chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: The patient experienced no symptoms; patient was administered an expired dose of VAQTA; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information on the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 01-JUN-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (exact dose not reported) intramuscularly, lot # S001485 with expiration date 12-MAY-2020. The patient did not experienced any symptoms. No product quality complaint was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S001485; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product container issue
Clinical narrative: no additional adverse event; one ROTATEQ was already open at both ends, neither hash mark was used, residue was leaking out on my hands; one ROTATEQ was already open at both ends, neither hash mark was used, residue was leaking out on my hands; one ROTATEQ was already open at both ends, neither hash mark was used, residue was leaking out on my hands; This spontaneous report was received from a nurse, who was reporting on herself. The patient's age, medical history, concurrent conditions and concomitant medications were not reported.  On 05-JUN-2020, the nurse was opening the 25 doses container of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660942, expiration date: 06-FEB-2021 and noticed that one rotavirus vaccine, live, oral, pentavalent (ROTATEQ) foil sleeve was already opened at both ends. The residue was leaking out on her hands. The oral dosing vial was closed and intact inside of the foil sleeve. Only one for all 25 vials was defective. No additional adverse event reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effects were reported; The patient received both PROQUAD and VARIVAX; This spontaneous report was received from a medical assistant concerning to a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 08-JUN-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot# S030205, expiration date 25-MAR-2021 (dose, frequency and route were not provided); and with varicella virus vaccine live (oka/merck)(VARIVAX) lot# S025910, expiration date 20-AUG-2021 (dose, frequency and route were not provided), both administered for prophylaxis (inappropriate schedule of product administration). The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; 3 patients received unspecified dose of ROTATEQ that was improperly stored.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-MAY-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660958, expiration date 23-MAR-2021 (strength, dose and route of administration not provided) for prophylaxis. Administered dose of vaccine was stored in temperature of 46.9 degrees Fahrenheit (F) for 1 hour. Data logger was involved. There were no previous excursions reported. No symptoms or adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003741: US-009507513-2005USA008179:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; 3 patients received unspecified dose of ROTATEQ that was improperly stored.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-MAY-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660958, expiration date 23-MAR-2021 (strength, dose and route of administration not provided) for prophylaxis. Administered dose of vaccine was stored in a temperature of 46.9 degrees Fahrenheit (F) for 1 hour. Data logger was involved. There were no previous excursions reported. No symptoms or adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA003740: US-009507513-2005USA008179:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: second vaccination triggered shingles outbreak; it triggered shingles outbreak; i am in pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix which triggered outbreak of Shingles. At the time of report, the patient was in pain and not impressed. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The reporter consented for follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal discomfort
Clinical narrative: difference with her nose; This case was reported by a consumer via call center representative and described the occurrence of nasal discomfort in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included malignant neoplasm of abdomen (Cancer survivor tumor in abdomen at age 57). Previously administered products included RECLAST (received on 5th october 2019).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and an unknown time after starting vitamin d, the patient experienced nasal discomfort. The patient was treated with vitamin d. On an unknown date, the outcome of the nasal discomfort was unknown.   It was unknown if the reporter considered the nasal discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and notice a difference with her nose. For tolerances of 2nd dose, refer case US2020091772, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091772:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Arthritis, Bone pain, Formication, Impaired work ability
Clinical narrative: Left shoulder muscle pain; Left shoulder joint pain; Creaking shoulder/the vaccine destroyed her shoulder joint; discomfort in her shoulder with muscle and joint pain/shoulder discomfort is getting worse; Range of motion difficulty/her arm is not working properly anymore; Inflammation of left shoulder; shoulder is always sore/shoulder where her bone is, there is inflammation; is not working properly; it feels like something is crawling around in her shoulder; This case was reported by a consumer via call center representative and described the occurrence of localized muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st April 2020, 7 days after receiving Shingrix, the patient experienced localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation. On an unknown date, the outcome of the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, movement disorder and shoulder arthritis were not recovered/not resolved and the outcome of the shoulder discomfort, shoulder pain, impaired work ability and crawling sensation were unknown.   It was unknown if the reporter considered the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and did not remember what part of left arm it was administered. The patient experienced discomfort in her shoulder with muscle and joint pain in and around her left shoulder.  The patient reported that when she lifts her arm over her head, her joints are creaking and her shoulder was always sore, she stated that it was like the vaccine destroyed her shoulder joint and was killing her arm and her arm was not working properly anymore.  The patient had range of motion problems, the pain was in upper shoulder where her bone was and there was inflammation, sometimes it feels like crawling around in her shoulder even when she is laying still, she can feel something going on in her shoulder continually.  The patient did not know if the problem stems from incorrect administration or from the vaccine itself and shoulder discomfort was getting worse and not better, she wants to know if there was a way to reverse the damage to her shoulder, she stated that she was willing to be a guinea pig.  The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Injection site pain, Joint range of motion decreased, Movement disorder, Musculoskeletal discomfort
Clinical narrative: Left shoulder muscle pain; Left shoulder joint pain; Creaking shoulder/the vaccine destroyed her shoulder joint; discomfort in her shoulder with muscle and joint pain/shoulder discomfort is getting worse; Range of motion difficulty/her arm is not working properly anymore; Inflammation of left shoulder; shoulder is always sore/shoulder where her bone is, there is inflammation; is not working properly; it feels like something is crawling around in her shoulder; This case was reported by a consumer via call center representative and described the occurrence of localized muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st April 2020, 7 days after receiving Shingrix, the patient experienced localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation. On an unknown date, the outcome of the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, movement disorder and shoulder arthritis were not recovered/not resolved and the outcome of the shoulder discomfort, shoulder pain, impaired work ability and crawling sensation were unknown.   It was unknown if the reporter considered the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and did not remember what part of left arm it was administered. The patient experienced discomfort in her shoulder with muscle and joint pain in and around her left shoulder.  The patient reported that when she lifts her arm over her head, her joints are creaking and her shoulder was always sore, she stated that it was like the vaccine destroyed her shoulder joint and was killing her arm and her arm was not working properly anymore.  The patient had range of motion problems, the pain was in upper shoulder where her bone was and there was inflammation, sometimes it feels like crawling around in her shoulder even when she is laying still, she can feel something going on in her shoulder continually.  The patient did not know if the problem stems from incorrect administration or from the vaccine itself and shoulder discomfort was getting worse and not better, she wants to know if there was a way to reverse the damage to her shoulder, she stated that she was willing to be a guinea pig.  The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Shoulder injury related to vaccine administration
Clinical narrative: Left shoulder muscle pain; Left shoulder joint pain; Creaking shoulder/the vaccine destroyed her shoulder joint; discomfort in her shoulder with muscle and joint pain/shoulder discomfort is getting worse; Range of motion difficulty/her arm is not working properly anymore; Inflammation of left shoulder; shoulder is always sore/shoulder where her bone is, there is inflammation; is not working properly; it feels like something is crawling around in her shoulder; This case was reported by a consumer via call center representative and described the occurrence of localized muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st April 2020, 7 days after receiving Shingrix, the patient experienced localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation. On an unknown date, the outcome of the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, movement disorder and shoulder arthritis were not recovered/not resolved and the outcome of the shoulder discomfort, shoulder pain, impaired work ability and crawling sensation were unknown.   It was unknown if the reporter considered the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and did not remember what part of left arm it was administered. The patient experienced discomfort in her shoulder with muscle and joint pain in and around her left shoulder.  The patient reported that when she lifts her arm over her head, her joints are creaking and her shoulder was always sore, she stated that it was like the vaccine destroyed her shoulder joint and was killing her arm and her arm was not working properly anymore.  The patient had range of motion problems, the pain was in upper shoulder where her bone was and there was inflammation, sometimes it feels like crawling around in her shoulder even when she is laying still, she can feel something going on in her shoulder continually.  The patient did not know if the problem stems from incorrect administration or from the vaccine itself and shoulder discomfort was getting worse and not better, she wants to know if there was a way to reverse the damage to her shoulder, she stated that she was willing to be a guinea pig.  The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint noise, Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain, Tenderness
Clinical narrative: Left shoulder muscle pain; Left shoulder joint pain; Creaking shoulder/the vaccine destroyed her shoulder joint; discomfort in her shoulder with muscle and joint pain/shoulder discomfort is getting worse; Range of motion difficulty/her arm is not working properly anymore; Inflammation of left shoulder; shoulder is always sore/shoulder where her bone is, there is inflammation; is not working properly; it feels like something is crawling around in her shoulder; This case was reported by a consumer via call center representative and described the occurrence of localized muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st April 2020, 7 days after receiving Shingrix, the patient experienced localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation. On an unknown date, the outcome of the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, movement disorder and shoulder arthritis were not recovered/not resolved and the outcome of the shoulder discomfort, shoulder pain, impaired work ability and crawling sensation were unknown.   It was unknown if the reporter considered the localized muscle pain, pain in joint involving shoulder region, shoulder injury related to vaccine administration, shoulder discomfort, movement disorder, shoulder arthritis, shoulder pain, impaired work ability and crawling sensation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm and did not remember what part of left arm it was administered. The patient experienced discomfort in her shoulder with muscle and joint pain in and around her left shoulder.  The patient reported that when she lifts her arm over her head, her joints are creaking and her shoulder was always sore, she stated that it was like the vaccine destroyed her shoulder joint and was killing her arm and her arm was not working properly anymore.  The patient had range of motion problems, the pain was in upper shoulder where her bone was and there was inflammation, sometimes it feels like crawling around in her shoulder even when she is laying still, she can feel something going on in her shoulder continually.  The patient did not know if the problem stems from incorrect administration or from the vaccine itself and shoulder discomfort was getting worse and not better, she wants to know if there was a way to reverse the damage to her shoulder, she stated that she was willing to be a guinea pig.  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Musculoskeletal pain, Pain in extremity
Clinical narrative: Sore arm; Site of injection was warm to touch; Red blotches at the site of injection and front of the shoulder; Shoulder was also sore; injection site red blotch; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AS54, expiry date 15th May 2022) for prophylaxis.   On 24th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 25th May 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced sore arm going all the way to the top of the shoulder, the site of injection was warm to touch, and red blotches appeared at the site of injection and front of the shoulder.  The front of the shoulder was also sore.  The side effects are subsiding, but it was still present as per pharmacist last conversation with patient. No other details were provided. This case linked with US2020091747, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091747:same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Sore arm; Site of injection was warm to touch; Red blotches at the site of injection and front of the shoulder; Shoulder was also sore; injection site red blotch; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AS54, expiry date 15th May 2022) for prophylaxis.   On 24th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 25th May 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injection site warmth, red blotches, shoulder pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced sore arm going all the way to the top of the shoulder, the site of injection was warm to touch, and red blotches appeared at the site of injection and front of the shoulder.  The front of the shoulder was also sore.  The side effects are subsiding, but it was still present as per pharmacist last conversation with patient. No other details were provided. This case linked with US2020091747, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091747:same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a pharmacist via call center representative and described the occurrence of adverse drug reaction in a elderly female patient who received Herpes zoster (Shingrix) (batch number 477S3, expiry date 17th October 2021) for prophylaxis.   On 6th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional information was provided as follows: The patient experienced side effects after receiving 1st dose. Due to side effects, the patient did not received 2nd dose of vaccine. The reporter consented to follow up. The pharmacist did not have specific data related to the side effects statement and she advised the patient on the hesitancy due to exposure risk concerns. No additional details given to the agent.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Skin irritation
Clinical narrative: redness/irritation; redness/irritation; This is a spontaneous report from a contactable nurse  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at 0.5 mL, single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced redness and irritation  on an unspecified date with outcome of unknown. The reported events were considered non serious.  No follow-up attempts are possible, information about batch number cannot be obtained
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Pain
Clinical narrative: Body aches, chills joint pain, general weakness,.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 15-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 17-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Age: 55.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given HPV vaccination at age 55 which is not approved for people over the age of 45. No adverse reactions reported by patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: After immunization, patient experienced upper shoulder pain when moving her arm.  Hoped it would resolve, but it did not.  Contacted the pharmacy for help.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Abdominal pain upper, Body temperature increased, Malaise, Pain in extremity
Clinical narrative: Patient complained at home of not feeling well and complained of stomach pain and leg pain.  Shortly afterwards patient vomited and experienced an elevated temperature.  Patient was kept quiet with ice applied to her leg and fluids encouraged.  Tylenol was given the next day.  Patient improved by the afternoon of the following day.  MD spoke with parents the evening of the event and the following morning.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Nodule
Clinical narrative: Mom states that pt started with small knots in both legs after vaccinations were given on 05/18/2020. The knots have gradually gotten bigger since that time. Mom brought her into the office today, 06/10/2020, for evaluation because the patient acts like the legs hurt where the knots are.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Feeling hot, Injection site pain, Pain
Clinical narrative: Several hours after the injection I developed soreness at the injection site. 11 Hours later I felt warm, achy. I checked my temperature at 3:30 PM  and it was 100.2.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Patient received the shot in the pharmacy and about an hour later, having already left the pharmacy, patient had to go to emergency room due to anaphylaxis
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: large amount of swelling( little larger than a softball), redness(small amount), itching, and pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, reporting improper dosing sequence. Patient has now received 4 Shingrix shots in the past 14 months.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Ear pain, Fatigue, Flushing
Clinical narrative: Onset of significant muscle and joint aches, fatigue, shivering, flushing (no fever) and mild nausea approx 12 hours after injection lasting through the next day with diminishing severity over first 24 hours after injection.  Site swelling, redness and warmth developed the next day and persisted for approx. 2 days.   Mild headache, mild fatigue and sore ear and throat present on day 6 after injection.  Now at day 6 all symptoms are largely resolved, residual is minimal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Onset of significant muscle and joint aches, fatigue, shivering, flushing (no fever) and mild nausea approx 12 hours after injection lasting through the next day with diminishing severity over first 24 hours after injection.  Site swelling, redness and warmth developed the next day and persisted for approx. 2 days.   Mild headache, mild fatigue and sore ear and throat present on day 6 after injection.  Now at day 6 all symptoms are largely resolved, residual is minimal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: Onset of significant muscle and joint aches, fatigue, shivering, flushing (no fever) and mild nausea approx 12 hours after injection lasting through the next day with diminishing severity over first 24 hours after injection.  Site swelling, redness and warmth developed the next day and persisted for approx. 2 days.   Mild headache, mild fatigue and sore ear and throat present on day 6 after injection.  Now at day 6 all symptoms are largely resolved, residual is minimal.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Chills, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Dose of Dtap-Polio not infant formula as of this report, chills has experienced some fever, o other reported symptoms
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Presyncope
Clinical narrative: Patient left the room after the vaccination with her mom and seemed fine. They were shopping out in front of the pharmacy when the mom came back over, approximately five minutes after they left the room. Patient was very dizzy and looked like she was going to faint. She was leaning heavily on mom. We immediately got her a chair, a cool wet cloth, and a bottle of water. Her mom had some crackers and she ate a few of those. After about five to ten minutes patient was able to get up and they left.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Rash
Clinical narrative: Administered adjuvant suspension only - without reconstitution of lyophilized antigen. Pt reported injection site (left arm) tenderness and chills for one day post admin. Pt also noted small rash on opposite arm (right arm), but noted may be from recent insect bites. Consulted with GSK for guidelines and monitoring parameters - none. IAC recommends repeating dose in 4 weeks. Notified prescriber and recommended follow up if appropriate. Instructed pt seek medical attention if symptoms persist or worsen.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears more noticeable at times than others, beginning approximately 1-2 weeks after first varicella vaccine dose. Second varicella vaccine dose given 4/20/2020, same lot#.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Hypersensitivity reaction: swollen, erythematous injection site reaction; approximately 2cm diameter and growing
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Musculoskeletal pain, Swelling
Clinical narrative: Headache, swollen painful shoulder, red
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: Hot to touch, Redness, Swelling to the size of a golf ball, Patient reported fever. Temp was 99 an hour after he took IBU on 6/09/2020.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: *Quarter size red mark on left leg. It is firm to the touch. *Treat with Topical Benedryl & oral Ibu. Told to schedule appt. if red area spreads or if a fever develops.
Age: 17.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Pain, Peripheral swelling, Tenderness
Clinical narrative: Adverse Reaction to Rt Arm symptoms Include tenderness, swelling Redness & Body aches Area measures 5x8cm
Sex: U
Vaccine: HEPAB, VARZOS
Symptoms: Pyrexia
Clinical narrative: fever 100.4 degree
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram T wave abnormal, Myocarditis, Troponin I increased
Clinical narrative: chest pain post SPV. Admitted. Diagnosed with myocarditis.   Symptoms: CHEST PAIN, UNSPECIFIED(R079).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Influenza, Injection site pain, Myalgia
Clinical narrative: vomiting; body ache; headache; injection site pain; sore arm; nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (Please refer the case US2020AMR093865 ).   On 2nd June 2020, the patient received the 2nd dose of Shingrix. On 2nd June 2020, 10 hrs after receiving Shingrix, the patient experienced vomiting, general body pain, headache, injection site pain, pain in arm and nausea. On an unknown date, the outcome of the vomiting, general body pain, headache, injection site pain, pain in arm and nausea were unknown.   It was unknown if the reporter considered the vomiting, general body pain, headache, injection site pain, pain in arm and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 2nd June 2020 at 1620, the patient received 2nd dose of Shingrix. The patient reported injection site pain almost immediately, and a sore arm about 1 hour later. About 10 hours after the dose, the patient began to experience headache, body ache, nausea, and vomiting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093865:Same patient
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: vomiting; body ache; headache; injection site pain; sore arm; nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (Please refer the case US2020AMR093865 ).   On 2nd June 2020, the patient received the 2nd dose of Shingrix. On 2nd June 2020, 10 hrs after receiving Shingrix, the patient experienced vomiting, general body pain, headache, injection site pain, pain in arm and nausea. On an unknown date, the outcome of the vomiting, general body pain, headache, injection site pain, pain in arm and nausea were unknown.   It was unknown if the reporter considered the vomiting, general body pain, headache, injection site pain, pain in arm and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 2nd June 2020 at 1620, the patient received 2nd dose of Shingrix. The patient reported injection site pain almost immediately, and a sore arm about 1 hour later. About 10 hours after the dose, the patient began to experience headache, body ache, nausea, and vomiting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093865:Same patient
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site pain, Nausea, Pain
Clinical narrative: vomiting; body ache; headache; injection site pain; sore arm; nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (Please refer the case US2020AMR093865 ).   On 2nd June 2020, the patient received the 2nd dose of Shingrix. On 2nd June 2020, 10 hrs after receiving Shingrix, the patient experienced vomiting, general body pain, headache, injection site pain, pain in arm and nausea. On an unknown date, the outcome of the vomiting, general body pain, headache, injection site pain, pain in arm and nausea were unknown.   It was unknown if the reporter considered the vomiting, general body pain, headache, injection site pain, pain in arm and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 2nd June 2020 at 1620, the patient received 2nd dose of Shingrix. The patient reported injection site pain almost immediately, and a sore arm about 1 hour later. About 10 hours after the dose, the patient began to experience headache, body ache, nausea, and vomiting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093865:Same patient
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: vomiting; body ache; headache; injection site pain; sore arm; nausea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (Please refer the case US2020AMR093865 ).   On 2nd June 2020, the patient received the 2nd dose of Shingrix. On 2nd June 2020, 10 hrs after receiving Shingrix, the patient experienced vomiting, general body pain, headache, injection site pain, pain in arm and nausea. On an unknown date, the outcome of the vomiting, general body pain, headache, injection site pain, pain in arm and nausea were unknown.   It was unknown if the reporter considered the vomiting, general body pain, headache, injection site pain, pain in arm and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 2nd June 2020 at 1620, the patient received 2nd dose of Shingrix. The patient reported injection site pain almost immediately, and a sore arm about 1 hour later. About 10 hours after the dose, the patient began to experience headache, body ache, nausea, and vomiting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093865:Same patient
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Swelling
Clinical narrative: Swelling to 2? by 1.5? by .5? and pain lasting for about a week
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Myalgia
Clinical narrative: Severe muscle aches, headache, needed to call in sick at work
Age: 1.17
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional adverse effect reported.; a 14-month old patient was administered PROQUAD rather than MMR II on 03-JUN-2020.; The patient also was adrninistered VARlVAX on 03-JUN-2020.; This spontaneous report was received from a medical assistant referring to a 14-month-old patientof unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 03-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot number S038144, which upon internal verification has been verified to be valid, expiration date reported and validated as 25-MAY-2021), subcutaneously for prophylaxis (dose, strength, vaccination scheme, site of vaccination were not reported) rather than measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). On the same date, the patient also was administered varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, strength, route of administration, vaccination scheme, site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). Sterile diluent (MERCK STERILE DILUENT) concomitantly used.  No additional adverse effect reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 03-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001904: US-009507513-2006USA001905: US-009507513-2006USA001906: US-009507513-2006USA001907: US-009507513-2006USA001908: US-009507513-2006USA001909: US-009507513-006USA001910: US-009507513-2006USA001911: US-009507513-2006USA001912: US-009507513-2006USA001913: US-009507513-2006USA001875: US-009507513-2006USA001876: US-009507513-2006USA001892: US-009507513-2006USA001914: US-009507513-2006USA001915: US-009507513-2006USA001916: US-009507513-2006USA001917: US-009507513-2006USA001893: US-009507513-2006USA001918: US-009507513-2006USA001919: US-009507513-2006USA001894: US-009507513-2006USA001895: US-009507513-2006USA001896: US-009507513-2006USA001897: US-009507513-2006USA001877: US-009507513-2006USA001878: US-009507513-2006USA001879: US-009507513-2006USA001880: US-009507513-2006USA001881: US-009507513-2006USA001882: US-009507513-2006USA001898: US-009507513-2006USA001899: US-009507513-2006USA001883: US-009507513-2006USA001884: US-009507513-2006USA001885: US-009507513-2006USA001886: US-009507513-2006USA001900: US-009507513-2006USA001887: US-009507513-2006USA001888: US-009507513-2006USA001889: US-009507513-2006USA001890: US-009507513-2006USA001903: US-009507513-2006USA001901: US-009507513-2006USA001891: US-009507513-2006USA001902: US-009507513-2006USA001874:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 30-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Age: 1.83
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; One improperly stored dose of VAQTA was administered to one patient; Information has been received from medical assistant referring to a 22-month-old patient of unknown gender. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.  On 14-APR-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dosage regimen, route of administration, and anatomical location were not reported; lot # S025993 was verified to be valid (for injection formulation), expiration date: 17-OCT-2020) as prophylaxis (product storage error).   The vaccine was stored in temperature of 68.58 degrees Fahrenheit (F) for a time frame of 9 hours 41 minutes. The previous temperature excursion was at 46.1 F for a time frame of 7 minutes. The call was not due to a data-logger. No adverse effect reported.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability