chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Muscle swelling, Myalgia
Clinical narrative: Patient reported to pharmacy Friday 8/10/18 to say his arm was sore. Area where immunized looked normal-no bruising, swelling, or discoloration. Bicep was puffy/swollen. I asked patient if he had fallen. He said no. He said he massaged the arm and applied ice. He said the ice made it feel better. I recommended he contact his doctor. He has not notified pharmacy of the outcome yet.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Intussusception.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Nausea
Clinical narrative: Several hours after patient received vaccination, he could not lift his arm. This was followed by intense nausea that kept him up all night long.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pustule
Clinical narrative: Large red area where injection was given; 1-2 mm white raised area; NOT hot to the touch; NO pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5th dtap and 4th IPV dose, erythema and induration at site of injection originally about 3 cm in size at onset.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Has large red area (approx. 3 by 1.5 inch rectangular area), tender and sore, firm knot-like spot at injection site - said there was some redness after her first dose but not like this. She has been taking an anti-inflammatory but said it is not helping much. Patient says it is very painful. Patient reports NO fever.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within hours of initial injection, area swelled to golf ball size, red, warm and very tender to touch. Worse on day two but gradually got better by day 5, treated with MOTRIN and TYLENOL and 4mg of prednisone in 3 doses.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: C-reactive protein, Lip swelling, Red blood cell sedimentation rate, Treatment noncompliance
Clinical narrative: Pt woke up the next morning (8/10/18) and notice his lower lip swollen. Denies SOB/DOB/throat swelling.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Muscle pain when muscle (where shot was given) is used to lift and or twist. Sharp pain when used only. This is report only; no visit to PCP. Pain noted next day and has stay the same .
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Musculoskeletal discomfort, Myalgia
Clinical narrative: Right arm, shoulder and neck are sore.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient received Pneum 23 vaccine earlier today. Returned to office with adverse site reaction- erythema, warmth, swelling. No SOB/difficulty breathing. Afebrile. Site inspected, consistent w localized reaction. Advised to take 1-2 tabs of BENADRYL 25mg every 6 hours as needed, TYLENOL 500mg 1-2 tabs PRN for pain control, ice area, as well as topical hydrocortisone 1% cream. If reaction worsens, there is any trouble breathing or increased swelling-- go to ER or urgent care. Patient in agreement w plan and satisfied w care provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
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. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. In or around August 2015, the patient was treated for shingles and zoster-related injuries. The outcome of the events is unknown. The patient suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-AUG-2018, the patient was vaccinated with and expired dose of VARIVAX lot # M025864, expired on -MAY-2018, for prophylaxis (dosage schedule and route of administration were not reported). Concomitant therapies included MERCK STERILE DILUENT lot N021030 which was not expired. No adverse event were reported.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of generalized rash in a 83-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 82 or 83 years old. The patient received the 1st dose of the SHINGRIX vaccine a couple of months before the date of reporting (exact date of vaccination was unknown). The patient experienced a full body rash. The patient decided not to receive the 2nd dose. The patient did not report the event to her doctor. The caller did not have any additional details.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Headache, Muscular weakness, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of weakness of arms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced weakness of arms, general body pain, headache, abdominal pain, pain in arm, swelling arm and upset stomach. On an unknown date, the outcome of the weakness of arms, general body pain, headache, abdominal pain, pain in arm and upset stomach were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved. It was unknown if the reporter considered the weakness of arms, general body pain, headache, abdominal pain, pain in arm, swelling arm and upset stomach to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the health care professional for his wife. The age at vaccination was not reported. In 2018, the patient received SHINGRIX on left deltoid. In 2018, a day or two after receiving SHINGRIX, the patient's arm almost fell off and got swollen. The patient also experienced diffuse body aching, upset stomach, headache and abdominal pain. The events were worse on the second day. The patient's arm was still swollen but no longer painful. Everything else had resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of weakness of arms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced weakness of arms, general body pain, headache, abdominal pain, pain in arm, swelling arm and upset stomach. On an unknown date, the outcome of the weakness of arms, general body pain, headache, abdominal pain, pain in arm and upset stomach were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved. It was unknown if the reporter considered the weakness of arms, general body pain, headache, abdominal pain, pain in arm, swelling arm and upset stomach to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the health care professional for his wife. The age at vaccination was not reported. In 2018, the patient received SHINGRIX on left deltoid. In 2018, a day or two after receiving SHINGRIX, the patient's arm almost fell off and got swollen. The patient also experienced diffuse body aching, upset stomach, headache and abdominal pain. The events were worse on the second day. The patient's arm was still swollen but no longer painful. Everything else had resolved.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from Other Health Care Professional on 06-Aug-2018. This case involves a 5 years old female patient who was vaccinated with 0.5 ml fourth dose of PENTACEL (batch number: C 5371AA and expiration date: 04-Jun-2018) (site of administration was not reported) via intramuscular route on 06 Aug 2018 (Powder: C5371AA expiry date: 04-Jun-2018 NDC 4928151005 and Liquid: C4976AA, expiry date: 04-Jun-2018 NDC 4928156005). The patient's medical history were not reported. No other concomitant given. It was an actual medication error due to expired dose of PENTACEL. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a female patient (age not reported) who was vaccinated with an expired dose of PENTACEL (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Initial unsolicited report received from a pharmacist on 06-Aug-2018. This case involves an unknown demographic patient (age and gender not reported) who was vaccinated MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. It was reported that the 5 days apart the patient requested the B series and was given MENACTRA instead. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to drug dispensing error. It was not reported whether the patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Chest X-ray, Dizziness, Headache
Clinical narrative: Swelling in entire left upper arm from shoulder down to elbow, area was red and painful) Fever, dizzy, weak, headache, whole body aches (in all muscles).
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Swelling in entire left upper arm from shoulder down to elbow, area was red and painful) Fever, dizzy, weak, headache, whole body aches (in all muscles).
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis
Clinical narrative: Swelling in entire left upper arm from shoulder down to elbow, area was red and painful) Fever, dizzy, weak, headache, whole body aches (in all muscles).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Anxiety, Dyskinesia, Eye movement disorder, Immediate post-injection reaction, Muscle contractions involuntary
Clinical narrative: Vaccine given and pt noted to have seizure like activity immediately after. Lasted ~20 seconds. Eyes rolled back, jerking of arms, and feet flexed. After episode pt alert and oriented x3. No s/s respiratory difficulty. Pt did not recall episode.BP stable. Reports pt with no food this am. Took ATARAX PRN as prescribed by MD for anxiety r/t vaccine. Hx of fainting with vaccines. Per mom pt has never had seizure like activity before. Had 2 seizure like episodes after vaccine (first immediately after and then 20 minutes later when attempting to sit up again).
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Seizure like phenomena
Clinical narrative: Vaccine given and pt noted to have seizure like activity immediately after. Lasted ~20 seconds. Eyes rolled back, jerking of arms, and feet flexed. After episode pt alert and oriented x3. No s/s respiratory difficulty. Pt did not recall episode.BP stable. Reports pt with no food this am. Took ATARAX PRN as prescribed by MD for anxiety r/t vaccine. Hx of fainting with vaccines. Per mom pt has never had seizure like activity before. Had 2 seizure like episodes after vaccine (first immediately after and then 20 minutes later when attempting to sit up again).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever, aches, fatigue, similar to a severe flu.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Presyncope
Clinical narrative: PATIENT WAS ADMIN VACCINE AFTER 20 MINUTES PATIENT VASOVAGAL IN LOBBY OF CLINIC.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: Patient had INFANRIX in right thigh and HAVRIX in left thigh on 8/7/18. Patient came back into office on 8/10/18 with knot on right thigh and heat at injection site. Mom states patient has been fussy and that she thinks his face seems swollen. He was having no breathing problems during his visit to the office and mom states no breathing problems prior to visit. Patient was seen by physician and told to use warm compresses on the right thigh. Physician states he did not see any swelling in the face. Patient allowed to go home.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Myalgia
Clinical narrative: Muscle pain in legs, extreme lethargy. Felt like had the flu. Lasted about 20hrs and then I was totally fine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site swelling, Pruritus, Rash, Urticaria
Clinical narrative: Pt arm swelled at injection site with large knot the next day and got hive like rash down arm as well. He states this happened after first dose as well but went away in 3 days. This time it hasn't gone away and actually spread down legs 3 days later. It has been over 3 weeks now and rash/hives still present. He states that it is not painful but is very itchy. He has tried using the Triamcinolone cream on the affected areas but it doesn't help. Advised to try BENADRYL orally and see if that helps.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Amylase increased, Back pain, Pancreatitis, Ultrasound abdomen normal
Clinical narrative: The following day after the injection, I started developing stomach pain which progressively got worse causing me to go to the emergency room. The pain continued in my stomach and started going into my back.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Insomnia, Pyrexia
Clinical narrative: On Tuesday the right arm at the injection site was sore by that afternoon, by the evening the joints became painful more so in the right arm to the point of a 9 on the pain scale 1-10. The pain was enough to prevent sleeping the night of the injection. On Wednesday afternoon a fever of 100.8 F developed which continued until approximately 9:00pm. On Thursday the only remaining side effect was soreness at the injection site continuing through Friday.
Age: 36.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone decreased, Chest X-ray, Chest pain, Computerised tomogram abnormal
Clinical narrative: On October 10, 2017 I was informed by nurse supervisor that I was due for Hep B #3. I went to received the shot which was administered by nurse. About 20 to 30 minutes after I was approach by nurse that informed of mistakenly giving me a flu shot rather than the Hep B #3 shot; immediately nurse moved forward in giving me the Hep B shot. On October 25, 2017 I woke up in the morning and realized I was unable to breathe right and/or swallow solid/fluid foods. I was treated at Hospital the same day and which blood work and CT scan were performed. I was informed after the testing results were received that I had a thyroid inflammation and thyroid nodules.
Age: 36.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Dysphagia, Goitre, Radioisotope scan, Respiration abnormal, Thyroid mass
Clinical narrative: On October 10, 2017 I was informed by nurse supervisor that I was due for Hep B #3. I went to received the shot which was administered by nurse. About 20 to 30 minutes after I was approach by nurse that informed of mistakenly giving me a flu shot rather than the Hep B #3 shot; immediately nurse moved forward in giving me the Hep B shot. On October 25, 2017 I woke up in the morning and realized I was unable to breathe right and/or swallow solid/fluid foods. I was treated at Hospital the same day and which blood work and CT scan were performed. I was informed after the testing results were received that I had a thyroid inflammation and thyroid nodules.
Age: 36.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Thyroiditis, Thyroxine, Ultrasound thyroid abnormal, Wrong drug administered
Clinical narrative: On October 10, 2017 I was informed by nurse supervisor that I was due for Hep B #3. I went to received the shot which was administered by nurse. About 20 to 30 minutes after I was approach by nurse that informed of mistakenly giving me a flu shot rather than the Hep B #3 shot; immediately nurse moved forward in giving me the Hep B shot. On October 25, 2017 I woke up in the morning and realized I was unable to breathe right and/or swallow solid/fluid foods. I was treated at Hospital the same day and which blood work and CT scan were performed. I was informed after the testing results were received that I had a thyroid inflammation and thyroid nodules.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Malaise, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever over 102 degrees, full body aches, headache, swelling and pain at site of injection, general malaise.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Fever over 102 degrees, full body aches, headache, swelling and pain at site of injection, general malaise.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Dizziness, Influenza like illness, Pyrexia
Clinical narrative: Feel like I have the flu, feel like I have a fever, chills (no fever), feel dizzy.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Influenza like illness
Clinical narrative: Upset stomach, felt faint, felt flu-ish.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Dizziness, Nausea, Pain
Clinical narrative: Fever greater than 102.5, chills, dizziness, aches, pains in thoracic area, nausea. Was going to emergency department to seek treatment today.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever greater than 102.5, chills, dizziness, aches, pains in thoracic area, nausea. Was going to emergency department to seek treatment today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Malaise
Clinical narrative: Headache, severe muscle and joint pain, weakness, nausea, malaise/fatigue.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Headache, severe muscle and joint pain, weakness, nausea, malaise/fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Myalgia, Pain
Clinical narrative: PT AWOKE MORNING FOLLOWING IMMUNIZATION. FELT SORE ACHY. WENT TO WORK. VERY BAD CHILLS/SHIVERS. PT TOOK OFF FOLLOWING DAY DUE TO SIDE EFFECT OF CHILLS AND ACHE. MUSCLES HURTS FROM SHIVERING.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Flatulence, Headache, Myalgia, Nausea
Clinical narrative: Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site vesicles
Clinical narrative: Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported nausea, muscle pain, rash, headache, severe diarrhea, gas, achiness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Diarrhoea, Fatigue, Gastrointestinal disorder
Clinical narrative: FATIGUE, SHIVERING, GASTROINTESTINAL (DIARRHEA, NAUSEOUS) - JUST WATCHING FOOD COMMERCIALS OR COOKING SHOWS ON TV WAS CAUSING ME TO VOMIT. HEADACHE, FELT LIKE HEART PALPITATIONS, INCREASED BP (SORRY, DON'T HAVE THE READING). BETWEEN GOING TO THE BATHROOM, I TRIED TO REMAIN CALM AND TRIED TO RELAX. DRANK A LOT OF WATER.  SYMPTOMS DISSIPATED AFTER ABOUT 5 HOURS. WAS QUITE EXHAUSTED AFTER. ABOUT TWO WEEKS AFTER THIS INCIDENT, FOR UNKNOWN REASON, SYMPTOMS REAPPEARED, BUT WERE MUCH MILDER.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Palpitations, Vomiting
Clinical narrative: FATIGUE, SHIVERING, GASTROINTESTINAL (DIARRHEA, NAUSEOUS) - JUST WATCHING FOOD COMMERCIALS OR COOKING SHOWS ON TV WAS CAUSING ME TO VOMIT. HEADACHE, FELT LIKE HEART PALPITATIONS, INCREASED BP (SORRY, DON'T HAVE THE READING). BETWEEN GOING TO THE BATHROOM, I TRIED TO REMAIN CALM AND TRIED TO RELAX. DRANK A LOT OF WATER.  SYMPTOMS DISSIPATED AFTER ABOUT 5 HOURS. WAS QUITE EXHAUSTED AFTER. ABOUT TWO WEEKS AFTER THIS INCIDENT, FOR UNKNOWN REASON, SYMPTOMS REAPPEARED, BUT WERE MUCH MILDER.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, and itching of left Deltoid.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: On 6/18/18-Patient's Mother was insistent that child needed Tdap and not Dtap. Mother argued with Physician and her child needs Tdap. Physician gave in and told MA to give Tdap. On 8/6/2018 patient's School Nurse called and stated she reported the wrong vaccine was given and she reported clinic. On 8/27/2018 I called CDC to make sure patient/child was not harm by adult dosage. CDC stated reviewed child's immunizations and stated since child had received already 3 dosed of Dtap previously he will be ok and no need to repeat any dosed.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: On 6/18/18 - Patient's Mother was insistent that child needed Tdap and not Dtap. Mother argued with Physician and her child needs Tdap. Physician gave in and told MA to give Tdap. On 8/6/2018 patient's school nurse called and stated she reported the wrong vaccine was given and she reported clinic. On 8/7/2018 I called CDC to make sure patient/child was not harm by adult dosage. CDC stated reviewed child's immunizations and stated since child has received already 3 doses of Dtap previously she will be ok and no need to repeat any doses.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dry skin, Injection site dryness, Injection site rash, Pruritus, Pyrexia
Clinical narrative: 8/9/2018: He had the varicella vaccine in right thigh and MMR vaccine in left thigh on 7/10/18. He developed a rash on his right thigh about a week after he received the vaccine. The rash has been dry and bumpy without vesicular lesions, scabbing or open wounds. It has been spreading and over the last few days involving his entire right side from his shoulder/arm down to ankle. He had been getting a couple of hives on his arm as well that have been itchy. Mom had not given him any anti-histamine as of yet. He did have a low grade temp a couple weeks ago with Tmax around 100. No nasal congestion, abdominal pain, vomiting, diarrhea. No known sick contacts. He is eating well. Mom states he eats eggs in quiches fine without reaction but does not like plain eggs otherwise. No new detergents, creams, soaps.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: 8/9/2018: He had the varicella vaccine in right thigh and MMR vaccine in left thigh on 7/10/18. He developed a rash on his right thigh about a week after he received the vaccine. The rash has been dry and bumpy without vesicular lesions, scabbing or open wounds. It has been spreading and over the last few days involving his entire right side from his shoulder/arm down to ankle. He had been getting a couple of hives on his arm as well that have been itchy. Mom had not given him any anti-histamine as of yet. He did have a low grade temp a couple weeks ago with Tmax around 100. No nasal congestion, abdominal pain, vomiting, diarrhea. No known sick contacts. He is eating well. Mom states he eats eggs in quiches fine without reaction but does not like plain eggs otherwise. No new detergents, creams, soaps.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Injection site erythema, Injection site nodule
Clinical narrative: Temperature of 102 degrees per mom. Red knotted area on left leg.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Lacrimation increased, Peripheral swelling, Throat irritation, Urticaria
Clinical narrative: After 2-3 hrs. pt. returned to pharmacy with hives on both arms, swelling of eyes (watering), itchy throat and hands began to swell. Pt. given 2 - 25 mg BENADRYL and referred wife to immediately go to urgent care. The need for EPIPEN didn't seem necessary at time.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site pain, Insomnia
Clinical narrative: Patient states stomach was upset and couldn't sleep for 24 hours plus the expected arm injection site pain.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse event noted. MMRV and Varicella vaccine given at the same visit instead of MMR and Varicella.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse event noted - MMRV and Varicella vaccine given at the same visit instead of MMR and Varicella.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Depressed level of consciousness, Lethargy
Clinical narrative: 10-15 minute onset of sudden lethargy. Very difficult to arouse patient with sternal rubs. 15 minutes later patient is arousable and crying. Still showing signs of lethargy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: Surrounding erythema measuring 13 cm in diameter that began approximately 24hrs after vaccination. Started on KEFLEX 500mg TID.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Fall, Nasal injury, Syncope
Clinical narrative: After HPV vaccine patient had syncopal episode and fell off of exam table and sustained traumatic injury to nose. Sent to ER for evaluation.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Diarrhoea, Dry mouth, Feeling abnormal, Gastrointestinal disorder, Nausea
Clinical narrative: Dry mouth, nausea, vomiting, diarrhea. Not feeling good in general several hours after vaccine was given. Patient denied drinking alcohol, eating something that didn't agree with him or anything else. His symptoms were mostly GI symptoms.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Dry mouth, nausea, vomiting, diarrhea. Not feeling good in general several hours after vaccine was given. Patient denied drinking alcohol, eating something that didn't agree with him or anything else. His symptoms were mostly GI symptoms.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy on Right side. Treatment prednisone 80 mg, valacyclovir 1000 mg TID, and REFRESH drops.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: C-reactive protein, Computerised tomogram head, Full blood count, Headache, Metabolic function test
Clinical narrative: Headache, nausea, vomiting, neck stiffness.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Nausea, Urine analysis, Vomiting
Clinical narrative: Headache, nausea, vomiting, neck stiffness.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: Began feeling feverish and generally not well around 2 pm. Fever was 100.4 by 5:30 pm; went to sleep, and when I woke up at 8:30 pm it was 101.9. Took 2 regular ADVIL and fever started to decrease and broke around 10:30 pm. Fever gone by 6:00;am and felt better by 9:00 am  Also, injection site was sore and very red. Redness has decreased in intensity and size, but still present at 4:00 am. Soreness has also slowly decreased, but still achy at 4:00 am.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site reaction, Malaise, Rash vesicular
Clinical narrative: After both the first and second doses of the SHINGRIX vaccine. First dose was May 17, 2018 and second dose was August 10, 2018. Received the first dose at pharmacy and the second at my doctor's office. I began to feel sick (tired, headache) 4-6 hours after both shots. Both times a shingles-like rash developed at the injection site. The first rash was about 3-5 inches in size and lasted 3-4 days. The second rash seems a little smaller. The day after the shots I felt worse (tired,headache, general malaise) than the day of the shot. Tylenol/Advil helped.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Urticaria
Clinical narrative: Patient experienced itchiness near the site of injection in the evening on 8/10/18 (the same day as vaccine was given). This morning (8/11/18) patient has hives up and down both arms, torso, back and legs. Patient bought and took Benadryl while here at pharmacy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Zosteriform rash on left underarm erupted 8 days post vaccine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Arm has redness at site of injection. 3 days later the site is still red and the redness has wrapped around her arm as well. no swelling but arm is warm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: The day after the vaccination I wake up with pain and redness in my arm, headache, nausea, muscle pain and fever.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The day after the vaccination I wake up with pain and redness in my arm, headache, nausea, muscle pain and fever.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reported the morning after vaccine was given. She experienced significant sore arm, fever, headache, and body aches.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Patient experienced arm pain from the injection site down to the lower arm and under the armpit to the point where she could not sleep on that side.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia, Musculoskeletal pain, Pain
Clinical narrative: He is having shoulder pain ever since getting this vaccine in his arm. It is still hurting. It hurt when he got the shot, but by the time he got home it felt really bad. I had called him for his second vaccine in this series and he stated he didn't want it because he arm still hurts and has limited motion and it wakes him up with shooting pain. He says it doesn't hurt when he presses on it.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: He is having shoulder pain ever since getting this vaccine in his arm. It is still hurting. It hurt when he got the shot, but by the time he got home it felt really bad. I had called him for his second vaccine in this series and he stated he didn't want it because he arm still hurts and has limited motion and it wakes him up with shooting pain. He says it doesn't hurt when he presses on it.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain lower, Abdominal tenderness, Discomfort
Clinical narrative: Patient came in today 8/11/18 to report that her left lower abdomen starting hurting and is "uncomfortable". Per patient this began "a couple of days after the injection. Patient showed me the tender area, there does not appear to be a rash or bruising.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling cold, Pain in extremity, Somnolence
Clinical narrative: Very sore arm. Very tired, sleepy, weak, cold.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Patient woke up with small red bumps starting from her torso and going up her body. Right arm was slightly itchy at the bend. Red bumps  were not hot to the touch. Upon follow up with the patient two hours later she was feeling better, the rash was subsiding. She did not take BENADRYL as advised.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient got shot in the afternoon of Aug 9th, the next day on the 10th after shower her husband noticed her left arm had a rash on it where SHINGRIX shot was given. Patient says it is not itchy or painful. When she came to pharmacy on Sat the 11th, she states she does have a lot allergy to meds and food. She is currently on ZYRTEC and takes one each day. The area is not swollen but red about 3 inches in length. Icing it is too late but suggested she take a BENADRYL tonight at bedtime and not take a ZYRTEC tomorrow but instead take another BENADRYL in the am and afternoon on Sunday. I asked if she has any facial or tongue swelling and the answer was no. I suggested topcial hydrocortisone cream on area too. Asked to please call or contact us again if any further issues or concerns. Cautioned her on 2nd shot to warn RPh and probably take a BENADRYL before the next shot.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Abdominal pain, Abnormal dreams, Blood test normal, Chills, Computerised tomogram normal
Clinical narrative: Seizure (very first event 8/4/18) Preceded by rapidly alternating chills and fever, very tired. Went to bed at 8 rather than typical 11pm. Started to drift off then wife got a call, and then took some time to fall asleep. Very strange dream that started as an interesting flow of small woven objects but at the end became fearful & chaotic & seemed to be spinning & puling me down. Wife observed convulsion with rhythmic jerking and grunting sounds but could not wake me. Loss of bladder control. She called 911 (I was at that time able to hear her but unclear about what had happened). Was not able to stand up for paramedics, transported out and admitted to ER. BP&P, EKG, X-Ray, CT and blood workup all reported normal. In ER/ED at about ~3am Saturday out at ~8am. Drove wife home. Saturday (afternoon) chills and fever now gone and we both felt the vaccine side effects were lessening but for redness & swelling near injection site, general soreness, muscle pain and tiredness. (Wife had less severe reactions during both first and second SHINGRIX vaccinations). Sunday gradual improvement but still injection arm redness & swelling, still tired and large muscle soreness. Still have problems lifting legs from sitting position. Top and inside of thighs sore and painful lifting them up. Monday More improved. Redness starting to fade but skin quite hot. Still have sore muscles in abdomen and upper thighs, but continue gradually improving. Saturday Fully recovered from symptoms.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Dyskinesia, Electrocardiogram normal, Erythema, Fatigue, Grunting
Clinical narrative: Seizure (very first event 8/4/18) Preceded by rapidly alternating chills and fever, very tired. Went to bed at 8 rather than typical 11pm. Started to drift off then wife got a call, and then took some time to fall asleep. Very strange dream that started as an interesting flow of small woven objects but at the end became fearful & chaotic & seemed to be spinning & puling me down. Wife observed convulsion with rhythmic jerking and grunting sounds but could not wake me. Loss of bladder control. She called 911 (I was at that time able to hear her but unclear about what had happened). Was not able to stand up for paramedics, transported out and admitted to ER. BP&P, EKG, X-Ray, CT and blood workup all reported normal. In ER/ED at about ~3am Saturday out at ~8am. Drove wife home. Saturday (afternoon) chills and fever now gone and we both felt the vaccine side effects were lessening but for redness & swelling near injection site, general soreness, muscle pain and tiredness. (Wife had less severe reactions during both first and second SHINGRIX vaccinations). Sunday gradual improvement but still injection arm redness & swelling, still tired and large muscle soreness. Still have problems lifting legs from sitting position. Top and inside of thighs sore and painful lifting them up. Monday More improved. Redness starting to fade but skin quite hot. Still have sore muscles in abdomen and upper thighs, but continue gradually improving. Saturday Fully recovered from symptoms.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Myalgia, Pain
Clinical narrative: Seizure (very first event 8/4/18) Preceded by rapidly alternating chills and fever, very tired. Went to bed at 8 rather than typical 11pm. Started to drift off then wife got a call, and then took some time to fall asleep. Very strange dream that started as an interesting flow of small woven objects but at the end became fearful & chaotic & seemed to be spinning & puling me down. Wife observed convulsion with rhythmic jerking and grunting sounds but could not wake me. Loss of bladder control. She called 911 (I was at that time able to hear her but unclear about what had happened). Was not able to stand up for paramedics, transported out and admitted to ER. BP&P, EKG, X-Ray, CT and blood workup all reported normal. In ER/ED at about ~3am Saturday out at ~8am. Drove wife home. Saturday (afternoon) chills and fever now gone and we both felt the vaccine side effects were lessening but for redness & swelling near injection site, general soreness, muscle pain and tiredness. (Wife had less severe reactions during both first and second SHINGRIX vaccinations). Sunday gradual improvement but still injection arm redness & swelling, still tired and large muscle soreness. Still have problems lifting legs from sitting position. Top and inside of thighs sore and painful lifting them up. Monday More improved. Redness starting to fade but skin quite hot. Still have sore muscles in abdomen and upper thighs, but continue gradually improving. Saturday Fully recovered from symptoms.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia, Seizure, Skin warm, Somnolence
Clinical narrative: Seizure (very first event 8/4/18) Preceded by rapidly alternating chills and fever, very tired. Went to bed at 8 rather than typical 11pm. Started to drift off then wife got a call, and then took some time to fall asleep. Very strange dream that started as an interesting flow of small woven objects but at the end became fearful & chaotic & seemed to be spinning & puling me down. Wife observed convulsion with rhythmic jerking and grunting sounds but could not wake me. Loss of bladder control. She called 911 (I was at that time able to hear her but unclear about what had happened). Was not able to stand up for paramedics, transported out and admitted to ER. BP&P, EKG, X-Ray, CT and blood workup all reported normal. In ER/ED at about ~3am Saturday out at ~8am. Drove wife home. Saturday (afternoon) chills and fever now gone and we both felt the vaccine side effects were lessening but for redness & swelling near injection site, general soreness, muscle pain and tiredness. (Wife had less severe reactions during both first and second SHINGRIX vaccinations). Sunday gradual improvement but still injection arm redness & swelling, still tired and large muscle soreness. Still have problems lifting legs from sitting position. Top and inside of thighs sore and painful lifting them up. Monday More improved. Redness starting to fade but skin quite hot. Still have sore muscles in abdomen and upper thighs, but continue gradually improving. Saturday Fully recovered from symptoms.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Urinary incontinence, X-ray normal
Clinical narrative: Seizure (very first event 8/4/18) Preceded by rapidly alternating chills and fever, very tired. Went to bed at 8 rather than typical 11pm. Started to drift off then wife got a call, and then took some time to fall asleep. Very strange dream that started as an interesting flow of small woven objects but at the end became fearful & chaotic & seemed to be spinning & puling me down. Wife observed convulsion with rhythmic jerking and grunting sounds but could not wake me. Loss of bladder control. She called 911 (I was at that time able to hear her but unclear about what had happened). Was not able to stand up for paramedics, transported out and admitted to ER. BP&P, EKG, X-Ray, CT and blood workup all reported normal. In ER/ED at about ~3am Saturday out at ~8am. Drove wife home. Saturday (afternoon) chills and fever now gone and we both felt the vaccine side effects were lessening but for redness & swelling near injection site, general soreness, muscle pain and tiredness. (Wife had less severe reactions during both first and second SHINGRIX vaccinations). Sunday gradual improvement but still injection arm redness & swelling, still tired and large muscle soreness. Still have problems lifting legs from sitting position. Top and inside of thighs sore and painful lifting them up. Monday More improved. Redness starting to fade but skin quite hot. Still have sore muscles in abdomen and upper thighs, but continue gradually improving. Saturday Fully recovered from symptoms.
Age: 75.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Computerised tomogram normal, Dyskinesia, Electroencephalogram normal, Erythema, Grunting
Clinical narrative: Seizure (very first event 8/4/18) Preceded by rapidly alternating chills and fever, very tired. Went to bed at 8 rather than typical 11pm. Started to drift off then wife got a call, and then took some time to fall asleep. Very strange dream that started as an interesting flow of small woven objects but at the end became fearful & chaotic & seemed to be spinning & puling me down. Wife observed convulsion with rhythmic jerking and grunting sounds but could not wake me. Loss of bladder control. She called 911 (I was at that time able to hear her but unclear about what had happened). Was not able to stand up for paramedics, transported out and admitted to ER. BP&P, EKG, X-Ray, CT and blood workup all reported normal. In ER/ED at about ~3am Saturday out at ~8am. Drove wife home. Saturday (afternoon) chills and fever now gone and we both felt the vaccine side effects were lessening but for redness & swelling near injection site, general soreness, muscle pain and tiredness. (Wife had less severe reactions during both first and second SHINGRIX vaccinations). Sunday gradual improvement but still injection arm redness & swelling, still tired and large muscle soreness. Still have problems lifting legs from sitting position. Top and inside of thighs sore and painful lifting them up. Monday More improved. Redness starting to fade but skin quite hot. Still have sore muscles in abdomen and upper thighs, but continue gradually improving. Saturday Fully recovered from symptoms.