chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain of short duration in lower back shoulder muscle; shingles pain; stabbing pain; Lower back pain; left arm with pain; pain in shoulder / pain of short duration in lower back shoulder muscle; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a month after receiving Shingrix, the patient experienced shoulder pain. On 17th August 2020, the patient experienced pain in arm, muscle pain, shingles, pain and low back pain. On an unknown date, the outcome of the pain in arm, shoulder pain, muscle pain, shingles, pain and low back pain were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, muscle pain, shingles, pain and low back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix my left arm with pain in the shoulder for a few days. The patient had short stabbing pain of short duration in the lower back shoulder muscle.  The reporter believes this was shingles pain.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscle fatigue
Clinical narrative: tired; headache; fell tired muscle tired; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced tiredness, headache and muscle fatigue. On an unknown date, the outcome of the tiredness, headache and muscle fatigue were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, headache and muscle fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and fell muscle, tired and headache.  The reporter asked how long would this last.
Age: 0.08
Sex: M
Vaccine: DTAP, IPV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Two staff members read the micr wrong, we thought today's date was 09/28/2020 and it was actually 08/28/2020. it was misread, we did inform mother of information and the provider is aware as well.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Patient developed fever at 2:00 pm on day of vaccines.  Max temp was 104.5  Had seizure at night that lasted 5 minutes.  She was seen at the ER.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV
Symptoms: SARS-CoV-2 test negative, Seizure, Urine analysis normal
Clinical narrative: Patient developed fever at 2:00 pm on day of vaccines.  Max temp was 104.5  Had seizure at night that lasted 5 minutes.  She was seen at the ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: The refrigerator where the vaccines ares tored had a temperature excursion that exceeded the viability of teh vaccines IPOL and MMR. No adverse effects were reported. The patient will be revaccinated at a later date.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: THE VACCINE REFRIGERATOR WENT OUT WHICH CAUSED THE IPOL AND MMR VACCINES TO BE COMPROMISED. NO ADVERSE EFFECTS HAVE BEEN REPORTED. THE PATIENT WILL BE REVACCINATED AT A LATER DATE.
Age: 69.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Cold sweat, Dizziness, Fall, Feeling hot
Clinical narrative: Patient felt faint went to sit down, but then fell from the seat. We moved him to the floor and placed him on his side. He was clammy but said he felt hot. Paramedics were called and arrived within 5 mins, then transported him to hospital
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: THE REFRIGERATOR WHERE THE VACCINES WERE STORED EXPERIENCED A TEMPERATURE EXCURSION AFFECTING THE IPOL AND MMR VACCINES. NO ADVERSE EFFECTS WERE REPORTED. THE PATIENT WILL BE RE VACCINATED.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient given an expire Polio vaccine.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: THE REFRIGERATOR WHERE THE VACCINES ARE STORED WENT OUT WHICH COMPROMISED THE ABOVE VACCINES MAKING THEM INVALID. NO ADVERSE EFFECTS WERE REPORTED. PATIENT WILL BE RE VACCINATED.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: Tiredness,  muscle pain, slight dizziness when turning my head quickly.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Feeling hot, Nausea, Peripheral swelling
Clinical narrative: Pt developed significant arm swelling overnight and said area felt hot and was nauseous. advised to seek acute care
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal pain, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Pt describes no pain upon receiving injection, but later the same evening and over the next 5-6 days, she developed very severe abdominal cramping, muscle aches, fatigue, loss of appetite and extreme thirst, as well as a low grade (~100F) fever. She says in the last 20 years since receiving the vaccine, she has never had any reaction like this before. In April/May 2020, she reports having tested positive for COVID-19 antibodies.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: SARS-CoV-2 test positive, Thirst
Clinical narrative: Pt describes no pain upon receiving injection, but later the same evening and over the next 5-6 days, she developed very severe abdominal cramping, muscle aches, fatigue, loss of appetite and extreme thirst, as well as a low grade (~100F) fever. She says in the last 20 years since receiving the vaccine, she has never had any reaction like this before. In April/May 2020, she reports having tested positive for COVID-19 antibodies.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The physician states that five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report was received from a physician and refers to a 12-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an 12-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # S026925 was confirmed to be not valid (expiration date, dose, anatomical location and route of administration were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of - 9.2 degrees Celsius (C) for 30 minutes and in the temperature of -14 degrees C to -10 degrees C ( -14.3 degrees C) for 30 minutes. There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA011114: US-009507513-2008USA011215: US-009507513-2008USA011552: US-009507513-2008USA011473:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; Nurse called to report a patient received improperly stored ROTATEQ on 7/29/2020; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-JUL-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally (strength, vaccination scheme and anatomical site of injection were not reported; lot number 1660981, expiration date: 13-APR-2021) as prophylaxis (product storage error). No additional adverse effect reported.  On an unknown date, the vaccine underwent a temperature excursion above 47 degrees Fahrenheit (F) / 9 degrees Celsius (C) (8.9C) for 33 minutes, as recorded by a data logger. There was no previous temperature excursion.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; A patient received expired VAQTA on 8/25/2020; This spontaneous information has been received from office manager, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On 25-AUG-2020, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) injection as prophylaxis, lot number S019435 with expiration date 23-AUG-2020 (strength, dose, frequency, route of administration and anatomical location were not provided) (expired vaccine used).  No additional adverse effect reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; Devicelotnumber: S019435; 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 suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation concerning patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. In 2016, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at Urgent Care for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a healthcare provider at Urgent Care located for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: passed out after getting the vaccine; This case was reported by a pharmacist via other manufacturer and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, less than a month after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant). In August 2020, the outcome of the passed out was recovered/resolved.   It was unknown if the reporter considered the passed out to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband. The age at vaccination was not reported. After receiving Shingrix, the patient passed out but came a couple of hours later. The reporter stated that, he was not the one who administered the vaccine to the patient, she got that at a different pharmacy, but reporter was a pharmacist.; Sender's Comments:  US-Pfizer-2020328749:
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Herpes zoster, Injection site erythema, Injection site swelling
Clinical narrative: large amount of swelling, larger than 100 mm thus grade 3 swelling, at the injection site; shingles; injection site was red; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, shingles and injection site erythema. Shingrix was discontinued. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, shingles and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The reporting nurse was the concerned patient. The nurse indicated that she did have the first shot of the Shingrix series, given at a pharmacy, but it was over a year ago. She never returned for the second shot (because she was afraid). She reported that when she received the first Shingrix shot she had a large amount of swelling, larger than 100 mm thus grade 3 swelling, at the injection site. She also indicated that the injection site was red. The patient currently had shingles. No further information was provided. Call Notes:Reporter provided limited information
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Hot feeling at the injection site; Soreness at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness at the injection site, soreness at the injection site, and a hot feeling at the injection site The reporter did not consent to follow up. This case has been linked with case US2020167493, US2020167496 and US2020167490, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167493:Wife influenza's case US-GLAXOSMITHKLINE-US2020167496:Mother in law's case US-GLAXOSMITHKLINE-US2020167490:Wife shingrix's case
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness and itching near the injection site; redness and itching near the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix. On 7th August 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient reported redness and itching near the injection site that last 3 days.   The itching was milder than the redness. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: area around the injection site was slightly more  warmth; area around the injection site was slightly more  red; there was swelling about the size bigger than a quarter / swelling is around 10 inches in circumference; the injection the injection site started to hurt /  painful; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 2nd dose of Shingrix. On 21st August 2020, immediately after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site pain. On 22nd August 2020, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received the second dose of the Shingrix vaccine on in her left arm. Soon after the injection the injection site started to hurt and there was swelling about the size bigger than a quarter.  The patient She stated may be around 22nd August 2020, the patient noticed the area around the injection site was slightly more red, warm, painful, and the swelling was around 10 inches in circumference and the patient stated the swelling diameter had been increasing. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report from a contactable physician via Pfizer sales representative.   A 16-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fainted on an unspecified date with outcome of unknown.    The information on the Lot / Batch number has been requested.; Sender's Comments: Based on the information provided and drug's safety profile, the event faint is possibly related to meningococcal group b rlp2086 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Fatigue
Clinical narrative: fatigue (mild to moderate); This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. A patient of unspecified age (reported as over 65) and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue (mild to moderate) on an unspecified date with outcome of recovered after 1-2 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Death, Extra dose administered, Wrong product administered
Clinical narrative: the patient received the wrong vaccine and received Menactra; the patient received the wrong vaccine and received Menactra; the patient passed away due to unknown cause; Initial information received on 24-Aug-2020 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 12-year-old male patient who passed away due to unknown cause (death) after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. It was reported that the patient received the wrong vaccine and received Menactra (wrong product administered and extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history and concomitant therapies (if any) were not provided.   On 15-Oct-2019, the patient received a first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, route and site of administration and other dosing details were not reported). On 12-Aug-2020, the patient received a second 0.5 ml dose of same vaccine (lot U6585AB, expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  In Aug-2020, the patient passed away due to unknown cause (death) a week following the administration of second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant as it led to death. It was a case of actual medication error due to wrong vaccine administered and extra dose administered (Nurse stated that the patient received the wrong vaccine and received Menactra).  Relevant laboratory test(s) and corrective treatment (if any) were not reported.  The patient died on an unknown date. It was unknown if an autopsy was done. Reporter stated that cause of death was still being investigated.  Batch number has been requested.; Sender's Comments: This case involves a 12-year-old male patient, who died one week after the vaccination with MENACTRA. The time to onset is compatible. Additional information regarding patient's relevant medical history, health condition at time of vaccination, concomitant medication and investigations ruling out other alternative etiologies, autopsy results for cause of death would be needed for complete assessment of the case. Based on the reported information role of the vaccine cannot be assessed.; Reported Cause(s) of Death: the patient passed away due to unknown cause
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Gait disturbance, Joint swelling, Laboratory test
Clinical narrative: 11 year had joint swelling with difficulty walking
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Electrocardiogram, Full blood count, Palpitations, Sinus tachycardia
Clinical narrative: Palpitations - sinus tachycardia sustained 100-130 x 12 hours
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Patient had extensive bruising covering entire upper arm and spreading down to the forearm after the injection. Spreading of bruising continued for 4 days after vaccination. Started to improve 7 days post vaccination.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: 1 week S/P injection developed flat red rash beginning at injection site and spread over most of upper arm
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: redness, swelling aprox 2 inches, lump at site, itching with no rash on upper and lower back and legs starting on 8/22 as of 8/28 site reaction is resolved but still has mild itching
Age: 11.0
Sex: M
Vaccine: HPV9, MMR, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Feeling abnormal, Nausea, Nervousness
Clinical narrative: 8/27/2020: Pt due for HPV, MCV4, Tdap, and MMR today; PMH includes seizures and syncope. This RN entered patient's room at approximately 0920 to administer due vaccines; pt was sitting upright on exam table when she verbalized feeling nervous about receiving vaccines; mother stood at pt's left side for comfort and provided a cellphone to use as a distraction. MMR was administered SC in right arm and MCV4 administered IM in right deltoid at approximately 0925. Pt appeared to tolerate injections well; shortly after administration pt verbalized feeling dizzy and was then placed in supine position on exam table. Before administering next set of vaccines, pt was given approximately 2-3 minutes to rest where she then verbalized being ready for vaccines; mother moved to pt's right side for comfort. Tdap and HPV administered IM in left deltoid. Less than 10 seconds later, pt said aloud "I am going to pass out". Immediately afterward, pt's eyes rolled back into head and her upper body began to shake for approximately 15-20 seconds; pt was unresponsive to vocal or physical stimuli during this time. Once pt's safety was ensured, this RN notified provider; provider then entered room to assess pt. O2 sat was checked and found to be 99%. Once pt was alert and responsive, she was placed in upright sitting position with back of exam table fully elevated for support; apple juice was provided and mother provided donuts for additional sugar intake. Pt verbalized feeling nauseous but did not vomit; pt then requested to go to the bathroom and was accompanied by her mother. Pt returned to room and was monitored for another 15+ minutes. At 0953, this RN re-entered exam room and pt reported feeling "better" but asked for additional time before leaving; provider was notified of same. Provider assessed pt; pt sent home w/o further incident. This RN will call mother tomorrow (8/28/2020) to check on pt's status.  8/28/2020: Called pt's mother today to f/u on pt's status r/t syncopal episode on 8/27/2020.  Pt's mother reports 1x episode of vomiting  yesterday after leaving clinic but that patient is "feeling well and is back to her normal self" today.
Age: 11.0
Sex: M
Vaccine: HPV9, MMR, MNQ, TDAP
Symptoms: Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: 8/27/2020: Pt due for HPV, MCV4, Tdap, and MMR today; PMH includes seizures and syncope. This RN entered patient's room at approximately 0920 to administer due vaccines; pt was sitting upright on exam table when she verbalized feeling nervous about receiving vaccines; mother stood at pt's left side for comfort and provided a cellphone to use as a distraction. MMR was administered SC in right arm and MCV4 administered IM in right deltoid at approximately 0925. Pt appeared to tolerate injections well; shortly after administration pt verbalized feeling dizzy and was then placed in supine position on exam table. Before administering next set of vaccines, pt was given approximately 2-3 minutes to rest where she then verbalized being ready for vaccines; mother moved to pt's right side for comfort. Tdap and HPV administered IM in left deltoid. Less than 10 seconds later, pt said aloud "I am going to pass out". Immediately afterward, pt's eyes rolled back into head and her upper body began to shake for approximately 15-20 seconds; pt was unresponsive to vocal or physical stimuli during this time. Once pt's safety was ensured, this RN notified provider; provider then entered room to assess pt. O2 sat was checked and found to be 99%. Once pt was alert and responsive, she was placed in upright sitting position with back of exam table fully elevated for support; apple juice was provided and mother provided donuts for additional sugar intake. Pt verbalized feeling nauseous but did not vomit; pt then requested to go to the bathroom and was accompanied by her mother. Pt returned to room and was monitored for another 15+ minutes. At 0953, this RN re-entered exam room and pt reported feeling "better" but asked for additional time before leaving; provider was notified of same. Provider assessed pt; pt sent home w/o further incident. This RN will call mother tomorrow (8/28/2020) to check on pt's status.  8/28/2020: Called pt's mother today to f/u on pt's status r/t syncopal episode on 8/27/2020.  Pt's mother reports 1x episode of vomiting  yesterday after leaving clinic but that patient is "feeling well and is back to her normal self" today.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dysgeusia, Feeling abnormal, Skin lesion, Skin reaction
Clinical narrative: metal taste, felt awful, had large local skin reaction  4inx2in large lesion
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area of redness and swelling around injection site measuring about 5 inches for 2 days after injection.  This occurred with last years vaccine as well.  Last years vaccine was a different vaccine all together.  Mom stated up until last year they only so this reaction to the FLU vaccine which he gets at the allergist due to his allergy to eggs.
Age: 64.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Tubulointerstitial nephritis
Clinical narrative: 11/15/2020:  ADMITTED with ACUTE INTERSTITIAL NEPHRITIS
Age: 64.0
Sex: F
Vaccine: FLU4, FLUC4
Symptoms: Acute kidney injury, Biopsy kidney abnormal, Blood creatinine increased, Immunosuppressant drug therapy, Renal impairment
Clinical narrative: 11/15/2020:  ADMITTED with ACUTE INTERSTITIAL NEPHRITIS
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced, redness and swelling  in entire upper arm. It was very painful and hard to move.  She saw a PA that prescribed and antibiotic and diagnosed cellulitis.  She is feeling better since she started the antibiotics.
Age: 23.0
Sex: F
Vaccine: DTAP, HPV9, PPV
Symptoms: Chills, Erythema, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Reports left arm pain, redness, chills, fast hearbeats and low grade fever. fast hearbeats resolved.   Advised pt to be seen to follow up. She declined. Stated will wait for one day if worsening she will go to the WIC.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain
Clinical narrative: severe headache; body aches; This is a spontaneous report from a contactable physician. A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) (lot# CN8296), via an unspecified route of administration, on 26Aug2020, at single dose, for immunisation. Medical history and concomitant medications were none. The patient experienced severe headache and body aches both on 26Aug2020 within hours from vaccination. Therapeutic measures were taken as a result of the events and included treatment with Advil and Benadryl. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020287180 same reporter/drug, different patient/event
Age: 79.0
Sex: U
Vaccine: PPV
Symptoms: Decreased appetite, Disorientation, Myalgia, Nausea, Pruritus
Clinical narrative: Box 17-Pneumovax; Severe muscular pain. Some relief after taking ADVIL. Also experiencing nausea, disorientation, extreme itching (hands, fingers, in-between fingers, arms, back, backside), loss of appetite.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Injection site pain
Clinical narrative: T. 102,  whole body shaking, weakness . The former two lasted about 3 hours. The weakness lasted 2 days. Also, sore injection site for 3 days (which I always get).
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Tremor
Clinical narrative: Approximately 9 1/2 hours after flu vaccine was administered, weakness and shaking showed up in both legs.  During the evening until I went to bed, the weakness was such that I was unsure of be stable enough to walk without a lot of concentration on the effort so that I would not fall.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Rash
Clinical narrative: Patient described normal soreness and slight rash of left arm starting day after injection that is still present a month later.  Patient is also experiencing pain the injection location a month later.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dehydration, Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: High Fever, Vomiting, Diarrhea, Body Rash, Dehydratation. After the vaccines my baby start to have fever, we email doctor, but no response so far today 8/28 on what to do. The fever contiue raise up to 102, we call the facility and the said that we can administrate Tylenol.  The fewer lower down, we call the facility again the 25th, they only said that we should take him to the ER, there is nothing that they can do. The body rash start, and vomiting and diarrhea, we took him to urgent care the 26 and the doctor said that that is normal that, there is nothing that he can do. He prescribe benadryl for the rash, but we decide that not to give to him, that visit only last for 10 minutes. We contact an external doctor, he take a look to the baby, and all the shymtoms, he said that the baaby was deshydratate, so he prescibe Pedialite, and Homepathic medicine (Guna Flam, Guna Allergy T, Guna Allegry Preven, Nux Vomica and some probiotics.
Age: 69.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Asthenia, Headache, Pain in extremity, Polyuria, Swelling
Clinical narrative: Severe arm pain  Severe swollen  Headache Diuresis  Body weakness
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, UNK, VARCEL
Symptoms: Decreased appetite, Fatigue, Injection site pain, Irritability, Pyrexia
Clinical narrative: Fatigue-within 30 minutes after shots Loss of Appetite- 1 hr after shots and lasted thru next day Sore Legs- about an hour after shots Unusually fussy- about 90 minutes after shots Fever of 102F- began at 10AM next day
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Expired product administered
Clinical narrative: Invalid dose given due to expiration date.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: 7 hours after injection I developed chills, fever (100 F), fatigue. dizziness, fatigue, weakness, nausea, loss of appetite, and a headache. These symptoms lasted for the next 24 hours and gradually subsided over the next 8 hours.  On 8/28/20 I woke up feeling normal again.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: 7 hours after injection I developed chills, fever (100 F), fatigue. dizziness, fatigue, weakness, nausea, loss of appetite, and a headache. These symptoms lasted for the next 24 hours and gradually subsided over the next 8 hours.  On 8/28/20 I woke up feeling normal again.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Tremor
Clinical narrative: Approximately 2-3 minutes after vaccine administration patient experienced muscle tremors and shaking.  Mother suspected tremors and shaking were related to anxiety of vaccine administration. Patient was given water and allowed to rest. Symptoms resolved in approximately 10-15 minutes.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Infection, Injection site warmth, Swelling
Clinical narrative: Patient woke up the next day and experienced a brief amount of swelling. Arm appeared red in a 3 inch around sit of infection consistent with an allergic reaction.  Site is described as warm or hot to touch.  Described as tolerable, will seek attention if needed; does not feel benadryl or cortisone cream over the counter was required but she would keep in mind. She does not have an md at this time but will go to an urgent care if condition worsens.
Age: 84.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site infection, Peripheral swelling
Clinical narrative: On 8/25 Patient was administered both Fluzone HD and Pneumovax 23 on left arm. On 8/26 she called to let us know her left arm was swollen. She was advised to contact her Dr. She saw her primary Dr. who told her the injection sites were infected. She was prescribed an antibiotic and ibuprofen. She called us 8/28 to inform us about the infection.
Age: 88.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: left arm is red, swollen, itchy and painful
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired vaccine. The vaccine expired on 8/2/20 and she received it in clinic on 8/24/20. No adverse reactions reported. Patient was notified and recommended to return to clinic in 4 weeks for titers. The rest of the vaccine stock was removed from the freezer.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, UNK, UNK, UNK, UNK
Symptoms: Blood test, Lumbar puncture, Meningitis pneumococcal, Pyrexia, Seizure
Clinical narrative: FEVER INITIATED ON DAY 6 AFTER VACCINES ADMINISTERED. HAD EVALUATION IN OFFICE ON DAY SEVEN, WHERE SEIZURE OCCURRED,  TRANSFERRED TO LOCAL ED, BY AMBULANCE , WHERE PNEUMOCOCCAL MENINGITIS WAS DIAGNOSED.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, UNK, UNK, UNK, UNK
Symptoms: Brain injury, Cochlea implant, Deafness, Developmental delay, Intensive care
Clinical narrative: FEVER INITIATED ON DAY 6 AFTER VACCINES ADMINISTERED. HAD EVALUATION IN OFFICE ON DAY SEVEN, WHERE SEIZURE OCCURRED,  TRANSFERRED TO LOCAL ED, BY AMBULANCE , WHERE PNEUMOCOCCAL MENINGITIS WAS DIAGNOSED.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, UNK, UNK, UNK, UNK
Symptoms: Laboratory test, Lethargy, Pyrexia, Sedative therapy, Seizure
Clinical narrative: FEVER INITIATED ON DAY 6 AFTER VACCINES ADMINISTERED. HAD EVALUATION IN OFFICE ON DAY SEVEN, WHERE SEIZURE OCCURRED,  TRANSFERRED TO LOCAL ED, BY AMBULANCE , WHERE PNEUMOCOCCAL MENINGITIS WAS DIAGNOSED.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5, UNK, UNK, UNK, UNK
Symptoms: Thrombosis, Ventricular drainage, Ventriculo-peritoneal shunt
Clinical narrative: FEVER INITIATED ON DAY 6 AFTER VACCINES ADMINISTERED. HAD EVALUATION IN OFFICE ON DAY SEVEN, WHERE SEIZURE OCCURRED,  TRANSFERRED TO LOCAL ED, BY AMBULANCE , WHERE PNEUMOCOCCAL MENINGITIS WAS DIAGNOSED.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Hypotonia, Malaise
Clinical narrative: About 6 minutes after the shot was administered my daughter was standing with me checking out of the medical clinic and suddenly felt "very thirsty" and then said, "Mama, I'm not feeling well. I am so dizzy," I looked at her and she looked very pale and scared and then leaned on me and suddenly she went limp and fainted. I called the nurse over to help me and then our doctor came running over to help my daughter. They were able to lay her down on the exam table and she came to within about a minute. She was sweating and very scared and feeling very sick. The doctor and nurse gave her crackers and water and took her blood pressure. She stayed there for about 15 minutes eating crackers, drinking water, and had a lollipop. She was still very scared but I was able to get her up and walking around and within a few more minutes we were able to leave the medical clinic.
Age: 13.0
Sex: F
Vaccine: IPV
Symptoms: Pallor, Syncope, Thirst
Clinical narrative: About 6 minutes after the shot was administered my daughter was standing with me checking out of the medical clinic and suddenly felt "very thirsty" and then said, "Mama, I'm not feeling well. I am so dizzy," I looked at her and she looked very pale and scared and then leaned on me and suddenly she went limp and fainted. I called the nurse over to help me and then our doctor came running over to help my daughter. They were able to lay her down on the exam table and she came to within about a minute. She was sweating and very scared and feeling very sick. The doctor and nurse gave her crackers and water and took her blood pressure. She stayed there for about 15 minutes eating crackers, drinking water, and had a lollipop. She was still very scared but I was able to get her up and walking around and within a few more minutes we were able to leave the medical clinic.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Nausea
Clinical narrative: Extreme pain at injection site 2.5 hrs after shot. Nausea, headache, general malaise for 2 days.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: patient stated the night after she received her injection the site where she received her injection felt like it was throbbing and it felt warm to touch, red and it felt like "an egg"
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored temperature excursion; This spontaneous report was received from a physician 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 therapies was provided.  On 05-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), dose: 1, lot # S020160, expiration date 30-JUN-2021 (exact dose and route of administration were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) dose: 1, lot # S038175, expiration date 26-NOV-2021 (exact dose and route of administration were not reported) for prophylaxis. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 50 degrees of F: from 6 degrees of F to 14 degrees of F (10 degrees of F) for 1 hour and 15 minutes, from 15 degrees of F to 46 degrees of F (44.8 degrees of F) for 1 hour and 30 minutes and from 47 degrees of F to 77 degrees of F (50 degrees of F) for 2 hours and 30 minutes. There was no previous temperature excursion reported.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one dose of expired and improperly stored PROQUAD was administered to a patient; one dose of expired and improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 3 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-AUG-2020, the patient was vaccinated with dose of expired and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) injection, subcutaneously, lot # S003868, expiration date 08-AUG-2020 (strength and dose were not reported) reconstituted in properly stored sterile diluent for prophylaxis.  On 04-AUG-2020, the dose of the vaccine was exposed to temperature excursion at -8.7 Celsius degrees (C) for 4 hours 30 minutes. The call was due to digital data logger. No additional adverse effect was reported.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Impaired work ability, Injection site pain, Pain, Pyrexia
Clinical narrative: Very sore arms, legs, and body the day after.  Rash on right arm and arm very tender next to where shot was given. Chills and fever 100.8  before i got up the next morning.  I did not go to work.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Very sore arms, legs, and body the day after.  Rash on right arm and arm very tender next to where shot was given. Chills and fever 100.8  before i got up the next morning.  I did not go to work.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Pain
Clinical narrative: moderate pain at site of injection,  malaise, body aches, sl. nausea.  pain persistent for several days, other symptoms subsided after 48 hours
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Oral herpes, Pruritus, Skin warm
Clinical narrative: I received a flu vaccine and immediately had itching on the arm i was injected. This spread down my arm and up my face on the side of injection. Area felts hot and itchy. The next morning I woke up with a cold sore, possible caused by the disruption to my immune system.  I only get a cold sore once every 8-10 years so it is not common for me. This was my first time receiving this vaccine.
Age: 78.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Rash
Clinical narrative: Patient reported a rash presented  to her left thigh  a day after the first Zoster shot (first shot given 6-19-2020) and patient did not report.  She was given a second shot on 8-26-2020 and a rash with bumps presented to her left thigh area.  She treated with hydrocortisone 0.1% topical cream and the rash is resolving..
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: injection given and patient almost immediately began feeling unwell, patient asked for some water and sat with mom. Patient then stated she was going to throw up and vomited.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site reaction, Myalgia, Nausea
Clinical narrative: Body aches, nausea, soreness in muscles at site of injection, headache, chills
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, nausea, soreness in muscles at site of injection, headache, chills
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 12 months old and given kinrix accidentally at 1 year well child check.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: At 8pm I developed a headache and slight stiff neck and didn't think much of it.  The next morning I woke up with a bad headache (which is unusual for me) , sore neck and slight chills.  I was out of commission the entire day.  No appetite, headache never really went away (it wasn't stabbing...more migraine) and I would feel a little dizzy/nauseaus when walking.  Never had a fever,cough, congestion.  Felt slightly better by bedtime.  On Thursday (I received shot on Tues, sick Wed) I felt pretty good most of the day but a little like I still had a touch of a flu.   At about 11pm I noticed a rash (flat, red, not itchy ) primarily on my right arm and left arm and some spots on legs and back.   I noticed my lip felt a little tingly but not bad.  My oxygen was fine, but my heart rate was a little high for just relaxing.  I took 2 Benadry at 11:30 and had no issues sleeping.  When I awoke at 4am to use the bathroom, I looked at my arms and they were almost clear....within minutes the rash reappeared.   I took one benadryl at 7am today and it seems the rash comes and goes but seems to be getting better.  My lips still feel a little tingly...almost like a windburn feel.   I have had hives twice in my lifetime but they were raised and itched.   I have never had a flu shot reaction prior to this (except getting a little sick a week or so later.)   I did call my Dr. s office and she was fine with just watching the symptoms unless they get worse.   I did not call the pharmacy.  Also, something I noticed was slight ear ringing and the joints in my fingers seem sore/stiff and sensitive to hot water.