chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm pain for a week after receiving SHINGRIX.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash
Clinical narrative: Rash & Arm swelling, redness
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Blood pressure increased, Chills, Fatigue, Pain in extremity
Clinical narrative: Patient reported that she had a chill, tiredness and sore arm in 3-4 days and after 1 week. She came back and reported that she had an increased blood pressure and blood glucose. Patient had history of hypertension and diabetes type 2 but stop taking medications, to treat these conditions in the past at least 5 years due to weight loss and exercise.
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test abnormal, Bowel movement irregularity, Coeliac disease, Constipation, Diarrhoea
Clinical narrative: I started having clay colored stools and irregular bowel movements, diarrhea, constipation, and cramps that did not go away over time. I was later diagnosed with Celiacs disease and I strongly feel this vaccination was the ?stressful ? factor that caused my body to develop an autoimmune disorder.
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Faeces discoloured, Muscle spasms, Stool analysis abnormal
Clinical narrative: I started having clay colored stools and irregular bowel movements, diarrhea, constipation, and cramps that did not go away over time. I was later diagnosed with Celiacs disease and I strongly feel this vaccination was the ?stressful ? factor that caused my body to develop an autoimmune disorder.
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Coeliac disease, Diarrhoea
Clinical narrative: I started having clay colored stools and irregular bowel movements, diarrhea, constipation, and cramps that did not go away over time. I was later diagnosed with Celiacs disease and I strongly feel this vaccination was the ?stressful ? factor that caused my body to develop an autoimmune disorder.
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test abnormal, Bowel movement irregularity, Coeliac disease, Constipation, Diarrhoea
Clinical narrative: Patient says she began having diarrhea the day after the vaccine and it is not getting any better.  She said she was diagnosed with Celiac Disease, but she does not agree with the diagnosis and thinks it is because of the vaccine.
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Faeces discoloured, Muscle spasms, Stool analysis abnormal
Clinical narrative: Patient says she began having diarrhea the day after the vaccine and it is not getting any better.  She said she was diagnosed with Celiac Disease, but she does not agree with the diagnosis and thinks it is because of the vaccine.
Age: 47.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Coeliac disease, Diarrhoea
Clinical narrative: Patient says she began having diarrhea the day after the vaccine and it is not getting any better.  She said she was diagnosed with Celiac Disease, but she does not agree with the diagnosis and thinks it is because of the vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Rash blisters.
Age: 29.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Wrong product administered
Clinical narrative: The patient consented to receiving PCV-13, but instead received HPV due to administration error.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Headache, Nausea, Pain
Clinical narrative: fever/chills, red/swollen mark on arm, nausea,  headache, body aches lasted around 24hrs-still has arm pain
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: fever/chills, red/swollen mark on arm, nausea,  headache, body aches lasted around 24hrs-still has arm pain
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Skin exfoliation, Swelling
Clinical narrative: Itching, swollen, blistered and peeling skin on both hands (on the fingers).
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Rash, Rash erythematous, Serum sickness
Clinical narrative: Pt came to pharmacy for  1st Shingrix in a series of two.  He went to the physician for a rash on bilateral ankles and bilateral inner arms and chest where they meet that he thought was chicken pox.  No other rash areas were notated. They were not oozing and were bright red. The actual Left Deltoid had no rash or redness, could not see the injection site.  The diagnosis code taken from the sheet the pt brought with him from his physician was:  T80.69x Serum sickness due to drug, avoid follow up vaccine.  Allergy to shingrix was marked as an allergy in the pharmacy record.
Age: 66.0
Sex: M
Vaccine: DT
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Limb discomfort
Clinical narrative: pain and discomfort in left shoulder/arm, lack of range of motion was severely limited,  burning, aching and throbbing sensation, the symptoms started  the day after the vaccination and continued 24 hrs a day for weeks.
Age: 66.0
Sex: M
Vaccine: DT
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Ultrasound scan, X-ray limb
Clinical narrative: pain and discomfort in left shoulder/arm, lack of range of motion was severely limited,  burning, aching and throbbing sensation, the symptoms started  the day after the vaccination and continued 24 hrs a day for weeks.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count normal, Influenza like illness, Myalgia, Pyrexia, Rash generalised
Clinical narrative: Low grade fever (100), sore muscles, rash all over body. Flu like symptoms.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site pain, Ultrasound scan abnormal
Clinical narrative: Patient reports severe pain in the left arm where the vaccine was administered.  She called the pharmacy two days after the injected and said her arm was very sore and was instructed to try an OTC analgesic and ice to ease the pain.  She followed up a few days later with her primary care physician who instructed her to wait a few more days to see if the pain goes away.  The patient then proceeds to see an orthopedic doctor who sent her for physical therapy.  The customer then said she couldn't afford the therapy and went back to the orthopedic for an injection into the shoulder (sometime in February 2019).  The pain went away almost immediately after that injection but came back a few weeks later.  The patient then went back to the orthopedic doctor who ordered an ultrasound and gave yet another injection.  The orthopedic doctor said there was a bruise from an injection found upon an ultrasound.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: SHINGRIX was given SQ-should have been IM. No adverse reactions noted.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: The night after getting the HPV his arm started getting swollen and warm. The redness continued to spread through the next couple of days. Went to ER.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blood pressure increased, Blood thyroid stimulating hormone, Brain natriuretic peptide, Discomfort
Clinical narrative: Precipitous rise in blood pressure; anxiousness; lightheadedness; generalized discomfort.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Metabolic function test
Clinical narrative: Precipitous rise in blood pressure; anxiousness; lightheadedness; generalized discomfort.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: shoulder rigid/neck got really stiff; shoulder really tender; neck got really tender; tiredness/felt exhausted; flu symptoms; This case was reported by a consumer and described the occurrence of stiffness shoulder in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced stiffness shoulder, shoulder pain, neck pain, exhaustion and flu symptoms. On an unknown date, the outcome of the stiffness shoulder was recovered/resolved and the outcome of the shoulder pain, neck pain, exhaustion and flu symptoms were unknown.   It was unknown if the reporter considered the stiffness shoulder, shoulder pain, neck pain, exhaustion and flu symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's son. The patient recently received the Shingrix vaccine (from date of reporting). The patient reported that anyway, about 3 hours after the vaccination with Shingrix, his shoulder on the shot side and neck got really stiff and tender, and the patient felt exhausted, but the patient got a good night's sleep and woke up. The reporter said that still stiff but it went away by midday (on the day of vaccination).  The reaction was in line with the flu like symptoms that he was told to expect. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: shoulder rigid/neck got really stiff; shoulder really tender; neck got really tender; tiredness/felt exhausted; flu symptoms; This case was reported by a consumer and described the occurrence of stiffness shoulder in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced stiffness shoulder, shoulder pain, neck pain, exhaustion and flu symptoms. On an unknown date, the outcome of the stiffness shoulder was recovered/resolved and the outcome of the shoulder pain, neck pain, exhaustion and flu symptoms were unknown.   It was unknown if the reporter considered the stiffness shoulder, shoulder pain, neck pain, exhaustion and flu symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's son. The patient recently received the Shingrix vaccine (from date of reporting). The patient reported that anyway, about 3 hours after the vaccination with Shingrix, his shoulder on the shot side and neck got really stiff and tender, and the patient felt exhausted, but the patient got a good night's sleep and woke up. The reporter said that still stiff but it went away by midday (on the day of vaccination).  The reaction was in line with the flu like symptoms that he was told to expect. The reporter consented to follow up.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patients received unspecified doses of PEDVAXHIB, MMR II, VAQTA that were improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-MAR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N024698, expiration date 08-SEP-2019, albumin status of rHA (recombinant human albumin) (exact dose and route of administration were not reported). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 10.9 degrees Celsius for 1 hour 14 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003833: US-009507513-1904USA003832:
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a adult female patient who received SHINGRIX for prophylaxis. On 31st March 2019, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced lip swelling. On an unknown date, the outcome of the lip swelling was not recovered/not resolved. It was unknown if the reporter considered the lip swelling to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received the SHINGRIX vaccine the day before reporting day and she awoke in the morning of reporting day with swollen lips. The reporter did not consent to follow up. The patient refused to provide any details or demographic and name information.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX (intradermal). On 30th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema and intramuscular formulation administered by other route. On 31st March 2019, the patient experienced feeling unwell and diarrhea. On 2nd April 2019, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site itching were not recovered/not resolved and the outcome of the injection site swelling, feeling unwell, diarrhea and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site itching, feeling unwell and diarrhea to be related to SHINGRIX. Additional case details were provided as follows: The patient was vaccinated with the dose of SHINGRIX subdermally between the elbow and deltoid and dose was administered in the wrong site, which led to intramuscular formulation administered by other route. After the injection, the patient experienced pain at the injection site, swelling and erythema. The next day, the patient did not feel well and experienced diarrhea. At the time of report, the symptoms related to the injection site were ongoing and now the patient experienced the itching at the site. No additional details reported.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX (intradermal). On 30th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema and intramuscular formulation administered by other route. On 31st March 2019, the patient experienced feeling unwell and diarrhea. On 2nd April 2019, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site itching were not recovered/not resolved and the outcome of the injection site swelling, feeling unwell, diarrhea and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site itching, feeling unwell and diarrhea to be related to SHINGRIX. Additional case details were provided as follows: The patient was vaccinated with the dose of SHINGRIX subdermally between the elbow and deltoid and dose was administered in the wrong site, which led to intramuscular formulation administered by other route. After the injection, the patient experienced pain at the injection site, swelling and erythema. The next day, the patient did not feel well and experienced diarrhea. At the time of report, the symptoms related to the injection site were ongoing and now the patient experienced the itching at the site. No additional details reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: SHINGRIX was given SQ-should have been IM. No adverse reactions reported.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presents to clinic today 4/9/19 with swelling in right upper extremity from shoulder to elbow, redness, skin hot to touch following vaccine injection on 4/8/19 treated with oral antibiotics
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site rash
Clinical narrative: Rash below injection, difficulty breathing. On 3/15, primary doctor prescribed prednisone 10 mg. 8 for 7 days. On 3/22 breathing better, but not the same as it was.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Abdominal pain upper, Blood electrolytes normal, Chest pain, Decreased appetite, Dizziness postural
Clinical narrative: low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Epistaxis, Hallucination, Headache, Lethargy, Loss of personal independence in daily activities
Clinical narrative: low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Abdominal pain upper, Abdominal tenderness, Chest discomfort, Chest pain, Decreased appetite
Clinical narrative: low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Dizziness, Dizziness postural, Epistaxis, Fatigue, Feeling abnormal
Clinical narrative: low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Full blood count, Hallucination, Headache, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MMRV, HEPA, IPV, MMRV
Symptoms: Metabolic function test, Pyrexia, Viral infection
Clinical narrative: low white blood cell count; a 13 year old male patient received PROQUAD; hallucinations (like dreams but not dreaming); HEADACHE; Fever to 101 degrees fahrenheit (constant then intermittent); unspecified number of Bloody noses; lethargy; epigastric pain; chest pain; decreased appetite; dizziness with standing; This spontaneous report was received from a nurse, referring to a 13 year old male patient. The patient's concurrent conditions were not reported. The patient did not have any concomitant therapies, significant medical history or drug allergies/reactions. The patient's historical drugs included behind on vaccination.  On 25-MAR-2019, the patient was vaccinated with albumin status rHA (recombinant Human albumin) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot# N035172, expiration date 09-JUN-2019, for prophylaxis (strength, dose, route and frequency were not reported), hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, route, frequency, lot#, expiration date and indication were not reported) and poliovirus vaccine inactivated (Vero) (IPOL) (strength, dose, route, frequency, lot#, expiration date and indication were not reported).  Between 28-MAR-2019 and 01-APR-2019, the patient developed headache, hallucinations described like dreams but not dreaming, fever to 101 degrees Fahrenheit, constant then intermittent (pyrexia), unspecified number of bloody noses (epistaxis), lethargy, epigastric and chest pain (abdominal pain upper and chest pain) with decreased appetite, and dizziness with standing (dizziness postural).  The patient did stay home from school and did not go to an emergency room or urgent care center, but sought medical attention and was seen by the physician assistant on 02-APR-2019.   On an unknown date in April 2019, a complete blood count with a electrolytes test was performed with normal results, except for a low white blood cell count. It was stated that the patient did not have a previous immunization reaction.  On 05-APR-2019, the physician assistant spoke with the parent and stated that the patient was back in school with no further symptoms (recovered). The patient did not receive any treatment.  The causality assessment was not provided.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concomitant products included Valacyclovir. On 24th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the shingles and inappropriate schedule of vaccine administered were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reported batch number for SHINGRIX was 9N559, which was changed to 9NJ59, as per sales data sheet. The patient developed Shingles after the first dose of SHINGRIX. No additional details were reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms such as chills, aching muscles, headache, nausea, stomach upset.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Flu-like symptoms such as chills, aching muscles, headache, nausea, stomach upset.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient was given MMR vaccination on 04/08/2019 with an expiration date of 04/05/2019
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: localized reaction affecting left thigh, treated with antibiotic and site is improving.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: LEFT ARM RED HOT WITH RED STREAK.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood lactate dehydrogenase normal, Borrelia test negative, C-reactive protein increased
Clinical narrative: Subsequent development of pericarditis, pleural effusion. Persistent, requiring pericardiocentesis, with elevated inflammatory markers. No other s/sx of ongoing autoimmunity. Treated with immunosuppression subsequently.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Complement factor C3, Complement factor C4, Complement factor normal, Electrophoresis protein normal, Hepatitis B core antibody negative
Clinical narrative: Subsequent development of pericarditis, pleural effusion. Persistent, requiring pericardiocentesis, with elevated inflammatory markers. No other s/sx of ongoing autoimmunity. Treated with immunosuppression subsequently.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hepatitis C antibody negative, Immunosuppressant drug therapy, Inflammatory marker increased, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart
Clinical narrative: Subsequent development of pericarditis, pleural effusion. Persistent, requiring pericardiocentesis, with elevated inflammatory markers. No other s/sx of ongoing autoimmunity. Treated with immunosuppression subsequently.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pericardial drainage, Pericarditis, Pleural effusion, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Subsequent development of pericarditis, pleural effusion. Persistent, requiring pericardiocentesis, with elevated inflammatory markers. No other s/sx of ongoing autoimmunity. Treated with immunosuppression subsequently.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Serum ferritin normal
Clinical narrative: Subsequent development of pericarditis, pleural effusion. Persistent, requiring pericardiocentesis, with elevated inflammatory markers. No other s/sx of ongoing autoimmunity. Treated with immunosuppression subsequently.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Immunosuppressant drug therapy, Pericarditis, Vaccine positive rechallenge
Clinical narrative: Subsequent development of pericarditis, pleural effusion. Persistent, requiring pericardiocentesis, with elevated inflammatory markers. No other s/sx of ongoing autoimmunity. Treated with immunosuppression subsequently.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: INJECTION SITE REACTION WITH REDNESS, SWELLING, BRUISING IN TWO SITES, HAD LOW GRADE FEVER IN FIRST 24 HOURS OF SHOT BUT HAS DISAPPEARED SINCE, RED REACTION IS STILL WARM ONE WEEK POST VACCINE
Age: 1.58
Sex: M
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Acne, Dermatitis, Eczema, Molluscum contagiosum, Rash
Clinical narrative: My son developed a red rash behind his knees. The rash persisted, and we treated it with a hydrocortisone cream. He was diagnosed with dermatitis on Jan. 26th, 2015.  His eczema continued, and he also developed a few small bumps (like pimples).  My husband (an MD) told me that it was just part of the eczema and that it would pass on its own.  We were so busy with moving into a rental home while building a new home and moving in, I didn't take my son back to address the tiny bumps for a long time (as they didn't seem to bother him).  We were told it was molluscum, and that it may take a year to clear up. At that point, he'd had the virus for so long, it cleared up within a few months of that visit.
Age: 1.58
Sex: M
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Rash erythematous
Clinical narrative: My son developed a red rash behind his knees. The rash persisted, and we treated it with a hydrocortisone cream. He was diagnosed with dermatitis on Jan. 26th, 2015.  His eczema continued, and he also developed a few small bumps (like pimples).  My husband (an MD) told me that it was just part of the eczema and that it would pass on its own.  We were so busy with moving into a rental home while building a new home and moving in, I didn't take my son back to address the tiny bumps for a long time (as they didn't seem to bother him).  We were told it was molluscum, and that it may take a year to clear up. At that point, he'd had the virus for so long, it cleared up within a few months of that visit.
Age: 27.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Musculoskeletal stiffness, Rash, Rash pruritic
Clinical narrative: Patient was in clinic 3/28/19 trying to get second dose of Varicella vaccine. He said  2 weeks after the Varicella injection, his left arm felt stiffness for 3 days,  he also had scattered small itchy raised rashes with no fluid inside on his upper body that increased in number gradually at about the same time . All rashes subsided within the next 2 weeks. He denies stiffness or any problem with his left arm and denies any other problem now. No Varicella vaccine was given on 3/28/19
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Client reported reaction of redness/swelling for 10 days in her left thigh. Client stated that swelling and redness covered her entire thigh from vaccine injection area to about the top of her knee. Client did not report this to the health department or her PCP. She stated it resolved on it's own. Client reported adverse reaction in April during an appointment for a different vaccination.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Blood test, Computerised tomogram spine, Hypoaesthesia, Pain in extremity
Clinical narrative: Patient complains of low back pain that radiates to right and left lower extremities within 12 hours of the vaccine being administered, patient states at first she has some numbness in her legs as well. Parent took patient to local ER before midnight on 4-3-19. Patient received CT of lumbar spine w/o contrast that came back with no abnormalities. Patient was treated in the ER with anti-inflammatories. Patient was released home from ER on 4-4-19 at 1:00AM with only mild pain in the lower back and legs but ambulatory at the time of discharge.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urine analysis
Clinical narrative: Patient complains of low back pain that radiates to right and left lower extremities within 12 hours of the vaccine being administered, patient states at first she has some numbness in her legs as well. Parent took patient to local ER before midnight on 4-3-19. Patient received CT of lumbar spine w/o contrast that came back with no abnormalities. Patient was treated in the ER with anti-inflammatories. Patient was released home from ER on 4-4-19 at 1:00AM with only mild pain in the lower back and legs but ambulatory at the time of discharge.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling red hot area about 4" around below the injection site. Day 4 now shows slight decrease in swelling and size of red area.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Feeling hot, Injection site inflammation
Clinical narrative: Swelling red hot area about 4" around below the injection site. Day 4 now shows slight decrease in swelling and size of red area.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Hypertension, Renal injury, Wheezing
Clinical narrative: I am unaware that there are more than 1 type of Hep B; therefore, I am unsure which vaccine was given to my son. When he was born I gave him hep b and vit k shot. A week later or that Saturday night after he was born we took him to the ER unknowing that we would of been in the hospital for a week. He had only ate twice a day and mainly slept. We thought it was not normal plus wheezing sound and we thought that was normal since hes getting his lungs cleared or something like that. Well anyways we took him to the ER and right away they put the oxygen tank on him and draw blood, etc. We are first time parents and felt like a failure. We got transferred to 2 different office locations due to needing a cardiologist and a kidney dr. Well it turns out that his reason was high blood pressure (reason for not eating often) and some damage to the left kidney I believe. I did not get high blood pressure while pregnant so I know that wasn't the cause and high blood pressure runs in the family but that's later in life due to the way we eat or our anger. I luckily took NT scans for the fun of it and to see my baby more and to see if he would have down syndrome or something abnormal...they found nothing and couldn't find the cause of this happening. As many drs would not blame the vaccine I truly believe it was the Hep b, another reason was because during the week stay and them taking my son to do some test and when they came back a dr was asking me if anyone of us (me and my partner) have a STD or some type of infection, which we don't, and that's when it hit me...the only infection he got inserted was the Hep B vaccine. When we got released he had to be on a medication for his kidney I believe which was something like Amoxypol or something like that. He has to be on the medication for his high blood pressure and be monitored. Hes doing much better and eating like a normal baby. He has to see a cardiologist throughout his childhood. It affected his left side of the heart as well and it is hard driving 2 hours away from home with an infant at the moment.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Site at arm turned slightly  red and swollen by evening time; within 24 hours the swollen area became red hot, itchy and her whole body was achy and felt feverish. The sit was hot to touch and she was feeling bad with pain for about 3 days. The site stayed inflamed until Sunday 4-7-19 then the redness started going away. She stated that she is better and her arm is slightly raised and hurting little.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Pain, Pain in extremity, Pyrexia
Clinical narrative: Site at arm turned slightly  red and swollen by evening time; within 24 hours the swollen area became red hot, itchy and her whole body was achy and felt feverish. The sit was hot to touch and she was feeling bad with pain for about 3 days. The site stayed inflamed until Sunday 4-7-19 then the redness started going away. She stated that she is better and her arm is slightly raised and hurting little.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Blood test normal, Gene mutation identification test positive, Nuclear magnetic resonance imaging normal, Partial seizures, Pyrexia
Clinical narrative: A high fever at night with a seizure activity. After the two-month vaccination, patient started to have partial seizures without notable reasons
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Seizure, Severe myoclonic epilepsy of infancy
Clinical narrative: A high fever at night with a seizure activity. After the two-month vaccination, patient started to have partial seizures without notable reasons
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Nurse accidently administered adult dose of VAQTA to unspecified child; This spontaneous report was received from a physician and refers to a child patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 05-APR-2019, a nurse accidently vaccinated the patient with an adult dose of hepatitis a vaccine, inactivated(VAQTA) lot # R012739, 1 milliliter once, intramuscular, expiration date 09-AUG-2019, for prophylaxis.