chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The GlaxoSmithKline (GSK) medical information scientist reported to GSK response center. The GSK medical information scientist reported that a day before the date of reporting, in afternoon around 2 pm central time, he was attending annual conference in 2018. The reporter told him that the patient who was older than fifty years of age had arm tenderness which was lasted for a couple of months. The reporter did not know if the tenderness interfered with the patient's daily activities. The patient did not receive a second dose of SHINGRIX. It was unknown whether the tenderness involved the site of injection. The patient received SHINGRIX at the reporter's pharmacy. No further related details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX. On 21st March 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 21st March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown administered by other route was unknown. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anymore. This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX vaccine on the left arm subcutaneously rather than intramuscular route, which led to incorrect route of vaccine administration. The patient's arm had a sore spot approximately the size of a silver dollar where the vaccine was administered, just above the elbow on back side of the left arm. This case was linked to case US2018049216, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received SHINGRIX (batch number YS53Y, expiry date unknown). Concurrent medical conditions included drug allergy (the patient was allergic to FLAGYL and MACRODANTIN). Concomitant products included Levothyroxine. On 16th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th January 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient experienced some arm soreness which resolved. The patient had denied permission to contact their physician. The first dose was given in a physician's office. For tolerance to next dose, refer case US2018GSK057095.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 7th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced fever (serious criteria other: as per reporter) and appetite lost (serious criteria other: as per reporter). The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the fever and appetite lost were recovered/resolved. It was unknown if the reporter considered the fever and appetite lost to be related to SHINGRIX. Additional details were reported as follows: The patient experienced loss of appetite. The patient required TYLENOL and Ibuprofen as an intervention for the symptoms and recovered a few days later. This case was one of the 3 cases reported by the same reporter.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a currently 75 years old female patient. The patients' concurrent conditions, concomitant therapy, medical history and historical drugs were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # N025563,expiry date:08-APR-2019) (strength, dose, frequency and route of administration were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature involved was 72-degree Fahrenheit for time frame of 48 hours. There was no previous temperature excursion. No data logger involved. No product quality complaint involved. This is one of two reports derived from same source of information. Sender's Comments: US-009507513-1804USA002459.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: This initial spontaneous report was received from a 67-year-old female patient with no pertinent medical history, concurrent conditions, drug reactions/allergies.  She was taking no concomitant medications. On 19-MAR-2018, the patient was vaccinated with ZOSTAVAX (dose, site and route of administration, lot number and expiration date were not reported) as routine vaccination. The patient reported she had severe side effects after having the vaccination. On 21-MAR-2018, she got a little rash on her hip. On 23-MAR-2018, she got a rash on her leg and face and had a tingle feeling in her leg. On 24-MAR-2018, she experienced tired, dizzy, tightness in chest (also reported as chest pain), and breathing problems. The patient further reported that she was in a lot of pain, she could not sleep, could not drive and was frustrated (exact onset date not specified considered to be 2018). She reported that "this almost killed her." No lab diagnostics/studies were performed. On 26-MAR-2018, the patient sought medical attention by visiting physician's office. She was treated with valacyclovir hydrochloride (VALTREX), acetaminophen (+) oxycodone hydrochloride (PERCOCET), gabapentin (NEURONTIN) ,and prednisone. The outcomes of tightness in chest/chest pain, rash, dizziness, fatigue, breathing problems, and tingle feeling in leg were not reported. At the time of the report, she had not recovered from pain, could not sleep, could not drive, and being frustrated. The causality between the events and ZOSTAVAX was considered related. The patient felt ZOSTAVAX should not be on the market because she had so many severe side effects after receiving the vaccination. She reported she may be getting a lawyer. When asked if she felt any of the events were life-threatening, the patient responded "yes, chest pain". Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Frustration tolerance decreased, Impaired driving ability, Insomnia, Pain, Paraesthesia
Clinical narrative: This initial spontaneous report was received from a 67-year-old female patient with no pertinent medical history, concurrent conditions, drug reactions/allergies.  She was taking no concomitant medications. On 19-MAR-2018, the patient was vaccinated with ZOSTAVAX (dose, site and route of administration, lot number and expiration date were not reported) as routine vaccination. The patient reported she had severe side effects after having the vaccination. On 21-MAR-2018, she got a little rash on her hip. On 23-MAR-2018, she got a rash on her leg and face and had a tingle feeling in her leg. On 24-MAR-2018, she experienced tired, dizzy, tightness in chest (also reported as chest pain), and breathing problems. The patient further reported that she was in a lot of pain, she could not sleep, could not drive and was frustrated (exact onset date not specified considered to be 2018). She reported that "this almost killed her." No lab diagnostics/studies were performed. On 26-MAR-2018, the patient sought medical attention by visiting physician's office. She was treated with valacyclovir hydrochloride (VALTREX), acetaminophen (+) oxycodone hydrochloride (PERCOCET), gabapentin (NEURONTIN) ,and prednisone. The outcomes of tightness in chest/chest pain, rash, dizziness, fatigue, breathing problems, and tingle feeling in leg were not reported. At the time of the report, she had not recovered from pain, could not sleep, could not drive, and being frustrated. The causality between the events and ZOSTAVAX was considered related. The patient felt ZOSTAVAX should not be on the market because she had so many severe side effects after receiving the vaccination. She reported she may be getting a lawyer. When asked if she felt any of the events were life-threatening, the patient responded "yes, chest pain". Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccination complication
Clinical narrative: This initial spontaneous report was received from a 67-year-old female patient with no pertinent medical history, concurrent conditions, drug reactions/allergies.  She was taking no concomitant medications. On 19-MAR-2018, the patient was vaccinated with ZOSTAVAX (dose, site and route of administration, lot number and expiration date were not reported) as routine vaccination. The patient reported she had severe side effects after having the vaccination. On 21-MAR-2018, she got a little rash on her hip. On 23-MAR-2018, she got a rash on her leg and face and had a tingle feeling in her leg. On 24-MAR-2018, she experienced tired, dizzy, tightness in chest (also reported as chest pain), and breathing problems. The patient further reported that she was in a lot of pain, she could not sleep, could not drive and was frustrated (exact onset date not specified considered to be 2018). She reported that "this almost killed her." No lab diagnostics/studies were performed. On 26-MAR-2018, the patient sought medical attention by visiting physician's office. She was treated with valacyclovir hydrochloride (VALTREX), acetaminophen (+) oxycodone hydrochloride (PERCOCET), gabapentin (NEURONTIN) ,and prednisone. The outcomes of tightness in chest/chest pain, rash, dizziness, fatigue, breathing problems, and tingle feeling in leg were not reported. At the time of the report, she had not recovered from pain, could not sleep, could not drive, and being frustrated. The causality between the events and ZOSTAVAX was considered related. The patient felt ZOSTAVAX should not be on the market because she had so many severe side effects after receiving the vaccination. She reported she may be getting a lawyer. When asked if she felt any of the events were life-threatening, the patient responded "yes, chest pain". Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy test, Increased tendency to bruise, Melanocytic naevus, Scleroedema, Skin disorder
Clinical narrative: This spontaneous report was received from an 80-year-old male patient regarding himself. Patient was taking medication for heart. Drug reactions/allergies were reported as none. Concomitant medications included lisinopril. On 01-NOV-2016 the patient was vaccinated with ZOSTAVAX, 1 DF for prophylaxis (dosing details were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT). On 08-NOV-2016 (reported as about a week later after receiving ZOSTAVAX), the patients skin started to feel like cardboard. He further clarified that his skin turned stiff at the ankles and then spread up the legs to his back and shoulders. It was also stated that since receiving the vaccine, the patient had more black moles on his skin and he bruised easily. Lab diagnostics/studies performed: allergies test, patch test. The patient sought medical attention by visiting the physician's office and to a dermatologist. Unspecified treatment was given for the events. Action taken with the suspect drug was not applicable. The outcome of the events was reported as recovering/resolving. Causality of the events was not provided. No product quality complaint (PQC) was present. Upon internal review, the event his skin turned stiff at the ankles and then spread up to legs to his back and his shoulders and his skin started to feel like card board (scleroedema) was considered to be medically significant.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin test
Clinical narrative: This spontaneous report was received from an 80-year-old male patient regarding himself. Patient was taking medication for heart. Drug reactions/allergies were reported as none. Concomitant medications included lisinopril. On 01-NOV-2016 the patient was vaccinated with ZOSTAVAX, 1 DF for prophylaxis (dosing details were not provided). Other suspect therapies included sterile diluent (STERILE DILUENT). On 08-NOV-2016 (reported as about a week later after receiving ZOSTAVAX), the patients skin started to feel like cardboard. He further clarified that his skin turned stiff at the ankles and then spread up the legs to his back and shoulders. It was also stated that since receiving the vaccine, the patient had more black moles on his skin and he bruised easily. Lab diagnostics/studies performed: allergies test, patch test. The patient sought medical attention by visiting the physician's office and to a dermatologist. Unspecified treatment was given for the events. Action taken with the suspect drug was not applicable. The outcome of the events was reported as recovering/resolving. Causality of the events was not provided. No product quality complaint (PQC) was present. Upon internal review, the event his skin turned stiff at the ankles and then spread up to legs to his back and his shoulders and his skin started to feel like card board (scleroedema) was considered to be medically significant.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning a 4 year old male patient. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 20-MAR-2018, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N029673 and expiration date of 21-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (26.258 Fahrenheit degrees) for 432 hours. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information regarding patient's medical history, concurrent conditions, concomitant medications and past therapies were not reported. On 02-APR-2018, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N013268, expiry date: 25-OCT-2018 for prophylaxis whose dose and route of administration were not reported. The PROQUAD administered was reconstituted with properly stored sterile diluent (MERCK) of unknown lot number and expiry date. On an unspecified date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live was subjected to a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit (9 degree Fahrenheit) for the time frame of 2 hours which was noted from a data logger. No adverse effect reported. It was reported that there was no previous temperature excursion. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA002406.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Pyrexia, Rash pustular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 9th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 7 hrs after receiving SHINGRIX, the patient experienced fever (serious criteria other: as per reporter), erythema of extremities (serious criteria other: as per reporter), pustule (serious criteria other: as per reporter) and appetite lost (serious criteria other: as per reporter). The patient was treated with ibuprofen, TYLENOL and antihistamine. On an unknown date, the outcome of the fever, erythema of extremities, pustule and appetite lost were recovered/resolved. It was unknown if the reporter considered the fever, erythema of extremities, pustule and appetite lost to be related to SHINGRIX. Additional details were reported as follows: Several hours after vaccination, the patient experienced loss of appetite, arm redness and arm pustule. The patient required TYLENOL, Ibuprofen and an antihistamine as an intervention for the symptoms and recovered after 3 days. This case was one of the 3 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of the patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that multiple patients had reported that after receiving SHINGRIX, they experienced soreness at the injection site, described as similar to soreness after the tetanus vaccine. The lot numbers and patient identifiers were not obtained. This case has been linked with case US2018051271and US2018051274, reported by same reporter.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patients states the next Am after receiving the vaccine that she awoke with body aches and 104 degree fever. This lasted throughout most of the day then stopped.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concomitant products included PNEUMOVAX 23. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved. The reporter considered the injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On the same day, the patient concomitantly received PNEUMOVAX 23 (batch number N031947, other manufacturer) in the right deltoid. The pharmacist reported that a consumer experienced redness and an elongated rash at the injection site. It was not painful. It had been 10 days since she had received the vaccine and the symptoms had not resolved. The reporter was unable to provide additional details. He would call back if he obtains more information.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Extensive swelling of vaccinated limb, Fatigue, Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a patient who received SHINGRIX. On 25th March 2018, the patient received the 1st dose of SHINGRIX. On 26th March 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the Office Manager. Next day after vaccination, the patient felt very tired and had chills, redness, also experienced a 4 inch diameter hot swelling at the injection site and injection site was not specified. The patient also reported that the soreness at the injection site was not as sore as it was before.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a patient who received SHINGRIX. On 25th March 2018, the patient received the 1st dose of SHINGRIX. On 26th March 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site warmth, tiredness, erythema and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the Office Manager. Next day after vaccination, the patient felt very tired and had chills, redness, also experienced a 4 inch diameter hot swelling at the injection site and injection site was not specified. The patient also reported that the soreness at the injection site was not as sore as it was before.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Staphylococcal infection
Clinical narrative: Pt came into the pharmacy and showed us the redness on his deltoid. He was at the doctor's office and the dr stated he has a staph infection and they drew a border around the redness.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Electrocardiogram, Sinus tachycardia
Clinical narrative: Sinus Tachycardia.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: After the HPV 9 vaccine was administered, patient had an episode of syncope and rolled off the exam table. The mom alerted staff and provider. Patient regained consciousness after a brief moment. Patient remained on floor and MD took patient's pulse and heart and lung sounds. The staff applied cool rag to forehead. The patient was monitored in office by medical provider for an hour after episode. Patient was examined for injuries. The provider provided an assessment of the patient. The patient was cleared by MD.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Capillary nail refill test, Hypoaesthesia, Inflammatory marker increased, Joint range of motion decreased
Clinical narrative: Flu Vaccine administered too high and too posterior resulting in almost immediate onset of persistent pain, weakness, loss of range of motion x 6 weeks. Some indication of possible neuro and/or vascular involvement: mottling, increased cap refill, cold to touch, numbness in fingers #4 and 5. Evaluated by workplace Nurse Practitioner, currently on leave for Worker's Comp. Unable to take NSAIDs due to history of gastric ulcers. Receiving Physical Therapy since 3/6/2018, 2 x week. Consult and being followed by Ortho since 3/21/2018. As of 4/5/2018, shoulder range of motion has improved with no improvement in pain, pain much worse when laying down, pain at rest has increased labs from 3/22/2018 show increased inflammatory markers and very slight increase in WBCs. Plan at this point is to administer cortisone injection into shoulder joint once labs reflect no active infection, if that is not possible, aspiration of fluid from Bursa under fluoro, if no improvement, surgical debridement of left shoulder Bursa.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Livedo reticularis, Pain, Peripheral coldness, Product administered at inappropriate site, White blood cell count increased
Clinical narrative: Flu Vaccine administered too high and too posterior resulting in almost immediate onset of persistent pain, weakness, loss of range of motion x 6 weeks. Some indication of possible neuro and/or vascular involvement: mottling, increased cap refill, cold to touch, numbness in fingers #4 and 5. Evaluated by workplace Nurse Practitioner, currently on leave for Worker's Comp. Unable to take NSAIDs due to history of gastric ulcers. Receiving Physical Therapy since 3/6/2018, 2 x week. Consult and being followed by Ortho since 3/21/2018. As of 4/5/2018, shoulder range of motion has improved with no improvement in pain, pain much worse when laying down, pain at rest has increased labs from 3/22/2018 show increased inflammatory markers and very slight increase in WBCs. Plan at this point is to administer cortisone injection into shoulder joint once labs reflect no active infection, if that is not possible, aspiration of fluid from Bursa under fluoro, if no improvement, surgical debridement of left shoulder Bursa.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Dizziness, Romberg test positive, Vertigo
Clinical narrative: Dizziness, lightheaded, vertigo, imbalance, positive Rhomberg's test, lateralization right with walking. Two brief episodes in evening and during the night. Examined by Dr. the next morning with these findings.
Age: 6.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: C-reactive protein increased, Erythema, Induration, Local reaction, Mobility decreased
Clinical narrative: Large local reaction with erythema, swelling, firmness, inability to move arm that began 5 hours after injection. Spread to elbow and chest. Responded to PO Benadryl.
Age: 6.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Swelling, White blood cell count normal, X-ray limb abnormal
Clinical narrative: Large local reaction with erythema, swelling, firmness, inability to move arm that began 5 hours after injection. Spread to elbow and chest. Responded to PO Benadryl.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site discomfort, Pain in extremity, Pruritus, Skin warm
Clinical narrative: When patient reported the reaction to me on March 19th, her arm was reddened and warm to touch. The hot, red area was approximately 4 inches across her arm and 5 inches in length. Patient states the reaction has been very itchy and painful over the weekend. States she took NAPROSYN for the pain. I gave her an ice pack to put over the site. She stated this helped her discomfort. I had her return the following day to check her arm. She stated the arm felt much better. No more pain. The reddened area was now light pink and no longer hot to the touch.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Fatigue, Pain in extremity, Pharyngeal oedema
Clinical narrative: Mom reports swelling of throat when she looked down her throat last p.m. at 10:00. Temperature of 101.1, arm sore, and tiredness.
Sex: U
Vaccine: HEPA, MMR, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concurrent and historical conditions, as well as the drug reactions/allergies were not reported. Concomitant medications included Merck sterile diluent. On an unknown dates in March 2018 (reported as administered on or after 15-MAR-2018), the patients were vaccinated improperly stored doses of M-M-R II (lot # M039913 with expiration date of 26-SEP-2018, lot # N020924 with expiration date of 01-AUG-2019) (strength, route, and anatomical location were not reported); PNEUMOVAX 23, (lot # N013541 with expiration date of 21-JAN-2019, lot # N013521 with expiration date of 23-JAN-2019, lot # N025656 with expiration date of 19-APR-2019) (strength, route, and anatomical location were not reported); ROTATEQ (orally), (lot # N005077 with expiration date of 21-NOV-2018, lot # N010707 with expiration date of 03-DEC-2018) (strength was not reported) and VAQTA (lot # N019924 with expiration date of 21-SEP-2018, lot # reported as N032753 with expiration date of 23-MAR-2019) (strength, route, and anatomical location were not reported); all vaccines were given for prophylaxis. No adverse effects were reported. It was reported that the abovementioned vaccines suffered a temperature excursion which ranged between 9 degrees C to 25 degrees C during 3 hours and 7 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Sex: F
Vaccine: HPV9
Symptoms: Colitis ulcerative
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in July 2016, the patient was vaccinated with most recent dose of GARDASIL 9 (dose, route, frequency, lot number and expiration date not specified) for human papilloma virus (HPV) vaccination. It was unknown if the patient was compliant to the dosing schedule. On an unspecified date, the patient developed ulcerative colitis. It was unknown, if patient received treatment for the event. It was unknown, if lab diagnostics/studies were performed. The outcome of the event colitis ulcerative was unknown. It was unknown, if the patient sought medical attention. Causality assessment was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event colitis ulcerative was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Antibody test abnormal, Pneumonia
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a 16 year old female patient. The patient's pertinent medical history was not reported. The patient's concurrent conditions included chronic sinusitis, chronic rhinitis and unspecified environmental allergies. Her concomitant medications included fluticasone propionate(FLOVENT) and cetirizine hydrochloride (ZYRTEC). On an unspecified date in 2008, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (reported as "high-risk group") and asthma (route of administration, lot # and expiration date were not reported). On an unspecified date in 2017, the patient was vaccinated with another dose of PNEUMOVAX 23 for prophylaxis and asthma (route of administration, lot # and expiration date were not reported). In July 2017, the patient was diagnosed with pneumonia. It was stated that the patient was prescribed with cefdinir and ceftriaxone sodium(ROCEPHIN) and recovered from the event on an unspecified date. In January 2018, the patient was diagnosed again with pneumonia. The patient was treated again with cefdinir and ceftriaxone sodium(ROCEPHIN) and recovered form the event on an unspecified date in February 2018. In March 2018, the patient underwent a "titre for pneumonia" which showed low antibodies (antibody test abnormal). At the time of this report, it was unknown if the patient had recovered from this event. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review, both episodes of pneumonia were determined to be medically significant events.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information regarding patient's medical history, concurrent conditions, concomitant medications and past therapies were not reported. On 03-APR-2018, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N013268, expiry date: 25-OCT-2018 for prophylaxis whose dose and route of administration were not reported. The PROQUAD administered was reconstituted with properly stored Merck sterile diluent of unknown lot number and expiry date. On an unspecified date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live was subjected to a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit (9 degree Fahrenheit) for the time frame of 2 hours which was noted from a data logger. No adverse effect reported. It was reported that there was no previous temperature excursion. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA002248.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Patient developed two red areas near the injection site. Both warm to the touch and slightly raised and painful. After three days redness reduced and pain reduced and swelling gone. No treatment, symptoms appear to be resolving.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Arm red/warm in LT arm where TDAP and MCV4 were given. Physician stated it did not look like cellulitis. Mother stated that the rash started Tuesday afternoon and within the last 24hrs had spread on the arm.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid disorder, Facial paralysis, Facial paresis, Headache, Muscle spasms
Clinical narrative: Left sided Facial paralysis after flu shot. October 30, 2017 received flu shot afternoon. October 31, 2017 eye and lip muscle spasms in a.m. and subsequent weakening of left facial muscles. Went to urgent care Dr. and started on valacyclovir 1gm TID and prednisone burst (tapered by PCP Dr. on Nov 1). Antivirals started in case it was related to shingles, as I had left posterior head pain, but no skin lesions. Symptoms were very responsive to prednisone- improved within 5 days. November 26, 2017- Recurrence of eye and lip spasms followed by weakening of left facial muscles, with more pronounced left eyelid weakness than on Oct 31, 2017. Nov 27, 2017- Valacyclovir 1gm TID and Prednisone 40mg daily x 5 days- Dr. December 1, 2017- Prednisone 40mg daily x 2, 30 x2, 20 x 2, 10 x 2. December 8, 2017- Valacyclovir 1mg TID x 7 days Dr. May (refill). December 17, 2017- Prednisone 3 days each dose (starting at 40mg)  on hand- didn't use. Dec 29, 2017- MRI brain with and without contrast showing no tumors or explanation for facial paralysis. Symptoms were resolved by this time and no recurrence of symptoms since. (Neurologist).
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging brain normal, Scan with contrast normal
Clinical narrative: Left sided Facial paralysis after flu shot. October 30, 2017 received flu shot afternoon. October 31, 2017 eye and lip muscle spasms in a.m. and subsequent weakening of left facial muscles. Went to urgent care Dr. and started on valacyclovir 1gm TID and prednisone burst (tapered by PCP Dr. on Nov 1). Antivirals started in case it was related to shingles, as I had left posterior head pain, but no skin lesions. Symptoms were very responsive to prednisone- improved within 5 days. November 26, 2017- Recurrence of eye and lip spasms followed by weakening of left facial muscles, with more pronounced left eyelid weakness than on Oct 31, 2017. Nov 27, 2017- Valacyclovir 1gm TID and Prednisone 40mg daily x 5 days- Dr. December 1, 2017- Prednisone 40mg daily x 2, 30 x2, 20 x 2, 10 x 2. December 8, 2017- Valacyclovir 1mg TID x 7 days Dr. May (refill). December 17, 2017- Prednisone 3 days each dose (starting at 40mg)  on hand- didn't use. Dec 29, 2017- MRI brain with and without contrast showing no tumors or explanation for facial paralysis. Symptoms were resolved by this time and no recurrence of symptoms since. (Neurologist).
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: At this point no reaction.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Administration site swelling, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: She complained of fever of 101 deg, swelling and pain of administration site, headache and neck pain. Pain in arm lasted 5 days and she felt sick enough to miss work on Monday after getting shot on Saturday.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: She complained of fever of 101 deg, swelling and pain of administration site, headache and neck pain. Pain in arm lasted 5 days and she felt sick enough to miss work on Monday after getting shot on Saturday.
Age: 40.0
Sex: F
Vaccine: DT
Symptoms: Back pain, Chest pain, Malaise, Pruritus, Swelling face
Clinical narrative: Chest and Back pain started in the evening of 4/4/18. I assumed it was heartburn, I felt unwell but could not put a finger on it. I took ZYRTEC 150 for reflux before going to bed. During the night I started feeling itchy but did not get up. At 6:00am on 4/5/18 I woke up and my face was swollen under my right eye extending to my lips. I had a large hive on the back of my left shoulder and hives on my hips. I took 50mg of BENADRYL with all my other daily medications.
Age: 40.0
Sex: F
Vaccine: DT
Symptoms: Urticaria
Clinical narrative: Chest and Back pain started in the evening of 4/4/18. I assumed it was heartburn, I felt unwell but could not put a finger on it. I took ZYRTEC 150 for reflux before going to bed. During the night I started feeling itchy but did not get up. At 6:00am on 4/5/18 I woke up and my face was swollen under my right eye extending to my lips. I had a large hive on the back of my left shoulder and hives on my hips. I took 50mg of BENADRYL with all my other daily medications.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Body temperature increased, Cellulitis, Erythema, Swelling
Clinical narrative: Patient spiked a temp to 101-103 this morning. Progression of redness. Has tried ibuprofen, BENADRYL, BENADRYL CREAM and didn't improve the redness. Swelling continued, diagnosis of Cellulitis, RX  clindamycin 75 mg/5 mL oral solution.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Hypotonia, Rash, Rash erythematous, Rash macular
Clinical narrative: Pt had limpness/hypotonic episode, redness in bilateral lower extremities, splotchy erythematous rash on abdomen for less than 1 min that occurred within few minutes of receiving vaccines, but then occurred again 2-3 hours again.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: The patient reported that she first had signs of weakness and paralysis. The symptoms got worse so she went to the emergency room and subsequently got hospitalized. She was diagnosed with Guillain-Barre Syndrome on 12/2/17, the day she was admitted to the hospital. The hospital neurologist said that this could have been triggered by the vaccination that was given. She was transferred to NeuroRehab on 12/13/17 and was there until 3/9/18. As of today, she has still not completely recovered and is still in a wheelchair.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Paralysis, Wheelchair user
Clinical narrative: The patient reported that she first had signs of weakness and paralysis. The symptoms got worse so she went to the emergency room and subsequently got hospitalized. She was diagnosed with Guillain-Barre Syndrome on 12/2/17, the day she was admitted to the hospital. The hospital neurologist said that this could have been triggered by the vaccination that was given. She was transferred to NeuroRehab on 12/13/17 and was there until 3/9/18. As of today, she has still not completely recovered and is still in a wheelchair.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Patient described of an elevated Heart Rate of 103-110 BPM for a few days post vaccination.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: THE PATIENT STOPPED IN THE PHARMACY ON 4.5.18 TO REPORT THE INCIDENT. SHE SAID THE NIGHT FOLLOWING HER VACCINATION ON 4.4.18, HER RIGHT ARM WAS SORE. THE NEXT MORNING WHEN SHE WOKE UP, HER RIGHT ARM, BEGINNING RIGHT BELOW THE INJECTION SITE AND EXTENDING TO ABOVE THE ELBOW WAS RED, SWOLLEN, AND SORE. THE PATIENT SAID INITIALLY IN THE MORNING THERE WAS SOME BRUISING, BUT BY THE TIME THE PATIENT ARRIVED AT THE PHARMACY IT WENT AWAY.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site erythema, Injection site pain, Malaise, Nausea
Clinical narrative: Headache, neck pain, nausea, malaise and local pain and redness (left deltoid).
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Neck pain
Clinical narrative: Headache, neck pain, nausea, malaise and local pain and redness (left deltoid).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Injection site swelling, Pyrexia, Somnolence
Clinical narrative: Inconsolable crying for an hr after vaccines administered. Moderate swelling on left thigh at injection site. Very sleepy, decrease in appetite, fever 102.6.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Oral herpes
Clinical narrative: The following morning after the SHINGRIX vaccine, I awoke with an oral cold sore and feeling as if I had the flu. These symptoms, along with an extremely painful injection site, continue to worsen throughout the evening into the next day. I developed a fever of 100.9 (PO). I felt as if I had a very bad flu with horrible muscle aches, chills, malaise, pounding headache, and fatigue. This lingered for 2 days but then I recovered fully. The cold sore, which appeared within 12 hours after administration of vaccine, took about 10 days to heal. This all was most concerning since I have CVID but yet lack any natural immunity to chickenpox. It was determined my MD that this was necessary as it was a non-live vaccine, and that I've had Shingles twice before the age of 45 years. Interestingly, two other women that I know, one in her 60s, and the other in her 70s, both who had the first SHINGRIX vaccine developed similar, yet more severe reactions. The one developed severe and multiple mouth sores in and outside of her mouth along with the flu like symptoms. The second developed mouth sores along with a very high fever and flu like symptoms which lingered for one week. In more cases, the mouth sores appeared, like myself, the following morning after administration. I have encouraged both of these women to report their adverse reactions to VAERS. I, and these other women, are most hesitant to receive the 2nd vaccine in 2 months after our reactions to the first.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chills, Injection site rash, Pyrexia
Clinical narrative: Pt states rash around sight, and bilateral elbows. Pt described fevers, chills, and joint pain following day.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Lethargy
Clinical narrative: Patient described severe flu-like symptoms: Myalgia, lethargy, headache, weakness, chills, fever and very sore arm. He experienced these symptoms after 1st dose too but it was far worse after second dose. It started about 12 hours after administration and lasted about 4 days. Patient is normally really fit and healthy - very similar to another patient who had a similar experience (same age too).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Patient described severe flu-like symptoms: Myalgia, lethargy, headache, weakness, chills, fever and very sore arm. He experienced these symptoms after 1st dose too but it was far worse after second dose. It started about 12 hours after administration and lasted about 4 days. Patient is normally really fit and healthy - very similar to another patient who had a similar experience (same age too).
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Site reaction was red, hot, very sore, and hard that lasted several days.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site reaction was red, hot, very sore, and hard that lasted several days.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever, rash over whole body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Breath sounds abnormal, Cough, Flushing, Rash papular, Vomiting
Clinical narrative: Parents report that within 5 minutes of getting vaccines, developed coughing, noisy breathing, and vomiting. Then developed flushing of his whole body with a couple red papules noted on his face, back, chest, and leg. No other medications given around this time and last food intake was 2 hours prior to event. Parents report that he got the vaccines around 4:20PM.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Nausea
Clinical narrative: Muscle aches in arms, legs, hands, feet and gluteus. Chills. Mild nausea.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Mobility decreased, Pyrexia
Clinical narrative: Patient came back 3 days after she was given 1st dose of SHINGRIX. She said she experienced fever and chills plus joint aches for 2 days after vaccine was given. She was unable to get out of bed.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, red arm near the injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cold sweat, Diarrhoea, Dizziness, Gait disturbance
Clinical narrative: Injection site very swollen and hot to the touch. Couldn't use left arm for 3 days, Extreme joint and muscle soreness. Light headed. Blurred Vision. Very Dizzy. No depth of field. Severe muscle cramps all over legs, arms and torso including neck. Headaches. Insomnia. Chronic Diarrhea. Nausea. Vomited. Severe hot and cold sweats. Not steady when I walk. It'll be a week tomorrow and I'm still in bed trying to recoup. I really don't want to get the second follow up shot in 2-6 months, I can't do this again.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Injection site very swollen and hot to the touch. Couldn't use left arm for 3 days, Extreme joint and muscle soreness. Light headed. Blurred Vision. Very Dizzy. No depth of field. Severe muscle cramps all over legs, arms and torso including neck. Headaches. Insomnia. Chronic Diarrhea. Nausea. Vomited. Severe hot and cold sweats. Not steady when I walk. It'll be a week tomorrow and I'm still in bed trying to recoup. I really don't want to get the second follow up shot in 2-6 months, I can't do this again.