chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP, HPV9
Symptoms: Dyspnoea, Injection site pain, Swelling face
Clinical narrative: the patient has injection site arm soreness, facial swelling and shortness of breath; the patient has injection site arm soreness, facial swelling and shortness of breath; the patient has injection site arm soreness, facial swelling and shortness of breath; This spontaneous report was received from a pharmacy technician referring to a currently 32-year-old female patient. The patient's pertinent concurrent conditions, medical history and concomitant medications were unknown by the reporter. The patient did not has any previous drug reactions or allergies.     On 28-MAY-2020, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the arm, as prophylaxis (concentration, vaccination scheme frequency, route of vaccination were not reported; reported lot number R027946 and expiration date 27-APR-2021). The patient was vaccinated on the same date with hepatitis b virus vaccine rhbsag (yeast) (1018 iss adj) (HEPLISAV) in a different injection site from hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported).   On an unspecified date in 2020 (reported as after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered), the patient had an injection site arm soreness, facial swelling and shortness of breath (injection site pain, dyspnoea and swelling face). It was reported that, the patient did not has any reaction to the first dose of pv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered. Also, the patient did not seek any medical attention, no laboratory diagnostic or studies were performed and no treatment was given to the patient.  At the time of this report, the outcome of swelling face, injection site pain and dyspnoea was reported as not recovered.   The causality assessment between the suspect therapies and the aforementioned events was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Malaise
Clinical narrative: covid-19; sickness; This case was reported by a consumer via patient support programs and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization and GSK medically significant) and sickness (serious criteria hospitalization). On an unknown date, the outcome of the covid-19 and sickness were unknown.   It was unknown if the reporter considered the covid-19 and sickness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient unintentionally advised she had been sick and hospitalized with COVID-19 for the past month during a general inquiry. No further information obtained before patient disconnected call.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: A month or 2 months after receiving Shingrix, the patient developed shingles. The reporter did not consent to follow up.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: the right arm is a little itchy and she is icing it now; feeling knocked out and tired; felt jittery; having an allergic reaction/three huge hives; the right arm was getting swollen; feeling lousy all over; right arm got tender, the pain was to the point that if the sheet brushed the area it was excruciating; the "TYLENOL was not working".; she did not sleep; arm is redish; This spontaneous report has been received from a 65 years old female patient, referring to herself. The patient's pertinent medical history included irritable bowel syndrome (IBS) and thyroid nodules. The patient was allergic to shrimp, lobster, crab and crayfish. The patient's concomitant therapies included loratadine, generic bupropion hydrochloride (WELLBUTRIN), pantoprazole, duloxetine hydrochloride, almotriptan malate (AXERT) and valacyclovir hydrochloride (VALTREX).   On 21-MAY-2020 (Thursday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S036811 with 02-AUG-2021; formulation vial, route, strength and dose were unknown) shot in her right arm (for the first time) for prophylaxis and a zoster rge vaccine (mammalian) (SHINGRIX) shot in her left arm.   On 22-MAY-2020 (Friday), the patient's right arm got tender and on the night the pain was to the point that if the sheet brushed the area it (the pain) was excruciating and the patient did not sleep (insomnia). On the same day (Friday night), the patient took acetaminophen (TYLENOL) (dose, strength, route, frequency, indication, lot number and expiration date were unknown). The patient stated the acetaminophen (TYLENOL) was not working (drug ineffective). On 23-MAY-2020 (Saturday morning), the patient took meloxicam. On the same day, the patient called the physician as she was feeling lousy all over and later in the day the right arm was getting swollen (peripheral swelling) and she took sulfamethoxazole (+) trimethoprim on the night. On 24-MAY-2020 (Sunday), the patient stated that she looked in the mirror and there were three huge hives. The patient stated she called the physician who told her to take diphenhydramine hydrochloride (BENADRYL) as the physician felt the patient was having an allergic reaction. On the same day, the patient took diphenhydramine hydrochloride (BENADRYL) and felt jittery afterwards. On 25-MAY-2020 (Monday) and 26-MAY-2020 (Tuesday), the patient took diphenhydramine hydrochloride (BENADRYL).  On 26-MAY-2020, the patient saw her physician. On 27-MAY-2020, the patient's arm was not as red as yesterday and the swelling had gone down. On the same day, the patient stated she was feeling knocked out and tired, the right arm was a little itchy. On an unknown date in May 2020, the patient received unspecified blood work which results were not provided. The outcome of drug ineffective and insomnia was unknown. The outcome of peripheral swelling was reported as recovering. The outcome of the other events was reported as not recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Arm Muscle Pain; This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (On 24th October 2019, received 1st dose. (For 1st dose refer case US2020088759).   On 11th March 2020, the patient received the 2nd dose of Shingrix. On 11th March 2020, less than a day after receiving Shingrix, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingrix.  Additional details were received as follows: The patient reported arm muscle pain with the second dose of Shingrix, which was not resolved. The patient also reported having a knot in muscle  that she had to stretch out.  No consent to follow-up with doctor was provided.  Patient was unable to provide lot number and expiration date. The reporter did not consent to follow-up. This case was linked to case US2020088759 for same patient. This case was linked to case US2020088762 by same reporter.  Note: the event of knot in muscle was captured in case US2020088759 as it was not confirmed whether after which dose the patient experienced the event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles/ came down with shingles after my 1st dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient came down with shingles after vaccination.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Tinnitus
Clinical narrative: Discomfort; Tinnitus; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2020, the patient received the 1st dose of Shingrix. In February 2020, less than 2 months after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the patient experienced discomfort. On an unknown date, the outcome of the tinnitus was recovering/resolving and the outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the tinnitus and discomfort to be related to Shingrix.  Additional details were reported as follows: In mid February 2020, patient developed Tinnitus. He stated that he thought it may have been caused by Shingrix and was inquired about the same.  The patient stated that he still experiences tinnitus on and off and that some days were better than others. He also stated that the first dose of Shingrix was not that bad in the sense that he only felt a little discomfort afterward. The reporter consented to follow up. The outcome for event discomfort was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Lymph node pain, Odynophagia
Clinical narrative: Shingles lesions on her face; blister/ lesions are red and have a blister in the middle.; gland on the right side of her neck that is sore; Hurts  to swallow; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had a history of Shingles and she had it several times).   On 22nd May 2020, the patient received the 1st dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced lymph node pain and swallowing painful. On 23rd May 2020, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles, blister, lymph node pain and swallowing painful were recovering/resolving.   It was unknown if the reporter considered the shingles, blister, lymph node pain and swallowing painful to be related to Shingrix.  Additional details were reported as follows: The patient stated that on the following day of vaccination with shingrix, she developed Shingles lesions on her face. She told that the lesions were red and had a blister in the middle. Less than a week after receiving shingrix vaccine, she also had a gland on the right side of her neck that was sore and it hurts when she swallows. The reporter did not have lot information. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blood test normal, Chest X-ray abnormal, Pneumonia, Pyrexia, Rash macular
Clinical narrative: 9 days after MMRV pt had onset of fever with no other symptoms. He had a seizure with fever on the second day of fever and went to the ED where he received IV hydration, blood work and a CXR. The chest xray was read as c/w pneumonia. His blood work was unremarkable and with previous hx of febrile seizure and his then normal sensorium he was discharged to home. He had a further 3 days of fever without cough or other symptoms. He broke out in a small macular rash generally on the day after the fever ended and the rash lasted for three days. He remained clinically well.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Seizure
Clinical narrative: 9 days after MMRV pt had onset of fever with no other symptoms. He had a seizure with fever on the second day of fever and went to the ED where he received IV hydration, blood work and a CXR. The chest xray was read as c/w pneumonia. His blood work was unremarkable and with previous hx of febrile seizure and his then normal sensorium he was discharged to home. He had a further 3 days of fever without cough or other symptoms. He broke out in a small macular rash generally on the day after the fever ended and the rash lasted for three days. He remained clinically well.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Slight Chill, Severe body aches (shoulders, Upper & Lower back, headache, nausea), occasional low-grade fever
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Slight Chill, Severe body aches (shoulders, Upper & Lower back, headache, nausea), occasional low-grade fever
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Injection site erythema, Pyrexia, Vaccination complication, Vaccination site induration
Clinical narrative: Call from mother 6/4/20, 8 days post vaccine. Telemedicine visit completed by physician 6/5/20. Patient has quarter size red area at vaccine site that feels hard to touch. Patient has fever high of 101. Patient received 2 other vaccines in the opposite leg on the same day and both are fine.  Vaccine reaction versus cellulitis?? Patient prescribed antibiotics starting 6/5/20 for treatment. Parent to call if red area becomes worse.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: The day after getting the Shingrix vaccine the patient's arm got swollen, red, and very painful (she had a hard time moving her arm, the pain was inside her arm). The pain lasted for 3 weeks, the redness and swelling lasted 2 weeks. The patient was seen by her PCP and they indicated that they thought she had an allergic reaction to the vaccine. The patient went to see her PCP two to three days after receiving the vaccine. The doctor gave her diclofenac gel to apply which helped a little. She used the gel for about a week.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, X-ray limb normal
Clinical narrative: The day after getting the Shingrix vaccine the patient's arm got swollen, red, and very painful (she had a hard time moving her arm, the pain was inside her arm). The pain lasted for 3 weeks, the redness and swelling lasted 2 weeks. The patient was seen by her PCP and they indicated that they thought she had an allergic reaction to the vaccine. The patient went to see her PCP two to three days after receiving the vaccine. The doctor gave her diclofenac gel to apply which helped a little. She used the gel for about a week.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Malaise, Myalgia, Nausea
Clinical narrative: Sore arm muscles, nausea, stomach pain, overall muscular pain in body.  In general, I do not  feel well at all.   I have taken 2 aleve pills to try and see if it will help.  So far I do not notice any relief.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site pruritus, Injection site rash, Local reaction
Clinical narrative: Vaccine received on 06/01/2020, 10am. No Adverse reaction until 06/04/2020. Localized reaction at the injection site. Injection-site pruritus and rash.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: Body aches, head ache, chills, sweats, stomach ache
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: resembling shingles; vestibular rash/vesicular rash on one side of the body; This case was reported by a physician via sales rep and described the occurrence of shingles in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number Y9K7L, expiry date 19th March 2022) and (batch number 9737P, expiry date 19th March 2022) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included hypertension.   On 19th May 2020, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, the dose was an unknown dose. On 23rd May 2020, 4 days after receiving Shingrix, the patient experienced shingles and vesicular rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient developed a unilateral vestibular rash on the right side of the lower trunk, resembling shingles. Till the time of reporting, the rash was persisting. Upon follow up on 27th May 2020, the reporter reported that, the patient developed vesicular rash on one side of his body (3 lesions) along L2-3 through C10 (lower thoracic and lumbar area).  The patent did not report any other symptoms, like pain, fever or sweats-according to the reporter.  The patient was prescribed Valtrex 1 gm three times a day for 7 days. Upon follow up on 28th May 2020, reporter correct address was provided. This case was 1 of 3 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed case of shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2020, the patient received the 1st dose of Shingrix .5 ml. On 23rd May 2020, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed case of shingles. The reporter thinks the shingles could be result of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: developed shingles; rash was unilateral; blistering; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th May 2020, the patient received the 1st dose of Shingrix. On 23rd May 2020, 4 days after receiving Shingrix, the patient experienced shingles, rash and blister. On an unknown date, the outcome of the shingles, rash and blister were unknown.   It was unknown if the reporter considered the shingles, rash and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient developed shingles. The rash was unilateral and blistering. This case was linked with case US2020AMR089341, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Scratch
Clinical narrative: her arm was very sore at the injection site; felt achy/very painful; felt like flu; severe itching; nerve pain on the inside of her arm her lower back and the top of her left thigh / the nerves were painful; nerve pain in her tongue; she had a hard time getting dressed; was a little past the 6 months when she got the 2nd dose; felt like a mild case of Shingles; got bruises from all the scratching; from all the scratching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose little past the 6 months).   In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 3 days after receiving Shingrix, the patient experienced shingles, contusion and scratch. On an unknown date, the patient experienced injection site pain, general body pain, influenza like illness, pruritus, nerve pain, tongue pain, activities of daily living impaired and drug dose administration interval too long. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the shingles, pruritus, nerve pain, contusion, scratch, tongue pain, activities of daily living impaired and drug dose administration interval too long were unknown and the outcome of the injection site pain, general body pain and influenza like illness were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site pain, general body pain, influenza like illness, pruritus, nerve pain, contusion, scratch, tongue pain and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in early January 2020 and her arm was very sore at the injection site, such that she had a hard time getting dressed. She also felt achy like she had the flu for a day afterwards. About 3 days after getting the vaccine she developed severe itching and nerve pain on the inside of her arm above the elbow, her lower back and the top of her left thigh. The nerve pain in her arm was the same arm where she received the injection.  The itching on her arm was so bad she got bruises from all the scratching.  The patient went to a minute clinic and was given steroid, which relieved some of the itching for about 1 week. It was very itchy and very painful and the symptoms lasted about 2 months. She thinks it felt like a mild case of Shingles. There was never any breakout on her skin, but the nerves were painful. Separate from the nerve pain, she also had pain at the injection site that also took a long time to resolve. In the past week to 10 days she has started having the same nerve pain in her tongue. It was not in the same part of her tongue all the time, it moves around.  The patient went to her dentist, and her dentist did not see any signs of infection on her tongue.  The reporter consented to follow up. Emergency room visit required.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; tired; Body ache; Stomachache; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for an unknown indication.   On 25th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever, tiredness, general body pain and stomach pain. On an unknown date, the outcome of the fever, tiredness, general body pain and stomach pain were recovered/resolved.   It was unknown if the reporter considered the fever, tiredness, general body pain and stomach pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced fever, stomachache, body ache and tired, which lasted from 5 to 6 days. No further details were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: severe muscle ache, nausea, headache
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: adverse events: nausea,  light headed (did not pass out) , dizziness, slight headache   treatment: water, squatted down to get low to the ground  outcomes: symptoms passed after a few minutes and did not return
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Chills,severe headache and nausea starting 8 hours after injection.  Loss of appetite and fatigue, weakness the entire next day.  On third day after injection severe headaches started at night (5/29) and continued for 6 days.  Had to get Tylenol 3 (codeine) as normal OTC meds couldn't touch the headaches.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Chills,severe headache and nausea starting 8 hours after injection.  Loss of appetite and fatigue, weakness the entire next day.  On third day after injection severe headaches started at night (5/29) and continued for 6 days.  Had to get Tylenol 3 (codeine) as normal OTC meds couldn't touch the headaches.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINES GIVEN UNNECESSARILY.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed itching rash behind knees and on top of thighs about two weeks after first injection.  Rash waxed and waned for about three weeks before subsiding.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Syncope
Clinical narrative: Pt had syncope episode, turn pale and fainted, oxygen was given and was monitor for 30 minutes in the office.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site movement impairment, Injection site swelling, Pyrexia
Clinical narrative: Full right thigh is swollen from knee cap to hip, impaired mobility as a result of swelling, low grade fever.  No treatment given at time of report.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Significant arm swelling and pain, fatigue lasting overnight into the next day. Arm pain remained 2 days
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Malaise, Pallor
Clinical narrative: he immediately stated he did not feel well and was going to faint. chair was lowered. patient given H2O and cool cloth BP dropped to 73/40. he was diaphoretic and pale. with laying flat bp returned to normal he felt better and left
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications were provided. On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S020241 and expiration date 23-AUG-2020; dose and route of administration were not reported). The vaccine underwent a temperature excursion with a temperature of 12.1 Celsius degrees for a time frame of 16 hours and 11 minutes. There was no previous temperature excursion. The call was because of a data logger. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: labeled expiration date was short dated to 1/30/2020 after a temperature excursion; labeled expiration date was short dated to 1/30/2020 after a temperature excursion; No adverse affects reported.; a dose of V ARIV AX was administered on 3/20/2020  after lhe labeled expiration date was short dated to 1/30/2020 after a temperature excursion; 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, concomitant medications and previous drug reactions or allergies was reported.   On 20-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002396, expiration date reported as 31-JAN-2021, but upon internal validation established as 23-JAN-2021 (dose and route of administration were not provided) for prophylaxis.  It was reported that the labeled expiration date was short dated to 30-JAN-2020 due to a temperature excursion on an unknown date. The patient did not experience any additional adverse effects.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA009775:
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse effect reported; "patient received MMR II in one injection site on 27-MAY-2020 and PROQUAD in another injection site on 27-MAY-2020."; This spontaneous report was received from the office manager, referring to a 12-month-old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 27-MAY-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa)(M-M-R II) injection as prophylaxis in one site (dosage regimen and anatomical location were not reported; lot number S014429, which has been verified to be valid, expiration date reported and validated as 09-MAY-2021), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHa)(PROQUAD) injection as prophylaxis in another site (dosage regimen and anatomical location were not reported; lot number S017240, which has been verified to be valid, expiration date reported and validated as 01-DEC-2020) (inappropriate schedule of product administration). Sterile diluent (MERCK STERILE DILUENT) was used. No additional adverse effect reported.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: the patient experienced left shoulder pain; the patient experienced left shoulder warmth; The patient experienced limited range of motion in the left shoulder; This spontaneous report was received from a registered nurse referring to a 81-year-old female patient. The patient's pertinent concurrent conditions included hypertension, hypothyroidism, elevated cholesterol (blood cholesterol increased) and gastrooesophageal reflux disease. Her concomitant medications included levothyroxine sodium, metoprolol (reported as metopropol), mirtazapine (manufacturer unknown), omeprazole and hydrochlorothiazide (+) triamterene(DYAZIDE). The patient had a previous drug reaction to penicillin, nabumetone and tobramycin.      On 25-AUG-2003, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, intramuscular as prophylaxis (concentration, vaccination scheme frequency, number of dose administered, lot number and expiration date were not provided), then on 27-MAY-2020, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, intramuscular in the left arm as prophylaxis (concentration, vaccination scheme frequency, number of dose administer were not reported, reported lot number S034299 and expiration date  01-JUL-2021)   On 28-MAY-2020, the patient experienced left shoulder pain (musculoskeletal pain), left shoulder warmth (joint warmth) and limited range of motion in the left shoulder (joint range of motion decreased). On the same date, the patient returned to the physician office for an evaluation of the left shoulder, therefore, the patient was advised to take acetaminophen (TYLENOL) or naproxen sodium (ALEVE) for the left shoulder pain and the patient should begin physical therapy to increased her left shoulder mobility. No laboratory diagnostic or studies were performed.  At the time of this report, the outcome of musculoskeletal pain, joint range of motion decreased and joint warmth was unknown by the reporter.     The causality assessment between therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was not reported.  This is one of two reports from 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: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; 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-009507513-2006USA001705:
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Skin exfoliation
Clinical narrative: Itchy skin upper thigh groin area that flakes for a few days and then it gets worse; skin flaking; This case was reported by a other health professional via interactive digital media and described the occurrence of itchy skin in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy skin and flaking skin. On an unknown date, the outcome of the itchy skin and flaking skin were not recovered/not resolved.   It was unknown if the reporter considered the itchy skin and flaking skin 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 an adult as per the vaccine indication. The patient received Shingrix and had itchy skin upper thigh groin area that flakes in a pattern words itchy than it used up for a few days and then it got worse.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash on my wrist/rash is about a half an inch wide and 3 inches long; This case was reported by a consumer and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2020, the patient received the 1st dose of Shingrix (unknown). On 16th May 2020, 21 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details: The age group was not reported but it was selected as adult as per the vaccine indication.  The patient received the first dose of Shingrix approximately one month ago and noticed a rash around a wrist where the patient weared a leather or silicone watch a red rash that was been on the patient's wrist for about a week an a half. The patient reported that the rash was red at comes and goes with the patient putting creams or oil (tea tree) or hydrocortisone on it. The rash was about a half an inch wide and 3 inches long. Till teh time of report, the patient had not taken a second dosage. The patient further enquired whether this was one of the side effects after the injection.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache 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 an adult as per the vaccine indication. The patient received Shingrix and had headache. The reporter asked how long do the side effects last.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: felt "bed sick"; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and injection site pain. On an unknown date, the outcome of the feeling unwell and injection site pain were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Several patients received Shingrix and experienced pain at the injection site and felt bed sick. The reporter did not consent to follow up. For tolerances of 2nd dose, refer case US2020091016, reported by same reporter for the several patients.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: body aches; stiffness in both hands and fingers/fingers stiffness; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number 5MHC6EB2X ?, GSK note the reported batch number did not match with any GSK lot number expiry date unknown, ) for prophylaxis.  On 26th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced general body pain and limbs stiffness. On an unknown date, the outcome of the general body pain and limbs stiffness were recovered/resolved.   It was unknown if the reporter considered the general body pain and limbs stiffness to be related to Shingrix.  Additional details were provided as follows: The patient reported to the pharmacist that 3 days following the vaccination, he experienced body aches all over his body and stiffness in both hands and fingers of both hands.  The symptoms lasted over a month.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Patient developed localized redness, swelling, and pain. Diagnosed with cellulitis in ER. Took 10 day course of Keflex. Symptoms resolving.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient developed localized swelling, redness, and warmth to the touch. No fever. Sx resolved without treatment.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Pain in extremity
Clinical narrative: 3/11/20 seen for right upper arm erythema, tenderness, and warmth- treated with Cephalexin 500 mg bid x10 days, which resolved, seen 6/5 for ongoing right arm pain and pain with range of motion
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: X-ray limb
Clinical narrative: 3/11/20 seen for right upper arm erythema, tenderness, and warmth- treated with Cephalexin 500 mg bid x10 days, which resolved, seen 6/5 for ongoing right arm pain and pain with range of motion
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: triedness, muscle pain, headache, shivering, fever, stomach pain, and nausea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: triedness, muscle pain, headache, shivering, fever, stomach pain, and nausea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed swelling on thigh the size of an adult's hand, redness covering whole front of thigh, warmth, pain. Temp 100 F at highest.  Sx resolving now.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: On 6/1/2020 patient experienced injection site pain and joint pain. 6/2/2020 {inj. site pain/joint pain/swelling @ site of injection, body aches, headache, fever the symptoms were resolved on 6/3/2020
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: On 6/1/2020 patient experienced injection site pain and joint pain. 6/2/2020 {inj. site pain/joint pain/swelling @ site of injection, body aches, headache, fever the symptoms were resolved on 6/3/2020
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fall, Head injury, Middle insomnia, Vomiting
Clinical narrative: Pt woke up dizzy in middle of night and fell and hit head.  now is having dizziness and vomiting  the morning after fall.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, C-reactive protein increased, Electromyogram, Full blood count normal, Grip strength decreased
Clinical narrative: Edema of right arm. Subsequent chronic pain in forearm/wrist/metacarpals. Paresthesia on dorsal surface of right hand. Muscle atrophy of forearm, Weakness of right arm and grip strength.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Metabolic function test normal, Muscle atrophy, Muscular weakness, Oedema peripheral, Pain
Clinical narrative: Edema of right arm. Subsequent chronic pain in forearm/wrist/metacarpals. Paresthesia on dorsal surface of right hand. Muscle atrophy of forearm, Weakness of right arm and grip strength.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, Red blood cell sedimentation rate increased
Clinical narrative: Edema of right arm. Subsequent chronic pain in forearm/wrist/metacarpals. Paresthesia on dorsal surface of right hand. Muscle atrophy of forearm, Weakness of right arm and grip strength.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Haematochezia, Rectal tenesmus
Clinical narrative: Mom noticed pt is straining to have  bowel movement, noticed red, stringy blood in stool- started today. 06/05/2020. Bowel movements prior to today have been normal per mom.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received first Shingrix dose on 06/29/2018 and second Shingrix dose on 03/18/2019. Per phone conversation with patient on 06/05/2020, the patient has developed shingles. Also confirmed with md office.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Mass, Musculoskeletal pain
Clinical narrative: Bump on shoulder occurring in 24 hours after administration Mildly painful, with pain extending to elbow for a while Lump has persisted for almost a year
Age: 37.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: patient was given both TDAP and HEP A. When she got home she developed nausea and vomiting. She called our office this morning, but did not go to ER or Urgent care. We are treating accordingly.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was administered an expired vaccination. The vaccine expired March 06, 2020 and was given on 06/02/2020. The patient had no adverse effects to the vaccine at the time or following the injection.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: fever, headache. chills. shivers. body ache. dizziness.tiredness
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever, headache. chills. shivers. body ache. dizziness.tiredness
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Dyskinesia, Nausea, Pallor
Clinical narrative: HPV, Tdap and Menactra vaccines were administered to right and left deltoid while patient was sitting on exam table. Patient tolerated well until about 5 min after vaccine administration, patient was sitting in chair next to mom and patient slumped forward, fainted and mom was instructed by MA to wrap her arms around patient so she would not fall out of chair. Patient's head jerked back and legs extended for a very brief period of time after fainting. Episode lasted about 1 minute and patient was responsive afterwards. MA called RN in to monitor patient while MA got juice and crackers. After fainting episode, patient was very pale and said she felt weak, dizzy and nauseous. MA assisted patient to lay on exam table and was given a pillow, juice, crackers. Patient stated she was feeling better after some juice and crackers but remained in clinic for about 45-50 minutes after episode as she stated she was still feeling dizzy and nauseous. Dr. evaluated patient several times after episode. After 50 minutes in clinic patient felt comfortable standing up and walking out of clinic with mom.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: HPV, Tdap and Menactra vaccines were administered to right and left deltoid while patient was sitting on exam table. Patient tolerated well until about 5 min after vaccine administration, patient was sitting in chair next to mom and patient slumped forward, fainted and mom was instructed by MA to wrap her arms around patient so she would not fall out of chair. Patient's head jerked back and legs extended for a very brief period of time after fainting. Episode lasted about 1 minute and patient was responsive afterwards. MA called RN in to monitor patient while MA got juice and crackers. After fainting episode, patient was very pale and said she felt weak, dizzy and nauseous. MA assisted patient to lay on exam table and was given a pillow, juice, crackers. Patient stated she was feeling better after some juice and crackers but remained in clinic for about 45-50 minutes after episode as she stated she was still feeling dizzy and nauseous. Dr. evaluated patient several times after episode. After 50 minutes in clinic patient felt comfortable standing up and walking out of clinic with mom.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A few hours after vaccination patient began feeling intense pain, swelling and increased temperature at the site of injection. Pain got worse and patient felt that it was radiating down to her elbow. Swelling and redness also got worse. On June 2, 4 days after injection, patient was given a prescription of Oral cephalexin.  A day later symptoms began to improve. On follow up, on June 5, day 8 after injection, patient's symptoms are 85 % improved. there is only mild tenderness on site. Full range of motion of left arm/shoulder.