chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd July 2020). Concurrent medical conditions included allergic reaction to wasp sting, allergy to chemicals and asthma. Concomitant products included prednisone.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a history of chemical allergies and asthma. On 9th September 2020, the patient was stung by a wasp on her right shin and she had a bad reaction to the wasp sting and had finished a steroid pack treatment of 4 mg of prednisone last on night of 19th September 2020. The patient got the flu vaccines and several times, but not every time the patient experience a fever that resolved. The reporter consented to follow up. This case has been linked with US2020AMR197139 and US2020193841 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197139:same patient Shingrix 1st dose US-GLAXOSMITHKLINE-US2020193841:same patient Shingrix 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: swelling in the arm; This case was reported by a physician via call center representative and described the occurrence of swelling arm 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 swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received the 1st dose of Shingrix a while ago and experienced swelling in the arm. The reporter did not consent to follow up. The Doctor said he could not clarify if the dose was administered IM or SQ because he did not administer it and did not know date of vaccination or when the symptoms started and did not agree to follow up and said that a pharmacist had already reported this. This case linked with US2020196165, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196165:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever and chills. The reporter asked how long after receiving Shingrix vaccine can side effects such as fever and chills occur.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got VERY sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and got very sick. The patient was scared to get second shot.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Illness
Clinical narrative: i amsick; is it possible to be allergic; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and allergic reaction. On an unknown date, the outcome of the sickness and allergic reaction were unknown.   It was unknown if the reporter considered the sickness and allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced allergic reactions and sickness after receiving a flu shot. No further information was provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Mobility decreased
Clinical narrative: swelling and knot the size of a goose egg at the injection site; knot / at the injection site which was very red; knot / at the injection site which was / slightly itchy.; her arm was sore for a couple of weeks; knot the size of a goose egg at the injection site; was not able to move her arm for 2 to 3 days; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 30th November 2021) for prophylaxis.   Concurrent medical conditions included allergy.   On 23rd July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, mobility decreased, pain in extremity and injection site lump. On an unknown date, the outcome of the injection site swelling and injection site lump were not recovered/not resolved and the outcome of the injection site erythema and injection site itching were unknown and the outcome of the mobility decreased and pain in extremity were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, mobility decreased, pain in extremity and injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received Singrix and she experienced injection site swelling, injection site knot the size of a goose egg, injection site redness, injection site slightly itchy, unable to move her arm for two to three days and sore arm for a couple of weeks. Till the time of reporting patient had a knot and swelling at injection site. The physician was wait for the swelling to resolve before administering the second dose. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: swelling and knot the size of a goose egg at the injection site; knot / at the injection site which was very red; knot / at the injection site which was / slightly itchy.; her arm was sore for a couple of weeks; knot the size of a goose egg at the injection site; was not able to move her arm for 2 to 3 days; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 30th November 2021) for prophylaxis.   Concurrent medical conditions included allergy.   On 23rd July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, mobility decreased, pain in extremity and injection site lump. On an unknown date, the outcome of the injection site swelling and injection site lump were not recovered/not resolved and the outcome of the injection site erythema and injection site itching were unknown and the outcome of the mobility decreased and pain in extremity were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, mobility decreased, pain in extremity and injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received Singrix and she experienced injection site swelling, injection site knot the size of a goose egg, injection site redness, injection site slightly itchy, unable to move her arm for two to three days and sore arm for a couple of weeks. Till the time of reporting patient had a knot and swelling at injection site. The physician was wait for the swelling to resolve before administering the second dose. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness developed at the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2022) for prophylaxis.   On 26th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed redness at the injection site and traveled down to the elbow area. The reporter consented to follow up.
Sex: F
Vaccine: FLUR4
Symptoms: Oral mucosal exfoliation, Oral pain
Clinical narrative: mucous membrane of her mouth peeling; mouth sore; Based on information received on 02-Sep-2020, the report previously considered as non-valid became valid as adverse event specified in the case.  Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from the patient   This case involves a female patient (age was not reported) who experienced sore mouth (oral pain) and mucous membrane of her mouth started peeling (oral mucosal exfoliation),  while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and while treated with CELECOXIB [CELEBREX] and LEVOFLOXACIN [LEVAQUIN].  The patient was vaccinated with 2 doses of Influenza Vaccine containing H1N1 antigen in the past since 1975 for prophylactic vaccination and had similar reactions (oral mucosal exfoliation and oral pain) when she takes medication that contains sulfa products.  The patient's family history and concomitant medications were not provided.  On an unknown date in 2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (batch number and other dosing details were not reported) for prophylactic vaccination. On an unknown date, the patient started taking CELECOXIB [CELEBREX] and LEVOFLOXACIN [LEVAQUIN] (batch number and other dosing details were not reported) for unknown indication.  On an unknown date, the mucous membrane of her mouth started peeling (oral mucosal exfoliation) and experienced sore mouth (oral pain), (unknown latency), following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, following the first dose intake and last dose intake of CELECOXIB and LEVOFLOXACIN.  These reactions were very strong.  Details of laboratory data were not reported.  The action taken for CELECOXIB [CELEBREX] and LEVOFLOXACIN [LEVAQUIN] was not reported.  The patient did not receive corrective treatment and just avoided eating foods that would aggravate the condition such as spicy foods.  On an unknown date, the patient had recovered from the events after several days.  There will be no information available on the batch number for this case.  Follow up information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case from the patient via phone  Case upgraded from non-valid to valid, new suspect drugs and events added.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Gait disturbance, Gait inability, Pain in extremity
Clinical narrative: The next morning post flu mist vaccine the patient woke up with pain in 1 leg, attempted to walk and stretch the leg but couldn't. Day 2, attempted to walk again and is limping, bow legged as if his knee is turned inward
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Neuralgia
Clinical narrative: Patient complains of nerve pain that requires MD visits and medication
Age: 31.0
Sex: F
Vaccine: FLUA4
Symptoms: Contusion, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: The day after receiving my flu shot during a workplace flu clinic, my arm had a dark red puffed out mark about two inches wide and an inch long at the injection site. It felt like fluid was underneath my skin like the injection never spread and it itched. Two days after the vaccine, the redness spread to a large circle on my arm with more itching. The redness lasted about four days and afterwards my arm was bruised.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: NO INITIAL REACTION NOTED AFTER INJECTION, HOWEVER BY 6PM EVENING OF INJECTION, PT NOTED SWELLING IN RIGHT DELTOID NEAR INJ SITE WITH MILD PAIN AND  SLIGHT ITCHINESS. PRESENTED TO WORK THIS MORNING AND REPORTED SYMPTOMS. 1 1/2 X 1 7/8 MINCH MILD SWELLING WITH SLIGHT PALE REDNESS INCETNER. REPORTS SORENESS AND SOME TICHINESS. AFEBRILE, NO OTHER COMPLAINTS. SEEN BY DR & REPORTED TO CORPORATE MEDICAL OPS DR. ENCOURAGED COLD COMPRESSES TO AREA AND REST ARM WHEN ABLE. INFORMED TO REPORT ANY WORSENING OR CHANGE IN CONDITION
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Pain
Clinical narrative: At 5 pm had achy arms bilaterally, later at 10:30 PM got severe shaking chills, fever 103, went to bed, woke during night with nausea, got up and vomited quite a few times, but only bile.  Achy all over, slight headache, stomach queasy.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: At 5 pm had achy arms bilaterally, later at 10:30 PM got severe shaking chills, fever 103, went to bed, woke during night with nausea, got up and vomited quite a few times, but only bile.  Achy all over, slight headache, stomach queasy.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Tiredness, sore arm, chills, Blah
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: arm was sore around the injection site and turned red; today 10/08 the arm is not so red and not so sore anymore
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Ultrasound scan abnormal
Clinical narrative: Patient complains of shoulder pain. Possible shoulder injury related to vaccine administration.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itching, tenderness then pain upper left arm, skin redness and slightly bumpy.  By the evening, symptoms got worse.  I took ibuprofen, benadryl ointment was applied after using ice at site.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was inadvertently administered a dose of VARIVAX which was improperly stored.; This spontaneous report has received from a pharmacist, referring to a patient of unknown age and gender. The patient's history condition, concurrent condition and concomitant medication were not provided.  On 06-AUG-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#T00034 with expiration date: 05-JAN-2022; route, dose and strength were unknown) for prophylaxis, which was improperly stored. No adverse effects reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 38 Fahrenheit degrees (F) for 672 hours. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: injection site reaction of redness had spread now, the redness was all around his biceps, upper arm and deltoids in left arm; injection site reaction of redness that has spread now. reaction is "very red but not itching as much as it was yesterday",; reaction is "very red but not itching as much as it was yesterday"; This spontaneous report was received from a pharmacist, referring to a 65-year-old male patient. Information about concomitant medication, pertinent medical history and drug reactions/ allergies was unknown.  On 22-SEP-2020 (also reported as 2 days ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dose, lot # T016160, expiration date 13-FEB-2022; strength and route were unknown) in the left arm deltoid for prophylaxis.  On 23-SEP-2020, the patient experienced injection site reaction of redness and itching. On 24-SEP-2020 (reported as now), injection site reaction of redness had spread, the redness was all around his biceps, upper arm and deltoids in left arm, and the reaction was very red but not itching as much as it was yesterday. The reporter would like to know if she needed to do something for this and how to manage this reaction. There was no treatment given to the events. The patient had sought medical attention. There was no intervention given to prevent serious criteria. The outcome of all events was reported as not recovered. The causality assessments between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and all events was unknown.  This is one of the two cases reported by the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T016160; expirationdate: 13-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2009USA010590:
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The 2nd dose of PROQUAD was given 1 month after 1st dose in error/Customer reporting a dose of PROQUAD being given too early in 2 patients.; This spontaneous report was received from an administrator, referring to a male patient (one of twins) of unknown age. The patient's historical condition, concurrent condition and concomitant medication were not provided.    On 25-SEP-2020, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# T016989, expiration date 11-NOV-2021; strength, route were unknown) for prophylaxis. Other suspect drug included sterile diluent. The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was given too early in the patient (also reported as the 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was given 1 month after 1st dose in error) (inappropriate schedule of vaccine administered).   This is one of two reports received from same reporter.; Sender's Comments:  US-009507513-2009USA010116:
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient has been unable to get in for second dose; This spontaneous report as received from a nurse refers to a 21-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.      On 09-MAR-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as first dose, 0.5 ml for prophylaxis (strength, frequency, route of administration, lot # and expiration date were not reported).  On an unknow date in 2020, the patient was unable to get in for second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 80.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Nausea, Pain, Peripheral swelling
Clinical narrative: swollen arm; body aches; a temp of 103; nausea; This spontaneous report was received from an 80-year-old female patient referring to herself. Her drug reactions/allergies included aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), sulfa, morphine, codeine, vancomycin and penicillin. Her concomitant therapies included blood thinner (unspecified), unspecified medication for blood pressure, zolpidem tartrate (AMBIEN) and diuretic (unspecified). No information regarding her pertinent medical history was provided.  On 30-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), single dose, intramuscularly (lot # T020639, expiration date not reported but upon internal validation established as 13-MAR-2022), for prophylaxis. On the same day, she was vaccinated with influenza virus vaccine (unspecified).  On 30-SEP-2020, the patient experienced a temperature of 103 (unit not provided) which at the reporting time (reported as now), was coming down due to her taking medication. On 30-SEP-2020, she started experiencing a swollen arm, body aches, and nausea. She reached out to her physician who was at the time out of town and she was advised to go to an urgent care but she was not going to. At the time of the report, she stated she had not recovered but was doing a little better. The outcome of body temperature increased was considered to be recovering. The outcome of the rest of the event was considered to be not recovered.  The reporter considered the events to be possibly related (reported as possible side effect) to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the events and influenza virus vaccine (unspecified) was not provided.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous report was received from a female patient who was reporting on herself. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On approximately 11-SEP-2020 (reported as 2 or 3 weeks ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection as a booster shot (prophylaxis) (lot #, expiration date, exact dose, dose #, route of administration and anatomical location were not provided ). On an unknown date in September 2020, the patient experienced arm pain for about a week after the injection. The outcome of the event was unknown.  The causality assessment was not provided.
Sex: F
Vaccine: MEN
Symptoms: Heart rate increased
Clinical narrative: BAD Reaction/ taken to / Emergency Room / her Heart Rate Finally slowed down; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was recovering/resolving.   It was unknown if the reporter considered the heart rate increased to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a bad Reaction to vaccine and was taken to the nearest emergency room. The patient's heart rate finally slowed down and she started to feel better.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Shaking; Muscle Aches; dizziness, and not being able to get out of bed; not being able to get out of bed; Injection site pain is described as almost the entire arm being in pain; This case was reported by a nurse via call center representative and described the occurrence of tremor in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 11 hrs 30 min after receiving Shingrix, the patient experienced tremor, muscle pain, dizziness, pain in arm and mobility decreased. On an unknown date, the outcome of the tremor, muscle pain, dizziness, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the tremor, muscle pain, dizziness, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The nurse is also the patient. The age at vaccination was not reported. The patient noted she was in her 60's but did not provide a date of birth. The reporter did not provide a lot number or expiration date for the dose. The patient experienced shaking, muscle aches, dizziness and not being able to get out of bed after dose of Shingrix.  The patient experiences were more severe following dose one. The patient got her dose one at 9:30 and began to experience events at 21:00 the same night.  The following day by 10:00 the events had resolved except for injection site pain. The injection site pain was described as almost the entire arm being in pain for approximately one week following the vaccination.  All events had completely resolved. The follow up to be directed to the reporter's home address. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020196135.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196135:same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Shaking; Muscle Aches; dizziness, and not being able to get out of bed; not being able to get out of bed; Injection site pain is described as almost the entire arm being in pain; This case was reported by a nurse via call center representative and described the occurrence of tremor in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 11 hrs 30 min after receiving Shingrix, the patient experienced tremor, muscle pain, dizziness, pain in arm and mobility decreased. On an unknown date, the outcome of the tremor, muscle pain, dizziness, pain in arm and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the tremor, muscle pain, dizziness, pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The nurse is also the patient. The age at vaccination was not reported. The patient noted she was in her 60's but did not provide a date of birth. The reporter did not provide a lot number or expiration date for the dose. The patient experienced shaking, muscle aches, dizziness and not being able to get out of bed after dose of Shingrix.  The patient experiences were more severe following dose one. The patient got her dose one at 9:30 and began to experience events at 21:00 the same night.  The following day by 10:00 the events had resolved except for injection site pain. The injection site pain was described as almost the entire arm being in pain for approximately one week following the vaccination.  All events had completely resolved. The follow up to be directed to the reporter's home address. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020196135.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196135:same patient, 2nd dose
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Mobility decreased
Clinical narrative: Tiredness; Headache; Shivering; Fever; Upset stomach; runs every day but has been unable to since the vaccination; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd September 2020, 6 hrs after receiving Shingrix, the patient experienced tiredness, headache, shivering, fever, upset stomach and mobility decreased. On an unknown date, the outcome of the tiredness, headache, shivering, fever, upset stomach and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache, shivering, fever, upset stomach and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient experienced  tiredness, headache, shivering, fever, upset stomach and mobility decreased after receiving 2nd dose of Shingrix. The reporter mentioned that the patient was still experiencing all the events and they had not gone away. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Tiredness; Headache; Shivering; Fever; Upset stomach; runs every day but has been unable to since the vaccination; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd September 2020, 6 hrs after receiving Shingrix, the patient experienced tiredness, headache, shivering, fever, upset stomach and mobility decreased. On an unknown date, the outcome of the tiredness, headache, shivering, fever, upset stomach and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache, shivering, fever, upset stomach and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient experienced  tiredness, headache, shivering, fever, upset stomach and mobility decreased after receiving 2nd dose of Shingrix. The reporter mentioned that the patient was still experiencing all the events and they had not gone away. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Rash
Clinical narrative: first dose of Shingrix on 21-Oct-2019; shingles; rash/ rash is with no pain; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 9DE73, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. In June 2020, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for dose 2 of Shingrix. The reporter sataed taht, after vaccination with dose 1 of Shingrix, the patient expeienced rash and shingles in June 2020 and the rash was with no pain but wwas still present as shingles. Till the time of reporting, the patient did not receive dose of Shingrix, which led to incomplete course of vaccination. No further information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Mobility decreased, Myalgia, Tremor, Vaccine positive rechallenge
Clinical narrative: Shaking; Muscle Aches; dizziness, and not being able to get out of bed; not being able to get out of bed; This case was reported by a nurse via call center representative and described the occurrence of tremor in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of tremor, Shingrix with an associated reaction of myalgia, Shingrix with an associated reaction of dizziness, Shingrix with an associated reaction of mobility decreased and Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date, refer case US2020AMR197707).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor, muscle pain, dizziness and mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tremor, muscle pain and dizziness were recovered/resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the tremor, muscle pain, dizziness and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The nurse is also the patient. The age at vaccination was not reported. The patient was in her 60's but did not provide a date of birth.  The reporter did not provide a lot number or expiration date for the dose. The patient experienced shaking, muscle aches, dizziness and not being able to get out of bed 2nd dose of Shingrix. All events had completely resolved. The reporter consented to follow up. The follow up to the be directed at the reporter's home address.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197707:same patient, 2nd dose
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Headache, Vomiting
Clinical narrative: Chills; Dizziness; Headache; Stomach Ache; Threw Up Bile; This case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received on an unknown date).   On 1st October 2020, the patient received the 2nd dose of Shingrix. On 1st October 2020, less than a day after receiving Shingrix, the patient experienced chills, dizziness, headache, stomach pain and bilious vomiting. On an unknown date, the outcome of the chills, dizziness, headache, stomach pain and bilious vomiting were not recovered/not resolved.   It was unknown if the reporter considered the chills, dizziness, headache, stomach pain and bilious vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller stated that after received dose of Shingrix, later that night she reported having chills, headache, dizziness, stomach aches, and throwing up bile.  The reporter wanted to know if these side effects were contagious.  The reporter stated that the side effects were going away but that she still had them.  The reporter stated she would get in touch with her HCP. The reporter did not consent to follow-up.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse practitioner.  This case is linked to case 2020SA268090, 2020SA268091, 2020SA268094, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 84 years old female patient who was vaccinated with 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes, lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error).   Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant was given to the patient on the same day.  It was an actual medication error case due to incorrect product storage.   It was reported that the boxes were cold, but the ice packs were not hard frozen, they gave 6 doses before they got call not to use product because it was too long in transit and asked if they should revaccinate patient.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose, Wrong technique in device usage process
Clinical narrative: some of the vaccine leaked out near where the needle attaches to the syringe as he did not tightened the needle on tight enough/ No AE; While vaccinating with Fluzone High-Dose Quadrivalent vaccine  some of the vaccine leaked out near where the needle attaches to the syringe/ No AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient (unknown demographics) who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number: UJ516AA, expiry date: 30-Jun-2021, dosing details, route and site of administration not reported) on an unknown date for prophylactic vaccination while some of the vaccine was leaked out as needle was not tightened enough (PT- wrong technique in product usage process and underdose).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to wrong technique in product usage process and vaccine underdose (latency: same day).  Addition description of event: reporter states he did not think he tightened the needle on tight enough and as he was giving the injection, some of the vaccine leaked out near where the needle attaches to the syringe. Reporter did not think that a lot of the vaccine leaked out and asked if he should revaccinate the patient.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever 101.4   All night , continueing into next day
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Started experiencing arm pain three hours after vaccine. Around 11pm, I woke up not feeling well. Vomitting liquid all night/morn, fever of 100.5, chills , headache. Fever broke the evening of 10/6/20. Feeling fine today but still experiencing a sore arm.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Started experiencing arm pain three hours after vaccine. Around 11pm, I woke up not feeling well. Vomitting liquid all night/morn, fever of 100.5, chills , headache. Fever broke the evening of 10/6/20. Feeling fine today but still experiencing a sore arm.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Pain of skin, Rash, Skin discolouration, Skin swelling
Clinical narrative: Very large rash, very inflammed. Skin looks dark and puffy, hot or warm to touch, very tender / painful to touch.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Very large rash, very inflammed. Skin looks dark and puffy, hot or warm to touch, very tender / painful to touch.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness all the way around the arm on the first day and on the second day the redness had swelled somewhat.  Patient took benadryl and ibuprofen.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Skin tightness
Clinical narrative: red swollen arm from shoulder to elbow; arm is tight, limited mobility. Patient is using Tylenol and Ibuprofen. applying a compress to injection site.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Headache
Clinical narrative: Diarrhea, headache, nausea, weakness, light headedness, chills
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Diarrhea, headache, nausea, weakness, light headedness, chills
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dysgeusia, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: Reports shortly after leaving health department noticed metallic taste in mouth (which is still present}. Doesn't remember well where went but did some shopping - thinks was in store. Was confused and unable to prepare meal and do usual chores last evening.  Today is felling better. Thinking is clearer. Does have headache today. Says does not remember doing chores yesterday afternoon but can tell did them.  There is stress in personal life at this time. Feels disorganized.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Memory impairment, Stress
Clinical narrative: Reports shortly after leaving health department noticed metallic taste in mouth (which is still present}. Doesn't remember well where went but did some shopping - thinks was in store. Was confused and unable to prepare meal and do usual chores last evening.  Today is felling better. Thinking is clearer. Does have headache today. Says does not remember doing chores yesterday afternoon but can tell did them.  There is stress in personal life at this time. Feels disorganized.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: pt reports residual pain - states shot high on arm - states immunizer changed needle sizes before giving prevnar in other arm - no issues with prevnar - only with hd flu - rec pt f/u w/dr as pain from flu shot should not be present 1mo later
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Chest discomfort, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: ABOUT AN HOUR AFTER SHOT BECAME NAUSEATED, DIZZY... DEVELOPED A FEVER... DIZZINESS PROGRESSED AND BECAME WORSE AS DAY WENT BY. VOMITING BEGAN, HEADACHES, SEVERE CHEST PRESSURE AND PAIN, BODY ACHES AND DIZZINESS/SYNCOPY WORSENED. WENT TO ER AT AROUND 8:45 P.M.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Nausea, Pain, Pyrexia, Syncope
Clinical narrative: ABOUT AN HOUR AFTER SHOT BECAME NAUSEATED, DIZZY... DEVELOPED A FEVER... DIZZINESS PROGRESSED AND BECAME WORSE AS DAY WENT BY. VOMITING BEGAN, HEADACHES, SEVERE CHEST PRESSURE AND PAIN, BODY ACHES AND DIZZINESS/SYNCOPY WORSENED. WENT TO ER AT AROUND 8:45 P.M.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting, X-ray
Clinical narrative: ABOUT AN HOUR AFTER SHOT BECAME NAUSEATED, DIZZY... DEVELOPED A FEVER... DIZZINESS PROGRESSED AND BECAME WORSE AS DAY WENT BY. VOMITING BEGAN, HEADACHES, SEVERE CHEST PRESSURE AND PAIN, BODY ACHES AND DIZZINESS/SYNCOPY WORSENED. WENT TO ER AT AROUND 8:45 P.M.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: He became lethargic, legs & head hurt, within 2 hours fever 102? 5 hours after injection.
Age: 53.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, chills, headache, muscle ache -- very severe for the first 18 hours from onset lasting 36 hours.
Age: 1.17
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Adenovirus test, Bacterial test negative, Bed sharing, Brain injury, Cardiomyopathy
Clinical narrative: The patient has been admitted due to an apparently acute-onset anoxic brain injury and unresponsive event two days after receiving the Varivax and Havrix vaccines, with leading diagnoses of inborn error of metabolism vs. myocarditis. The night prior to the event she seemed well, and she slept in her parents bed overnight, awakening multiple times for her bottle and behaving normally. The following morning the patient was found unresponsive in the parents' bed. Initial evaluation showed diffuse hypoxic-ichemic brain injury on CT head, EEG with diffuse slowing, hypoglycemia, leukocytosis, myocardial dysfunction on echocardiogram, and hypotension requiring pressors. She was intubated and admitted to the PICU. Started on empiric antibiotics, though LP could not be obtained. Blood viral and bacterial testing was negative. MRI shows small multifocal infarcts. She is now extubated and improving, with underlying etiology unclear
Age: 1.17
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cerebral infarction, Computerised tomogram head abnormal, Cytogenetic analysis, Cytomegalovirus test negative, Echocardiogram abnormal
Clinical narrative: The patient has been admitted due to an apparently acute-onset anoxic brain injury and unresponsive event two days after receiving the Varivax and Havrix vaccines, with leading diagnoses of inborn error of metabolism vs. myocarditis. The night prior to the event she seemed well, and she slept in her parents bed overnight, awakening multiple times for her bottle and behaving normally. The following morning the patient was found unresponsive in the parents' bed. Initial evaluation showed diffuse hypoxic-ichemic brain injury on CT head, EEG with diffuse slowing, hypoglycemia, leukocytosis, myocardial dysfunction on echocardiogram, and hypotension requiring pressors. She was intubated and admitted to the PICU. Started on empiric antibiotics, though LP could not be obtained. Blood viral and bacterial testing was negative. MRI shows small multifocal infarcts. She is now extubated and improving, with underlying etiology unclear