chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 71-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. Concomitant products included valaciclovir hydrochloride (Valacyclovir).  On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced pruritus. On 5th May 2018, the patient experienced hyperesthesia, feeling irritated, facial swelling and facial pain. In May 2018, the patient experienced shingles. On an unknown date, the outcome of the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain were recovered/resolved. It was unknown if the reporter considered the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient had itching over the right eye on the forehead area. On 5th May 2018, 2 days after vaccination, the patient felt irritated, along with itching, bumps and pain on the right side of the face feeling sensitive. On 8th May 2018, less than a week after vaccination she went to pharmacy notifying them that she has Shingles. On 9th May 2018 at 8:30 AM, she had an appointment with her dermatologist who confirmed that she had Shingles. The itching and irritation lasted for couple weeks. The patient had recovered from the symptoms. The batch number reported 9A539 for SHINGRIX was not found and changed to 9AS39 as per sales data.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 71-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. Concomitant products included valaciclovir hydrochloride (Valacyclovir).  On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced pruritus. On 5th May 2018, the patient experienced hyperesthesia, feeling irritated, facial swelling and facial pain. In May 2018, the patient experienced shingles. On an unknown date, the outcome of the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain were recovered/resolved. It was unknown if the reporter considered the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient had itching over the right eye on the forehead area. On 5th May 2018, 2 days after vaccination, the patient felt irritated, along with itching, bumps and pain on the right side of the face feeling sensitive. On 8th May 2018, less than a week after vaccination she went to pharmacy notifying them that she has Shingles. On 9th May 2018 at 8:30 AM, she had an appointment with her dermatologist who confirmed that she had Shingles. The itching and irritation lasted for couple weeks. The patient had recovered from the symptoms. The batch number reported 9A539 for SHINGRIX was not found and changed to 9AS39 as per sales data.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 71-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. Concomitant products included valaciclovir hydrochloride (Valacyclovir).  On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced pruritus. On 5th May 2018, the patient experienced hyperesthesia, feeling irritated, facial swelling and facial pain. In May 2018, the patient experienced shingles. On an unknown date, the outcome of the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain were recovered/resolved. It was unknown if the reporter considered the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient had itching over the right eye on the forehead area. On 5th May 2018, 2 days after vaccination, the patient felt irritated, along with itching, bumps and pain on the right side of the face feeling sensitive. On 8th May 2018, less than a week after vaccination she went to pharmacy notifying them that she has Shingles. On 9th May 2018 at 8:30 AM, she had an appointment with her dermatologist who confirmed that she had Shingles. The itching and irritation lasted for couple weeks. The patient had recovered from the symptoms. The batch number reported 9A539 for SHINGRIX was not found and changed to 9AS39 as per sales data.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Herpes zoster, Hyperaesthesia, Irritability, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 71-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown) for prophylaxis. Concomitant products included valaciclovir hydrochloride (Valacyclovir).  On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced pruritus. On 5th May 2018, the patient experienced hyperesthesia, feeling irritated, facial swelling and facial pain. In May 2018, the patient experienced shingles. On an unknown date, the outcome of the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain were recovered/resolved. It was unknown if the reporter considered the pruritus, shingles, hyperesthesia, feeling irritated, facial swelling and facial pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient had itching over the right eye on the forehead area. On 5th May 2018, 2 days after vaccination, the patient felt irritated, along with itching, bumps and pain on the right side of the face feeling sensitive. On 8th May 2018, less than a week after vaccination she went to pharmacy notifying them that she has Shingles. On 9th May 2018 at 8:30 AM, she had an appointment with her dermatologist who confirmed that she had Shingles. The itching and irritation lasted for couple weeks. The patient had recovered from the symptoms. The batch number reported 9A539 for SHINGRIX was not found and changed to 9AS39 as per sales data.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye irritation, Herpes ophthalmic, Herpes virus infection, Vision blurred
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist mentioned that multiple patients had experienced flu like symptoms for days. The pharmacist did not have specifics for these patients as she was very busy. This case has been linked to the case US2018GSK101803 and US2018GSK101804, reported by the same reporter. Follow up information received from pharmacist on 10th July 2018: The primary reporter details were updated. The VAERS details were updated.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blindness unilateral
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist mentioned that multiple patients had experienced flu like symptoms for days. The pharmacist did not have specifics for these patients as she was very busy. This case has been linked to the case US2018GSK101803 and US2018GSK101804, reported by the same reporter. Follow up information received from pharmacist on 10th July 2018: The primary reporter details were updated. The VAERS details were updated.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist mentioned that multiple patients had experienced flu like symptoms for days. The pharmacist did not have specifics for these patients as she was very busy. This case has been linked to the case US2018GSK101803 and US2018GSK101804, reported by the same reporter. Follow up information received from pharmacist on 10th July 2018: The primary reporter details were updated. The VAERS details were updated.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Heart rate decreased, Oxygen saturation decreased, Syncope, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old male patient. The patient had no concomitant therapies, pertinent medical history and drug reactions or allergies. On 09-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N026814, expiry date: 15-JUL-2020, intramuscular for prophylaxis (dose was not reported). On the same date, after 3-5 minutes, the patient passed out. He was taken to a local emergency room where he was evaluated and his lab diagnostics showed decreased oxygen saturation level. The patient was given supplemental oxygen as an intervention to prevent serious criteria. He was released from the emergency room and recovered on an unknown date in July 2018. The causality assessment was not reported. Upon internal review, the events of the patient passed out and decreased oxygen saturation level were considered to be medically significant.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Oxygen saturation decreased
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old male patient. The patient had no concomitant therapies, pertinent medical history and drug reactions or allergies. On 09-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N026814, expiry date: 15-JUL-2020, intramuscular for prophylaxis (dose was not reported). On the same date, after 3-5 minutes, the patient passed out. He was taken to a local emergency room where he was evaluated and his lab diagnostics showed decreased oxygen saturation level. The patient was given supplemental oxygen as an intervention to prevent serious criteria. He was released from the emergency room and recovered on an unknown date in July 2018. The causality assessment was not reported. Upon internal review, the events of the patient passed out and decreased oxygen saturation level were considered to be medically significant.
Age: 72.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Back pain, Insomnia, Middle insomnia, Paraesthesia
Clinical narrative: Paresthesia in both feet sufficiently strong to keep me from falling asleep and awakening me during the night. One night, I awakened to momentary paresthesias in my hands near the base of both thumbs as well as in my feet. The reaction is not as strong now and the intensity varies. Fatigue lasted awhile.
Age: 72.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Chills, Influenza like illness
Clinical narrative: Paresthesia in both feet sufficiently strong to keep me from falling asleep and awakening me during the night. One night, I awakened to momentary paresthesias in my hands near the base of both thumbs as well as in my feet. The reaction is not as strong now and the intensity varies. Fatigue lasted awhile.
Age: 72.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Fatigue, Insomnia, Middle insomnia, Paraesthesia
Clinical narrative: Paresthesia in both feet sufficiently strong to keep me from falling asleep and awakening me during the night. One night, I awakened to momentary paresthesias in my hands near the base of both thumbs as well as in my feet. The reaction is not as strong now and the intensity varies. Fatigue lasted awhile.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced a large, 3 to 4 inch red rash that was swollen and painful. Patient was instructed to ice it and use pain medications to provide relief. The rash initially grew slightly in size before minimizing over the next few days. Spoke with patient today, 7/18/18, and she says the site is now painless, but still has a now brownish-colored spot remaining.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discolouration, Rash, Rash erythematous, Swelling
Clinical narrative: Patient experienced a large, 3 to 4 inch red rash that was swollen and painful. Patient was instructed to ice it and use pain medications to provide relief. The rash initially grew slightly in size before minimizing over the next few days. Spoke with patient today, 7/18/18, and she says the site is now painless, but still has a now brownish-colored spot remaining.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Achey, fever, shivers.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: Severe chills and shaking.
Sex: M
Vaccine: PNC, PPV
Symptoms: Drug physiologic incompatibility, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 39 year old male patient. Concurrent conditions included HIV infection. Medical history, historical or concomitant drugs were not reported. The medical assistant informed that on the same unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 Injection, for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported), and a dose of PREVNAR for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date not reported). No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 24-DEC-2015, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2014, the patient was treated at a medical facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 13 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 17-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an other referring to a 5 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 03-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Sex: U
Vaccine: MENB
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site blisters in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown. It was unknown if the reporter considered the injection site blisters to be related to BEXSERO. Additional details were provided as follows: The reporting physician had reported this case previously to VAERS. The age at vaccination was not reported. The physician stated that he had the patient, who had blistering at the injection site, after administration of BEXSERO. This case was linked with US2018GSK123551, reported by the same reporter.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dermatitis, Injection site swelling, Pruritus, Rash, Rash generalised
Clinical narrative: W/in sev hours of above vaccines Dev swelling at site and hives on arm. Rash generalized to hives on trunk, ext. face rash at this time (10d later) is more dermatitis like with ID reaction - still getting new pruritic lesions S/P BENADRYL Now on prednisone and ZYRTEC.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin lesion, Urticaria
Clinical narrative: W/in sev hours of above vaccines Dev swelling at site and hives on arm. Rash generalized to hives on trunk, ext. face rash at this time (10d later) is more dermatitis like with ID reaction - still getting new pruritic lesions S/P BENADRYL Now on prednisone and ZYRTEC.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, headache, chills, muscle pain.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and warmth near axillae under injection site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Had fever,upset stomach,dizziness,headache. All normal side effects. The adverse reaction was severe shoulder pain(not soreness) limited to no range of motion on right arm. As of today most of pain is gone, soreness is still present. Range of motion almost normal. Still have a tightness in shoulder. Shoulder is constantly popping, just about whenever I move it more than a little.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Joint noise, Joint stiffness, Pyrexia
Clinical narrative: Had fever,upset stomach,dizziness,headache. All normal side effects. The adverse reaction was severe shoulder pain(not soreness) limited to no range of motion on right arm. As of today most of pain is gone, soreness is still present. Range of motion almost normal. Still have a tightness in shoulder. Shoulder is constantly popping, just about whenever I move it more than a little.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Pyrexia, Rash, Rash macular, Rash papular
Clinical narrative: Parent noticed a red spot on the right thigh near the injection site 3 hours after vaccination on 7/16/18. No other rashes were noted that day. Mild fever was reported at 1AM on 7/17/18, 99.2 temporal. Parent gave TYLENOL and symptoms resolved. No additional fevers. When child woke up 7/17/18, parents noticed a rash above the waist which was spreading to upper arms and head. At the time of the office visit, provider noted faint erythematous blanchable patch  about 1 cm. size and 1 inch from injection site on R. thigh and erythematous macules and papules on torso, back, upper arms, head. The provider's impression was that the rash was more likely to be viral versus hives. I called parent to follow-up today to see if symptoms have resolved, changed or worsened but I was unable to reach them.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Seven hours post injection, started to feel chills and achy-lasting all night. At 10:10 am today I took my temperature orally-99.9.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, Biopsy oesophagus abnormal, Chest pain, Endoscopy abnormal, Eosinophilic oesophagitis
Clinical narrative: The day following immunization, patient's lymph nodes became swollen especially notable in the underarm area bilaterally, indicating a systemic autoimmune reaction to the vaccine. Symptoms lasted for 10 days. On the evening of 1/7/2017 patient went to the ER for severe chest pain and heart palpitations. Pain was determined to be caused by Eosinophilic Esophagitis (dx via EG biopsy), related to NEW egg allergy (patch test confirmed). Egg albumin is an ingredient in the FLUARIX vaccine. Injecting food proteins is known to cause food sensitivities and allergies. Upon receiving positive allergy test results for egg allergy Pt eliminated eggs, chicken and turkey from diet and incorporated non-prescription practices. Follow-up Endoscopy in August 2017 showed that her efforts had cured the Eosinophilic Esophagitis, but had left scarring caused by the disease.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Food allergy, Lymphadenopathy, Oesophageal stenosis, Palpitations, Skin test positive
Clinical narrative: The day following immunization, patient's lymph nodes became swollen especially notable in the underarm area bilaterally, indicating a systemic autoimmune reaction to the vaccine. Symptoms lasted for 10 days. On the evening of 1/7/2017 patient went to the ER for severe chest pain and heart palpitations. Pain was determined to be caused by Eosinophilic Esophagitis (dx via EG biopsy), related to NEW egg allergy (patch test confirmed). Egg albumin is an ingredient in the FLUARIX vaccine. Injecting food proteins is known to cause food sensitivities and allergies. Upon receiving positive allergy test results for egg allergy Pt eliminated eggs, chicken and turkey from diet and incorporated non-prescription practices. Follow-up Endoscopy in August 2017 showed that her efforts had cured the Eosinophilic Esophagitis, but had left scarring caused by the disease.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Tremor
Clinical narrative: Severe shaking and chills in the evening. Woke up with headache in the morning.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: Patient states his temperature rose to 101 degrees F for one day post immunization.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased
Clinical narrative: Left upper arm with diffuse swelling, redness no individual lesions, pulses are 2 positive and equal with slight decreased ROM of shoulder due to swelling and pain.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on lower right back consistent with shingles per MD. 2 days after SHINGRIX Vaccine. Pt given ZOSTAVAX back in 2015. Started on VALTREX 1g PO TID for 7 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain in extremity, Pyrexia
Clinical narrative: Painful arm times 5 days, awakened from sleep first night, low grade fever.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: Patient stated that 2 days after receiving vaccine she is having severe pain in her elbow. She did state that she has a chronic intermittent mild pain in her elbow. She is concerned the vaccination agitated the elbow condition, because the pain is very severe. I advised patient to contact her doctor for further evaluation.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 102.7 at home the night he received vaccines. Temp was 102 in office 7/17/18.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Middle insomnia, Pain in extremity, Pyrexia
Clinical narrative: Painful arm times 5 days, sleepless night-awakened, low grade fever.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: The patient's Doctor ordered routine vaccinations of DTap, HIB (ACT HIB), and PCV-13 (Prevnar) for said child. A newly employed medical assistant administered PENTACEL (DTap, IPV,HIB), HIB (ACTHIB), and PVC-13 (PREVNAR) in error. This resulted in the patient receiving a double dose of the HIB vaccination and an unnecessary dose of IPV. The vaccine co-ordinator of the office spoke with the immunization epidemiologist nurse at the Department of Health and inquired about risks or reactions to be looking for. The nurse felt that HIB is a "benign" vaccination and did not suspect that there would be any serious adverse reactions. Told us to have mother keep a look out for any side effects that may be more pronounced with the double dosage. The patient's Doctor spoke with the child's mother on 7/18/2018 at approx. 10:30 AM to inform her of error that occurred,  the patient's mother reported that as of that time, patient did not exhibit any adverse reactions. Was told to call if any concerns arose. Procedures were put in place for more training of said employee.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash generalised
Clinical narrative: No fever, but rash all over body.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Pain
Clinical narrative: Fatigue, body aches, flu-like symptoms x 1 week; pain at site for 3 days.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Allergy to vaccine, Chills, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Began having pain in left arm evening that vaccines were given. Developed fever of 99.5 degrees with sweats and chills. Temperature the day after the vaccine was 100.4 degrees and pain in the left arm from elbow to shoulder. Pain is rated at a "7" on a scale of 1-10. There is no redness. Mother reports "looks a little swollen compared to right arm." Mom believes arm is warmer than right arm. Provider spoke with Mom and advised ADVIL for sx control and to continue to monitor. This was added as an allergy on patient's medication list.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccination administered was expired. Patient had not experienced any symptoms and will return to the pharmacy for re-vaccination today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Patient reports low grade fever 99, redness at site, and heat at site of injection.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Head discomfort, Ocular discomfort, Pain, Paranasal sinus discomfort
Clinical narrative: Patient felt fine the day and evening of vaccine, slight acheyness, but awoke the next morning feeling lightheaded and dizzy. She sat on the edge of the bed then got to her hands and knees to let the dog out so that she didnt fall and faint. Throughout the day she felt like she was having sinus head pressure symptoms and her eyes felt pressure. By the evening she felt fine again but does not want to have the second dose of the vaccine. She did not make a doctor visit but did mention it to physician at next routine visit.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Chills, Crying, Cyanosis, Irritability, Lethargy
Clinical narrative: Brought today by parents. Received polio and DTaP vaccines 2 days ago, on Monday morning. Fine on Monday, somewhat tired, but seemed normal. Gave ibuprofen for presumed pain. About 1:30am Tuesday morning woke up feverish and inconsolable until about 4am. Up at 6:30am, better but still fussy. Seemed ok, went to daycare. Daycare called later at 2pm saying pt had fever of 102.5. Last night was normal - eating, drinking, playful. Overnight was normal. Then this morning fever returned with chills. Vomited, purple lips, lethargic. Had received these vaccines in the past without reaction. Febrile reaction to vaccination - Unclear etiology. Reassured that pt is interactive and well-appearing today. Recommended TYLENOL and ibuprofen for fevers as needed. No contraindications to vaccinations in the future. Due for Hib, HepA, and varicella.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Brought today by parents. Received polio and DTaP vaccines 2 days ago, on Monday morning. Fine on Monday, somewhat tired, but seemed normal. Gave ibuprofen for presumed pain. About 1:30am Tuesday morning woke up feverish and inconsolable until about 4am. Up at 6:30am, better but still fussy. Seemed ok, went to daycare. Daycare called later at 2pm saying pt had fever of 102.5. Last night was normal - eating, drinking, playful. Overnight was normal. Then this morning fever returned with chills. Vomited, purple lips, lethargic. Had received these vaccines in the past without reaction. Febrile reaction to vaccination - Unclear etiology. Reassured that pt is interactive and well-appearing today. Recommended TYLENOL and ibuprofen for fevers as needed. No contraindications to vaccinations in the future. Due for Hib, HepA, and varicella.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN WAS EXPIRED, PROVIDER NOTIFIED AND PT WILL BE REVACCINATED WHEN PROPER DOSING IS RECEIVED AT CLINIC.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Within 3-4 days I contracted the Shingles virus.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Dizziness, Musculoskeletal stiffness
Clinical narrative: Stiff neck, lightheaded, weakness and joint pain. Started 7/14/2018.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Syncope
Clinical narrative: Vasovagal response- syncope episode. Patient stood up to walk to lab for a blood drawn had syncopal episode.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abscess
Clinical narrative: 2 weeks after injection, still has an abscess - Tx - cold compresses and keeping an eye on it for now.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a child patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 18-JUN-2018, the patient was vaccinated with the first dose of ROTATEQ oral liquid, orally, lot# R003534, expiration date 31-AUG-2019 for prophylaxis. The patient received about quarter to half a dose but spit it up and then received a little more and retained it. No adverse effect were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring to herself. She was 6 weeks pregnant at the reporting time. There was no information about patient's concomitant medications or pertinent medical history reported. On 18-MAY-2018, the patient was vaccinated with a first dose of Oka/Merck VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. On 09-JUN-2018, the patient was vaccinated with a second dose of Oka/Merck VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Aggression, Agitation, Blood test abnormal, Constipation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of constipation in a 2-year-old female patient who received BOOSTRIX for prophylaxis. On 5th May 2018, the patient received BOOSTRIX. On 5th May 2018, unknown after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information was reported as follows: The healthcare professional did not have the lot number or expiry date for BOOSTRIX. The healthcare professional reported that they inadvertently administered a 2 year old patient with BOOSTRIX, which led to inappropriate age at vaccine administration. Follow-up information reported by the other healthcare professional on 11th July 2018 was as follows: On the date of reporting the healthcare professional called the representative and updated with information provided to them by the patient's mother. All the information provided by the healthcare professional in this call was documented. The reporter details were updated. The reporter also stated that the healthcare professional was a supervisor at a chain of urgent care facilities, not the child's pediatrician. The case was upgraded to serious for the event constipation with seriousness criteria as other serious (as per reporter). On 24th May 2018, the patient was vaccinated with BOOSTRIX. Eleven and a half weeks after the vaccination, the patient was diagnosed with high formaldehyde level by her pediatrician, constipation, hemorrhoids and behavioral changes of agitation and hitting. The patient was treated with by the pediatrician with probiotics and a detox soup. The outcome of the events constipation, hemorrhoids and behavioral changes was recovered. The VAERS details were updated. Healthcare professional also stated they were available via email for follow up questions if needed. Lab Comments: On an unknown date, the patient carried out formaldehyde test that showed high formaldehyde level.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Haemorrhoids
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of constipation in a 2-year-old female patient who received BOOSTRIX for prophylaxis. On 5th May 2018, the patient received BOOSTRIX. On 5th May 2018, unknown after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information was reported as follows: The healthcare professional did not have the lot number or expiry date for BOOSTRIX. The healthcare professional reported that they inadvertently administered a 2 year old patient with BOOSTRIX, which led to inappropriate age at vaccine administration. Follow-up information reported by the other healthcare professional on 11th July 2018 was as follows: On the date of reporting the healthcare professional called the representative and updated with information provided to them by the patient's mother. All the information provided by the healthcare professional in this call was documented. The reporter details were updated. The reporter also stated that the healthcare professional was a supervisor at a chain of urgent care facilities, not the child's pediatrician. The case was upgraded to serious for the event constipation with seriousness criteria as other serious (as per reporter). On 24th May 2018, the patient was vaccinated with BOOSTRIX. Eleven and a half weeks after the vaccination, the patient was diagnosed with high formaldehyde level by her pediatrician, constipation, hemorrhoids and behavioral changes of agitation and hitting. The patient was treated with by the pediatrician with probiotics and a detox soup. The outcome of the events constipation, hemorrhoids and behavioral changes was recovered. The VAERS details were updated. Healthcare professional also stated they were available via email for follow up questions if needed. Lab Comments: On an unknown date, the patient carried out formaldehyde test that showed high formaldehyde level.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 80 years adult female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included post herpetic neuralgia (4 months after the shingles, post herpetic neuralgia for 2 months and she was in pain and it went into an itch for an additional) and shingles (history of shingles 5 years ago). On 7th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced erythema of extremities, tissue puffing, itchy upper limbs and allergic skin reaction. On an unknown date, the outcome of the erythema of extremities, tissue puffing, itchy upper limbs and allergic skin reaction were recovered/resolved. The reporter considered the erythema of extremities, tissue puffing and itchy upper limbs to be related to SHINGRIX. It was unknown if the reporter considered the allergic skin reaction to be related to SHINGRIX. Additional details were reported as follows: Patient reported that she had a reaction after receiving the SHINGRIX vaccine which included muscle redness, terrible itch and puffiness. The patient visited her physician and he prescribed an ointment which helped her condition. She claimed that the itchiness and redness were on her whole muscle and the injection site was at her outer arm. The physician thought that she might had an allergy to something in the vaccine.  He described her condition as a topical allergic reaction. The patient's reactions lasted for two weeks after the vaccination. The patient had denied permission to contact their physician.
Age: 57.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 57-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On 9th July 2018 10:00, the patient received dTpa vaccine. On 9th July 2018, several hours after receiving dTpa vaccine, the patient experienced diarrhea, injection site pain and tiredness. On an unknown date, the outcome of the diarrhea, injection site pain and tiredness were unknown.  It was unknown if the reporter considered the diarrhea, injection site pain and tiredness to be related to dTpa vaccine. Additional details were provided as follows: The patient was not sure what brand vaccine she received on the reporting day. The patient only knew it was a Tdap for Pertussis. The patient received the vaccine on the right arm. The patient reported pain at the injection site immediately upon vaccination and her arm had been sore all day. The patient ate lunch late in the day around 4:00 and experienced the diarrhea shortly after that. The patient felt tired all day following the vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling was recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on an unknown upper arm. The pharmacist reported that one of the patient complained that her arm was swollen. The pharmacist believed that symptoms started the day after the SHINGRIX injection. The pharmacist said that it was a large part of her upper arm where she received the injection, not just the site of the injection. The pharmacist was unsure if the patient was still having the symptoms. The pharmacist saw the patient a few days before the reporting date, and the swelling went down a lot but her arm was still red.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 16th June 2018, the patient received SHINGRIX (intramuscular) 50 mcg/mg. On 16th June 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills and cold. On 17th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the cold was unknown. It was unknown if the reporter considered the fever, chills and cold to be related to SHINGRIX. Additional details were provided as follows: The patient reported that on the day of her SHINGRIX vaccination, she developed a high fever that night that lasted into the next day. The patient also had chills and had been cold ever since the day of her SHINGRIX vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX the patient experienced injection site erythema, malaise and injection site swelling. On an unknown date, the outcome of the injection site erythema, malaise and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, malaise and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient experienced redness and swelling at the injection site the size of a softball that lasted 2 weeks, and also had general malaise that lasted about 2 weeks. The healthcare professional returned to pharmacy to receive 2nd dose of SHINGRIX to patient last night from the day of reporting. The health care professional did not yet administer her 2nd dose of SHINGRIX until he contacted GlaxoSmithkline to ask if patient would be able to receive her 2nd dose of SHINGRIX with these types of reactions to the 1st dose of SHINGRIX.  No further information was provided.