chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Febrile convulsion, Seizure, Sensory integrative dysfunction, Sensory processing disorder
Clinical narrative: Febrile seizure and regressed into Autism
Age: 66.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Erythema, Limb mass, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient described that the night of her vaccination she had a bump under her left arm. The next morning it was swollen, red, hot, and a rash began to develop. Patient reported that the rash was located above her elbow. We recommended that she take ibuprofen, benadryl, and ice the area on her arm.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Sore arm, fever like symptoms,: headache, chills, aches and pains,  nausea,
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm, fever like symptoms,: headache, chills, aches and pains,  nausea,
Age: 73.0
Sex: M
Vaccine: MMR
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Body temperature increased, Leukopenia, Liver function test increased
Clinical narrative: 5 days of low grade fever to 100.8 max, malaise, myalgia, accompanied by leukopenia, thrombocytopenia, elevated LFT's, and macular rash on legs, arms, and torso.  Blood tests improved over the next few days as documented in lab work on 5/21/19 and 5/24/19.
Age: 73.0
Sex: M
Vaccine: MMR
Symptoms: Lymphocyte count, Malaise, Myalgia, Platelet count, Pyrexia
Clinical narrative: 5 days of low grade fever to 100.8 max, malaise, myalgia, accompanied by leukopenia, thrombocytopenia, elevated LFT's, and macular rash on legs, arms, and torso.  Blood tests improved over the next few days as documented in lab work on 5/21/19 and 5/24/19.
Age: 73.0
Sex: M
Vaccine: MMR
Symptoms: Rash macular, White blood cell count decreased
Clinical narrative: 5 days of low grade fever to 100.8 max, malaise, myalgia, accompanied by leukopenia, thrombocytopenia, elevated LFT's, and macular rash on legs, arms, and torso.  Blood tests improved over the next few days as documented in lab work on 5/21/19 and 5/24/19.
Age: 0.33
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: high Fever 104, vomiting
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Malaise, Nausea, Oral pruritus
Clinical narrative: redness and pain and soreness at injection site lasting 2 days, Fever, itching, general malaise, nausea, itching in mouth
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia
Clinical narrative: redness and pain and soreness at injection site lasting 2 days, Fever, itching, general malaise, nausea, itching in mouth
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: patient called 5/31/2019 at 12pm complaining of a feeling like she burnt the roof of her mouth.  Started one day after vaccination.  She says that there are sores on the roof of her mouth.  She is not sure if this is coincidental or related to the vaccine.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient had received second shingrix shot and a tdap shot on 9/11/18 after being on a wait list for second dose of shingrix. patient was not taken off the wait list when vaccinated 9/11/18 and was called to get these two shots when we received a shipment 10/16/18. patient then came in and received a third shingles shot and second tetanus shot. patient did not report any adverse events. it was realized at patients next doctors apt that she had received a double dose.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Influenza like illness
Clinical narrative: & Chilling; coughing; flu-like illness
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Nausea
Clinical narrative: & nausea; myalgia; flu-like symptoms
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Visual impairment
Clinical narrative: & BODY ACHES; VISUAL CHANGES
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; Inadvertently administered an expired dose of VAQTA; This spontaneous report was received from a nurse regarding a 22 year old patient of unknown gender. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 29-MAY-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) via intramuscular route, lot # R002487 and expiry date: 21-APR-2019 (strength and dose not reported) for prophylaxis (expired product administered). No adverse effects were reported (no adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: ILL; This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a male 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 unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got ill after receiving 1st dose of Shingrix. The reporter stated that, the healthcare professional was not at work and could not provide patient demographics, lot number, or expiration dates. The health care provider had not provided any other information. The reporter noted that the patient was a physician and would be contacting GlaxoSmithKline with additional details. This case has been linked with case US2019092174, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: malaise; This case was reported by a nurse via sales rep and described the occurrence of malaise in a 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, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The nurse reported that one of her friend received Shingrix and experienced malaise and was in bed all weekend after receiving the vaccine. The reporter did not provide any additional details.  The adverse event was reported during a conference, so there was no opportunity to obtain additional details, however contact detials were provided.
Sex: U
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Tired; Muscle pain; Decreased appetite; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender started to receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on 04Jan2019 at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  During the month of May2019, the patient experienced headache, tiredness, muscle pain  and decreased appetite. All the reported events were non serious and the outcome was unknown.   The reporter is wondering if the reported events can be caused by Prevenar 13 also 4 or 5 months after vaccination.  The information on the batch number has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: & bilateral rash on arms and shoulders
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient presented with region of redness measuring 6cm x 7cm at site of injection with warmth present
Age: 16.0
Sex: M
Vaccine: MNQ, MENB, MNQ
Symptoms: Crying, Feeling cold, Heart rate increased, Pain in extremity, Tremor
Clinical narrative: Shaking uncontrollably, accelerated heart rate up to 110, crying, sudden pain in right leg, feeling cold
Age: 16.0
Sex: M
Vaccine: MNQ, MENB, MNQ
Symptoms: Crying, Dizziness, Tremor
Clinical narrative: Shaking uncontrollably, accelerated heart rate up to 110, crying, sudden pain in right leg, feeling cold
Age: 16.0
Sex: M
Vaccine: MNQ, MENB, MNQ
Symptoms: Crying, Feeling cold, Heart rate increased, Pain in extremity, Tremor
Clinical narrative: injections received @ 300-315 PM. Around 430-500 PM pt. started getting dizzy, shaky, & crying. Pt. went to ER & symptoms subsided.
Age: 16.0
Sex: M
Vaccine: MNQ, MENB, MNQ
Symptoms: Crying, Dizziness, Tremor
Clinical narrative: injections received @ 300-315 PM. Around 430-500 PM pt. started getting dizzy, shaky, & crying. Pt. went to ER & symptoms subsided.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Pain in muscles, feverish, fatigue
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Allergy test, Eczema, Milk allergy
Clinical narrative: Eczema and dairy allergy
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hyperaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: My daughter has a huge red welt on her right arm at the injection site - size of grapefruit, it is extremely warm and sensitive. It hurts A LOT to touch and limits her arm movement.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: My daughter has a huge red welt on her right arm at the injection site - size of grapefruit, it is extremely warm and sensitive. It hurts A LOT to touch and limits her arm movement.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash / red area around where shot was given.  Applying Benadryl cream - seems to be lessening.
Age: 52.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Blood test, CSF protein increased, Central nervous system lesion, Chest X-ray, Headache
Clinical narrative: Headaches started in the left side of my head but did not cease.  MRI on May 3rd revealed brain lesion, MRI C-Spine May 8 - Clear, MRI T-Spine, MRAngio, Chest Xray May 14th Clear, Lumbar Puncture May 20th - Elevated Protein - Headaches continued, Repeart Brain MRI
Age: 52.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic
Clinical narrative: Headaches started in the left side of my head but did not cease.  MRI on May 3rd revealed brain lesion, MRI C-Spine May 8 - Clear, MRI T-Spine, MRAngio, Chest Xray May 14th Clear, Lumbar Puncture May 20th - Elevated Protein - Headaches continued, Repeart Brain MRI
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Rash, Rash erythematous, Skin warm
Clinical narrative: she felt pain at the injection site and developed a rash on the same arm that the vaccine was administered in (on her left arm).; she felt pain at the injection site and developed a rash on the same arm that the vaccine was administered in (on her left arm).; she felt pain at the injection site and developed a rash on the same arm that the vaccine was administered in (on her left arm).; the rash was red, and that the patient reported that the rash was "painful at first but not now", and that it was warm to the touch.; the rash was red, and that the patient reported that the rash was "painful at first but not now", and that it was warm to the touch.; This spontaneous report was received from a pharmacist and refers to a 74-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-MAY-2019, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly in left arm, lot# R034249, expiration date: 07-AUG-2020 (exact dose and frequency was not provided) for prophylaxis. On 22-MAY-2019 (also reported as "later that day"), the patient felt pain at the injection site and developed a rash on the same arm that the vaccine was administered in (on her left arm). On 23-MAY-2019, the patient went in to the pharmacy to report the rash to the pharmacist, and the pharmacist noted that the rash was red, and that the patient reported that the rash was "painful at first but not now", and that it was warm to the touch. The outcome of the events was reported as not recovered. No treatment was given for the events. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: One patient received a dose of VARIVAX follwing temperature excursions of 15 degree Fahrenheit (F) /46 degree Fahrenheit (-9 degree celcius to -8 degree celcius) (31.3 degree Fahrenheit) for 15 hours; No adverse effects; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On an unknown date, the patient was vaccinated with temperature excursion varicella virus vaccine live (oka/merck) (VARIVAX) via subcutaneous route, lot # N027628 and expiry date: 14-OCT-2019 (strength and dose not reported) for prophylaxis. The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) /46 degree Fahrenheit (-9 degree celsius to -8 degree celsius) (31.3 degree Fahrenheit) for 15 hours (Product storage error). Previous temperature excursion of vaccine was 6 degree Fahrenheit to 14 degree Fahrenheit (-14 degree celsius to -10 degree celsius) (14.4 degree Fahrenheit) for 46 hours. The call was due to digital data logger. No adverse effects were reported (no adverse event). Product quality complaint was not involved.
Sex: F
Vaccine: MMR
Symptoms: Allergy to vaccine, Immunosuppression, Renal transplant
Clinical narrative: This spontaneous report was received from a physician via Pfizer refers to a female patient of unknown age. The patient's concurrent condition, concomitant medications, medical history, past drugs, allergies and reactions were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) for prophylaxis (dosage schedule was not reported). On an unknown date, the patient experienced drug allergy to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (drug hypersensitivity). The drug allergy reaction was reported as kidney transplant (renal transplant) and mmunosuppression. The reporter considered renal transplant, drug hypersensitivity and immunosuppression to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown). Upon internal review, the event immunosuppression and renal transplant was considered to be medically significant. This is one of the two reports.
Sex: F
Vaccine: MMR
Symptoms: Injection site pruritus
Clinical narrative: having some itching at the injection site; patient was given a vaccination of MMR II intramuscularly; This spontaneous report as received from a pharmacist refers to a non-pregnant female patient of unknown age. The patient's historical condition included asthma. The patient was not having any breathing problems. No information regarding the patient's concomitant medication, drug reactions and allergies was provided.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status of recombinant human albumin (rHA), injection, 0.5 milliliter, intramuscularly in the right deltoid, lot # R015163, expiration date 29-MAY-2020, which was diluted in a sterile diluent (DILUENT MRK) injection, intramuscularly in the right deltoid (dose, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced itching at the injection site. At the time of the report, the patient not recovered from the event of itching at the injection site.  The relatedness between itching at the injection site and suspect therapies was not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: arm swelling; redness; Pain in arm; fever; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number C5E43, expiry date 10th August 2021) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site pain and fever. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain and fever were recovering/resolving.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix on left deltoid. From her elbow to her shoulder there was redness, swelling and soreness or pain on the left arm.  Also reported 3 hour fever.  At the time of the call the pharmacist reported that symptoms were resolved or resolving.  No additional details were provided at the time of this call. There is an unclear information provided in the source document regarding to the event fever. It seems that the fever has resolved in 3 hours (Also reported 3 hour fever), hence the 3 hours has been considered as a duration of the event fever and not the time to onset. For further clarity the clarification has been requested for the same.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Weakness; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of weakness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced weakness and pain in arm. On an unknown date, the outcome of the weakness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the weakness and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on unknown arm. The patient stated last time patient got the shot it knocked patient down.  The patient felt very weak.  The patient also reported that he had arm pain after the injection. The outcome reported for all adverse events in the structured field of database is " RECOVERED/RESOLVED WITH SEQUEL" instead of " Recovered/Resolved" (outcome uploaded in database)
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: injection site redness; injection site warmth; injection site swelling; Pain; injection site pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) and (batch number 2792L, expiry date 21st September 2021) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 15th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 16th May 2019, the patient experienced erythema of extremities, skin warm, swelling arm and pain. On an unknown date, the outcome of the pain in arm, erythema of extremities, skin warm, swelling arm and pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, skin warm, swelling arm and pain to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported that the patient experienced redness, warmth, pain, and swelling approximately 2.5 inches below injection site. The health care professional reported that the arm pain began the night Shingrix was received, pain, swelling, warmth, and redness began the next morning.  The health care professional reported that the events had improved since they began, but not have not resolved.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site extravasation
Clinical narrative: Leaking at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site leaking. On an unknown date, the outcome of the injection site leaking was unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.  Additional details were provided as follows: The health care professional called in to inquire any information on this type of leakage. The patient received the Shingrix vaccine and fluid leaked out and when health care professional went to put a band aid on more fluid leaked out. More leaked later when patient went home. The health care professional stated the injection went fine and they think this might be sebaceous fluid.  The patient's information was gathered.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Insomnia, Middle insomnia, Muscular weakness
Clinical narrative: shoulder joint pain/knees and ankles pain; finger weakness/weakness from shoulders to fingers; neck pain; severe join pain in her shoulders, elbows, wrists, fingers, knees, ankles; insomnia/pain is waking her up in the middle of the night; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 73-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th April 2019, the patient received Boostrix. On 1st May 2019, 1 days after receiving Boostrix, the patient experienced joint pain, hands weakness of, neck pain and pain in arm. In May 2019, the patient experienced insomnia. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the joint pain was recovering/resolving and the outcome of the hands weakness of, insomnia, neck pain and pain in arm were unknown.   It was unknown if the reporter considered the joint pain, hands weakness of, insomnia, neck pain and pain in arm to be related to Boostrix.  Additional details were provided as follows:  The reporter stated that she had the Boostrix vaccine at the pharmacy on 30th April 2019 in left deltoid. The patient stated that the day after the injection she started to had severe join pain in her shoulders, elbows, wrists, fingers, knees, ankles and neck. The patient experienced weakness from shoulders to fingers. And about 2 weeks after the injection her knees and ankles were better but the rest was still bothering her. Caller reports the pain is waking her up in the middle of the night. She had been taking Alleve two tablets twice a day for the pain. She saw her doctor for the pain on Monday and he told her she probably was having a reaction to something in the vaccine.  She had bloodwork drawn but that the results were not back yet. The reporter consented to follow up.      Lab Comments: On an unknown date, blood work drawn but that the results were not back yet
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: shoulder joint pain/knees and ankles pain; finger weakness/weakness from shoulders to fingers; neck pain; severe join pain in her shoulders, elbows, wrists, fingers, knees, ankles; insomnia/pain is waking her up in the middle of the night; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 73-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 30th April 2019, the patient received Boostrix. On 1st May 2019, 1 days after receiving Boostrix, the patient experienced joint pain, hands weakness of, neck pain and pain in arm. In May 2019, the patient experienced insomnia. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the joint pain was recovering/resolving and the outcome of the hands weakness of, insomnia, neck pain and pain in arm were unknown.   It was unknown if the reporter considered the joint pain, hands weakness of, insomnia, neck pain and pain in arm to be related to Boostrix.  Additional details were provided as follows:  The reporter stated that she had the Boostrix vaccine at the pharmacy on 30th April 2019 in left deltoid. The patient stated that the day after the injection she started to had severe join pain in her shoulders, elbows, wrists, fingers, knees, ankles and neck. The patient experienced weakness from shoulders to fingers. And about 2 weeks after the injection her knees and ankles were better but the rest was still bothering her. Caller reports the pain is waking her up in the middle of the night. She had been taking Alleve two tablets twice a day for the pain. She saw her doctor for the pain on Monday and he told her she probably was having a reaction to something in the vaccine.  She had bloodwork drawn but that the results were not back yet. The reporter consented to follow up.      Lab Comments: On an unknown date, blood work drawn but that the results were not back yet
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: trouble lifting arm above her head; Itchiness; Tiredness; Arm Pain/injection site soreness; injection site Redness; Low-grade Fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd April 2019, less than a day after receiving Shingrix, the patient experienced tiredness, pain in arm, injection site erythema, fever and pruritus. On an unknown date, the patient experienced injected limb mobility decreased. The patient was treated with paracetamol (Tylenol). On 4th April 2019, the outcome of the tiredness and fever were recovered/resolved. On 6th April 2019, the outcome of the injection site erythema and pruritus were recovered/resolved. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain in arm, injection site erythema, fever, injected limb mobility decreased and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix dose right arm and felt tired and had a low grade fever for 2 days. The injection site being red and sore for 4 days, but has had continuous arm since vaccine.  The arm pain as continuous that sometimes goes up or down arm extending to arm pit resulting in trouble lifting arm above her head.  Her internist recommended using ice or heat for relief and reports it minimized pain minimally, but currently she still had arm pain The reporter consented to follow up.  The patient's internist advised caller not to receive 2nd dose. The outcome reported for all adverse events in the structured field of xml is recovering and recovered/resolved with sequel instead of recovered and not recovered (outcome uploaded in Argus)
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: trouble lifting arm above her head; Itchiness; Tiredness; Arm Pain/injection site soreness; injection site Redness; Low-grade Fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd April 2019, less than a day after receiving Shingrix, the patient experienced tiredness, pain in arm, injection site erythema, fever and pruritus. On an unknown date, the patient experienced injected limb mobility decreased. The patient was treated with paracetamol (Tylenol). On 4th April 2019, the outcome of the tiredness and fever were recovered/resolved. On 6th April 2019, the outcome of the injection site erythema and pruritus were recovered/resolved. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain in arm, injection site erythema, fever, injected limb mobility decreased and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix dose right arm and felt tired and had a low grade fever for 2 days. The injection site being red and sore for 4 days, but has had continuous arm since vaccine.  The arm pain as continuous that sometimes goes up or down arm extending to arm pit resulting in trouble lifting arm above her head.  Her internist recommended using ice or heat for relief and reports it minimized pain minimally, but currently she still had arm pain The reporter consented to follow up.  The patient's internist advised caller not to receive 2nd dose. The outcome reported for all adverse events in the structured field of xml is recovering and recovered/resolved with sequel instead of recovered and not recovered (outcome uploaded in Argus)
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: trouble lifting arm above her head; Itchiness; Tiredness; Arm Pain/injection site soreness; injection site Redness; Low-grade Fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd April 2019, less than a day after receiving Shingrix, the patient experienced tiredness, pain in arm, injection site erythema, fever and pruritus. On an unknown date, the patient experienced injected limb mobility decreased. The patient was treated with paracetamol (Tylenol). On 4th April 2019, the outcome of the tiredness and fever were recovered/resolved. On 6th April 2019, the outcome of the injection site erythema and pruritus were recovered/resolved. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, pain in arm, injection site erythema, fever, injected limb mobility decreased and pruritus to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix dose right arm and felt tired and had a low grade fever for 2 days. The injection site being red and sore for 4 days, but has had continuous arm since vaccine.  The arm pain as continuous that sometimes goes up or down arm extending to arm pit resulting in trouble lifting arm above her head.  Her internist recommended using ice or heat for relief and reports it minimized pain minimally, but currently she still had arm pain The reporter consented to follow up.  The patient's internist advised caller not to receive 2nd dose. The outcome reported for all adverse events in the structured field of xml is recovering and recovered/resolved with sequel instead of recovered and not recovered (outcome uploaded in Argus)
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Local reaction, Pain, Swelling
Clinical narrative: Redness; Swelling; Pain; Stomach issues; This case was reported by a other health professional via call center representative and described the occurrence of erythema 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 erythema, swelling, pain and upset stomach. On an unknown date, the outcome of the erythema, swelling, pain and upset stomach were unknown.   It was unknown if the reporter considered the erythema, swelling, pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Pharmacy Intern on behalf of physician. The age at vaccination was not reported. The batch number was not reported. The pharmacy Intern on the line reporting that the patient went to the Emergency Room with a severe local reaction to the Shingrix.  The patient had redness, swelling, pain and some stomach issues.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: rash on body/ red bumps on body; itching all over; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 17th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced generalized rash and generalized pruritus. On an unknown date, the outcome of the generalized rash and generalized pruritus were not recovered/not resolved.   It was unknown if the reporter considered the generalized rash and generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The patient was experiencing a rash, red bumps, and itching all over the body. The reporter consented to follow up.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: Patient experienced inflammation with systemic response after second dose of shingrix. Given acetaminophen and methylprednisolone and symptoms resolved
Age: 71.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Urticaria Pruritus & Mid-sternal chest tightness, itchiness
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Headache
Clinical narrative: I have had headaches in the front right side of my head and the back right side of my head for the past 5 1/2 weeks, since April 18, 2019 when I got the 2nd dose of shingrix 50 Mcg/0.5 ml inj. I feel weak. I feel tired, fatigue, upset stomach. In my opinion, the shingrix vaccine is not a safe vaccine! Too many side effects! I will never get it again!
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: & SHAKING
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray normal, Eye movement disorder, Fatigue, Febrile convulsion, Hypotonia
Clinical narrative: Within 48 hours, around 9a on 11/08/2018, patient developed a fever.  She became extremely fatigued. She refused to play or get off the couch for the entire day. By 6pm her fever had increased to 104 degrees. It was around this time when she woke up from a small nap and started to vomit. Her body went completely limp. Her eyes rolled in the back of her head. I, her mother, picked her up off of the couch and laid her on the floor as she continued to vomit with her eyes rolled back. Emergency services were called. She was taken to the Hospital around 7pm and diagnosed with a febrile seizure.  The medical team continued to monitor her for several hours to ensure she did not have any recurring symptoms. We were sent home around midnight that same night.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Within 48 hours, around 9a on 11/08/2018, patient developed a fever.  She became extremely fatigued. She refused to play or get off the couch for the entire day. By 6pm her fever had increased to 104 degrees. It was around this time when she woke up from a small nap and started to vomit. Her body went completely limp. Her eyes rolled in the back of her head. I, her mother, picked her up off of the couch and laid her on the floor as she continued to vomit with her eyes rolled back. Emergency services were called. She was taken to the Hospital around 7pm and diagnosed with a febrile seizure.  The medical team continued to monitor her for several hours to ensure she did not have any recurring symptoms. We were sent home around midnight that same night.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: incorrect route of administration. no adverse event reported
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: sever chill and shivering.  minor fever around 100 degrees Farenheit
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine on 5/28 - presented to the pharmacy today with swelling/redness/heat/ itching  at the site of injection. Pt reported taking tylenol for pain/ swelling. Explained to patient that this looked like a typical injection site reaction and that we would forward the information on. Told patient it would be fine to take benadryl to help with swelling. Encouraged her to come back / follow up with md if it got worse.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Piloerection, Pyrexia
Clinical narrative: Patient called this morning with a fever and red face and goose bumps.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient complained of pain and swelling under the injection site, approximately the middle of the upper arm. Area was large and inflammed. Patient did not report any vaccination allergies before administering the shingrix shot, however, when she came in today to inquire about the side effect, she stated that she has had an allergic reaction to the flu shot perviously and had forgotten about it.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014100: US-009507513-1905USA014101: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014106: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014102:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, route, lot# and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event was not reported. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or around 26-JUN-2016, the pt was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dosage schedule, route, lot number and expiration date were not provided). On an unspecified date, shortly after vaccination, the pt suffered hearing loss. As a direct and proximate result of ZOSTAVAX vaccine, the pt's symptoms resulted in in physical limitations, mental and emotional distress and severe, serious, progressive, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life and physical impairment. At the time of the report, the pt had permanent hearing loss (not recovered). The reporter considered hearing loss to be related to ZOSTAVAX. Upon internal review, the event hearing loss was considered disabling (due to sustained, severe and permanent personal injuries) and medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Computerised tomogram, Deafness unilateral, Disorientation, Nuclear magnetic resonance imaging
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-JAN-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not specified) for its intended purpose: the prevention of shingles. On or about 04-NOV-2017, the patient experienced complete hearing loss in her left ear. On or about 05-NOV-2017, the patient continued to experience hearing loss in her left ear and felt disoriented so she went to an emergency room, where a computerized tomography (CT) scan was done (results not specified). On or about 28-NOV-2017, the patient continued to experience hearing loss in her left ear.  She had a magnetic resonance imaging (MRI) done (results not specified). On or about 29-NOV-2017, the patient was tested for hearing loss by a physician of an Ear Nose and Throat Surgery center, who documented hearing loss in the patient's left ear. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of The Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events were not resolved.  Causality assessment was related. The events complete hearing loss in her left ear and feeling disoriented were considered disabling. Upon internal review, the event of complete hearing loss in her left ear was considered to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 12-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014106: US-009507513-1905USA014099: US-009507513-1905USA008566: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 10-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA008566: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 24-JAN-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly, lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA008566: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100: