chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Headache, Pain in extremity
Clinical narrative: sore arm; headache; back ache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included rectal carcinoma (started 4 years ago the port was still present.).   On 1st September 2020, the patient received Influenza vaccine Quadrivalent unspecified season. In September 2020, less than a week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm, headache and back pain. On an unknown date, the outcome of the pain in arm, headache and back pain were unknown.   It was unknown if the reporter considered the pain in arm, headache and back pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine, and experienced those symptoms.  The name of the vaccine was unknown.  The patient had a history of rectal cancer 4 years ago and the port was still present and she made the comment that she may had to get her port flushed out. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: duration of fatigue post injection; This case was reported by a physician via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. The patient experienced fatigue post injection. The reporter wanted to give patient a clearer answer beyond probably a few days.  It was unclear whether patient had received Shingrix or not as no probing questions were asked prior to end of chat. The reporter did not consent to follow up.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Local reaction, Mass, Skin warm
Clinical narrative: A pretty significant mass raised and warm to touch/ it was a localized reaction; Initial information was received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA229573 (same reporter).  This case involves a 30 years old female patient who had a pretty significant mass raised and warm to touch, it was a localized reaction (inflammation), while she received vaccine  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not pr ovided.  The patient did not receive any concomitant vaccinations.   On 24-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ432AB, expiry date 30-Jun-2021, form: prefilled syringe) once via intramuscular route in the right deltoid for prophylactic vaccination.  On 24-Aug-2020, the patient developed a non-serious pretty significant mass raised and warm to touch, (inflammation) on same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient was evaluated in office by an Obstetrics/gynaecologist who said his impression was it was a localized reaction.  No laboratory data was provided.  The patient did not receive any corrective treatment.  At the time of report, the outcome of event was recovering (reported as The reaction had improved following day).
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Shingles like rash on chest and under arm on right side.  Fever up to 101.
Age: 83.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PATIENT CALLED ME TODAY ON 09/010/2020 SAYING THAT SHE DEVELOPED SWELLING  AROUND INJECTION SITE ON RIGHT ARM , TENDER PAINFUL AS WELL  I ADVISED PATIENT TO TAKE TYLENOL AND APPLY COLD COMPRESSES AND CALL ME BACK TOMORROW  IF SYMPTOMS LASTS
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: chills, fever, nauseous
Age: 53.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Five hours after injections (8:30 PM), started feeling fatigue and muscle and joint soreness.  Two hours later (10:30 PM) while in bed, experienced sever chills and fever of 101 F.   Took Nyquil at 3:00 AM, measured temperature at 6:00 AM, was 98 F.  Fatigue and minor chills continued for the remainder of the morning.  No breathing or GI issues noted during event.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Dizziness, Gait disturbance, Injection site pain, Vertigo
Clinical narrative: I do not know which kind of injected influenza vaccine (inactivated or recombinant) it was. I have decreasing soreness at the injection site. In the middle of the night, I woke up in bed, rolled over, and felt vertigo. The dizziness (feeling of spinning or losing balance) continued when I woke up in the morning, and comes and goes as I lean over or move. It is kind of mild. I have not fallen over, but there were a couple times I took a stumbling step to catch my balance.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Chills first thing in the morning followed by dizziness, temperature was 100.1, then vomiting.  Chills lasted approximately four hours.   Fever lasted about four hours.  Vomiting lasted about 15 minutes, then body aches and severe weakness lasted throughout the rest of the day .
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Chills first thing in the morning followed by dizziness, temperature was 100.1, then vomiting.  Chills lasted approximately four hours.   Fever lasted about four hours.  Vomiting lasted about 15 minutes, then body aches and severe weakness lasted throughout the rest of the day .
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Cough, Headache, Influenza, Muscle spasms
Clinical narrative: Pyloric valve cramped....5 hours of gutshot-like pain until I found a video on how to calm the cramping and then manually emptying the stomach.   Then, 2 days of flu symptoms....headache,  intense bodyache, clogged sinuses, no energy, dry cough.   I had never experienced pyloric valve contraction before, nor had I ever experienced adverse reactions to a flu shot. Corona virus symptoms began 08/08/2020...positive test results confirmed 08/11/2020.   Sickness abated on 08/19/2020, but am still not back up to full stamina.
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Pain, Sinus congestion
Clinical narrative: Pyloric valve cramped....5 hours of gutshot-like pain until I found a video on how to calm the cramping and then manually emptying the stomach.   Then, 2 days of flu symptoms....headache,  intense bodyache, clogged sinuses, no energy, dry cough.   I had never experienced pyloric valve contraction before, nor had I ever experienced adverse reactions to a flu shot. Corona virus symptoms began 08/08/2020...positive test results confirmed 08/11/2020.   Sickness abated on 08/19/2020, but am still not back up to full stamina.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: Patient describes nausea, weakness, fatigue that occurred a day after receiving the high dose flu vaccine (9/9). She received it at lab diagnostics while getting lab work and called us, her PCP office to report symptoms. She feels slightly better today (9/10) but still feels fatigued and weak.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood glucose increased, Generalised tonic-clonic seizure, Loss of consciousness
Clinical narrative: Provided patient flu shot to left deltoid at 9:05 am, started to have a grand mal seizure around one minute later around 9:06, patient was placed in supine position then turned on his right side, Emergent target team assist requested and 911 called, when 3 Target team members arrived, providers protected patient while on exam table while provider checked patient vital signs, over the next 3-4 minutes patient was in and out of alertness and was able to tell me he is diabetic, EMT arrived and a blood glucose was checked. Patient then ambulated with assist to stretcher and transported to hospital.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain
Clinical narrative: Patient reported about 6 hours after getting the vaccination starting with symptoms of chills, headache, body aches and flu like symptoms that lasted a full 24 hours until resolving.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Feeling of body temperature change
Clinical narrative: chills,  fever 99.5 F - 101.4 F,  headache, facial burning, body aches, joint pain, fatigue,  burning ocular orbits,  teeth pain, hot/cold,  These symptoms lasted approximately 7 -8 days; it felt like I had an actual influenza infection.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Influenza like illness, Pain, Pyrexia, Toothache
Clinical narrative: chills,  fever 99.5 F - 101.4 F,  headache, facial burning, body aches, joint pain, fatigue,  burning ocular orbits,  teeth pain, hot/cold,  These symptoms lasted approximately 7 -8 days; it felt like I had an actual influenza infection.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: PATIENT DELEVOPED REDNESS AND INDURATION FOR ONE WEEK. MD SAW PATIENT VIA TELEHEALTH VISIT AND TREATED FOR CELLULITIS.
Age: 11.0
Sex: F
Vaccine: FLU4, HEP, IPV, MMRV, TDAP
Symptoms: Abdominal pain, Blood glucose normal, Pallor, Presyncope, Slow response to stimuli
Clinical narrative: Approximately 2-3 minutes after vaccine administration patient turned very pale and had a pre-syncopal episode.  She was able to respond to commands with a sluggish response.  Complained of abdominal pain.  Patient placed supine, vital signs stable.  Patient recovered spontaneously within 5 minutes.  No LOC, no nausea or vomiting.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 100.4. Localized site pain, redness and swelling x 24 hrs
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Irritability, Pain, Pyrexia, Swelling
Clinical narrative: fever, pain, swelling, redness at site, extreme irritability, refusal to  BF
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Allergy to vaccine, Hypersensitivity, Injection site erythema
Clinical narrative: PATIENT PRESENTED TO THE PHARMACY TODAY AT 10:25AM STATING THAT SHE HAD AN ALLERGIC REACTION TO THE FLU SHOT GIVEN ON 9/9/20. HER SYMPTOMS WAS STOMACH HURTS, REDNESS AT THE INJECTION SITE. THE ER GAVE HER PREDNISONE AND PEPCID. VISUALLY TODAY, MRS IS NOT SHOWING ANY ALLERGIC REACTIONS ON HER ARMS, NECK FACE ETC. AND STATES THAT SHE FELLS GOOD.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient experienced severe flu like symptoms including body aches chills and a fever of close to 104 for 3 days straight, starting about 6 hours after receiving the vaccination. This was 2nd dose in the series. She just now reported it to the pharmacist. She said she also experienced a severe headache. She called her PCP because she was concerned it was not normal, the doctor assured her it could happen with this vaccination the symptoms finally resolved after a full 72 hours.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Dizziness
Clinical narrative: Employee came back to employee health 1.5 hours after the vaccination complaining of severe dizziness and chest heaviness.  No shortness of breath, wheezing or signs of airway restrictions.  No nausea or vomiting. No redness or bruising at injection site.  Blood pressure taken was 150/88.  Heart rate was 120.  Employee taken to facility Emergency Department  by wheelchair.
Age: 71.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This patient reported swelling, itching, and pain at and around the injection site.  She sought evaluation at the ER due to the late hour of onset of symptoms.  She presented at the pharmacy late 9/8 to inform us of the event, and she exhibited an area of redness and swelling approximately 5" in diameter on her left arm, extending from the center of the deltoid.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Urticaria
Clinical narrative: Dizziness Hives
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; PROQUAD administered post temperature excursion; This spontaneous report has been received from a liscensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications  were not reported.   On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) (lot # S031881 with expiration date 07-APR-2021; albumin status rHA) (0.5 milliliter) involved in temperature excursion outside of the recommended prescribing information range (date unspecified) (of -9 degree celsius (C) to 8 C (-2.8 C), during 5 hours and 2 minutes) as prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (STERILE DILUENT). The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The patient did not experience any adverse event.; Sender's Comments:  US-009507513-2009USA001227: US-009507513-2009USA001249:
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: dizzy; very exhausted; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced dizziness and exhaustion. On an unknown date, the outcome of the dizziness and exhaustion were unknown.   It was unknown if the reporter considered the dizziness and exhaustion to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient administered Shingrix last Wednesday from reporting time. The patient had one good day but since then, he/she was dizzy and very exhausted, even after a decent night of sleep. The patient wanted to know how long will the side effects last. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Inflammation, Mass, Pain, Peripheral swelling
Clinical narrative: red knots that were swollen / right thigh had 2-3 streaks of red marks; arm "welted up" with big, red knots that were swollen; red knots that were swollen and painful (especially on the wrist, knuckles, and forearm) / soreness; Inflammation; Itchiness; welted up; red knots; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On 28th August 2020, less than a day after receiving Shingrix, the patient experienced erythema, swelling arm, pain, inflammation, pruritus, welts and mass. The patient was treated with benadryl (nos) (Benadryl). On 29th August 2020, the outcome of the erythema, swelling arm, pain, inflammation, pruritus, welts and mass were recovered/resolved.   It was unknown if the reporter considered the erythema, swelling arm, pain, inflammation, pruritus, welts and mass to be related to Shingrix.  Additional details were provided as follows: The patient did not have known allergies, and never having a bad reaction to anything before. It was reported that the patient experienced a bad reaction after getting the 1st dose of the Shingrix vaccine.  The patient received the 1st Shingrix shot, on her left arm as well as the pneumonia shot on her right arm. About 3-4 hours afterwards, her left arm welted up with big, red knots that were swollen and painful (especially on the wrist, knuckles, and forearm).  The patient's inner right thigh had 2-3 streaks of red marks that were not as bad as the reaction on her left arm. She also experienced soreness, inflammation, and itchiness. The patient took Benadryl the next day, and not too long after everything got better and the reactions were subsided.  The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: red knots that were swollen / right thigh had 2-3 streaks of red marks; arm "welted up" with big, red knots that were swollen; red knots that were swollen and painful (especially on the wrist, knuckles, and forearm) / soreness; Inflammation; Itchiness; welted up; red knots; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On 28th August 2020, less than a day after receiving Shingrix, the patient experienced erythema, swelling arm, pain, inflammation, pruritus, welts and mass. The patient was treated with benadryl (nos) (Benadryl). On 29th August 2020, the outcome of the erythema, swelling arm, pain, inflammation, pruritus, welts and mass were recovered/resolved.   It was unknown if the reporter considered the erythema, swelling arm, pain, inflammation, pruritus, welts and mass to be related to Shingrix.  Additional details were provided as follows: The patient did not have known allergies, and never having a bad reaction to anything before. It was reported that the patient experienced a bad reaction after getting the 1st dose of the Shingrix vaccine.  The patient received the 1st Shingrix shot, on her left arm as well as the pneumonia shot on her right arm. About 3-4 hours afterwards, her left arm welted up with big, red knots that were swollen and painful (especially on the wrist, knuckles, and forearm).  The patient's inner right thigh had 2-3 streaks of red marks that were not as bad as the reaction on her left arm. She also experienced soreness, inflammation, and itchiness. The patient took Benadryl the next day, and not too long after everything got better and the reactions were subsided.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fall, Functional gastrointestinal disorder, Limb injury, Nausea
Clinical narrative: Aching; Chills; had three falls; two motor vehicle accidents; affected her right shoulder and arm; bowel movement difficulty; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo.   In October 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea. On an unknown date, the outcome of the pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea were unknown.   It was unknown if the reporter considered the pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose Shingrix. The patient experienced the events during the period between her first and second vaccine. The reporter did not consent to follow up. The patient reported bowel movement difficulty.  The patient reported nausea that worsened in 2019, and alleviated May 2020.  The patient reported she was prescribed an antiemetic to treat nausea. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR176013:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Road traffic accident
Clinical narrative: Aching; Chills; had three falls; two motor vehicle accidents; affected her right shoulder and arm; bowel movement difficulty; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo.   In October 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea. On an unknown date, the outcome of the pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea were unknown.   It was unknown if the reporter considered the pain, chills, fall, motor vehicle accident, limb injury, bowel dysfunction and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose Shingrix. The patient experienced the events during the period between her first and second vaccine. The reporter did not consent to follow up. The patient reported bowel movement difficulty.  The patient reported nausea that worsened in 2019, and alleviated May 2020.  The patient reported she was prescribed an antiemetic to treat nausea. For tolerance to 2nd dose refer linked case US2020AMR177680, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR176013:same patient
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red spot at the injection site / Got bigger and was raised and puffy; Red spot at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 44-year-old female patient who received HBV (Engerix B adult) (batch number IMM28 ? and 90746 ?, GSK note the reported batch number did not match with any GSK lot number expiry date unknown, ) for prophylaxis.  Concurrent medical conditions included latex allergy.   On 20th July 2020, the patient received the 1st dose of Engerix B adult (intramuscular). On an unknown date, the dose was an unknown dose. On 21st July 2020, 1 days after receiving Engerix B adult, the patient experienced injection site erythema. On 23rd July 2020, the patient experienced injection site swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site swelling was unknown.   The reporter considered the injection site erythema and injection site swelling to be unrelated to Engerix B adult.  Additional details were provided as follows: The reporter was the patient and nursing student.  The patient received Engerix B intramuscularly in her left deltoid and the next day she noticed a red spot at the injection site.   About 3 days later she noticed that it got bigger and bigger and was raised and puffy and red. She took oral Benadryl and it went away and resolved in about one week. The injection was given via pre-filled syringe and was not able to find a VALID lot number on the paperwork.  The reporter stated that they could contact her health care provider to obtain the lot number.  The health care provider indicated that did not think it was a reaction to the shot however the patient did not feel that she should continue the series since it was not anaphylaxis. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Illness, Influenza like illness, Social problem
Clinical narrative: really sick; due to COVID, / she never received the second dose; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. In 2019, the patient received TETANUS VACCINE. On an unknown date, less than a year after receiving Shingrix and TETANUS VACCINE and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, sickness and social problem. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of Shingrix. The patientreceived the Shingrix vaccine in 2019 and experienced a reaction that included flu like symptoms for 24 hours and they were bad, and she was really sick.   The next day she felt like a brand new person and her side effects resolved.   The patient received a tetanus shot on the same day, so she was not certain if her side effects were related to receiving both vaccines on one day. The patient was scheduled to receive the second dose in February 2020, however, due to COVID, and the side effects she experienced, she never received the second dose.   The reporter Consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Atrioventricular block, Coronary artery bypass, Coronary artery disease, Social problem, Transfusion
Clinical narrative: coronary artery disease (three blockages); Three blockages; has also not received the second dose of Shingrix due to the COVID-19 outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of coronary artery disease in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced coronary artery disease (serious criteria clinically significant/intervention required), heart block and social problem. The patient was treated with total blood transfusion. On an unknown date, the outcome of the coronary artery disease, heart block and social problem were unknown.   It was unknown if the reporter considered the coronary artery disease and heart block to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced coronary artery disease with three blockages and had to have a triple bypass and blood transfusions.  This patient had also not received the 2nd dose of Shingrix due to the COVID-19 outbreak. The reporter consented to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: arm swollen and red and unable to move it; arm swollen and red and unable to move it; arm swollen and red and unable to move it; inflammation; This is a spontaneous report from a contactable Pharmacist. A patient of unknown age and gender received pneumococcal 13-val conj vac (DIPHT CRM197 PROTEIN) (PREVNAR 13) on unknown date at single dose via unknown route of administration for immunization. Medical history and concomitant medications were not reported. Reporter wanted to know whether these were common side effects and any management recommendations: arm swollen and red and unable to move it. Reporter was just glad to know that it was being recorded and expected to happen and did not realize that sometimes it occurred 7-14 days after injection. Reporter given this shot for a lot of patients and this was the very first time reporter had this complaint. Patient was advised to get Benadryl, Tylenol and ibuprofen for inflammation, and ice. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: 11 year male patient administered expired dose of Tenivac, no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case received from another health professional. This case involves a 11 year old male patient who received 0.5 mL expired dose of vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6014AB and expiry date: 20-Jul-2020) via intramuscular route in the left deltoid on 17-Aug-2020.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  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 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.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 5 year male patient administered expired dose of Ipo, no AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 year old male patient who received 0.5 mL fourth expired dose of vaccine IPV (VERO) [IPOL] (lot N1K931M and expiry date: 18-Nov-2019) via an intramuscular route at an unknown administration site on 25-Aug-2020.  Medical history, medical treatment, vaccination and family history were not provided.  On 25-Aug-2020, concomitant medications included patient was treated with TUBERCULIN PPD (TUBERSOL) for Tuberculin test.  It was a case of actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  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 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.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: pt states the day after vaccines were given (9/9/2020) some, small, red, painful welts/stripes developed by the site of the flu injection and radiated toward her underarms.  Pt states the pain and welts seemed to be resolving as of  9/10/2020.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Rash
Clinical narrative: Pt had a rash 5-6 hours after receiving vaccination
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Eye oedema, Eye swelling, Headache, Hypertension
Clinical narrative: muscle aches, stomach tightness, swollen right eye with edema, headache, fever 99.8 (my normal is 97.2), hypertension 170/97 (my normal is 120/70 or less), general malaise.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: muscle aches, stomach tightness, swollen right eye with edema, headache, fever 99.8 (my normal is 97.2), hypertension 170/97 (my normal is 120/70 or less), general malaise.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills
Clinical narrative: 8 hour after injection, I experienced chills and shivering for about 2 hours.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to pharmacy the day following injection with complaint of redness, swelling, and pain in the arm around injection site. Patient reported on 9/10/2020 that the swelling and redness has improved and she is not having much pain.
Sex: M
Vaccine: UNK
Symptoms: Brain injury, Respiratory arrest
Clinical narrative: Suddenly stopped breathing, brain damage
Age: 0.5
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event noted at this time. Was suppose to receive Pediarix
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous, Vaccination complication
Clinical narrative: On 9/3/20 the child started a rash of red spots (no fluid)  on face, arms, and chest. Visited the LPRH ER on Friday 9/4/20 and doctor diagnosed a reaction to vaccinations per foster parent. Red spots were gone by Sunday 9/6/20.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 50 years old and received the high dose flu vaccine.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Urticaria
Clinical narrative: PT came 2 days after having her flu shot saying that she was achy on the first day after the shot then on the second day she broke up in hives all over her body, pt got flu shot before and she only has allergy to penicillin per her consent
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was given high dose flu vaccine instead of regular flu vaccine
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; An expired dose of PROQUAD was given to a patient 5 days after expiry; This spontaneous report was received from a nurse and refers to a patient of 4 years old and unknown gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    The reporter stated that on 13-AUG-2020, the patient was vaccinated with an expired (5 days after expiry) dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml (dosage regimen was not provided) lot # reported as S003866 expiration date 08-AUG-2024 (discrepant information)  , albumin status: rha  for prophylaxis. No additional adverse events reported.
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 12-months-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    On 25-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not provided) lot # S024364 expiration date 06-AUG-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The improperly stored dose experienced temperature of -14 degree Celsius (°C) to -10°C (average temperature was -13.04°C) for 45 min. There was no previous temperature excursions. The call was because a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA000691: US-009507513-2009USA000716:
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: Medical assistant gave a 12 month PROQUAD and MMR II simultaneously; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On an unknown date, the medical assistant gave the patient vaccination with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) simultaneously with the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route of administration, anatomical location, lot # and expiration dates were not reported for both vaccines), for prophylaxis (inappropriate schedule of vaccine administered).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Costumer reporting AE administration of improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    On 03-SEP-2020, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not provided, albumin statu: rHA) lot # T012422 (has been verified to be valid lot #) expiration date 19-SEP-2022, for prophylaxis.   The improperly stored dose experienced a temperature excursion of 14.4 degree Fahrenheit (F) for 30 min. There were no previous temperature excursions. The call was because a digital data logger. No additional adverse event was reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA003067:
Age: 67.0
Sex: F
Vaccine: FLUX, PPV, VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: first dose of Shingrix / November 22, 2019 / not received second dose yet; arm was sore the next day / arm was also sore / caused a sore arm too; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 22nd November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season (intramuscular) and PNEUMONIA VACCINE. On 23rd November 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced incomplete course of vaccination. On 24th November 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix in an unknown arm. After receiving 1st dose, the patient's arm was sore. The patient also received unspecified flu vaccine in the opposite arm and that arm was also sore. Pneumonia vaccine was administered in an unspecified arm and reportedly caused a sore arm too. The reporter did not consent to follow up. This case was linked with case US2020178102, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178102:Same reporter (husband´s case)
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 14 year old was administered flublok quadrivalent/no AE; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 year-old-male patient who was vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2006 and expiry date 22-May-2021) via unknown route at an unknown administration site on 04-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration  At the time of report no adverse event was reported.  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 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.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 years old was administered flublok quadrivalent/no AE; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 year-old-male who was vaccinated with 0.5 mL  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2006 and expiry date 22-May-2021) via unknown route at an unknown administration site on 04-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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 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.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Aggression, Dyskinesia, Echocardiogram normal, Irritability, Magnetic resonance imaging brain normal
Clinical narrative: Onset of unusual hand movements / possible tics, as well as irritability and aggressive behavior. Seen by Dr. (pediatric neurology) and not thought to be c/w Sydenham's chorea.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Streptococcus test negative, Sydenham's chorea, Tic
Clinical narrative: Onset of unusual hand movements / possible tics, as well as irritability and aggressive behavior. Seen by Dr. (pediatric neurology) and not thought to be c/w Sydenham's chorea.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Three days after getting the vaccine, client woke up with pain in his arm hurting to the point of difficulty lifting his arm . Took Tylenol and muscle cream.  8/2 started ibuporfen.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Rash all over arm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Myalgia, Pruritus, Throat tightness, Tremor
Clinical narrative: Itching, shortness of breath, muscle soreness, throat tightness, shaking
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Beginning around midnight after the vaccination, I developed flu-like symptoms. I had chills, body aches, headache, body fatigue and weakness. It lasted at least 36 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Beginning around midnight after the vaccination, I developed flu-like symptoms. I had chills, body aches, headache, body fatigue and weakness. It lasted at least 36 hours.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Bone pain, Cold sweat, Dizziness, Erythema, Feeling hot
Clinical narrative: After administration of shingrix vaccine she felt dizzy, light headed, and she got very hot, (hot flash).  Her skin was red and hot and clammy.  I prepared to administer Epi-pen but her breathing was OK.  Cooled her down with fan, water,,,, reaction subsided in about 10 mins.   after about 20 mins she felt normal again,   Then after about 50 mins she stood up and felt faint and same reaction started over only this she stated she bone pain everywhere, especially her back.    911 was called and they monitored her and took her to er
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hot flush, Skin warm
Clinical narrative: After administration of shingrix vaccine she felt dizzy, light headed, and she got very hot, (hot flash).  Her skin was red and hot and clammy.  I prepared to administer Epi-pen but her breathing was OK.  Cooled her down with fan, water,,,, reaction subsided in about 10 mins.   after about 20 mins she felt normal again,   Then after about 50 mins she stood up and felt faint and same reaction started over only this she stated she bone pain everywhere, especially her back.    911 was called and they monitored her and took her to er
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: Pt developed new onset vertigo at 2am (approximately 12 hours after vaccine was administered)
Age: 68.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Night sweats, Pyrexia
Clinical narrative: pt states thats, the night of getting flu shot and prevnar she experiened high fever,night sweats. nothing else was reported. pt states that she did not take any medication and it went away the next day.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea
Clinical narrative: Patient stated that he suffers from diarrhea, and had to use the bathroom twice in a row as soon as he went home from the pharmacy. Fellow pharmacist recommended OTC medication for treatment.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: Pt received flu shot on 9/3.  Patient called pharmacy on 9/8 stating that 1 day after the flu shot she had a swollen lymph node and 4 days after the flu shot her hands started to itch and she started to get a rash on her hands and her arms. She reported having no fever.
Age: 0.42
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO adverse affects.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Left arm swelling plus redness st vaccination site