chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: CHOL, FLUC4, HEP, HEPA, MMR, PPV, TDAP, TYP
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Myalgia, Nausea
Clinical narrative: 03/15/2019 Nausea and Muscle Aches. 03/16/2019 Chills, Muscle aches, Generalized Joint pain.  Left arm pain and limitation of range of motion. Pain of left arm 8/10. Headache, Tiredness and Lightheadedness. 03/17/2019 Redness on left deltoid injection site described by patient as 3-4 inches in diameter and redness on left upper chest. Can move her arm. Tender to touch. Describes pain as 5/10.
Age: 51.0
Sex: F
Vaccine: CHOL, FLUC4, HEP, HEPA, MMR, PPV, TDAP, TYP
Symptoms: Pain in extremity, Tenderness
Clinical narrative: 03/15/2019 Nausea and Muscle Aches. 03/16/2019 Chills, Muscle aches, Generalized Joint pain.  Left arm pain and limitation of range of motion. Pain of left arm 8/10. Headache, Tiredness and Lightheadedness. 03/17/2019 Redness on left deltoid injection site described by patient as 3-4 inches in diameter and redness on left upper chest. Can move her arm. Tender to touch. Describes pain as 5/10.
Age: 49.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Approximately 4 weeks after the first MMR vaccination the employee reported redness/pink coloration and warmth to the injection site and the feeling of a hard lump. She went to Urgent Care on 3/17 and was diagnosed with an abscess and prescribed Keflex.
Age: 49.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Inflammation, Injection site erythema, Ultrasound scan abnormal, Vaccination site mass, Vaccination site pain
Clinical narrative: Approximately 4 weeks after the first MMR vaccination the employee reported redness/pink coloration and warmth to the injection site and the feeling of a hard lump. She went to Urgent Care on 3/17 and was diagnosed with an abscess and prescribed Keflex.
Age: 49.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Vaccination site swelling
Clinical narrative: Approximately 4 weeks after the first MMR vaccination the employee reported redness/pink coloration and warmth to the injection site and the feeling of a hard lump. She went to Urgent Care on 3/17 and was diagnosed with an abscess and prescribed Keflex.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Influenza like illness
Clinical narrative: I started early morning with the shivers and chills then later a low grade temperature.I was very weak and tired.Felt achy all over. Almost like having the flu.It lasted 24 hrs. I only took ADVIL for achyness and low grade temp.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I started early morning with the shivers and chills then later a low grade temperature.I was very weak and tired.Felt achy all over. Almost like having the flu.It lasted 24 hrs. I only took ADVIL for achyness and low grade temp.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient is reporting tingling and her hands and legs and feet.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Patient experienced pain, numbness and impairment of left arm from shoulder to hand soon after receiving the vaccine. Patient reported that the pain and numbness did not go away and after 2 months she went to physical therapy where they massaged her arm on 2 separate visits. Patient was reluctant to return for her second dose of SHINGRIX, however, currently she reports she has regained full use of her left arm.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Intial chlls, headache, severe muscle aches. Worsening headache and abdomenal pains over the next several days. Persistent chills, low grade fever abdomenal pain.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Dizziness, Emotional distress, Eye disorder, Headache
Clinical narrative: Headache, dizziness, fever, diarrhea, eyes floating, irritibility, inconsolable.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Irritability, Pyrexia
Clinical narrative: Headache, dizziness, fever, diarrhea, eyes floating, irritibility, inconsolable.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Patient reports Nausea, dizziness, extreme fatigue, and hot/cold sweats that began same day as vaccination. No treatment given. Symptoms improving but still persistent after 4 days post vaccination given. On 7/25/2017 Patient received GARDASIL 9 first dose in series and MENACTRA and reported same side effects however severity was lower at this time. No reported symptoms with second dose of GARDASIL. During the first dose of the vaccination the symptoms only persisted for 3 days and then resolved on their own.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: INJECTION SITE BECAME RED, SWOLLEN 6X8CM IN SIZE, AND TENDER TO TOUCH. WE SAW HIM IN THE OFFICE TODAY. HE WAS PRESCRIBED KEFLEX 500MG BID X 5DAYS. THERE IS CONCERN OUR SYRINGE PLUNGER IS MADE WITH LATEX.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Defaecation urgency, Dizziness, Dyspnoea, Eye movement disorder, Nausea
Clinical narrative: SHINGRIX administered intramuscularly to right deltoid while standing patient then a few seconds later said she felt dizzy/lightheaded she immediately sat down. Her eyes started rolling back in her head and her head tilted back she was unresponsive upon questioning, breathing labored. then at 1:20pm pharmacist administered epinephrine 0.3mg into her Right thigh muscle and had a coworker call 911.  A few seconds after she was able to respond and speak sentences and breathing seemed to regulate. She felt like she was going to vomit and needed to make a bowel movement when the paramedics arrived.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: SHINGRIX administered intramuscularly to right deltoid while standing patient then a few seconds later said she felt dizzy/lightheaded she immediately sat down. Her eyes started rolling back in her head and her head tilted back she was unresponsive upon questioning, breathing labored. then at 1:20pm pharmacist administered epinephrine 0.3mg into her Right thigh muscle and had a coworker call 911.  A few seconds after she was able to respond and speak sentences and breathing seemed to regulate. She felt like she was going to vomit and needed to make a bowel movement when the paramedics arrived.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-AUG-2017, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. On an unspecified date, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-DEC-2011, at age 74, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from his ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-JUN-2017, at age 64, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Guillain-Barre syndrome. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the Guillain-Barre syndrome is unknown. Upon internal review, Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Aggression, Amnesia, Insomnia, Mania, Sleep study
Clinical narrative: This spontaneous report as received from a physician assistant, via a company representative, referring to a 12 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 02-JUL-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). Other suspect vaccines administered on the same day,  included MENACTRA and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (indication, strength, route, dosage schedule, lot number and expiration date were not reported). On 03-JUL-2018, according to the patient's mom, the patient turned manic, started having awful tantrums (aggression), memory loss (amnesia), and cannot sleep (insomnia). The patient had sleep studies done (no results provided) and a referral to a neurologist who basically said that the patient should see a psychiatrist. The outcome of aggression, insomnia, amnesia and mania was reported as not recovered. Causality assessment was not provided.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Malaise, Pruritus, Rash, Rash macular
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of rash in a 57-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (In early June of Mid May of 2018, the patient received the 1st dose). Concurrent medical conditions included tuberculosis (In October 2018). In November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 5 hrs after receiving SHINGRIX, the patient experienced rash, pruritus, erythromacular rash and feeling unwell. The patient was treated with Rifampin. On an unknown date, the outcome of the rash, pruritus, erythromacular rash and feeling unwell were unknown. It was unknown if the reporter considered the rash, pruritus, erythromacular rash and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: On an unspecified date in October 2018 for his latent Tuberculosis his Tuberculosis never activated after receipt of the 1st dose of SHINGRIX. He patient clarified that he did not take Rifampin due to any effect caused by the vaccine. Within 5 hours of receiving SHINGRIX series on 19th November 2018 or 20th November 2018, the patient was not feeling great. The rash and itching started. The patient thought that it was the SHINGRIX vaccine. The doctor said that the rash and itching were definitely from the Rifampin, not shingles vaccine. When the Rifampin was stopped, the rash cleared up but the itching has persisted. Recently, the itching has become more intense. On an unspecified date, the patient developed a faint rash that is uncomfortable. It was not a vesicular rash, but just red dots on his stomach, neck, and scalp.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Influenza like illness, Pain, Pruritus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling, pruritus, fever, chills, influenza like illness, pain and erythema. On an unknown date, the outcome of the swelling, pain and erythema were recovered/resolved and the outcome of the pruritus, fever, chills and influenza like illness were unknown. It was unknown if the reporter considered the swelling, pruritus, fever, chills, influenza like illness, pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain redness swelling 3.5 to 4 weeks duration. The patient experienced itching has lasted since shot. The patient experienced fever, chills and described it like having the flu.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling, pruritus, fever, chills, influenza like illness, pain and erythema. On an unknown date, the outcome of the swelling, pain and erythema were recovered/resolved and the outcome of the pruritus, fever, chills and influenza like illness were unknown. It was unknown if the reporter considered the swelling, pruritus, fever, chills, influenza like illness, pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain redness swelling 3.5 to 4 weeks duration. The patient experienced itching has lasted since shot. The patient experienced fever, chills and described it like having the flu.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received FLULAVAL QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was recovered/resolved. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients received flu vaccine and were flu positive. The reporter observed that they got better faster and were not as sick. The reporter agreed to be contacted for follow up. This case was considered, as suspected vaccination failure case since the details regarding time to onset for target disease was unknown at the time of reporting. This case has been linked with case US2019AMR044915, reported by the same reporter. Lab Comments: On an unknown date, the patients were positive for flu.
Sex: F
Vaccine: FLU4
Symptoms: Candida infection, Dyspnoea, Influenza, Nasal congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of thrush in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Co-suspect products included TRELEGY ELLIPTA inhalation powder for flu symptoms. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season and TRELEGY ELLIPTA (inhaled) 1 puff(s) once daily (1 puff(s) daily). On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season and TRELEGY ELLIPTA, the patient experienced thrush, nasal congestion, difficulty breathing and flu symptoms. The action taken with TRELEGY ELLIPTA was unknown. On an unknown date, the outcome of the thrush and flu symptoms were unknown and the outcome of the nasal congestion and difficulty breathing were not recovered/not resolved. It was unknown if the reporter considered the thrush, nasal congestion, difficulty breathing and flu symptoms to be related to Influenza vaccine Quadrivalent 2018-2019 season and TRELEGY ELLIPTA. Additional details were provided as follows: The patient experienced flu symptoms after receiving a dose of flu vaccine. The patient 2 samples of TRELEGY ELLIPTA, when she started the second sample she was diagnosed with thrush. Reporter had difficulty understanding the questions and her answers were not always clear.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site reaction, Rash macular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of feeling bad in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of adverse reaction. On 28th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2019, 1 days after receiving SHINGRIX, the patient experienced feeling bad and injection site reaction. On 3rd March 2019, the patient experienced red blotches. On an unknown date, the outcome of the feeling bad, injection site reaction and red blotches were unknown. It was unknown if the reporter considered the feeling bad, injection site reaction and red blotches to be related to SHINGRIX. Additional details were reported as follows: The physician reported that a patient who had a previous reaction to ZOSTAVAX received the first dose of SHINGRIX. The patient developed an injection site reaction and reported feeling crummy the day after vaccination. Three days later, the patient developed three erythematous blotches on the arm distal to the injection site. At the time of the call the reporter stated that the blotches had resolved. No additional information, lot or expiration provided. The physician stated that the patient received the vaccination at a pharmacy and he took report on the reaction but did not have the vaccine information or site at the time of the call.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number P57AA, expiry date 5th July 2021) for prophylaxis. The patient's past medical history included sinus infection (she had a sinus infection a few weeks previous) and multiple allergies (her allergies were acting up again). On 6th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash. On an unknown date, the outcome of the injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash were unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist noted that the patient experienced with redness, tenderness, and raised skin around injection site. The health care professional describes the tenderness as sore. Raised skin was described as appearing to be a hive but not itching. The patient reported that she got SHINGRIX this week about 2 pm. And by 9 pm that evening she was running a fever and not feeling well. She wasn't sure if that was due to the SHINGRIX or that she had had a sinus infection a few weeks previous and her allergies were acting up again. She currently has a 2-inch diameter red knot on her arm and what looks like a rash that was not itchy, but was very sore to the touch.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number P57AA, expiry date 5th July 2021) for prophylaxis. The patient's past medical history included sinus infection (she had a sinus infection a few weeks previous) and multiple allergies (her allergies were acting up again). On 6th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash. On an unknown date, the outcome of the injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash were unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness, skin disorder, fever, hives, injection site swelling, feeling unwell and painful rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist noted that the patient experienced with redness, tenderness, and raised skin around injection site. The health care professional describes the tenderness as sore. Raised skin was described as appearing to be a hive but not itching. The patient reported that she got SHINGRIX this week about 2 pm. And by 9 pm that evening she was running a fever and not feeling well. She wasn't sure if that was due to the SHINGRIX or that she had had a sinus infection a few weeks previous and her allergies were acting up again. She currently has a 2-inch diameter red knot on her arm and what looks like a rash that was not itchy, but was very sore to the touch.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 6th March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On 7th March 2019, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left arm and experienced arm pain at the injection site the day after. A day before the date of reporting, the patient also noticed redness at the area the size of a grape, not raised just the circle size of a grape. After showering at the date of reporting, the redness grew to the size of an apple again not swollen. It was located below where the injection was given. The patient consented to follow up. This case was linked with US2019043026, reported by the same reporter.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B antibody negative, Product administered to patient of inappropriate age, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old female patient who received ENGERIX B for prophylaxis. On an unknown date, the patient received ENGERIX B 1 ml. On an unknown date, unknown after receiving ENGERIX B, the patient experienced inappropriate age at vaccine administration, lack of drug effect, therapy non-responder and hepatitis B antibody negative. On an unknown date, the outcome of the inappropriate age at vaccine administration, lack of drug effect, therapy non-responder and hepatitis b antibody negative were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration, lack of drug effect, therapy non-responder and hepatitis b antibody negative to be related to ENGERIX B. Additional details were provided as follows: The nurse reported that the patient received 1ml of ENGERIX B when 0.5 ml was indicated for her age group, which led to inappropriate age at vaccine administration. The reporter also stated that they had to restart the series due to nonreactive lab work. Lab Comments: Lab test performed on an unknown date.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister
Clinical narrative: Blisters in her upper lip.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test, Rash, Rash pustular
Clinical narrative: Lab tier showed no immunity. Employee given VARIVAX Dose # 1 on 3/1/2019. Presented to work on 3/18/2019 with diffuse rash with pustules over torso and limbs. Seen by Infectious Disease physician. Employee sent home. Will follow up with Dr. for further care.
Age: 8.0
Sex: F
Vaccine: FLU4, HEP, IPV, VARCEL
Symptoms: Cyanosis, Face injury, Fall, Head injury, Immediate post-injection reaction
Clinical narrative: Immediately after receiving vaccines Patient walked about 10 ft over to table and began having a seizure. Seizure lasted less than 30 seconds- fell to ground from standing, hit head/face on table, circumoral cyanosis, eyes fixed. EMS assessed child and she was stable, they recommended she be evaluated by a doctor. Mom transported child to Hospital for further evaluation. No prior history of seizures.
Age: 8.0
Sex: F
Vaccine: FLU4, HEP, IPV, VARCEL
Symptoms: Pupil fixed, Seizure
Clinical narrative: Immediately after receiving vaccines Patient walked about 10 ft over to table and began having a seizure. Seizure lasted less than 30 seconds- fell to ground from standing, hit head/face on table, circumoral cyanosis, eyes fixed. EMS assessed child and she was stable, they recommended she be evaluated by a doctor. Mom transported child to Hospital for further evaluation. No prior history of seizures.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Approximately 10 minutes after the vaccine was given, he fainted. No injury was sustained. He was sitting in a patient chair. History of fainting with the HPV vaccine. The patient was here for his physical. Dr. monitored him and continued his exam. The patient left the office in no apparent distress.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash macular
Clinical narrative: Mom came in 1 mth later with patient having rash on left leg. The rash was light pink to red and macular papular in nature, no itching. MD assessed the patient and determined that it looked like a rash from MMR not Varicella.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Autism spectrum disorder, Crying, Feeding disorder, Injection site erythema, Injection site rash
Clinical narrative: My son ended up getting an extremely high fever untreatable by TYLENOL or ibuprofen. The site of the injection was flaming red, accompanied by a rash. He ended up being unable to eat or nurse and became generally unresponsive to us after screaming for many hours, and we had to take him to the ER. At the ER he ended up having to get fluids and was monitored. We were there maybe a day. There wasn't much they could do for him, and once his fever was lowered they released him home. It took him weeks to get back to the point of nursing and behaving somewhat normally. Maybe six months later he was diagnosed with a learning disability and later we found out it was Autism.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Learning disability, Pyrexia, Screaming, Unresponsive to stimuli
Clinical narrative: My son ended up getting an extremely high fever untreatable by TYLENOL or ibuprofen. The site of the injection was flaming red, accompanied by a rash. He ended up being unable to eat or nurse and became generally unresponsive to us after screaming for many hours, and we had to take him to the ER. At the ER he ended up having to get fluids and was monitored. We were there maybe a day. There wasn't much they could do for him, and once his fever was lowered they released him home. It took him weeks to get back to the point of nursing and behaving somewhat normally. Maybe six months later he was diagnosed with a learning disability and later we found out it was Autism.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pain
Clinical narrative: Within one hour of receiving the vaccine pt experienced body aches and nausea. Took Motrin and felt better within 2 hours.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Seizure
Clinical narrative: Three days after recieving these vaccinations he began to have a series of seizures, as of this date (3/18/19) he has had 11 sezuries with and without fever. He stops breathing for some, some need resuce medication to come out of them as one lated 11 1/2 minutes and was given many medications to come out of. He has been hospitalized as well.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Pt c/o acute onset local soreness throughout left arm (site of vaccination) and fever beginning 11:00 pm same day. Pt was unable to document temperature due to no thermometer on hand, but felt it was at least 100 degrees F. Pt was able to take temp 15MAR19 at 12:30 pm which resulted in 100.4 degrees F. 9:00 pm 15MAR19, pt felt his temperature was higher and c/o general malaise and soreness. Pt finally noticed relief of symptoms by 12:00 am 16MAR19.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: "Red bump, pain numbness, Heat" per pt. Pt reports redness, swelling and pain with intermittent numbness at injection site for approx 2-3 days following vaccine administration. Presented to clinic 5 days later with touch sensitivity at site. No other complaints. Pt advised to utilize heat/OTC medications as needed. Monitor for new/worsening symptoms and return to clinic as needed.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received his flu vaccine on 3/14/19. On 3/15/19 pt. noticed swelling, redness and heat bellow injection site. Treated site with ice to reduce swelling. Pt. mother brought pt. in on 3/18/19, no irritation at injection site. Mild swelling, redness below site. Per NP continue to monitor site and use ice to reduce swelling.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Sensitive skin
Clinical narrative: First shingles outbreak January 2018 left buttock. First SHINGRIX dose 5/15/2018 left deltoid. Second SHINGRIX dose 8/1/2018 left deltoid. Second shingles outbreak approximately 9/30/2018 left buttock, smaller area than first outbreak. Continued sensitivity in that location currently.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Decreased appetite, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: 2/4/2019 slight redness and swelling at injection site of Left arm and fever of 100.3 that evening, treatment with TYLENOL, local reaction and fever resolved in less than 24hrs. 2/5/2019 stomach ache and decreased appetite lasted 2 days. 2/7/2019 rash on both legs and abdomen which cleared within hours, no treatment.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Rash
Clinical narrative: 2/4/2019 slight redness and swelling at injection site of Left arm and fever of 100.3 that evening, treatment with TYLENOL, local reaction and fever resolved in less than 24hrs. 2/5/2019 stomach ache and decreased appetite lasted 2 days. 2/7/2019 rash on both legs and abdomen which cleared within hours, no treatment.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Patient called Pharmacy and reported the following on 3/16/2019:  Patient experienced fever starting the day after injection of second dose. The fever lasted about 3 days. She then developed a rash on her back and stomach which spread to the tops of her shoulders. She described the rash as itching and burning. She continues to have pain on her shoulders. The pain has spread to her neck and head.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash pruritic, Urine analysis
Clinical narrative: Patient called Pharmacy and reported the following on 3/16/2019:  Patient experienced fever starting the day after injection of second dose. The fever lasted about 3 days. She then developed a rash on her back and stomach which spread to the tops of her shoulders. She described the rash as itching and burning. She continues to have pain on her shoulders. The pain has spread to her neck and head.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Burning sensation, Herpes zoster, Hyperhidrosis, Micturition urgency
Clinical narrative: Patient called Pharmacy and reported the following on 3/16/2019:  Patient experienced fever starting the day after injection of second dose. The fever lasted about 3 days. She then developed a rash on her back and stomach which spread to the tops of her shoulders. She described the rash as itching and burning. She continues to have pain on her shoulders. The pain has spread to her neck and head.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Neck pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: Patient called Pharmacy and reported the following on 3/16/2019:  Patient experienced fever starting the day after injection of second dose. The fever lasted about 3 days. She then developed a rash on her back and stomach which spread to the tops of her shoulders. She described the rash as itching and burning. She continues to have pain on her shoulders. The pain has spread to her neck and head.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash pruritic, Scab, Vaccine positive rechallenge
Clinical narrative: Patient called Pharmacy and reported the following on 3/16/2019:  Patient experienced fever starting the day after injection of second dose. The fever lasted about 3 days. She then developed a rash on her back and stomach which spread to the tops of her shoulders. She described the rash as itching and burning. She continues to have pain on her shoulders. The pain has spread to her neck and head.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Pt states 3-13 she had redness of injection site. The next day 3-14 she had low grade fever, chills, and the redness of injection site increased size. Injection site was also warm. She went to urgent care and was given antibiotic to treat cellulitis.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Erythema, Exposure during pregnancy, Foetal heart rate abnormal, Laboratory test normal
Clinical narrative: Redness on arm with golf ball size knot. Friday 1/4 experienced shortness of breath, nausea and heart rate between 105-110. Wed 1/9- My son, which was a perfect pregnancy was born stillborn at 32 weeks -his heart just stopped.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Nodule, Premature delivery, Stillbirth
Clinical narrative: Redness on arm with golf ball size knot. Friday 1/4 experienced shortness of breath, nausea and heart rate between 105-110. Wed 1/9- My son, which was a perfect pregnancy was born stillborn at 32 weeks -his heart just stopped.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-MAR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In April 2016, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a healthcare provider. On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Redness, swelling where shot was given, headache, nausea, body aches, sore joints.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Redness, swelling where shot was given, headache, nausea, body aches, sore joints.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Eye pruritus, Ocular hyperaemia, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: 4 days after receiving the HPV vaccine patient developed itching red eyes, face and small red bumps all over body and was scratching a lot. Patient was given ZYRTEC 10mg 1 QD and BENADRYL 25mg-50mg HS. She was advised to return to the clinic if symptoms persist or worsen.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Small lump under skin where shot was given. Patient reported some pain after shot was given but then pain dissipated.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction - swelling and itching.
Age: 76.0
Sex: F
Vaccine: FLUR4, PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient states she had a vaccine 03/04/2019 and reported noticing her left arm being more painful and redness. Per patient yesterday 2 marks about an inch apart one right over the injection site were red and circular areas that raised and unsure that there was any warmth. These red areas were about the size of a quarter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe arm pain, numbness and tingling in arm and hand on left side. Sharp shooting pain last >7 days.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Balance disorder, Chest X-ray normal, Cyanosis, Decreased appetite, Diarrhoea
Clinical narrative: A few hours after his vaccines he was lethargic, stumbling when walking, fever, vomiting, diarrhea .. the following day his lips, hands and feet were turning blue/purple on and off and very cold. Took him to the ER and all tests, X-ray and oxygen came back fine but his color came back too. Brought him home and he was turning blue again and I gave him albuterol and it went away. Still very lethargic, no appetite and constant fever for 4 days. Broke out in a bad rash/ Eczema on day 3 and I had to rush him to pediatrician. Was told it was normal and Keep monitoring him and that it was definitely a reaction from vaccines. Slowly started getting better on day 4 but still a little lethargic and losing his balance. Day 6 and he is finally eating and doing better.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Eczema, Gait disturbance, Influenza virus test negative, Lethargy, Peripheral coldness
Clinical narrative: A few hours after his vaccines he was lethargic, stumbling when walking, fever, vomiting, diarrhea .. the following day his lips, hands and feet were turning blue/purple on and off and very cold. Took him to the ER and all tests, X-ray and oxygen came back fine but his color came back too. Brought him home and he was turning blue again and I gave him albuterol and it went away. Still very lethargic, no appetite and constant fever for 4 days. Broke out in a bad rash/ Eczema on day 3 and I had to rush him to pediatrician. Was told it was normal and Keep monitoring him and that it was definitely a reaction from vaccines. Slowly started getting better on day 4 but still a little lethargic and losing his balance. Day 6 and he is finally eating and doing better.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Pyrexia, Rash, Respiratory syncytial virus test negative, Vaccination complication, Vomiting
Clinical narrative: A few hours after his vaccines he was lethargic, stumbling when walking, fever, vomiting, diarrhea .. the following day his lips, hands and feet were turning blue/purple on and off and very cold. Took him to the ER and all tests, X-ray and oxygen came back fine but his color came back too. Brought him home and he was turning blue again and I gave him albuterol and it went away. Still very lethargic, no appetite and constant fever for 4 days. Broke out in a bad rash/ Eczema on day 3 and I had to rush him to pediatrician. Was told it was normal and Keep monitoring him and that it was definitely a reaction from vaccines. Slowly started getting better on day 4 but still a little lethargic and losing his balance. Day 6 and he is finally eating and doing better.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, heat at site of injection, followed by fever, chills, fatiguea and muscle aches. Symptoms  reached zenith about 24 hours and then began to lessen. On +4 day as this is written, arm still sore, persistent fatigue abut flu-like symptoms, while present are milder.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pain, swelling, heat at site of injection, followed by fever, chills, fatiguea and muscle aches. Symptoms  reached zenith about 24 hours and then began to lessen. On +4 day as this is written, arm still sore, persistent fatigue abut flu-like symptoms, while present are milder.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatinine normal, Protein urine present, Proteinuria, Urine abnormality
Clinical narrative: Foamy urine, sudden onset morning March 26, 2018.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Vaccine was given and it was expired on 10/19/18, unaware of this until after vaccination was given.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Deafness unilateral, Rash, Tinnitus
Clinical narrative: Got a shot on Wednesday the 13th, woke up on the 14th with rash and hearing loss in the left ear. It is now the 18th, I still have slight rash and hearing is restored with ringing in left ear still.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Redness the size of a fist; Hot; Itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Hypoaesthesia
Clinical narrative: Arm that received injection went numb and was unable to use the arm for 8 hours. Chest pain was also a symptom.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vision blurred
Clinical narrative: Sitting down in recliner on 2/3/19 at 4:00pm, vision started going blurry and then felt like she was going to faint. This went on for several minutes. This feeling gradually went away.  She did not feel good for about a week after vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Headache, Heart rate increased
Clinical narrative: Patient states about a week after she got her SHINGRIX 2nd dose, she started having elevated blood pressure (between 160s/90s) and elevated heart rate (85 to 99). Patient states she never had high blood pressure in her life, states she went to Dr. and doctor ran "a bunch of tests" but didnt know exactly what was done. She states she is following up with doctor tomorrow (3/19/2019). She states she also has a headache when her blood pressure and Heart rate are high. I told her to definitely call her doctor regarding the headache and she said she was going to right then. Patient is positive this was caused by the SHINGRIX vaccination.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Skin warm, Urticaria
Clinical narrative: Patient presented to the pharmacy 2 days post vaccination with a ~6cm (diameter) round raised welt on vaccination arm in a location around where vaccination was given. Patient stated she started to notice it the afternoon after the vaccine. She reported that it had not worsened over the last 48 hours but did not seem to be getting any smaller/better either. She reported pain in her back and arm in the first 24 hours which has now subsided. Patient did not report any itching associated with the "welt". She did mention that it was hot to the touch and painful when palpated. The patient is monitoring her symptoms and will be contacted in 24h to see if they have worsened/subsided.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site swelling, Insomnia, Joint range of motion decreased
Clinical narrative: First there was some swelling at the injection site. That went away after a few days. It became very painful within 24 hrs and I lost most range of motion for at least a month. I also still have some tingling and numbness in my left hand. To this day I cannot sleep on my left side unless I take MOTRIN for the pain and I do not have full range of motion in my left arm anymore.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Paraesthesia
Clinical narrative: First there was some swelling at the injection site. That went away after a few days. It became very painful within 24 hrs and I lost most range of motion for at least a month. I also still have some tingling and numbness in my left hand. To this day I cannot sleep on my left side unless I take MOTRIN for the pain and I do not have full range of motion in my left arm anymore.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Pain at injection site, fever, tired, diarrhea. Headache, shivering, upset stomach.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pain at injection site, fever, tired, diarrhea. Headache, shivering, upset stomach.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Monoplegia, Paraesthesia, Pruritus
Clinical narrative: Itching, tingling, intermittent paralysis of extremities.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Pain, Pain in extremity
Clinical narrative: Intense body aches and pains especially in the legs. Extreme Fatigue and Lethargy.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Pruritus, Urticaria, Varicella
Clinical narrative: The day after vaccination I had big welts that itched. I went to the doctor 3 days later and was diagnosed with Varicella and given treatment. The welts began to spread throughout my body and the itching became worse and accompanied with a burning sensation. The symptoms still persist and have gotten worse.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Atelectasis, Bacterial test negative, Barbiturates negative
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Basophil count normal, Basophil percentage increased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Diplopia, horizontal and vertical requiring hospitalization. No cause for pt's symptoms identified.