chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Posture abnormal
Clinical narrative: Vaccine administered at 5:38 pm without any prior issues, patient sitting in chair. After 1 minute she asks if she can sit for a while. I respond yes and ask if she is ok. She responds "yes, this happens sometimes, it didn't happen the last time though."  5:40 pm  I offered her water, handed it to her at which time she falls into a slump, becomes diaphoretic,  leans her head back against the wall, closes her eyes, water bottle falls and she clinches her fists and moans.  I support her head against my chest and inform her that she is ok. After 30 seconds she arouses at which time I call my assistant for help.  Apply cool compresses to her neck and head. BP is 100/48 and oxygen is 100%.  After an additional 1-2 minutes she asks if she can move to the exam table to lie down.  We allow her to stand, no symptoms, she takes a few step to the exam table and proceeds to sit of the exam table when she becomes limp and is placed back in the chair.  She becomes diaphoretic but remains alert. 5:55 pm  BP 102/62, oxygen 100%.  Patient provided water to drink.  After 1-2 minutes she transfers to the exam table without incident, legs elevated, drinks water with cool compresses.  Patient remains alert and she is monitored. 6:20 pm BP 123/70 oxygen 100%  patient is alert and oriented x 3 and stable, she is able to stand and walk around the room without incident.  Patient remains in the waiting area for an addition 15 minutes before being discharged
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, International normalised ratio increased, Limb discomfort, Malaise, Mental impairment
Clinical narrative: The second shot of shingles was a bad "trip". I got the shot Saturday at noon time. By 7pm, I was not well, but I blame myself and my pushing myself with skiing. Two hours after, I realized that the book had fallen on the floor, so I decided to go to bed. By Sunday 2 a.m., I woke with my left arm hurting and heavy, my neck was very stiff, my jaw was not really opening. The right side felt better. I went to the bathroom, thinking get dress, call 911 I am having a heart attack. Curios, my heart was functioning as always. Finally, I observed the bandage on my right arm, and I told myself "No, no heart attack, shingles vaccine". I couldn't sleep, not I was awake. I walked my house back and for. I tried to drink coffee and my body rejected it. I drank seltzer water with orange or cranberry juice. Eating was an issue because my body rejected any solid food and my jaw was not chewing. I had to cut a phone conversation because my left jaw started to act out painfully. I was not able to read or watch TV. I cancelled a dinner appointment. Finally, I laid down on my bed about 8 pm, and woke up Monday at 7 a.m. As you know, I never sleep so many hours. I feel better today. I venture out to do driving errands. Last note: CDC requested to pass this information to my physician for her/him to send it to CDC. It there is a next time, I will do this shot with someone at my house. Really, my brain was functioning poorly  Another consequence of the shingles vaccine, my INR 4.5 today. I absolutely believe that it is the shingles vaccine not my diet. Please, pass this info to Dr. Warfarin is a tough medicine to deal with it.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pain in jaw, Trismus
Clinical narrative: The second shot of shingles was a bad "trip". I got the shot Saturday at noon time. By 7pm, I was not well, but I blame myself and my pushing myself with skiing. Two hours after, I realized that the book had fallen on the floor, so I decided to go to bed. By Sunday 2 a.m., I woke with my left arm hurting and heavy, my neck was very stiff, my jaw was not really opening. The right side felt better. I went to the bathroom, thinking get dress, call 911 I am having a heart attack. Curios, my heart was functioning as always. Finally, I observed the bandage on my right arm, and I told myself "No, no heart attack, shingles vaccine". I couldn't sleep, not I was awake. I walked my house back and for. I tried to drink coffee and my body rejected it. I drank seltzer water with orange or cranberry juice. Eating was an issue because my body rejected any solid food and my jaw was not chewing. I had to cut a phone conversation because my left jaw started to act out painfully. I was not able to read or watch TV. I cancelled a dinner appointment. Finally, I laid down on my bed about 8 pm, and woke up Monday at 7 a.m. As you know, I never sleep so many hours. I feel better today. I venture out to do driving errands. Last note: CDC requested to pass this information to my physician for her/him to send it to CDC. It there is a next time, I will do this shot with someone at my house. Really, my brain was functioning poorly  Another consequence of the shingles vaccine, my INR 4.5 today. I absolutely believe that it is the shingles vaccine not my diet. Please, pass this info to Dr. Warfarin is a tough medicine to deal with it.
Age: 35.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Limb discomfort, Wrong product administered
Clinical narrative: Patient given Varicella instead of MMR as requested. Patient has complaint of red, itchy sore arm.
Age: 60.0
Sex: M
Vaccine: MENB
Symptoms: Injection site mass
Clinical narrative: Patient received Bexero injection 1 month ago and still has a lump in left arm. It may have been from administration error. Where the patient was pointing was right below the deltoid muscle.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received the Shingrix Zoster vaccine and the next day had pain, swelling, and redness in/near the location of the shot.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: Long-lasting (well over 48 hours) feeling of debilitation after receiving shingles vaccine.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: patient to receive Shingrix vaccine. After RN re-constituted vial and drew up the reconstituted vial, she noted she only ad 0.2ml and it should be 0.5ml.
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle spasms, Pain in extremity
Clinical narrative: Patient had arm pain and muscle spasms/ problems lifting arm over head post vaccination.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Influenza like illness, Myalgia
Clinical narrative: Shingrix shot. Both times. Muscle pain and flu like symptoms that started 12 hours after shot and lasted 24 hours. Very uncomfortable but took Tylenol and discomfort reduced somewhat.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Arthralgia
Clinical narrative: SERIOUS REACTION TO FLU VACCINE PT WITH NO JOINT PAINS PRIOR TO 9/27/19. ON 9/27/19, SHE RECEIVED FLU SHOT. 5-7 DAYS AFTER FLU SHOT SHE DEVELOPED ARTHRALGIAS, WHICH HAVE BEEN PERSISTENT & PROGESSIVE OVER FOLLOWING MONTHS. NOW HAS SEVERE JOINT PAINS AND TESTING SHOWS (+) ANA, (+) SSB, (+) SCL-70. SHE NOW HAS A RHEUMATOLOGIC CONDITION WHICH WAS CAUSED BY HER FLU SHOT. SHE HAD NO PREVIOUS HISTORY, OR PRIOR SIGNS OR SYMPTOMS, OF ANY RHEUMATOLOGIC CONDITION.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was inadvertently administrated a dose of VARIVAX on 12/5/2019, that had been improperly stored; No additional adverse effect reported; This spontaneous report has been received from a vaccine coordinator who is also an office manager, referring to a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 05-DEC-2019, the patient received improperly stores vaccine of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 1 dosage form, lot number S021926, expiration date on 15-JUL-2021 (concentration, frequency, route of administration, and anatomical location were not provided) as prophylaxis; that was reconstituted with a properly stored sterile diluent. No adverse events were reported. Additionally, it was reported that the vaccine experienced a temperature of 1.2°C degrees Celsius, for 3 hours and 9 minutes, the temperature was recorded by a data logger. The was not previous temperature excursion reported.   The outcome of the event was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: on 12/18/2019 a dose of improperly stored PROQUAD was administered to a patient; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, and previous drug reactions and allergies were not provided. The sterile diluent (MERCK STERILE DILUENT) was considered a concomitant medication.  On 18-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Therapy type: rHA), at a dose of 0.5 milliliters (ml), lot number R017800 and expiration date 19-DEC-2019 for prophylaxis (strength, frequency, route of administration, and anatomical location was not provided). The sterile diluent (MERCK STERILE DILUENT) was properly stored.  The vaccine was stored at a temperature of -12.2 Celsius for a timeframe of 25 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, and previous drug reactions and allergies were not provided. The sterile diluent (MERCK STERILE DILUENT) was considered a concomitant therapy.  On 10-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy type: rHA), lot number S006833 and expiration date 02-SEP-2020 for prophylaxis. (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided). The sterile diluent (MERCK STERILE DILUENT) was reported to be properly stored.  The vaccine was stored at 6 degree Fahrenheit to 14 degree Fahrenheit (7.2 Fahrenheit) for a timeframe of 25 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: mother of the patient believes the patient inadvertently received the "wrong vaccinations"; This spontaneous report was received from a medical assistant, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.  According to the medical assistant, the patient's mother believed that on 13-NOV-2019, the patient was inadvertently vaccinated with a dose of hepatitis b vaccine (recombinant) (thimerosal free)(RECOMBIVAX HB) lot number R021372 expiration date 25-MAY-2021, as prophylaxis (strength, vaccination regimen and route of administration were not provided).  The patient's mother believed the patient inadvertently received the wrong vaccinations (wrong product administered) on 13-NOV-2019; she believed that the vaccinations administered were intended for her younger child. However, the medical assistant reported that the patient was supposed to receive doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); varicella virus vaccine live (oka/merck) (VARIVAX); and hepatitis a vaccine, inactivated (VAQTA) (strength, dose, vaccination regimen, route of administration, lot numbers, and expiration dates were not provided) which, according to their documentation, were indeed administered to the patient on that same date as prophylaxis. It was reported by the medical assistant that the patient's mother had a history of post-partum depression.  At the time of this report, the outcome of wrong product administered was unknown.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; The patient was inadvertently administered an expired dose of properly stored MMR II; This spontaneous report was received from a medical assistant referring to a 41 year old female patient. Information on the patient's medical history and concurrent conditions were not reported. On 28-JAN-2020, the patient was inadvertently administered an expired dose of properly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin)(M-M-R II) (strength, dose details, route, indication and anatomical location were not reported) of lot # N027782 and expiration date:16-AUG-2019 (expired product administered) which was reconstituted with properly stored sterile diluent (manufacturer unknown). The patient did not experience any additional adverse effects.
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; Information has been received from a lawyer referring to a 65 year-old male patient (pt) regarding a case in litigation. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 20-OCT-2017, the pt was administered zoster vaccine live (ZOSTAVAX) vaccine at a local pharmacy by a pharmacist for the long-term prevention of shingles and zoster-related conditions.        On 23-APR-2018, 6 months 4 days after vaccination, the pt was treated and diagnosed with pneumonia. At the reporting time, the outcome of pneumonia was unknown and this event was considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, pneumonia was considered a medically significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Eye injury, Retinal detachment, Surgery, Vision blurred
Clinical narrative: vision loss; blurred vision/retinal detachment; eye injuries; 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 concurrent conditions, medical history, or concomitant medications.  On 30-MAY-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided). Approximately in September 2017, reported as within four to five months after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe eye injuries, blurred vision, vision loss and retinal detachment resulting in extensive medical treatment and several procedures and surgeries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries, emotional injuries and loss of consortium. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events of severe eye injuries, vision loss and retinal detachment was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of severe eye injuries, vision loss and retinal detachment were considered to be disabling. Upon internal review, the events of vision loss and retinal detachment were considered to be medically significant.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Glare, Ophthalmic herpes zoster, Vision blurred, Visual impairment
Clinical narrative: Denies any flashes of light; Herpes zoster opthalmicus; VISION IS BLURRY; glare problem; Floaters right eye; Vision is getting worse; This case was reported by a physician and described the occurrence of ophthalmic herpes zoster in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) unknown for ophthalmic herpes zoster.   The patient's past medical history included herpes zoster, ophthalmic herpes zoster (zoster conjuctivitis with redness on eyelid, pressure, eye pain and pulling around right eye. eyes got tired more than usual.), double vision (brief episode of transient double vision), photophobia (right eye light sensitive and tearing), nerve compression, arm operation, temporal headache, ex-smoker, reading disorder (struggling to read), facial pain, hyponatremia and excessive drinking. Previously administered products included Erythromycin, Vigamox, Cyclopegic, Atropine, Zirgan, Cyclogel, Prednisolone and Trileptal. Concurrent medical conditions included post herpetic trigeminal neuralgia, anterior membrane dystrophy, corneal guttata, headache, palpitation, cataract (left eye) and vitreous detachment. Concomitant products included gabapentin.   On 31st August 2018, the patient received the 1st dose of Shingrix. On 5th July 2016, the patient started Valtrex (oral) 1000 mg twice daily (2000 mg daily). On 29th July 2016, the dose was changed to 1000 mg 3 times daily (3000 mg daily). On an unknown date, the dose was changed to 1000 mg once daily (1000 mg daily). On 19th August 2016, the dose was changed to 1000 mg 3 times daily (3000 mg daily). On an unknown date, the dose was changed to 1000 mg once daily (1000 mg daily). On an unknown date, less than 2 months after receiving Shingrix and unknown after starting Valtrex, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), blurred vision, glare, eye floaters and vision decreased. On an unknown date, the outcome of the ophthalmic herpes zoster, blurred vision, glare, eye floaters and vision decreased were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, blurred vision, glare, eye floaters and vision decreased to be related to Shingrix and Valtrex.  Additional details were provided as follows:  The patient presented for follow up of post herpatic trigeminal neuralgia and reported that vision on right eye was doing ok. The patient's left eye had cataract and can't see very well even after correction. Post vaccination the patient had floaters right eye but denied any flashes of light. The reporter stated that in left eye onset was gradual, vision was blurred with moderate severity and occurred constantly. In left eye the vision was getting worse and had glare problem at night and had herpes zoster opthalmicus. The patient denied any eye pain or irritation. This case is linked to case US2020AMR013062 and US2020AMR012677AA reported for the same patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitreous floaters
Clinical narrative: Denies any flashes of light; Herpes zoster opthalmicus; VISION IS BLURRY; glare problem; Floaters right eye; Vision is getting worse; This case was reported by a physician and described the occurrence of ophthalmic herpes zoster in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) unknown for ophthalmic herpes zoster.   The patient's past medical history included herpes zoster, ophthalmic herpes zoster (zoster conjuctivitis with redness on eyelid, pressure, eye pain and pulling around right eye. eyes got tired more than usual.), double vision (brief episode of transient double vision), photophobia (right eye light sensitive and tearing), nerve compression, arm operation, temporal headache, ex-smoker, reading disorder (struggling to read), facial pain, hyponatremia and excessive drinking. Previously administered products included Erythromycin, Vigamox, Cyclopegic, Atropine, Zirgan, Cyclogel, Prednisolone and Trileptal. Concurrent medical conditions included post herpetic trigeminal neuralgia, anterior membrane dystrophy, corneal guttata, headache, palpitation, cataract (left eye) and vitreous detachment. Concomitant products included gabapentin.   On 31st August 2018, the patient received the 1st dose of Shingrix. On 5th July 2016, the patient started Valtrex (oral) 1000 mg twice daily (2000 mg daily). On 29th July 2016, the dose was changed to 1000 mg 3 times daily (3000 mg daily). On an unknown date, the dose was changed to 1000 mg once daily (1000 mg daily). On 19th August 2016, the dose was changed to 1000 mg 3 times daily (3000 mg daily). On an unknown date, the dose was changed to 1000 mg once daily (1000 mg daily). On an unknown date, less than 2 months after receiving Shingrix and unknown after starting Valtrex, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), blurred vision, glare, eye floaters and vision decreased. On an unknown date, the outcome of the ophthalmic herpes zoster, blurred vision, glare, eye floaters and vision decreased were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, blurred vision, glare, eye floaters and vision decreased to be related to Shingrix and Valtrex.  Additional details were provided as follows:  The patient presented for follow up of post herpatic trigeminal neuralgia and reported that vision on right eye was doing ok. The patient's left eye had cataract and can't see very well even after correction. Post vaccination the patient had floaters right eye but denied any flashes of light. The reporter stated that in left eye onset was gradual, vision was blurred with moderate severity and occurred constantly. In left eye the vision was getting worse and had glare problem at night and had herpes zoster opthalmicus. The patient denied any eye pain or irritation. This case is linked to case US2020AMR013062 and US2020AMR012677AA reported for the same patient.
Age: 54.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: the 54 years old patint received gardasil 9.; patient had a prescription from his doctor; Information has been received from a pharmacist via company representation referring to a 54 year old male patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient had a prescription from the doctor(product administered to patient of inappropriate age and product prescribing error).
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My legs are aching; This case was reported by a consumer via call center representative and described the occurrence of leg pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th January 2020, the patient received the 2nd dose of Shingles vaccine. In January 2020, less than a week after receiving Shingles vaccine, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was not recovered/not resolved.   It was unknown if the reporter considered the leg pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient legs were aching after receiving 2nd dose of shingles vaccine. The patient asked could he/she could take Motrin to relieve the pain.
Sex: F
Vaccine: VARZOS
Symptoms: Diplopia, Rash
Clinical narrative: double vision; rash down to the elbow on arm injection received on; This case was reported by a pharmacist via call center representative and described the occurrence of double vision in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) 5 ml. On 28th January 2020, 2 days after receiving Shingrix, the patient experienced double vision and rash. On an unknown date, the outcome of the double vision and rash were unknown.   It was unknown if the reporter considered the double vision and rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced double vision and a rash down on her elbow in the arm where she received her injection after receiving Shingrix vaccine. The reporter consented for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hepatitis c and shingles (25 years before reporting date). Concurrent medical conditions included autoimmune disorder (IGE autoimmune disease).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was resolved with sequelae.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 66 or 67 years. The patient received a dose of Shingrix and experienced pain at the injection site that only lasted for 1 night, then resolved. The patient did not consent to follow up. This case has been linked to US2020017554, reported by the same reporter.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site indentation, Injection site reaction, Injection site swelling, Muscle injury, Pain in extremity
Clinical narrative: The date of immunization and 2 to 3 days following arm was very sore.  This was second  in series of two and first immunization left arm extremely sore also, so thought nothing of it.  In November, I  woke up and left arm was hurting.  Looked in mirror in bathroom and there was a huge dent in my arm with swelling above and pain.  Today 02/05/2020 the site looks bigger and deeper.  Dent in arm can be seen by others.  I showed to nurses at Health Department, regular doctor, and OBGYN and all concurred it was from immunization.  Muscle and tissue damage occured.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Tissue injury
Clinical narrative: The date of immunization and 2 to 3 days following arm was very sore.  This was second  in series of two and first immunization left arm extremely sore also, so thought nothing of it.  In November, I  woke up and left arm was hurting.  Looked in mirror in bathroom and there was a huge dent in my arm with swelling above and pain.  Today 02/05/2020 the site looks bigger and deeper.  Dent in arm can be seen by others.  I showed to nurses at Health Department, regular doctor, and OBGYN and all concurred it was from immunization.  Muscle and tissue damage occured.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful swelling and erythema on inner left arm from elbow to armpit, not on deltoid/ lateral left arm where vaccination was given.  Per urgent care notes, there was a "sac" by the inner elbow when provider saw her on 2/2/20 at 11:19am.  Dx cellulitis.  Rx'd cephalexin 500mg TID x 7 days
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site nerve damage, Injection site pain
Clinical narrative: Pharmacist administered two vaccines (Influenza vaccine and Pnemovax 23 vaccine) in the right arm and one vaccine (Heplisav) in the left arm on 01/30/2020.  Pt stated there was pain with the injection of the Pneumovax23 vaccine that radiated down his arm.  Pt saw a doctor 2 days later that stated injection likely hit his axillary nerve.  Pt was prescribed a steroid dose pack.  Pt contacted the pharmacist about the event 5 days later to let her know.  Pt was not experiencing any more pain at that point.  Pharmacist reported to patient's PCP, VAERS, and the institution's Patient Safety Network.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abnormal behaviour, Crying, Decreased eye contact, Dyskinesia, Feeling cold
Clinical narrative: Saturday my daughter woke up extremely hyper. She could not seem to control her behavior. She did not make eye contact with me but instead would look past me. She could not sit down and she was running, skipping, galloping almost non stop. We couldn't even get her to sit still to eat. She seemed to have uncontrollable tics putting her finger in her nose over and over (something she did not do prior). She also kept licking things over and over and would touch things and lick her finger over and over seemingly with no control. Saturday night, she woke up around 1:30 am crying. She kept telling us she could not close her eyes, but they were closed. She was very panicky. She was unable to self soothe. She had some arm and leg movements that appeared to be involuntary.  She cried and yelled about hair touching her arm and then could not warm up no matter how many blanket we put on her. When we tried to put the t.v on to calm her she began yelling it's too bright. The crying and panicking went on until approximately 3:30 am. Sunday she woke up hyper and it was a repeat of Saturday. Sunday night she woke up and did basically the same thing she did the night before but it was slightly less severe. Monday, she was calmer but still slightly hyper and still continued with the licking and behaviors such as putting her finger in her nose. When I correct her she usually just looks at me with a blank stare. Its not like her at all. She is still not 100% herself. She is still doing some of the odd behavior but not as often. We are looking into hyper baric chamber therapy and some detox regimens. No treatment has been given so far.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Panic reaction, Photophobia, Psychomotor hyperactivity, Staring, Tic
Clinical narrative: Saturday my daughter woke up extremely hyper. She could not seem to control her behavior. She did not make eye contact with me but instead would look past me. She could not sit down and she was running, skipping, galloping almost non stop. We couldn't even get her to sit still to eat. She seemed to have uncontrollable tics putting her finger in her nose over and over (something she did not do prior). She also kept licking things over and over and would touch things and lick her finger over and over seemingly with no control. Saturday night, she woke up around 1:30 am crying. She kept telling us she could not close her eyes, but they were closed. She was very panicky. She was unable to self soothe. She had some arm and leg movements that appeared to be involuntary.  She cried and yelled about hair touching her arm and then could not warm up no matter how many blanket we put on her. When we tried to put the t.v on to calm her she began yelling it's too bright. The crying and panicking went on until approximately 3:30 am. Sunday she woke up hyper and it was a repeat of Saturday. Sunday night she woke up and did basically the same thing she did the night before but it was slightly less severe. Monday, she was calmer but still slightly hyper and still continued with the licking and behaviors such as putting her finger in her nose. When I correct her she usually just looks at me with a blank stare. Its not like her at all. She is still not 100% herself. She is still doing some of the odd behavior but not as often. We are looking into hyper baric chamber therapy and some detox regimens. No treatment has been given so far.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Confusional state, Diarrhoea, Opisthotonus, Pain, Screaming
Clinical narrative: Shot at 12:00 pm Fell asleep in the car (very unusual) Screamed awake at 12:36 pm  He was arching and screaming like he was pained and confused. He has only screamed like this after getting ear tubes placed and coming off anesthesia. Post surgery scream lasted less than 15 minutes. Fell asleep mid scream in my arms at 2:28 Sleepy cries and whimpers for entire nap Woke at 3:48 pm screaming and pooping diarrhea  Stopped screaming when his dad got home (5:14?) Motrin at 7:00 pm Slept 7:18-9:23 pm Up and down most of the night and the next day arching, whimpering, screaming.  6:35-6:48am staring not moving   I called the advice nurse line and was told not to bring him in because screaming in pain was normal. I regret this and wish I had sought a doctor?s examination.
Age: 0.5
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Staring
Clinical narrative: Shot at 12:00 pm Fell asleep in the car (very unusual) Screamed awake at 12:36 pm  He was arching and screaming like he was pained and confused. He has only screamed like this after getting ear tubes placed and coming off anesthesia. Post surgery scream lasted less than 15 minutes. Fell asleep mid scream in my arms at 2:28 Sleepy cries and whimpers for entire nap Woke at 3:48 pm screaming and pooping diarrhea  Stopped screaming when his dad got home (5:14?) Motrin at 7:00 pm Slept 7:18-9:23 pm Up and down most of the night and the next day arching, whimpering, screaming.  6:35-6:48am staring not moving   I called the advice nurse line and was told not to bring him in because screaming in pain was normal. I regret this and wish I had sought a doctor?s examination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient started feeling achy,  having chills, and running a fever at approx. 12:00 PM on 2/4/2020. Patient also has a hot red raised area on her right arm where vaccine was given.  No treatment was done just ice every couple hours off and on. Patient has taken Tylenol and Ibuprofen as needed to help with fever. Patient keeping an eye on it at this time.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient started feeling achy,  having chills, and running a fever at approx. 12:00 PM on 2/4/2020. Patient also has a hot red raised area on her right arm where vaccine was given.  No treatment was done just ice every couple hours off and on. Patient has taken Tylenol and Ibuprofen as needed to help with fever. Patient keeping an eye on it at this time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Side effects were significant fatigue, headache, and some muscle pain (though muscle pain was not significant).  Some soreness at the injection site occurred but this seemed normal.  With the first Shingrix shot, I had no significant side effects.  However, with the second shot I had significant tiredness and headache which interfered with my normal activities.  The side effects lasted 3 days, until midday on 2/1/2020.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills, Fever, headache, aches and pains, tiredness
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradyphrenia, Chills, Fatigue, Feeling cold, Injected limb mobility decreased
Clinical narrative: SHINGRIX shingles vaccine #1 - ~11:30am. Friday, Sept 6, 2019   - food tasted a bit off to me approx 2 hours later  - by late afternoon Extremely painful left upper arm,  by evening I could barely move that arm as it hurt so much  AND seemed unresponsive! with me having to lift it with my other hand to move it sometimes  - evening also brought on feeling chilled, shivering, but no fever.                        Sinus headache and a bit of a wet cough!!!                          waves of nausea, no vomiting  - Woke from sleep  at 1:30am: shivering, with a 100.7 degree fever WITH Tylenol already on board for arm pain. AND RACING, pounding heart beat!!!! Feeling like I was exerting myself! I couldn't count my pulse with fingers at wrist or neck, so  used my blood pressure cuff to measure  115 - 120 beats per minute for next 3 hours, measuring at 30 minute intervals. (BP normal)  -  Waves of nausea, felt like I could vomit, but didn't. CONSIDERED for some time whether heading to the Emergency Room was what I should do!!!!   - went back to bed at 4:30 am with heart rate averaging around 85 bpm Accelerated Heart Rate lasted a minimum of 3 hours -as I don't know what it was before I woke up or how long it took to raise to 115-120, nor do I know how long it took to recover other than it was normal by ~8am.  - SATURDAY - woke achy, still sinus headache, still occasional wet cough -      NO fever,        heart rate back to within my normal range - upper 60s.,       L arm feeling much better     took a 3 hour nap in the late afternoon of Saturday due to tiredness. - SUNDAY - near normal - just a bit slow thinking, and a bit body achy. - a bit body achy for another day or so
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Productive cough
Clinical narrative: SHINGRIX shingles vaccine #1 - ~11:30am. Friday, Sept 6, 2019   - food tasted a bit off to me approx 2 hours later  - by late afternoon Extremely painful left upper arm,  by evening I could barely move that arm as it hurt so much  AND seemed unresponsive! with me having to lift it with my other hand to move it sometimes  - evening also brought on feeling chilled, shivering, but no fever.                        Sinus headache and a bit of a wet cough!!!                          waves of nausea, no vomiting  - Woke from sleep  at 1:30am: shivering, with a 100.7 degree fever WITH Tylenol already on board for arm pain. AND RACING, pounding heart beat!!!! Feeling like I was exerting myself! I couldn't count my pulse with fingers at wrist or neck, so  used my blood pressure cuff to measure  115 - 120 beats per minute for next 3 hours, measuring at 30 minute intervals. (BP normal)  -  Waves of nausea, felt like I could vomit, but didn't. CONSIDERED for some time whether heading to the Emergency Room was what I should do!!!!   - went back to bed at 4:30 am with heart rate averaging around 85 bpm Accelerated Heart Rate lasted a minimum of 3 hours -as I don't know what it was before I woke up or how long it took to raise to 115-120, nor do I know how long it took to recover other than it was normal by ~8am.  - SATURDAY - woke achy, still sinus headache, still occasional wet cough -      NO fever,        heart rate back to within my normal range - upper 60s.,       L arm feeling much better     took a 3 hour nap in the late afternoon of Saturday due to tiredness. - SUNDAY - near normal - just a bit slow thinking, and a bit body achy. - a bit body achy for another day or so
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sinus headache, Taste disorder
Clinical narrative: SHINGRIX shingles vaccine #1 - ~11:30am. Friday, Sept 6, 2019   - food tasted a bit off to me approx 2 hours later  - by late afternoon Extremely painful left upper arm,  by evening I could barely move that arm as it hurt so much  AND seemed unresponsive! with me having to lift it with my other hand to move it sometimes  - evening also brought on feeling chilled, shivering, but no fever.                        Sinus headache and a bit of a wet cough!!!                          waves of nausea, no vomiting  - Woke from sleep  at 1:30am: shivering, with a 100.7 degree fever WITH Tylenol already on board for arm pain. AND RACING, pounding heart beat!!!! Feeling like I was exerting myself! I couldn't count my pulse with fingers at wrist or neck, so  used my blood pressure cuff to measure  115 - 120 beats per minute for next 3 hours, measuring at 30 minute intervals. (BP normal)  -  Waves of nausea, felt like I could vomit, but didn't. CONSIDERED for some time whether heading to the Emergency Room was what I should do!!!!   - went back to bed at 4:30 am with heart rate averaging around 85 bpm Accelerated Heart Rate lasted a minimum of 3 hours -as I don't know what it was before I woke up or how long it took to raise to 115-120, nor do I know how long it took to recover other than it was normal by ~8am.  - SATURDAY - woke achy, still sinus headache, still occasional wet cough -      NO fever,        heart rate back to within my normal range - upper 60s.,       L arm feeling much better     took a 3 hour nap in the late afternoon of Saturday due to tiredness. - SUNDAY - near normal - just a bit slow thinking, and a bit body achy. - a bit body achy for another day or so
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse symtoms reported; was inadvertently administered a dose of ZOSTAVAX via the intramuscular route rather than the recommended subcutaneous route on 08/07/2019; This non-valid spontaneous report was received from a pharmacist regarding an unspecified patient of unknown age and gender. Information about the patients' pertinent medical history, concurrent conditions, drug allergies or reactions, and concomitant therapies were not reported.  On 07-AUG-2019, the patient was inadvertently vaccinated intramuscularly, instead of the recommended subcutaneous route (incorrect route of product administration), with a dose of zoster vaccine live (ZOSTAVAX)(lot # S000618 with expiration date not reported, but upon internal validation was establish as 06-APR-2020) as prophylaxis (strength, dose number, and anatomical site of vaccination were not reported). The vaccine was reconstituted with sterile diluent (DILUENT MRK INJ)(lot # and expiration date were not reported). No adverse symptoms reported.  This is a non-valid case due to lack of patient identifiers.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a six month old patient was inadvertently administered a dose of GARDASIL 9 on 1/24/2020; This spontaneous report was received from nurse regarding a 6-month-old patient of unknown gender. The patient's pertinent medical history concurrent conditions, drug allergies or reactions, and concomitant therapies were not reported.  On 24-JAN-2020, the patient was inadvertently vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) injection (route of administration, anatomical location, lot number, and expiration date were not reported), for prophylaxis (product administered to patient of inappropriate age). The reporter indicated that the injection site looks good and the patient was doing fine.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse event; the patient was inadverentently administered a dose of Proquad and Varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JAN-2020, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019461, expiration date 24-JUN-2021 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S021619, expiration date 09-JAN-2021 (for both vaccines dose and route of administration were not reported), for prophylaxis. The vaccines were diluted with sterile diluent. No additional adverse event was reported. The outcome of the events was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Unspecified number of patient were vaccinated with improperly stored doses of PROQUAD and VARIVAX; This non-valid spontaneous report was received from a Licensed Practical Nurse referring to unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  On 24-JAN-2020, unspecified number of patients were vaccinated for prophylaxis with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage schedule, route and anatomical location were not reported; lot number: S022916 and expiration date: 19-JAN-2021; ) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage schedule, route and anatomical location were not reported; lot number: S020965, expiration date: 07-JUL-2021).   The improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of 25.9 Celsius Degrees for 2 hours and 56 minutes without a previous temperature excursion and was call because a digital data logger. No adverse effects were reported. No additional information available.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; patient was administered one dose of PNEUMOVAX 23 in March, 2018 and was given a second dose on 29JAN2020; This spontaneous report received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported.  The pharmacist reported that the patient was administered the first dose of Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX 23) for prophylaxis, on an unspecified date in March, 2018 (Lot # S027979 has been verified to be a valid lot number for  Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX 23), expiration date reported as 31-MAY-2021, but upon internal validation established as 30-MAY-2021).  On 29-JAN-2020, the patient was given a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23)(inappropriate schedule of product administration). No additional symptoms were reported.