chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 01-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 07-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 04-NOV-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 30-JAN-2020, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain in extremity, Rotator cuff syndrome
Clinical narrative: rotator cuff problem; arm was extremely painful / what was causing this pain/injection spot pain; has been uncomfortable ever since / arm has been bothering me a lot; This case was reported by a consumer and described the occurrence of rotator cuff injury in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced rotator cuff injury, pain in extremity and discomfort. On an unknown date, the outcome of the rotator cuff injury, pain in extremity and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the rotator cuff injury, pain in extremity and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on an unknown arm. After receiving Shingrix, the patient's arm was extremely painful for 3 days, and had been uncomfortable ever since.  The patients' arm that had the 1st injection had been bothering him/her a lot for the last 3 months from the time of reporting. The patient was uncertain as to what was causing this pain. A couple days ago from the date of reporting, the patient made a movement and thought that it was the same pain the patient experienced after receiving the initial injection. The patient's pain was so bothering that he/she went to the doctor the past week from the date of reporting. She thought, the patient might have a rotator cuff problem and was arranging physical therapy. The patient received 2nd dose in January 2020 in different arm. This case was linked with case US2020AMR096017, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR096017:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 9 months after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. In mid or late November 2019, the patient received 1st dose of shingle vaccine and annual flu shot and experienced side effects. The patient stated that healthcare professional refused to give patient the 2nd dose within the 6 month range because of CDC guidance on Covid 19 and potential side effects similar to Shingles vaccine side effect. The patient wanted to know How effective was just the first dose of the shingles vaccine versus both doses in clinical trials and also what was the longest interval between dose 1 and dose 2, beyond 6 months, where the second dose can still be given and still effective. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: left me a really sore arm; redness; This case was reported by a other health professional and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (mild case).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine and had sore arm for weeks and redness.  This case has been linked with case US2020AMR097354, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Aches/ Body Aches; Haven't slept much; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a day after receiving Shingrix, the patient experienced pain, difficulty sleeping and fever. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the pain, difficulty sleeping and fever were not recovered/not resolved.   It was unknown if the reporter considered the pain, difficulty sleeping and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix at 9 pm and had not slept much last two nights. The patient had body aches and 102.1 degree F fever. The patient was treated with aleve and asked how long was this going to last.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysuria, Pain, Pyrexia
Clinical narrative: difficulty with urination; high fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of urination difficulty in a 61-year-old male 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 urination difficulty, fever and general body pain. On an unknown date, the outcome of the urination difficulty, fever and general body pain were unknown.   It was unknown if the reporter considered the urination difficulty, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and had urinary difficulty, high fever and body aches also. The reporter asked was a side effect of Shingrix difficulty with urination.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: area is red; hot to touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix in upper arm and area was red and hot to touch.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via call center representative and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as anadult as per the vaccine indication. The reporter wanted to know what to take for pain after the Shingrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: muscle ache/muscle ache at the Shingrix injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain 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 injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain 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 adult as per vaccine indication. The age group was not reported but was selected as per the vaccine indication. The patient experienced muscle ache at the Shingrix injection site. The patient asked how long it could last.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Headache; muscle ache; dizziness; fatigue; This case was reported by a consumer and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced headache, muscle pain, dizziness and fatigue. On an unknown date, the outcome of the headache, muscle pain, dizziness and fatigue were unknown.   It was unknown if the reporter considered the headache, muscle pain, dizziness and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was reported by patient's husband. The patient had immunization with Shingrix 36 hours ago prior to the reporting date and still experiencing headache, muscle ache, dizziness, and fatigue. The reporter asked If a person is having side effects from Shingrix, how long should they normally last. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Myalgia, Pain
Clinical narrative: Very red sore area 3 inches below injection site; Very red sore area 3 inches below injection site; Feeling crappy; Muscles soreness; This case was reported by a other health professional via call center representative and described the occurrence of pain localized in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included BCG injection with an associated reaction of keloid scar (had as a child). Concurrent medical conditions included keloid scar.   On 1st June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced pain localized, localized erythema, feeling bad and muscle soreness. On an unknown date, the outcome of the pain localized was recovering/resolving and the outcome of the localized erythema was not recovered/not resolved and the outcome of the feeling bad and muscle soreness were recovered/resolved.   It was unknown if the reporter considered the pain localized, localized erythema, feeling bad and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a very sore red area associated with a keloid scar about 3 inches below injection and feeling crappy for about 24 hours, and muscle soreness both which went away after about 24 hours. The day before reporting there was still a very sore red area associated with a keloid scar about 3 inches below injection site and at date of reporting seems to be going away as well. The reporter consented to follow up and gave permission for GSK to follow up with her if needed.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash on her left shoulder; This case was reported by a consumer via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th June 2020, 14 days after receiving Shingrix, the patient experienced rash. On 5th June 2020, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient developed a rash on her left shoulder near where she received the injection. The patient wanted to make sure it was not contagious.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: rash as the size of a half dollar; warm to the touch and ongoing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) and (batch number 57EE5, expiry date 25th April 2022) for prophylaxis.   On 29th May 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, 1 week after receiving Shingrix, the patient experienced rash and skin warm. On an unknown date, the outcome of the rash and skin warm were recovered/resolved.   It was unknown if the reporter considered the rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was reported as 4RS5J, however was changed to 4RF5J as per sales data sheet. the patient received Shingrix batch. The patient experienced a rash as the size of a half dollar, warm to the touch, and ongoing approximately one week after receiving dose one of Shingrix.  The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pain, Sensitive skin
Clinical narrative: swelling at the injection site; pain in the body; Headache; very sensitive from her elbow to her shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date unknown) for prophylaxis.   On 3rd June 2020, the patient received the 1st dose of Shingrix. On 4th June 2020, 1 days after receiving Shingrix, the patient experienced injection site swelling, general body pain, headache and sensitive skin. On an unknown date, the outcome of the injection site swelling, general body pain, headache and sensitive skin were unknown.   It was unknown if the reporter considered the injection site swelling, general body pain, headache and sensitive skin to be related to Shingrix.  Additional information was provided as follows: The patient experienced events a day before reporting. The reporter consented to follow up. No expiration date was provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Knee pain; This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced knee pain. The patient was treated with cortisone (non-proprietary) (Cortisone Shot). On an unknown date, the outcome of the knee pain was unknown.   The reporter considered the knee pain to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a Cortisone shot after receiving the Shingrix.  The Cortisone was received for Knee Pain. The reporter consented to follow up. The pharmacist did not know the specific condition and did not feel it was related to receiving the Shingrix vaccination.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Malaise, Pain in extremity
Clinical narrative: sick, and "didn't feel good"; Arm Ache; Back Ache; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced feeling unwell, pain in arm and back pain. On an unknown date, the outcome of the feeling unwell was unknown and the outcome of the pain in arm and back pain were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, pain in arm and back pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix three weeks ago and had back ache, arm ache, sick, and did not feel good. The patient was unable to provide lot number, expiration date, or healthcare provider information for follow up. The reporter did not consent to follow up.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: diagnosed with pneumonia; diagnosed with pneumonia; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age (78 unknown unit) receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient's medical history and concomitant medications did not be reported. The patient was diagnosed with pneumonia on 01Feb2020 but he had already had the vaccines available, but with the Covid 19 virus in circulation, who knows what he was experiencing, but the Levoquin antibiotic did the trick and patient did not have to be hospitalized. The outcome of event pneumonia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: she had this shot and did have pneumonia years after receiving it; she had this shot and did have pneumonia years after receiving it; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient stated that this shot could help you from having pneumonia. She stated that she had this shot and did have pneumonia years after receiving it and the doctor advised her it could have been much worse if she had received this shot (as reported). Outcome of the event was unknown.   Information on the batch number has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was suppose to be administered daptacel, but received adacel, no AE; Patient was suppose to be administered daptacel, but received adacel, no AE; Initial information was received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 15 months old male patient who received 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6602AA, expiry date 25-Feb-2022 via intramuscular route in left upper leg) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) for prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided. Patient had recieved 3 Pentacel (DIPHTHERIA VACCINE TOXOID HIB VACCINE CONJ (TET TOX) PERTUSSIS VACCINE ACELLULAR 2-COMPONENT POLIO VACCINE INACT 3V (VERO) TETANUS VACCINE TOXOID).  Concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported (symptoms none 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: 0.17
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol was stored at the highest temperature 12.3 degrees C and total excursion time was 25 minutes, product was opened and was given a vaccine 24 hours after the excursion/ No AE; Initial information was received on 09-Jun-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 weeks old (11 weeks 3 days) male patient who was vaccinated with the dose of suspect IPV (VERO) [IPOL] which was stored at the highest temperature 12.3 degrees C and total excursion time was 25 minutes, product was opened and was given a vaccine 24 hours after the excursion (product storage error)  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included HIB VACCINE (HIB VACCINE); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination given on 13-May-2020.  On 13-May-2020, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot P1F541M and expiry date 07-Dec-2020) via unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to incorrect product storage.  case details: the reporter called know the stability data of Ipol vaccine. Reporter stated that that the patient received an IPOL dose from a multidose vial that had been out of range as the refrigerator was turn off.  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 Directiveand 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.
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Immunisation reaction, Injection site swelling
Clinical narrative: received DTaP. developed swelling on injection site w/erythema extending to arm and face. Went to ER. Dx'ed w/immunization reaction no medication was needed. When he returned 5-27-20, He was well. (-) Swelling.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: NAUSEA, VOMITING, SEVERE HEADACHE A COUPLE HOURS AFTER THE VACCINES WERE GIVEN- PARENT BROUGHT HER TO A LOCAL ER(The Hospital) WHERE SHE RECEIVED IV FLUIDS, AND MEDICATION FOR HER HEADACHE PER THE MOTHER. WE HAVE REQUESTED THESE RECORDS FROM THE HOSPITAL SO AT THIS TIME ALL WE KNOW IS FROM THE MOTHER. PATIENT WAS RELEASED A FEW HOURS LATER, PARENT STATES SHE HAS BEEN DOING WELL SINCE.
Age: 32.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site vesicles, Rash erythematous, Rash pruritic
Clinical narrative: ON 6-12-2020, INJECTION SITE TO BACK OF RIGHT ARM STARTED WITH FLUID FILLED VESICLES. APPROXIMATELY 3 INCHES IN DIAMETER. NO PAIN OR ITCHING AT SITE. ITCHY RED BUMPS BEGAN TO TORSO ON 6-12-2020
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema ( 10 cm), swelling and pain at injection site, headache, malaise, body aches.  Difficulty moving shoulder d/t pain
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Malaise, Pain
Clinical narrative: Erythema ( 10 cm), swelling and pain at injection site, headache, malaise, body aches.  Difficulty moving shoulder d/t pain
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia, Rash macular
Clinical narrative: Parent described patient developing a tennis ball-sized area of swelling with a line of redness surrounding it around the DTaP injection site on the left upper arm as well as fever up to 101 F the day after receiving the injection. No other symptoms were reported. Patient was given Ibuprofen and Tylenol by her parent. Patient was seen in office 3 days after immunization. At that time, there was a macular erythematous rash on the L upper arm in a circular shape. No raised area was noted on exam.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Headache, severe dizziness starting 2-3 hours after injection, lasting about 12 hours. Fatigue, full body aches and pains starting within 12 hours of injection, lasting about 48 hours. Fever, chills starting within 12 hours of injection, lasting about 36 hours. Mild lightheadedness and diarrhea starting about 64 hours after injection, still ongoing as of  6/15/20
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, severe dizziness starting 2-3 hours after injection, lasting about 12 hours. Fatigue, full body aches and pains starting within 12 hours of injection, lasting about 48 hours. Fever, chills starting within 12 hours of injection, lasting about 36 hours. Mild lightheadedness and diarrhea starting about 64 hours after injection, still ongoing as of  6/15/20
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema
Clinical narrative: Two-inch red circle around the bandage; Spontaneous report received on 23MAR2012.  A consumer reported that he developed a "two-inch red circle around the bandage" (PT: Injection site erythema) following the administration of ACAM2000 (smallpox (vaccinia) vaccine, live). The patient was received Smallpox vaccine and bandaged it up. Later, he had noticed two-inch red circle around the bandage. Outcome was unknown at the time of report.  Company Comment: Local injection site reactions like erythema could happen after ACAM2000 vaccination, and the causality of the event is assessed as possible. The case is considered non-serious as per medical assessment and case information.; Sender's Comments: Local injection site reactions like erythema could happen after ACAM2000 vaccination, and the causality of the event is assessed as possible. The case is considered non-serious as per medical assessment and case information.
Sex: U
Vaccine: VARZOS
Symptoms: Dysuria
Clinical narrative: difficulty with urination; This case was reported by a consumer via call center representative and described the occurrence of urination difficulty 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 urination difficulty. On an unknown date, the outcome of the urination difficulty was not recovered/not resolved.   It was unknown if the reporter considered the urination difficulty 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. The age at vaccination was not reported. After receiving Shingrix, the patient experianced difficulty with urination. The reporter wanted to know difficulty with urination side effect of Shingrix.
Sex: M
Vaccine: PNC13
Symptoms: Nasopharyngitis, Synovitis, Viral infection
Clinical narrative: Her son has a tendency to have transient synovitis 4-7 weeks following a cold or a virus.; Her son has a tendency to have transient synovitis 4-7 weeks following a cold or a virus.; Her son has a tendency to have transient synovitis 4-7 weeks following a cold or a virus.; This is a spontaneous report from a contactable consumer (Mother). A male patient of an unspecified age received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced a tendency to have transient synovitis 4-7 weeks following a cold or a virus on unspecified date. The mother reported her son has never had it after a vaccine. They have been in quarantine and have not been exposed to any sickness. Her son had what looked like a transient episode this week. It has went away.  The mother was asking if there is any report of joint inflammation with pneumococcal 13-val conjugate vaccine (dipht crm197 protein). The events were non serious. The outcome of the event synovitis was recovered on unspecified date. The outcome of the events cold and viral infection was unknown.  No follow-up attempts are Needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Feeling cold, Headache
Clinical narrative: About 10:30 at night I became very cold and my teeth started chattering (this has never happened to me before), I got a terrible headache, upset to stomach, sweating.  I WAS AFRAID I WAS  GETTING THE CORONAVIRUS. By 4:00a.m. , 6/13/20, I was not cold, no chattering teeth, but the rest of the day I did not feel good. My arm hurt almost immediately, and still hurts today.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: About 10:30 at night I became very cold and my teeth started chattering (this has never happened to me before), I got a terrible headache, upset to stomach, sweating.  I WAS AFRAID I WAS  GETTING THE CORONAVIRUS. By 4:00a.m. , 6/13/20, I was not cold, no chattering teeth, but the rest of the day I did not feel good. My arm hurt almost immediately, and still hurts today.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient was given vaccine and soon after began having shooting pain down her arm. She believed the vaccine was given too high (was given slightly higher than usual). She continued to have pain down her arm throughout the next day, so she contacted her PCP. She was prescribed a prednisone taper to help with the pain, which she said was helping.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13, RV5
Symptoms: Haematemesis, Haematochezia, Ultrasound scan normal
Clinical narrative: Mom stated that patient spit-up twice and the second time the spit up contained little clumps of blood. Patient did not have a fever and was acting normal. On June 12 patient's mom reported that the patient had what appeared to be a bloody ring around his stools for the past 2 days on several occasions. Patient was not fussy.  Patient went to the ED. Ultrasound normal.  Dr. advised mom avoid milk for 1-2 months.  Told mom to call our office if patient still has bloody stools in 7 days or call sooner if worsening.  However, the bloody spit-up and stools most likely related to Rotateq since started 6 days after vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Another nurse was showing me how to draw up the Menveo injection, she handed me the vials and told me what to do and she handed me the correct vial to chart on. I gave the pt the injection and when I sat back at my desk to chart and realized the injection was outdated 03/20.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Customer states she is experiencing a new shingles outbreak.    Rash appeared on the back of her leg beginning on 3/31/20 and  6/13/2020.    Customer visited Dr. on 3/28/20.    Her 2nd rash appeared 6/13/20; but she has not yet made an appointment to see her regular doctor.   The pharmacy placed a call to the office for a refill of Acyclovir 800 mg #10, (1 bid) today.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Cardiac arrest, Death, Sudden infant death syndrome
Clinical narrative: Suffered Cardiac Arrest at Home and died. (Sudden unexplained infant death)
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received a pediatric dose of Hepatitis A for her second dose.  The patient was contacted by telephone and returned to the clinic for an adult dose of Hepatitis A to complete her series.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Musculoskeletal stiffness
Clinical narrative: Fever 100.4; Stiff Neck; Chills;body aches;Diarrhea; Joint Pain; Pain in Arm; Swelling;Redness;1/3 upper arm.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever 100.4; Stiff Neck; Chills;body aches;Diarrhea; Joint Pain; Pain in Arm; Swelling;Redness;1/3 upper arm.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Pyrexia, Swelling
Clinical narrative: PT C/O HAVING A FEVER ON SATURDAY 101.5 AND FEELING TIRED,DIARRHEA AND SWELLING ON HER LEFT ARM LIKE A BUG BITE.DENIED SOB,HIVES.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypoaesthesia, Injection site pain, Injection site reaction
Clinical narrative: about 12 hours after injection patient developed body aches,  chills sensitivity to light, headache and nausea that lasted until 6/14/20 night.  red rash developed 6" below the injection site 6/14/20 and continues to grow when seen in the clinic. 6/15/20 rash has double in size, numbness and tingly in arm and fingers, constant ache from the top of the left shoulder to the top of the neck.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Neck pain, Pain, Paraesthesia, Photophobia
Clinical narrative: about 12 hours after injection patient developed body aches,  chills sensitivity to light, headache and nausea that lasted until 6/14/20 night.  red rash developed 6" below the injection site 6/14/20 and continues to grow when seen in the clinic. 6/15/20 rash has double in size, numbness and tingly in arm and fingers, constant ache from the top of the left shoulder to the top of the neck.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: about 12 hours after injection patient developed body aches,  chills sensitivity to light, headache and nausea that lasted until 6/14/20 night.  red rash developed 6" below the injection site 6/14/20 and continues to grow when seen in the clinic. 6/15/20 rash has double in size, numbness and tingly in arm and fingers, constant ache from the top of the left shoulder to the top of the neck.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling, Tenderness
Clinical narrative: 7 cm werical by 5 cm horizontal area of swelling and tenderness under the skin. No Hives and erythema no increased warmth
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest discomfort, Erythema, Oedema, Skin lesion, Skin warm
Clinical narrative: 22 YOF pt with c/o localized erythematous lesion on LUE that she noticed this morning after Varicella vaccine was administered. Vaccine was given on 6-14-20. She also had MMR and Tubersol administered on the same date but on RUE. Pt denies any other symptoms except for chest tightness that she had yesterday that lasted 5 minutes with no other symptoms. She reports the chest discomfort is recurrent and that it occurs once a week or every 2 weeks. She denies discomfort today. She has not been evaluated by a specialist and declined PCP or Cardiology referral today. Pt afebrile. No distress noted. P.E unremarkable except as noted for 4 cm (W)x 3.5 cm (L) erythematous and edematous lesion on LUE. Blanching noted. Atea is warm and tender to touch. No drainage. C/D/I area.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Tenderness
Clinical narrative: 22 YOF pt with c/o localized erythematous lesion on LUE that she noticed this morning after Varicella vaccine was administered. Vaccine was given on 6-14-20. She also had MMR and Tubersol administered on the same date but on RUE. Pt denies any other symptoms except for chest tightness that she had yesterday that lasted 5 minutes with no other symptoms. She reports the chest discomfort is recurrent and that it occurs once a week or every 2 weeks. She denies discomfort today. She has not been evaluated by a specialist and declined PCP or Cardiology referral today. Pt afebrile. No distress noted. P.E unremarkable except as noted for 4 cm (W)x 3.5 cm (L) erythematous and edematous lesion on LUE. Blanching noted. Atea is warm and tender to touch. No drainage. C/D/I area.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pyrexia, Tenderness
Clinical narrative: 100.5 F fever, feverish feeling, fatigued; very sore right shoulder; took 1 Tylenol, fever reduced to 99.3. Really wanted to lie down but had to work (sitting). Took 2 Ibuprophen ~ 8 PM same day. Tender shoulder well into Saturday evening.
Age: 32.0
Sex: F
Vaccine: JEV1
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Paraesthesia, Syncope
Clinical narrative: Patient received the Japanese Encephalitis Vaccine and started to don her blouse.  Pt stated that she needed to sit down and began to slouch over.  I caught the patient and gently leaned her back on the exam table and lifted her legs and placed on the exam table  foot rest.  I was speaking to the patient until she regained consciousness.  Patient was pale and sweating.  Once patient regained consciousness, the patient stayed laying down and was given a cold pack.  Patient stayed laying down for roughly five minutes and then was able to sit up and had the exam table placed into the seated position.  patient stated her fingers were tingling. Patient was given a glass of water and crackers and felt better within moments. Patient stated she did not eat breakfast and did not drink much water but had a Monster energy drink.  I sat with the patient for about 20 minutes after the episode and ensured she felt well enough to stand and walk.  I consulted a medical provider to ensure nothing else was required. Patient felt well enough to leave and did not wish to be seen by a provider was escorted to her car by another team member.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: constant 'field of crickets' sound,  and ringing in the ears (sometimes loud, sometimes not as loud), I have noticed when I move my jaw sometimes the ringing stops and sometimes it get much louder (happens in both ears but the constant 'field of crickets' is always. steady decrease of hearing.. I think I have lost at least half my hearing now. I fear it is getting worse. My doctors have pushed my appts back and back because of CoVid19. I have now tried to move to (I just called today 6/15/2020) Monday July 13, 2020 for new patient appt. I hope I am not totally deaf by then.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Anosmia, Taste disorder
Clinical narrative: Starting next day patient states she has lost smell and everything tastes foul.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Pyrexia, Rash, Streptococcus test negative
Clinical narrative: Fever developed on 6/10/2020.  responded to Ibuprofen and Tylenol.  Rash developed on 6/15/2020 after no fever for 24 hours.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 DAYS AFTER VACCINE, LEFT THIGH WAS RED AND SWOLLEN TIMES 1 DAY. MOM GAVE TYLENOL AND COOL COMPRESS
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: fever, redness, swelling, hard at injection site
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Patient presented today with a roughly 2 to 3 inch diameter area of redness/bruising at the injection site. Patient stated that he had already been evaluated by a physician who did not display any concern. No treatment was recommended other than ice and rest. Patient stated that the worst of the symptoms had developed by midnight of the night of injection and have improved slightly since then.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: local swelling on the left deltoid area, red and itchy, no pus
Age: 23.0
Sex: F
Vaccine: HPV9, MMR
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: After a couple minutes of receiving vaccine, patient stated she felt a little light headed. She appeared to pass out in the chair and was not responding to her name for a couple seconds. After less than a minute, she opened her eyes and was responsive again.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: nausea, vomiting, myalgias, chills. Did not take temperature. Severe fatigue for three days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: red, itchy bumps on interior of both arms
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Dizziness
Clinical narrative: Within 2 minutes of receiving the vaccine, the patient reported she felt very light headed and though she may pass out.  She did not pass out, but did need to lie down for approximately 10 minutes before she began to feel better.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature fluctuation, Cold sweat, Fatigue, Hypersomnia
Clinical narrative: extreme fatigue, rash on forearms and torso.  Fluctuating low/hi temperature 97 - 99 deg F. 5 weeks after, 6/13/20 recurring symptoms of extreme fatigue, rash on forearms. Lack of energy, clamminess. low energy.  sleeping all the time.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: extreme fatigue, rash on forearms and torso.  Fluctuating low/hi temperature 97 - 99 deg F. 5 weeks after, 6/13/20 recurring symptoms of extreme fatigue, rash on forearms. Lack of energy, clamminess. low energy.  sleeping all the time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: 6/12 830 pm patient experienced fever + chills lasted over night then starting 3 AM on 6/13 patient had diarrhea. Diarrhea lasted 3 days despite taking immodium over the counter
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PT COMPLAINED OF PAiN IMMEDIATELY AFTER INJECTION OF HPV. MORE THAN THE OTHER VACCINES. 5-31-2020 @ 3pm. REDNESS, TENDERNESS, SWELLING AND WARMESS NOTED AROUND INJECTION SITE.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain
Clinical narrative: PT COMPLAINED OF PAiN IMMEDIATELY AFTER INJECTION OF HPV. MORE THAN THE OTHER VACCINES. 5-31-2020 @ 3pm. REDNESS, TENDERNESS, SWELLING AND WARMESS NOTED AROUND INJECTION SITE.