chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Learning disorder, Nausea, Pyrexia
Clinical narrative: crying at time of shot.  increased later to unconsolable crying and wailing within a few hours.  Never happened before with previous  vaccines in the past.  Onset of fever within hours of the shot that increased throughout the afternoon.  Nausea and aversion to food. Aversion to any soothing mechanisms.  The most alarming was that her receptive and expressive language was affected.  She went from knowing 10+ different signs in Sign Language and communicating nonverbally effectively with us for months, to losing this ability the day of the shot.  At first we thought she still wasn't feeling well from the shots but this carried on with so much confusion on her end and it took months and lots of work for her to relearn all what she lost.  In the work I do, I had never seen a setback like this in a healthy child who only showed developmental progress until this time.   It was a major setback in her communication and learning.  Stopped communicating with caregivers nonverbally, despite knowing and performing Sign Language for months.  Would only do one sign and looked confused.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: i had hep b at chc .... while i was at school for dental assisting they came and offered the vaccine to my class. i didnt know back then vaccines could cause damage. I am now aware and connecting dots. I developed shingles. I am not sure if shingles is specifically listed as a side effect, but i think if nothing else it lowered my immune system enough to bring out shingles (I know vaccines work the way the work and lower the immune system via how they work). I am dx with postherpectic neuralgia now.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Migraine, Pain
Clinical narrative: The day after I got the shot I got a migraine, that I did not think was related at first.  After having the migraine for 10 days I went to see Dr., because I also had a rash on my head.  Turns out I had Shingles and the migraine, which lasted 14 days was the Shingles pain.  At first we assumed I was already coming down with the Shingles and just did not get the shot in time, HOWEVER, after receiving the 2nd Shingles shot in February at Pharmacy, I also came down with Shingles 2 days later, in the exact same spot, although a much milder case
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Eczema
Clinical narrative: i had a flu vaccine at Health Dept on 1/29/2014, i am not sure the lot number or anything they would have that. I got eczema from it.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchial hyperreactivity, Bronchitis, Malaise
Clinical narrative: I got the flu vaccine on 11/14/16 ended up with bronchitis with component of reactive airway disease on 12/22/16. I went to the dr after a week of feeling ill.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Rash
Clinical narrative: Fever, headache, nausea, fatigue. It lasted about 8 days. On the first shingrix shot I got a rash on my arm but that went away without a problem. The sangria 50 MCG faccine is not listed in the options in Item 17. I wasn't able to put it in the box.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses instead of one.
Age: 26.0
Sex: F
Vaccine: FLUA3
Symptoms: Pharyngitis
Clinical narrative: got flu shot flu>3 at health dept on 8-26-11 ended up with pharyngitis on 12/6/11.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis
Clinical narrative: i had the fluarix quad pn 9/17/14 and on 10/30/14 i had skin dermatitis.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Swelling
Clinical narrative: patient received vaccine on 6/18/20 noticed the injection site was very red warm to touch and had some swelling. She also noticed swelling from the injection site to her groin. Patient was examined on 6/22/20. Lymph nodes were enlarged on examination
Age: 44.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: I contacted staff at pharmacy to make an appointment for a #13 pneumococcal vaccine prior to my visit on Friday, June 12.  I stated my health condition and she indicated I did not need an appointment. On June 12, I arrived at pharmacy just prior to 9:00 a.m. Person was one of the pharmacy staff members I greeted as they arrived to work.    When the pharmacy opened, I approached the counter and asked staff for the pneumococcal vaccine shot.  Staff, who appeared to be training a male employee, asked why I needed the vaccine.  I explained to staff that we previously spoke on the phone at which time I provided her with my information and confirmed my insurance was covering this vaccine.  She said the only way insurance would cover this for my age was if I had ?a disease? and asked me in front of other customers if I had ?a disease?. Despite being uncomfortable answering her question in front of other customers, I answered ?yes?. She then asked ?which disease?? and I responded despite being uncomfortable with other customers present.  While she and I completed billing documents she often turned to the trainee as he posed several questions including ?Who normally gives the vaccines??  After completing documents, I was asked to wait by a small private area. A few minutes later, the hesitant young man directed me to a small room where he would give me the vaccine.  Since he seemed unsure, I asked him to verify which vaccine he was administering.  He confirmed and proceeded with the shot on my left shoulder.  I became aware of sharp pain while entering my vehicle and noticed that the Band-Aid provided by the pharmacy was placed unusually high on my shoulder. Due to the pain in my shoulder, I limited activity hoping it would resolve in a couple of days. Since the pain did not resolve, I researched and based on the injection site, I fear this vaccine was not properly administered.  It is evident that this young man was improperly trained.  He administered the vaccine at an incorrect site and it appears an improper sized needle was used based on the fact that I weigh less than 100 lbs.    Presently I still have pain and limited range of motion on my left arm.  I have a future appointment with a neurologist.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Significant discomfort upon injection on dose #1.   Later in the evening and throughout the night: Myalgia, Grade 3, fever, headache, and nausea. The following morning and lasting for 24 hours, headache.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Hives type rash all over body. Unsure if related to amoxicillin or other environmental exposure, but family claims no context and has been on amoxicillin in the past with no reaction.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Feeling abnormal, Feeling hot, Mydriasis, Syncope, Tinnitus
Clinical narrative: Approximately 2 minutes after injections the patient stood up to walk out of room and said she didn't feel good.  I sat her immediately in chair and she fainted.  After a few seconds she was alert and said her ears were ringing and her eyes seemed blurry.  Her pupils were dilated.  She was not sweating but said she felt really hot.  After a few moments her pupils were normal size and she was able to sip on some water and felt much better.  She did not have shortness of breath.  After about 15 minutes she was able to stand and felt back to normal.  Her family doctor was contacted and the situation explained to him and he felt she was fine to leave the pharmacy.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Vision blurred
Clinical narrative: Approximately 2 minutes after injections the patient stood up to walk out of room and said she didn't feel good.  I sat her immediately in chair and she fainted.  After a few seconds she was alert and said her ears were ringing and her eyes seemed blurry.  Her pupils were dilated.  She was not sweating but said she felt really hot.  After a few moments her pupils were normal size and she was able to sip on some water and felt much better.  She did not have shortness of breath.  After about 15 minutes she was able to stand and felt back to normal.  Her family doctor was contacted and the situation explained to him and he felt she was fine to leave the pharmacy.
Age: 45.0
Sex: M
Vaccine: ANTH, RAB
Symptoms: Injection site scar, Musculoskeletal stiffness, Scab
Clinical narrative: Pt received 2 Immunizations listed above and had a local scar on his left deltoid. Pt c/o slight stiffness but no pain. pt states he developed a scab and picked it. Pt states the site was not painful at all and received his second Rabies shot today. Pt was told to monitor the site and if it got worse to notify the clinic.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Child's mother reports that he felt "crummy" for 3+ days after vaccination. On Day 3-4 after vaccination he felt light headed without fainting. He also 5-6 inches of redness at injection site with little swelling.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune thyroiditis, Blister, Blood test, Burning sensation, Erythema
Clinical narrative: First week following = flu type symptoms Next week rash & blisters all over face; gradually turned into painful swollen dark red face - itchy, painful Got worse each week:(    Finally diagnosed with Hashimoto disease from all this!!!   Still struggling with the Hashimoto disease, trying to control it
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Influenza like illness, Pain, Pruritus, Rash
Clinical narrative: First week following = flu type symptoms Next week rash & blisters all over face; gradually turned into painful swollen dark red face - itchy, painful Got worse each week:(    Finally diagnosed with Hashimoto disease from all this!!!   Still struggling with the Hashimoto disease, trying to control it
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling face
Clinical narrative: First week following = flu type symptoms Next week rash & blisters all over face; gradually turned into painful swollen dark red face - itchy, painful Got worse each week:(    Finally diagnosed with Hashimoto disease from all this!!!   Still struggling with the Hashimoto disease, trying to control it
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: The patient started to experience tinnitus within 2-3 hours of receiving the vaccine. She stated it was still continuing at 7 pm following the vaccination. The ringing had not worsened, and she stated it seemed to be improving.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dysphagia, Dyspnoea, Rash, Rash erythematous
Clinical narrative: Patient complained of difficulty swallowing and shortness of breath. Sent to ER from home. ER doctor notes fine red rash over trunk/arms. No Airway issues. Pt. Given Benadryl & monitored.
Age: 9.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 7.5 x 6 cm Local reaction with swelling, redness, warmth and induration
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient states he got an injection on Tuesday for shingles. And then yesterday he had a procedure done on his eye. Then yesterday afternoon started feeling bad, al major muscles aching, really tired, and feeling puny. this morning he noted a large lump on the collarbone, and the arm is very sore where he got the shot. But this lump is near the collarbone area and appears to be a lymph node, its very sore to touch. There is no redness, he denies fever/chills
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient states he got an injection on Tuesday for shingles. And then yesterday he had a procedure done on his eye. Then yesterday afternoon started feeling bad, al major muscles aching, really tired, and feeling puny. this morning he noted a large lump on the collarbone, and the arm is very sore where he got the shot. But this lump is near the collarbone area and appears to be a lymph node, its very sore to touch. There is no redness, he denies fever/chills
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: UPPER LT THiGH SWELLing From INGUINAL CREVISE to KNEE.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Trace pain/reddness 1 day after. Day 3 - office exam, 15 x 15 cm swelling, redness pain. Borders drawn - advised tylenol/ibuprofen; cool compress. if redness exceeds borders, call office
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Dependence on respirator, Endotracheal intubation, Gastrointestinal disorder, Guillain-Barre syndrome
Clinical narrative: 9/10/2015 patient presented to Hospital, ED with GI complaints and severe abdominal pain and was discharged home, returned 9/11/2015 and admitted to hospital and was hospitalized for 30 days. Required intubation for Guillain Barre Syndrome and critical care. Transferred to Long Term Care Hospital, for further care due for ventilator dependent care then to medical center for more rehabilitation then finally home.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Intensive care
Clinical narrative: 9/10/2015 patient presented to Hospital, ED with GI complaints and severe abdominal pain and was discharged home, returned 9/11/2015 and admitted to hospital and was hospitalized for 30 days. Required intubation for Guillain Barre Syndrome and critical care. Transferred to Long Term Care Hospital, for further care due for ventilator dependent care then to medical center for more rehabilitation then finally home.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Cardiac failure congestive, Condition aggravated, Death, Dementia, Dysstasia
Clinical narrative: My husband was in the hospital for pneumonia 12/01/2019 and release to go home 12/02/2019.  He was given antibiotics to take for 20 days. we went to Dr.'s office on the 12/12/2019 and he was give a quad flu shot.  He did not have any problems until 12/28/2019.  When he awoke that day he said he felt awful, and this continued the next day.  He felt like he was burning up and running a fever.  On 12/29/2019 he could not stand and lost use of his legs.  He was taken to the hospital where he continue to have problems with his legs and confusion in his mind. He was in the hospital for a week.  He was then transfer to a assisted living home where he received physical therapy.  He never recovered and passed away on 04/27/2020.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Fall, Feeling abnormal, Feeling hot, Gait disturbance, Intensive care
Clinical narrative: My husband was in the hospital for pneumonia 12/01/2019 and release to go home 12/02/2019.  He was given antibiotics to take for 20 days. we went to Dr.'s office on the 12/12/2019 and he was give a quad flu shot.  He did not have any problems until 12/28/2019.  When he awoke that day he said he felt awful, and this continued the next day.  He felt like he was burning up and running a fever.  On 12/29/2019 he could not stand and lost use of his legs.  He was taken to the hospital where he continue to have problems with his legs and confusion in his mind. He was in the hospital for a week.  He was then transfer to a assisted living home where he received physical therapy.  He never recovered and passed away on 04/27/2020.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Malaise, Mobility decreased, Muscular weakness, Peripheral swelling, Walking aid user
Clinical narrative: My husband was in the hospital for pneumonia 12/01/2019 and release to go home 12/02/2019.  He was given antibiotics to take for 20 days. we went to Dr.'s office on the 12/12/2019 and he was give a quad flu shot.  He did not have any problems until 12/28/2019.  When he awoke that day he said he felt awful, and this continued the next day.  He felt like he was burning up and running a fever.  On 12/29/2019 he could not stand and lost use of his legs.  He was taken to the hospital where he continue to have problems with his legs and confusion in his mind. He was in the hospital for a week.  He was then transfer to a assisted living home where he received physical therapy.  He never recovered and passed away on 04/27/2020.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Confusional state, Death, Dysstasia, Feeling abnormal, Feeling hot
Clinical narrative: My husband was in the hospital for pneumonia 12/01/2019 and release to go home 12/02/2019.  He was given antibiotics to take for 20 days. we went to Dr.'s office on the 12/12/2019 and he was give a quad flu shot.  He did not have any problems until 12/28/2019.  When he awoke that day he said he felt awful, and this continued the next day.  He felt like he was burning up and running a fever.  On 12/29/2019 he could not stand and lost use of his legs.  He was taken to the hospital where he continue to have problems with his legs and confusion in his mind. He was in the hospital for a week.  He was then transfer to a assisted living home where he received physical therapy.  He never recovered and passed away on 04/27/2020.
Age: 78.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Musculoskeletal disorder, Pyrexia
Clinical narrative: My husband was in the hospital for pneumonia 12/01/2019 and release to go home 12/02/2019.  He was given antibiotics to take for 20 days. we went to Dr.'s office on the 12/12/2019 and he was give a quad flu shot.  He did not have any problems until 12/28/2019.  When he awoke that day he said he felt awful, and this continued the next day.  He felt like he was burning up and running a fever.  On 12/29/2019 he could not stand and lost use of his legs.  He was taken to the hospital where he continue to have problems with his legs and confusion in his mind. He was in the hospital for a week.  He was then transfer to a assisted living home where he received physical therapy.  He never recovered and passed away on 04/27/2020.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abdominal discomfort, Decreased appetite, Irritability, Pyrexia, Vomiting
Clinical narrative: Low grade fever, loss of appetite, vomiting/upset stomach , extreme fussiness. Three days so far.
Sex: U
Vaccine: MMRV, MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No other adverse effects were reported in the patient.; Nurse reports that a patient received a dose of PROQUAD that was reconstituted with MENACTRA instead of sterile diluent.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies was not provided.  On 11-JUN-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage schedule, route of administration and anatomical location were not reported) (lot number S003188 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 07-APR-2021) for prophylaxis. The vaccine was reconstituted with meningococcal acywconj vaccine (dip toxoid) (MENACTRA), 0.5 milliliter (ml) (lot number U6585AA, and expiration date 11-APR-2021) instead of sterile diluent (product preparation issue). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported; an unspecified dose in VARIVAX immnunization series was administered to patient after being improperly stored.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions and previous drug reactions or allergies were not reported.      On 12-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number S031496, which was verified to be a valid one, and expiration date reported and validated as 07-OCT-2021 (dose number, dosage schedule, anatomical site of injection and route of administration were not provided), as prophylaxis (product storage error). The administered vaccine was reconstitued with a properly stored sterile diluent (DILUENT MRK) (lot number S033782, which has been verified to be valid, and expiration date  not reported but upon internal validation established as 18-JUN-2022). The vaccine was exposed to a temperature of 40.1 degrees Fahrenheit (F) during a time frame of 4 hours. There was a previous temperature excursion of 5.7 degrees Celcius (C) for a time frame of 8 hours, as recorded by digital data logger. No symptoms or additional adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered neuropathy (neuropathy peripheral). As a result of these symptoms, she was seen and treated by medical providers and was still under their care. As a direct and proximate result, her symptoms have 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 patient' condition. As a result, she sustained severe and permanent personal injuries. Further, as a tragic consequence, 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, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for neuropathy peripheral was not recovered due to ongoing treatment.   Upon internal review, the neuropathy peripheral was considered a medically significant event.  The neuropathy peripheral was a disabling event.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: painful blistering rash; painful blistering rash; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient of an unknown age and gender. The medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered a painful blistering rash (rash vesicular/rash). As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result, the patient's symptoms have 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 patient' condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for painful blistering rash was considered to be not recovered due to ongoing treatment.   The painful blistering rash was considered to be a disabling event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: postherpetic neuralgia; herpes zoster; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were not provided. On or around 26-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered a painful rash on her head from the right parietal area of scalp around the back of the head onto her left occipital region. She was diagnosed with herpes zoster and postherpetic neuralgia. As a direct and proximate result, her symptoms have 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, she sustained severe and permanent personal injuries. Further, as a tragic consequence, 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, she suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for herpes zoster and postherpetic neuralgia was not recovered.   The herpes zoster and postherpetic neuralgia were considered disabling events.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; patient was inadvertently administered a dose of PROQUAD on 6/16/2020, that had been improperly stored; This spontaneous report was received from a licensed practical nurse, referring to a 12-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions, or allergies were not reported.  On 16-JUN-2020, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (vaccination scheme, anatomical location and route of administration were not reported; lot number S030215, which has been verified to be valid, expiration date reported and validated as 25-MAR-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). No additional adverse event.  The vaccine experienced a temperature excursion of 7.2 degrees Fahrenheit (F) for 30 minutes. There were previous temperature excursions on 05-JUN-2020 with a temperature range of 6F to 14F for 1 hour, and between 15F to 46F for 4 hours; on 08-JUN-2020 with a temperature range of 6F to 14F for 1 hour and 50 minutes; and on 15-JUN-2020 with a temperature range of 6F to 14F for 20 minutes, as recorded by a data logger.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The medical history, concurrent conditions and concomitant medications were not provided. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not reported) by a pharmacist at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequent to vaccination, the patient was treated by a healthcare provider at a hospital for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of those 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 for herpes zoster was not recovered.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle soreness, tiredness.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: Soreness, dull pain and weakness on left shoulder various days and weeks following the flu shot. Over time, has continually been bothersome and sore when doing chores such as lifting cups and glasses, crossing over body to wash, dress such as put on my bra and blouses. Cannot exercise well, sharp pain at times if lift overhead or try to do pushups.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, MENB
Symptoms: Body temperature
Clinical narrative: Patient developed temperature of 101*F two day after receiving Pentacel and inadvertent Trumenba.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No other adverse effects; 73 year old patient received a dose of VAQTA in 2018, and received a pediatric dose yesterday; 73 year old patient received a dose of VAQTA in 2018, and received a pediatric dose yesterday; This spontaneous report as received from a nurse refers to a 73-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2018l, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 10-JUN-2020 (reported as yesterday), the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) strength reported as 25/0.5, 0.5 ml (route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; on 6/12/2020 a patient was administered an improperly stored dose of VARIVAX; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, pertinent medical history or drug reactions/allergies was not provided.  On 12-JUN-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S031496, expiration date 07-OCT-2021) (strength, dose schedule and anatomical site of injection not reported) subcutaneously for prophylaxis (product storage error). The sterile diluent (manufacturer unknown) (lot # T000494, expiration date 06-JUL-2022) used for administration of the dose was properly stored.  The administered dose of the vaccine experienced a temperature of 43.8 Fahrenheit degrees for 29 hours and 30 minutes recorded by a data logger. The patient experienced no symptoms. There was no previous temperature excursion. No product quality complaint involved.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: unspecified rash on her face; This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  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) intramuscularly (dose, lot # and expiration date were not provided) for routine vaccination.  On an unknown date (reported as a day after being vaccinated), the patient experienced rash on her face. The patient sought for medical attention by returning to the physician's office.  The outcome of the event was reported as recovered/resolved on an unknown date.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) ( GARDASIL 9) was not provided.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: wrong vaccine administered; This spontaneous report was received from a pharmacist via Pfizer refers to a patient of unknown gender and age (age also reported as 53 with units not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date (also reported as "within a month"), the patient was wrongly vaccinated with second dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, anatomical route of administration, lot/ batch number and expiry date for both the vaccines were not reported) (wrong product administered). It was reported that on an unknown date in September (year not specified), the patient received first dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The reporter also enquired about when would the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) be given after two doses of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The outcome of wrong product administered was unknown.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; A patinet was administered improperly stored M-M-R-II; This spontaneous report was received from a medical assistant, regarding a 13 months old patient of unknown gender. Information about the patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 04-MAY-2020, the patient received a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot # S004118 and expiration date was 11-FEB-2021) (strength, dose, route and anatomical site of injection were not reported) for prophylaxis, which was improperly stored (product storage error). Sterile diluent (STERILE DILUENT) (lot # and expiration date unknown by the reporter) used to reconstitute the vaccine was properly stored. The improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) experienced temperature of -58 degree Fahrenheit (F) to +46 degree F with 33.3 F for 17 hours and 30 minutes. The previous temperature excursion was above 47 degree F with 47 F for a time frame of 20 minutes. A data logger was involved. No additional adverse effects reported. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Limb mass, Malaise, Pain in extremity
Clinical narrative: lump in my arm; I would hurt this bad; feel like I want to die from the pain; This case was reported by a consumer via call center representative and described the occurrence of mass in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mass, pain in arm and feeling unwell. On an unknown date, the outcome of the mass, pain in arm and feeling unwell were not recovered/not resolved.   It was unknown if the reporter considered the mass, pain in arm and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient never had chicken pocks. The patient received Shingrix and get a lump in his/her arm and hurt this bad from taking the shot.  The patient felt like want to die from the pain.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Immediate post-injection reaction, Malaise, Vomiting
Clinical narrative: Vomiting; diarrhea; "not feeling well"; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced vomiting, diarrhea and feeling unwell. On an unknown date, the outcome of the vomiting, diarrhea and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the vomiting, diarrhea and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose 1 of Shingrix and developed vomiting, diarrhea and was not feeling well immediately after the dose.  He stated these symptoms lasted for two days and then resolved. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Formication
Clinical narrative: Two months or less from the time of the shingles shot given my chin felt like worms crawling all over. Progressed throughout my face and the top of my head. It now, when it hits me, feels like ants crawling all over my face and head, when the feeling of ants strike me, thus to take my hands
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Patient presented on day  3 from vaccination date with  erythemic/edemic swelling surround the insertion site on her rt thigh. Mother of child states the swelling was noticed the following am from the vaccination date. Swelling has not decreased since onset and states she has used over the counter diphenhydramine x1 to assist with swelling. Mother of child states patient has had recations prior to this though never greater than a half-dollar size surrounding injection site from  prior vaccinations. Area of edema/erythema measured horizontally 5in./12.7cm and vertically 2.75in./6.9cm.  Rx prescribed of Prednisolone suspension @ 2mg/kg/day, 7ml/21mg BID x 5 days with use of OTC diphenhydramine  6.25mg BID to QD for the next 2-3 days for improvement in patient comfort. Patient directed to return to facility in 1 week. +++++patient did not follow up for 1 week evaluation+++
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Developed varicella lesions 5 days after vaccine administration.  No treatment required and no other sxs developed.  By day 9 several were starting to crust over and no new lesions were developing.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Body temperature increased, Pain, Tremor
Clinical narrative: Began to feel weak, body aches + shaking. Temp 101.2. Seen in ER. Given IV fluids, Tylenol + Motrin
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Nausea, Sleep disorder, X-ray
Clinical narrative: Pt seen for CPE on 6/15/20 was given Bexsero vaccine in left deltoid pt. was advised would be sore, advised strongly to do leg muscle but pt wanted in her arm. On the weekend prior to receiving vaccine pt was at the lake on Sunday 6/16/20 and fell off a jet-ski that flipped over had some pain on 6/15/20 and 6/16/20 from this but no swelling or bruising. Pt had no weakness in arm after accident and was able to assist in cranking(heavy) jet-ski onto trailer, and could move arm following day.   Pt brought up this injury on date of physical. On 6/16/20 pt was seen again due to shoulder pain  in left arm. No swelling or bruising. Pt stated she could not even hold her arm up and was having  to "carry her arm". Pt was unsure if from jet-ski incident or related to vaccine. Pt was started on Naproxen, given a sling  for arm, and given order for x-ray on 6/16/20.  Pt was seen again on 6/17/20 and stated she could not move left arm. Stated Naproxen was not even touching the pain. No swelling or bruising. Was also having some nausea. Stated the pain was in shoulder and under left breast bone. Pt did not go for x-ray and stated she did not go" due to her not being able to manipulate her arm". Pt was started on acetaminophen-hydrocodone tablet and given injection of Phenagran in Rthigh IM. Pt came in for another appt on 6/19/20 stating pain was unbearable and unable to move arm. Pt stated she had to sleep sitting up due to pain. Pt was given Norflex and referral to ortho.
Age: 1.83
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Blood test abnormal, Joint range of motion decreased, Joint swelling, Juvenile idiopathic arthritis
Clinical narrative: In days after vaccine we noticed swelling in her right wrist and she no longer used the wrist. She complained of pain. Was later diagnosed with Juvenile Arthritis.
Age: 1.83
Sex: F
Vaccine: MMR
Symptoms: X-ray abnormal
Clinical narrative: In days after vaccine we noticed swelling in her right wrist and she no longer used the wrist. She complained of pain. Was later diagnosed with Juvenile Arthritis.
Age: 14.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Body temperature increased, Fatigue, Headache, Vertigo
Clinical narrative: Headache described as worse then a regular headache, vertigo and temperature of 102.1, exhaustion started the night of the shot and headache, temperature, and vertigo started early AM following day.  Temp decrease to low grade Saturday Night, and headache and vertigo finally subsided that night exhaustion continued until Monday morning. Temperature and all other reactions had subsided.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Real bad sore muscles all over my body. Hard to move without pain.
Age: 0.33
Sex: M
Vaccine: IPV
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Rash on leg looked like red bumps spread down down injection site RVL.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient received both the Varicella and Proquad vaccines.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Discomfort, Headache, Injection site pain
Clinical narrative: Pain and swelling at injection site, fever, chills, weakness, severe body aches and heaviness, sleeplessness, extreme thirst. Rest and attempted sleep, Aleve, drinking fluids. Symptoms started to alleviate around 12:00 noon 6/23/2020 except for a headache.  Note:  This was the second of the two shot series and I experienced the same exact adverse events with the initial shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pyrexia, Thirst
Clinical narrative: Pain and swelling at injection site, fever, chills, weakness, severe body aches and heaviness, sleeplessness, extreme thirst. Rest and attempted sleep, Aleve, drinking fluids. Symptoms started to alleviate around 12:00 noon 6/23/2020 except for a headache.  Note:  This was the second of the two shot series and I experienced the same exact adverse events with the initial shot.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient received an adult dose of Hepatitis A
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient states they developed a low grade fever for the two days after the vaccine (06/20 & 06/21). Patient then began to develop a rash the third day (06/22). They used hydrocortisone cream to help with this. I spoke with them about possibly using benadryl if needed and following up with their PCP to determine further need for care. As of today (06/23/20) patient still has rash.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: General Malaise began approximately 4 hours after receiving vaccine. Patient reported having this feeling for 3 days. Patient also reported severe nausea  the night of receiving vaccine, but did not report vomiting.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: expired product
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Call me it is timing out
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash
Age: 18.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Magnetic resonance imaging, Pain in extremity, X-ray limb
Clinical narrative: On 6/13/2020 patient went to Urgent care complaining that left arm was still having pain since receiving vaccine on 6/2/2020.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chest pain, Headache, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Migratory arthralgias started with chest pain then shoulder pain. also in left knee and foot with numb toes. Random dull aches. Variable time of spells and variable joints involved costochondral and shoulder, knee and foot. Not all areas sore at once. Constant dull headache since shortly after vaccine. She tried her inhaler, proair wondering if asthma related and tried 81 mg bayer asa. No real response to either.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Migratory arthralgias started with chest pain then shoulder pain. also in left knee and foot with numb toes. Random dull aches. Variable time of spells and variable joints involved costochondral and shoulder, knee and foot. Not all areas sore at once. Constant dull headache since shortly after vaccine. She tried her inhaler, proair wondering if asthma related and tried 81 mg bayer asa. No real response to either.
Age: 1.33
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Fever and rash ( varicella)
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: rash all over body
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: patient contacted clinic, informed staff that she had a rash breakout around her chest and back, not at vaccine site. No difficulty breathing or fevers reported. informed pt that will submit a Vaers report. Furthermore, informed pt that if she experiences any shortness of breath or difficulty breathing that she should report to the ER or call 911.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Immediate post-injection reaction, Influenza like illness, Injection site pain, Neuralgia
Clinical narrative: Injection stung when he received it.  He has had many vaccinations in his life and none have every stung like this.  Achy.  General heavy weight flu like symptoms.  Extreme nerve pain at site of post herpetic area.  Symptoms lasted about 3 days.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Injection stung when he received it.  He has had many vaccinations in his life and none have every stung like this.  Achy.  General heavy weight flu like symptoms.  Extreme nerve pain at site of post herpetic area.  Symptoms lasted about 3 days.
Age: 1.83
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Swelling face, Urticaria
Clinical narrative: fever, hives on face and body, swollen cheeks
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: none
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Face and eye swelling and blotchy rash to face.  Localized reaction with redness, warmth, and swelling to left thigh.  No wheezing or distressed breathing, no vomiting, no lip or tongue swelling.  Vitals remained stable.  Treated with oral Benadryl, oral Decadron, and oral Tylenol.