chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Headache, Loss of consciousness, Nausea, Paraesthesia, Speech disorder
Clinical narrative: passed out; loss of hearing and vision; loss of hearing and vision; bad headache; tingling; difficulty to process words and thoughts and difficult to speak; difficulty to process words and thoughts and difficult to speak; Nausea; Slurred speech; was acting weird like she could not process her thoughts; This is a spontaneous report from a contactable consumer (mother). A female patient of unspecified age received meningococcal group b rlp2086 (TRUMENBA) on unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. Mother calls for information about for how long does the symptoms presented after the administration of the vaccine meningococcal group b rlp2086 will pass on patient. She reported that patient was administered today with the vaccine meningococcal group b rlp2086 and after 15 minutes of the administration the patient passed out, reporting a bad headache, tingling, loss of hearing and vision, difficulty to process words and thoughts and difficult to speak. She reported that the patient was administered with the vaccine on an empty stomach. She said that her daughter also had lost vision in one eye, was acting weird like she could not process her thoughts, and had slurred speech. She said that she called the physician back to ask them what they should do and they said to bring her back to the office so they could look at her. She said that she took her back to the doctor's office and her blood pressure was good and her daughter started feeling better and the vision in her eye was coming back. She said that her daughter took the vaccine on an empty stomach. She went to feed her and her daughter felt like she was going to throw up again. She told her daughter to eat and she got an extremely bad headache. She said that her daughter was trying to text and her daughter could not get her words to keep up with her texts. She took her daughter to the hospital and it was really busy so they left and her daughter is currently laying down with her head in her lap. She said that her daughter's symptoms started with nausea. The outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Thinking abnormal, Vomiting
Clinical narrative: passed out; loss of hearing and vision; loss of hearing and vision; bad headache; tingling; difficulty to process words and thoughts and difficult to speak; difficulty to process words and thoughts and difficult to speak; Nausea; Slurred speech; was acting weird like she could not process her thoughts; This is a spontaneous report from a contactable consumer (mother). A female patient of unspecified age received meningococcal group b rlp2086 (TRUMENBA) on unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. Mother calls for information about for how long does the symptoms presented after the administration of the vaccine meningococcal group b rlp2086 will pass on patient. She reported that patient was administered today with the vaccine meningococcal group b rlp2086 and after 15 minutes of the administration the patient passed out, reporting a bad headache, tingling, loss of hearing and vision, difficulty to process words and thoughts and difficult to speak. She reported that the patient was administered with the vaccine on an empty stomach. She said that her daughter also had lost vision in one eye, was acting weird like she could not process her thoughts, and had slurred speech. She said that she called the physician back to ask them what they should do and they said to bring her back to the office so they could look at her. She said that she took her back to the doctor's office and her blood pressure was good and her daughter started feeling better and the vision in her eye was coming back. She said that her daughter took the vaccine on an empty stomach. She went to feed her and her daughter felt like she was going to throw up again. She told her daughter to eat and she got an extremely bad headache. She said that her daughter was trying to text and her daughter could not get her words to keep up with her texts. She took her daughter to the hospital and it was really busy so they left and her daughter is currently laying down with her head in her lap. She said that her daughter's symptoms started with nausea. The outcome of events was unknown.  Information about batch/lot number has been requested.
Age: 27.0
Sex: M
Vaccine: HEPAB, HIBV, IPV, MNQ, PNC13, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: The Meningococcal Conjugate vaccine that I administered was 11 days expired (5/31/2020) when I gave it. I did not catch this error until I had begun charting, at which point, I took the following steps:  1. Assessed client for any adverse effects and monitored closely for 10 minutes. 2. Made client aware of situation and informed them of steps I would take to rectify the situation. 3. Promptly alerted supervisory staff.   Client stated that he felt fine and did not appear to be experiencing any adverse effects, so I allowed him to leave the clinic with the understanding that if anything changed, he should contact me immediately.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Altered state of consciousness, Dizziness, Dysarthria, Electrocardiogram, Heart rate decreased
Clinical narrative: About 5 minutes after administration patient began feeling dizziness like she was going to pass out, sweats, blurred vision, ears ringing, bilateral hands tingling, lethargic, slurred speech, color pale. Vitals were monitor, pulse low, BP not reading, 911 was called. cool compresses were applied to patient neck. Within 25 minutes patients symptoms began improving more responsive, speech normal, color normal, BP and pulse WNL.  Paramedics evaluated patient for stability and was clear to return home
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Hyporesponsive to stimuli, Lethargy, Pallor, Paraesthesia
Clinical narrative: About 5 minutes after administration patient began feeling dizziness like she was going to pass out, sweats, blurred vision, ears ringing, bilateral hands tingling, lethargic, slurred speech, color pale. Vitals were monitor, pulse low, BP not reading, 911 was called. cool compresses were applied to patient neck. Within 25 minutes patients symptoms began improving more responsive, speech normal, color normal, BP and pulse WNL.  Paramedics evaluated patient for stability and was clear to return home
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus, Vision blurred
Clinical narrative: About 5 minutes after administration patient began feeling dizziness like she was going to pass out, sweats, blurred vision, ears ringing, bilateral hands tingling, lethargic, slurred speech, color pale. Vitals were monitor, pulse low, BP not reading, 911 was called. cool compresses were applied to patient neck. Within 25 minutes patients symptoms began improving more responsive, speech normal, color normal, BP and pulse WNL.  Paramedics evaluated patient for stability and was clear to return home
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Rash
Clinical narrative: patient presented with a large rash. it extended down interior and exterior portions of right arm. It occured on the day of the vaccine. Patients rash also extended from the injection site about 8 to 9 inches down bilaterally.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: The morning following administration, patient developed hives, which progressively worsened over 16 hours.  Treated in the ER with IV steroid, antihistamine and H2 blocker.  Now on oral steroid, antihistamine and H2 blocker with symptoms that come and go.  No oral mucosal involvement or joint pains.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Right shoulder/neck/arm/finger pain and numbness.  Pain has been constant since the injection.  minor relief using acetaminophen 600 mg  and/or ibuprofen 600 mg .
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided.      On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S035108, with an expiration date in 03-MAY-2021), that underwent a temperature excursion of 7.9 degrees Fahrenheit, during a time frame of 1 hour an 8 minutes, for prophylaxis (strength, dose and route were not provided). The diluent used for administration of the dose was properly stored. Digital data logger was involved, however it was reported that there was no previous temperature excursion. The patient experienced no symptoms.
Age: 20.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional adverse effects reported; patient was administered improperly stored M-M-R II; This spontaneous report was received from a nurse and refers to a 20 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 08-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S010706 and expiration date 08-APR-2021 for prophylaxis (dose strength, frequency and route of administration were not provided). The vaccine was reconstituted with properly stored sterile diluent, lot# R006906 and expiration date 18-DEC-2020.     It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had a temperature excursion above 47°F: 58 F for 1 hour. No previous temperature excursions were reported. Digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This spontaneous report was received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 13-MAR-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient experienced herpes zoster.     As a direct and proximate result Plaintiff had 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. The outcome of herpes zoster was assessed as not recovered. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: did not feel well; This case was reported by a consumer via call center representative and described the occurrence of malaise 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, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Caller reports that she received her first Shingrix shot 2 weeks after a flu shot, she did not feel very well after her first Shingrix shot.  On 2nd June 2020, the patient received 2nd dose of Shingrix. The reporter did not consent to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: several patients already exceeded the 6 month recommended schedule; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the several patients already exceeded the 6 month recommended schedule from 2nd dose for Shingrix due to COVID 19. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discomfort, Herpes zoster, Pain, Paraesthesia
Clinical narrative: Patient had a reactivation of herpes zoster on the face. She had tingling off and on on the right side of face after the first dose 5 months ago.  After the second dose she awoke the next day with painful grouped blisters on the right lateral cheek and right side of glabella and discomfort in the right er.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Immediate post-injection reaction, Pyrexia, Rash, Swelling, Urticaria
Clinical narrative: DTAP + IPV given on 06/01/2020 @ 11am, fever spike next day, welt on lower right corner under mouth, 2 days after injection, a small light colored rash appeared . Injection given on the right leg. Called doctor, facetimed as well, said it was normal, give Benadryl 5ml, and if it got worse to call back.  MMR-V given on 06/10/2020 @ 11am, swelling and a welt immediately after. Swelling started to go down a little, then on 06/12/2020 burn looking type rash appeared and had spread. Welt never went away. Contacted doctor, they said it was normal and to do a cold compress, and if it got worse to call back. Injection give on left leg.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Headache, Nausea, Pain in extremity
Clinical narrative: This morning after having received my second dose of Zoster yesterday, I felt nauseous, dizzy, hot (I was dripping with perspiration) then got a head ache. I have rested much of the day. My arm has been sore. These are among the common reactions. The first one only caused soreness.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Affect lability, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Day after vaccination, patient reports fever, chills, body ache, malaise, nausea, vomiting, headache, fatigue, mood swings with emotional lability. Pain with movement of right arm especially with flexion of deltoid, tenderness near triceps. Admits to sensitivity apparent skin follicles with his body aches. Increased hours of sleep totaling 50-60 hours in the last 3 days. Right arm has even erythema spanning across entire area where deltoid would sit. Hardness and tenderness palpated on upper aspect of deltoid. No open sores or discernment of insertion site. Denies pruritis, urticaria, difficulty breathing, coughing, wheezing, dizziness or loss of consciousness.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Malaise, Mood swings
Clinical narrative: Day after vaccination, patient reports fever, chills, body ache, malaise, nausea, vomiting, headache, fatigue, mood swings with emotional lability. Pain with movement of right arm especially with flexion of deltoid, tenderness near triceps. Admits to sensitivity apparent skin follicles with his body aches. Increased hours of sleep totaling 50-60 hours in the last 3 days. Right arm has even erythema spanning across entire area where deltoid would sit. Hardness and tenderness palpated on upper aspect of deltoid. No open sores or discernment of insertion site. Denies pruritis, urticaria, difficulty breathing, coughing, wheezing, dizziness or loss of consciousness.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Day after vaccination, patient reports fever, chills, body ache, malaise, nausea, vomiting, headache, fatigue, mood swings with emotional lability. Pain with movement of right arm especially with flexion of deltoid, tenderness near triceps. Admits to sensitivity apparent skin follicles with his body aches. Increased hours of sleep totaling 50-60 hours in the last 3 days. Right arm has even erythema spanning across entire area where deltoid would sit. Hardness and tenderness palpated on upper aspect of deltoid. No open sores or discernment of insertion site. Denies pruritis, urticaria, difficulty breathing, coughing, wheezing, dizziness or loss of consciousness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Injection site warmth, Pain in extremity
Clinical narrative: chills, warm injection site, diarrhea, sore arm - patient is resting at home
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pigmentation disorder, Skin exfoliation
Clinical narrative: Reported reaction much later than dose. Per Patient arem was initially sore- but not like the whole deltoid she says just "one little spot". Area initianlly red a flakey then darker pigment. Now light pink scar of 14mm x 17mm. She does not describe it in a manner consistent with cellulitis or allergic reaction. Told her to get preservative free next year.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Blood glucose normal, Culture urine, Insomnia, Lethargy, Protein urine present
Clinical narrative: Mom reported:  Difficulty going to sleep last night-restless for 2 hours from the time mother started putting patient to bed Patient woke this morning extremely lethargic, unable to stay awake.  Patient seemed to be breathing rapidly Patient vomited 3 times yesterday
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Respiratory rate increased, Restlessness, Somnolence, Urine ketone body present, Vomiting
Clinical narrative: Mom reported:  Difficulty going to sleep last night-restless for 2 hours from the time mother started putting patient to bed Patient woke this morning extremely lethargic, unable to stay awake.  Patient seemed to be breathing rapidly Patient vomited 3 times yesterday
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Erythematous hot indurated reaction at site of injection on R upper thigh presented 48 hours after injection and grew 10 x8cm . The site was painful, but itchy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient developed hives all over the body by the next morning
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Pt. may have been given an expired vaccine. Sibling also vaccinated at the same time. Unable to know who got what vaccine
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever of 103 chills body aches pain in legs and arms started at 3:00am the day after she received vaccine.  At noon on the day after vaccine a rash appeared on her leg which her dr diagnosed as shingles.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: fever of 103 chills body aches pain in legs and arms started at 3:00am the day after she received vaccine.  At noon on the day after vaccine a rash appeared on her leg which her dr diagnosed as shingles.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: patient had redness stated few hours after vaccine and was worsening over time, he had to go ER and his provider prescribed  Keflex 500, and anit-histamin . Patient will be monitered for further symptoms.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: 6-8 hours after injection, patient complained of 10/10 pain at injection site and R upper arm, with nearly circumferential erythema, swelling, and induration around bicep region. He was febrile to 39.1C R axilla and 38C L axilla at the time. Pain on adduction of shoulder, flexion of elbow, and flexion of wrist. Neurovascularly intact distal to affected area. Patient was treated with multiple doses of diphenhydramine, acetaminophen, and ibuprofen. Swelling began to slowly subside after 24 hours, though remained intensely tender to palpation.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: 6-8 hours after injection, patient complained of 10/10 pain at injection site and R upper arm, with nearly circumferential erythema, swelling, and induration around bicep region. He was febrile to 39.1C R axilla and 38C L axilla at the time. Pain on adduction of shoulder, flexion of elbow, and flexion of wrist. Neurovascularly intact distal to affected area. Patient was treated with multiple doses of diphenhydramine, acetaminophen, and ibuprofen. Swelling began to slowly subside after 24 hours, though remained intensely tender to palpation.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient may have been given an expired vaccine. Sibling was vaccinated at the same time, no way of knowing who got the expired vaccine.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain, redness and swelling at injection site
Age: 5.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was administered the Tdap vaccine instead of the DTaP that was supposed to be given as age appropriate.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: Pt reports L arm pain and numbness, extending down to 4th and 5th finger, weakness in hand earlier today upon waking. No current numbness/weakness, resolved this AM. Now having mainly deltoid pain, especially with raising arm
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperventilation, Laboratory test, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: Patient was sitting in a chair when all of a sudden her hands became twisted, her wrists wrapped around each other, and she became unconscious.  Her legs went straight out and body became rigid in a prone position.  Her head went back and her breathing became very deep (rattling sound).  Seizure began and estimated to last between 2.5 to 3 minutes.  Then patient became conscious again and had no recollection of event other than headache (patient unsure if she had headache prior to seizure or not).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle rigidity, Posture abnormal, Seizure
Clinical narrative: Patient was sitting in a chair when all of a sudden her hands became twisted, her wrists wrapped around each other, and she became unconscious.  Her legs went straight out and body became rigid in a prone position.  Her head went back and her breathing became very deep (rattling sound).  Seizure began and estimated to last between 2.5 to 3 minutes.  Then patient became conscious again and had no recollection of event other than headache (patient unsure if she had headache prior to seizure or not).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Blood test, Burning sensation, Catheterisation cardiac, Computerised tomogram
Clinical narrative: Patient got 2nd shot 5/21 and prescription filled for cipro (5/22-pm). About 10 minutes after ingesting the cipro, he started having aggressive strange pains throughout the body, nerve endings felt like on fire. Haited till next morning and had to be admitted to hospital.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram, Neuralgia, Pain, Urine analysis
Clinical narrative: Patient got 2nd shot 5/21 and prescription filled for cipro (5/22-pm). About 10 minutes after ingesting the cipro, he started having aggressive strange pains throughout the body, nerve endings felt like on fire. Haited till next morning and had to be admitted to hospital.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Progress Notes PA-C (Physician Assistant) ? ? PA Medical ? ? 6/12/2020  9:42 AM ? ? Signed   I stepped in to see left upper arm.  Had PPSV23 a week ago in left arm.  She has no allergy to anything.  Never had any issues with vaccinations in past.    Moderate edema in lower upper left arm, more medial, noticeable from walking into the room. Mild redness and does feel warmer than other skin on left and right arm.  Had 2+ Bicep reflex in both arms on exam  Grip strength is 4/5 B.  Can flex and extend left elbow joint as well as pronation and supination.  Unable to reach away from her body.  She reports her left upper arm and even posterior shoulder last week after injection was swollen, which is not now.    Recommend starting keflex 500mg QID x 7 days.  Can use warm compresses to arm.  Will see her back in a week or sooner if sx's worsen.  If her ROM is still decreased at that time, ortho consult recommended, or trail of prednisone? Will consult with PharmD, CDE, BC-ADM      I spoke with PharmD, CDE, BC-ADM about the above.  Agrees with plan, certainly atypical.  Lets see how she does with this plan and if not better in a week, can do prednisone with close eye on INR.  May also need to report this vaccination adverse reaction.
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: 4" area of erythema Inj site
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Red, raised site reaction, hives on arms and legs. Occurred 2-3 days after vaccine. Started antihistamine on day 5 to help itching
Age: 1.33
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse event reported; The pharmacy student stated that on 6/2/2020, the patient was inadvertently administered properly stored PROQUAD (S0l 7244, 2/1/2020) along with three other properly stored vaccines: VARIVAX; This spontaneous report was received from a pharmacy student, referring to a 16-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 02-JUN-2020, the patient was inadvertently administered with a properly stored doses of mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number S017244, which has been verified to be valid, expiration date reported and valid as 01-DEC-2020); varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S025612, which has been verified to be valid, expiration date reported and valid as 18-AUG-2021); and concomitantly vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number S036823, which has been verified to be valid, expiration date and reported as 31-MAR-2022) as prophylaxis; and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (indication, lot number AW5491 and expiration date on an unspecified day in December 2021) (dose, vaccination scheme and anatomical site of vaccination, were not reported for any of the vaccines) as prophylaxis (inappropriate schedule of vaccine administered). A properly stored sterile diluent (MERCK STERILE DILUENT) was used to reconstitute mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse event were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; On 01-JUN-2020 a patient was administered an improperly stored dose of M-M-R II.; This spontaneous report was received from an administrator, referring to a patient of unknown gender and age. The patient's concurrent conditions, pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not provided.  On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (dosage schedule, vaccination scheme, route of administration, and anatomical site of vaccination were not reported; lot number S014430 has been verified to be a valid lot number, expiration date reported and validated as 09-MAY-2021) as prophylaxis (product storage error).  According to the reporter, the administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) experienced a temperature excursion during a timeframe of 20 hours. Furthermore, it was reported that, the temperature to evaluate the storage vaccine was unknown by reporter. No previous temperature excursion was reported. Additionally, a data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around August 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX), for its intended purpose of preventing shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In or arounf July 2018, the pt was diagnosed with shingles by a physician. The pt's outbreak lasted several weeks and caused severe pain and suffering. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. As a result of using zoster vaccine live (ZOSTAVAX), the pt suffered serious, severe, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt also claimed to have incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The reported event was considered to be not recovered, and related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Painful, itchy rash on her lower back; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or about February 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy as recommended for routine adult health maintenance and for its intended purpose: the prevention of shingles (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as soon after receiving the vaccine), the patient began experiencing a painful, itchy rash on her lower back. Initially, she felt that the rash could be poison oak and she treated the rash with medications at home. The patient's rash seemed to improve with home treatment and then would reoccur almost immediately. Therefore, she spoke to her primary care provider regarding the recurring rash and she was instructed to return to the office immediately during the next rash outbreak. In or around July 2013, the patient visited the physician and was immediately diagnosed with shingles (herpes zoster). During an outbreak, the patient's shingles rash would last several weeks and causes severe pain, suffering and mental anguish. At the reporting time, the patient continued to have shingles outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition. In addition, the patient sustained severe and permanent personal injuries. Further, the patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, she had incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of herpes zoster was not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster was considered a disabling event by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: The patient suffered an outbreak of shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for it intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered on outbreak of shingles (herpes zoster). As a result of these symptoms, the pt was seen and treated by medical providers and at the reporting time, she was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. In addition, the pt sustained severe and permanent personal injuries; and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of this report, the pt was not recovered from herpes zoster. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered a disabling event by the reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis, MD prescribed Cefdinir 300mg 2qd
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Injection site pain, Muscle twitching
Clinical narrative: 1:00 AM Started with elevated body temperature, didn?t take temperature but felt very warm/hot while trying to sleep. Chills followed and also overall body soreness. Some body twitches located in chest abdominal area. Headache also occurred throughout duration and continues this morning (vaccination was yesterday afternoon), general soreness also continues. Area of injection is tender, feels bruised.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 1:00 AM Started with elevated body temperature, didn?t take temperature but felt very warm/hot while trying to sleep. Chills followed and also overall body soreness. Some body twitches located in chest abdominal area. Headache also occurred throughout duration and continues this morning (vaccination was yesterday afternoon), general soreness also continues. Area of injection is tender, feels bruised.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Early morning June 12 after getting the shot on June 11: I had Nausea, headache, shivering, extreme tiredness, sore arm up to my neck. I had the shot Thursday June 11 and felt too sick to work on Friday June 12 or do any activity. It is now Saturday June 13 and I still have headache, a little nausea, sore arm, and tiredness.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Early morning June 12 after getting the shot on June 11: I had Nausea, headache, shivering, extreme tiredness, sore arm up to my neck. I had the shot Thursday June 11 and felt too sick to work on Friday June 12 or do any activity. It is now Saturday June 13 and I still have headache, a little nausea, sore arm, and tiredness.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Early morning June 12 after getting the shot on June 11: I had Nausea, headache, shivering, extreme tiredness, sore arm up to my neck. I had the shot Thursday June 11 and felt too sick to work on Friday June 12 or do any activity. It is now Saturday June 13 and I still have headache, a little nausea, sore arm, and tiredness.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Early morning June 12 after getting the shot on June 11: I had Nausea, headache, shivering, extreme tiredness, sore arm up to my neck. I had the shot Thursday June 11 and felt too sick to work on Friday June 12 or do any activity. It is now Saturday June 13 and I still have headache, a little nausea, sore arm, and tiredness.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Shivers, nausea, back pain, arm pain, fever
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient called the day after receiving the vaccine and reported a fever of 101 degrees. Provided OTC recommendations to control fever and encouraged patient to reach out to primary care physician and pharmacy if fever continues. Followed up with patient in the afternoon after the fever was reported, and she reported that the fever had subsided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Nausea, Pain, Pyrexia
Clinical narrative: Diffuse Aches & Pains starting same day as vaccination, still present at time of reporting on 6/12. Nausea, Headache, moderate to severe still present at time of reporting. low-grade fever (self reported as high 99's on 6/9) resolved as of 6/9. Hand numbness on injection arm starting from the morning after injection (6/9) and resolving by the next day (6/10).
Age: 27.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site reaction, Syncope
Clinical narrative: Pt was given both shots on the same day, Varivax in left arm and Boostrix in right arm.. Patient fainted after second shot. Called the next day to report injection site reaction on left arm (Varivax).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Pain at injection site (0.5 hr after administration) , 5 hours later severe stomach cramp, nausea and urge to vomit (dry heaving), intense perspiration, almost blackout with tingling in both arms. 12 hrs later fever and shivers, general malaise. 24 hrs later muscle ache, headache. After about 36 hours gradual recovery. Thank you
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Pain at injection site (0.5 hr after administration) , 5 hours later severe stomach cramp, nausea and urge to vomit (dry heaving), intense perspiration, almost blackout with tingling in both arms. 12 hrs later fever and shivers, general malaise. 24 hrs later muscle ache, headache. After about 36 hours gradual recovery. Thank you
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: Pain at injection site (0.5 hr after administration) , 5 hours later severe stomach cramp, nausea and urge to vomit (dry heaving), intense perspiration, almost blackout with tingling in both arms. 12 hrs later fever and shivers, general malaise. 24 hrs later muscle ache, headache. After about 36 hours gradual recovery. Thank you
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Myalgia, Nausea, Pain in extremity
Clinical narrative: Weakness, muscle pain, soreness of the left arm, minor nausea and minor upset stomach.
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Emotional distress, Eye swelling, Injection site rash, Opisthotonus, Pyrexia
Clinical narrative: Inconsolable screaming for 9 days, fever, eye swelling, small rash on left thigh, back arching,
Age: 0.75
Sex: F
Vaccine: PNC13
Symptoms: Screaming
Clinical narrative: Inconsolable screaming for 9 days, fever, eye swelling, small rash on left thigh, back arching,
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Very red and big swelling in area
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection Site got red, hot and is swollen. The area has grown in 2 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Body aches, chills, nausea, headache and tired from 12p 6/11/2020 - 9a 6/12/2020. Diarrhea 6p - 12a 6/12/2020. Took tylenol and mobic on 6/11/2020
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, chills, nausea, headache and tired from 12p 6/11/2020 - 9a 6/12/2020. Diarrhea 6p - 12a 6/12/2020. Took tylenol and mobic on 6/11/2020
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever 101.5, BP 99/50, HR 112, headache, nausea, myalgia, chills, abdominal pain.  It has now been 2 days and I expect I will have to miss work tomorrow.  If I had realized how severe the side effects would be I would not have had the vaccination.  I will not be having the second dose.  As a physician I will encourage patients to consider whether the benefits justify tolerating the potential side effects.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101.5, BP 99/50, HR 112, headache, nausea, myalgia, chills, abdominal pain.  It has now been 2 days and I expect I will have to miss work tomorrow.  If I had realized how severe the side effects would be I would not have had the vaccination.  I will not be having the second dose.  As a physician I will encourage patients to consider whether the benefits justify tolerating the potential side effects.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Itchiness at site of injection for last two days
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: Red skin outbreak below the injection site  (hives?) (shingles outbreak?)
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pain
Clinical narrative: adverse events: sore around vaccination site, body aches (even toes), shivering, fever, tired, nausea, light-headed treatment: acetaminophen events went away on their own after  about 36 hours
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: adverse events: sore around vaccination site, body aches (even toes), shivering, fever, tired, nausea, light-headed treatment: acetaminophen events went away on their own after  about 36 hours
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: SHINGRIX WAS ADMINISTERED 22 DAYS AFTER THE FIRST DOSE.  THIS IS DOSE IS CONSIDERED INVALID AND HAS TO BE REPEATED.  THE PATIENT HAS REPORTED NO ADVERSE SIDE EFFECTS.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccine site became red 6/13/2020 at  2:00 pm the day of the injection, but not itching and then redness went away. This morning 6/14/2020, the area was sore  to move arm and to touch.  At 9:00 am site was not red or itching.  6/14/2020 at 2:00 pm Employee has 2 inch by 1 1/2 inch raised red area with a knot in the center, that is warm to touch and itches.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth, Pain
Clinical narrative: Vaccine site became red 6/13/2020 at  2:00 pm the day of the injection, but not itching and then redness went away. This morning 6/14/2020, the area was sore  to move arm and to touch.  At 9:00 am site was not red or itching.  6/14/2020 at 2:00 pm Employee has 2 inch by 1 1/2 inch raised red area with a knot in the center, that is warm to touch and itches.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Within 24 hours of vaccination, patient experienced fever, nausea, and headache. This lasted for approximately 36-48 hours. Patient returned to symptom free state at approximately 48 hours from time of vaccination.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient reported she  first noticed symptoms the morning after the immunization (approximately 8am). Initial symptoms were red splotches around the injection site and slight soreness. The next day symptoms had advanced to a red circular raised area,  was hard/firm to the touch, and continued soreness to the affected area. The patient stated the area was "the size of a half dollar. Patient reports no other signs or symptoms.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Rash macular
Clinical narrative: Patient reported she  first noticed symptoms the morning after the immunization (approximately 8am). Initial symptoms were red splotches around the injection site and slight soreness. The next day symptoms had advanced to a red circular raised area,  was hard/firm to the touch, and continued soreness to the affected area. The patient stated the area was "the size of a half dollar. Patient reports no other signs or symptoms.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Musculoskeletal pain, Pain, Peripheral swelling
Clinical narrative: Approx 6:30 PM, felt swelling in arm and hardness in arm. Soreness in shoulder blade area. Could not lift arm without pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Pain at injection site.  Dizziness & shivers.  Slight fever.  Fatigue
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: fatigue, headache, shivering, nausea, vomiting, fever, myalgia
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: fatigue, headache, shivering, nausea, vomiting, fever, myalgia