prevnar 13 shot on 11Jul and since then she was having a painful lump on her arm the size of a walnut. She also ended up in the emergency room because of it. She would like to know how long it will stay there since her physician does not know what to do with it. Outcome of the events was unknown.   Information on the batch number has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: approximately 4 1/2 days after administration in the morning, patient woke up with a rash near the injection site of Shingrix vaccine.  She described it as "narrow," approximately 1 inch wide and 2 inches long by her estimation.  The area has remained sore for the duration since vaccination.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Dizziness, Fall, Headache, Injection site pain
Clinical narrative: Dizziness and headache which led to patient falling and bruising hip. Site of injection was painful and warm to touch. Pt used ice and OTC Nsaids to relieve pain. Pt stated this helped.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Dizziness and headache which led to patient falling and bruising hip. Site of injection was painful and warm to touch. Pt used ice and OTC Nsaids to relieve pain. Pt stated this helped.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Decreased appetite, Fatigue, Full blood count, Haematocrit decreased, Headache
Clinical narrative: The day after pt received vaccination, she c/o redness, swelling, and pain of upper right arm. Pt also reported headache, fatigue, nausea, loss of appetite and fever.  Pt took 1,000 mg of Tylenol every 6 hours for 3 days after vaccine. She was seen in clinic on 7/29/19 and prescribed clobetasol 0.05% topical cream BID and ondansetron 8 mg sublingual tablet for nausea.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Metabolic function test, Nausea
Clinical narrative: The day after pt received vaccination, she c/o redness, swelling, and pain of upper right arm. Pt also reported headache, fatigue, nausea, loss of appetite and fever.  Pt took 1,000 mg of Tylenol every 6 hours for 3 days after vaccine. She was seen in clinic on 7/29/19 and prescribed clobetasol 0.05% topical cream BID and ondansetron 8 mg sublingual tablet for nausea.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: The day after pt received vaccination, she c/o redness, swelling, and pain of upper right arm. Pt also reported headache, fatigue, nausea, loss of appetite and fever.  Pt took 1,000 mg of Tylenol every 6 hours for 3 days after vaccine. She was seen in clinic on 7/29/19 and prescribed clobetasol 0.05% topical cream BID and ondansetron 8 mg sublingual tablet for nausea.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; one 43 year old patient inadvertently received one dose of PROQUAD; Information has been received from a nurse referring to a 43 year old patient of unknown gender. The patient's drug reactions/allergies, pertinent medical history and concomitant medication were not provided.  On 10-JUL-2019, the patient was inadvertently vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R026720, expiration date 17-MAR-2020, subcutaneous for prophylaxis (strength, dose and frequency were not provided) (Inappropriate age at vaccine administration). Other suspect therapy included sterile diluent(manufacturer unknown). No adverse effects reported. The outcome of the events was unknown. The causality assessment was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at patient place, for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated by a healthcare professional at the patient place, since she experienced shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not provided and the causality of the events was related.