chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 2nd dose of SHINGRIX. On 6th December 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient presented a very swollen, painful, itchy and 4-inch red area on her upper arm after receiving her dose of SHINGRIX shot. On the date of reporting, the same symptoms continued.  The patient asked what she could do to relieve these symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pyrexia, Weight decreased
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of fever in a elderly male patient who received SHINGRIX for prophylaxis. Concomitant products included propranolol hydrochloride (Propranolol), acetylsalicylic acid (Aspirin), tamsulosin hydrochloride (Tamsulosin), finasteride, rosuvastatin calcium (Rosuvastatin) and pregabalin (Lyrica). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, weight loss and dizziness. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the weight loss and dizziness were unknown.  It was unknown if the reporter considered the fever, weight loss and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not know the date of the SHINGRIX vaccine administration. The patient called to report an untoward reaction to the SHINGRIX and stated that, he was put down in bed for 3 weeks and he finally went to the emergency room. The patient was released on the same day. The patient had fever for 13 days, lost 20 pounds, and was also very dizzy. The patient refused 2nd shot of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (On an unknown date 1st dose received without reaction).  On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient 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 details were reported as follows: The age at vaccination was not reported. The patient seem to be having a reaction to the 2nd dose of the shingles vaccine. The patient stated it was Flu like symptoms. The patient was asking if this was known side effects. This case has been linked to case US2018GSK226580 , reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (On an unknown date 1st dose received without reaction).  On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient 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 details were reported as follows: The age at vaccination was not reported. The patient seem to be having a reaction to the 2nd dose of the shingles vaccine. The patient stated it was Flu like symptoms. The patient was asking if this was known side effects. This case has been linked to case US2018GSK226579, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in thigh in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in thigh. On an unknown date, the outcome of the pain in thigh was recovered/resolved. It was unknown if the reporter considered the pain in thigh to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter informed that, the patient was hesitant to get her second dose of shingrix because the patient relayed to the reporter that, the day after the patient received her SHINGRIX vaccination, which was administered in her arm as indicated, the patient experienced significant pain in her thighs, that lasted a long time, could not remember how many days, and still on occasion would have some pain in her thighs but once she moves in the am, she was then fine. This was all the information reporter could obtain at this time from the reporter. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Malaise, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced vomiting, diarrhea and sickness. On an unknown date, the outcome of the vomiting, diarrhea and sickness were unknown. It was unknown if the reporter considered the vomiting, diarrhea and sickness to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter saw several other friends in her community who she had contact with and they all had the symptoms of throwing up and having diarrhea. Even though they weren't sick before they took it, then they got sick after vaccination with SHINGRIX so swiftly. The reporter asked would that affect absorption.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Malaise, Rash, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (for years). Concomitant products included VALTREX. In April 2018, the patient received the 1st dose of SHINGRIX. In June 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced rash and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles, rash and feeling unwell were unknown. It was unknown if the reporter considered the vaccination failure, shingles, rash and feeling unwell to be related to SHINGRIX and SHINGRIX. Addition details were received as follows: The age at vaccination was not reported. The patient was plagued with recurring shingles for years. The old shingles vaccine did not work to prevent regular outbreaks. After 60 days, the patient received 2nd dose of SHINGRIX. The patient was on VALTREX, 1gram dose, daily, for about 5 years. After SHINGRIX shot, the patient continued on VALTREX for 90 days and weaned off it over this period of time. The patient felt so healthy and awesome, no shingles for several months. However, beginning of November the patient started to feel all the symptoms of coming down with shingles again. The patient had shingles, not a lot of rash but symptoms were brutal. The patient back on the Valtrex and definitely not feeling the best from the lingering effects. The patient did not take any medications, only supplements. The patient was physically fit and eat a nutritional diet. The patient was asking about others who were having this problem.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient just had his 2nd dose of SHINGRIX and forgot that he had a bad reaction to his 1st dose. The patient inquired about taking Ibuprofen to treat his current symptoms, but he did not elaborate. He did not want to share any additional details regarding his experience. The reporter did not consent to follow-up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, headache, muscle pain, nausea, injection site pain, weakness and fatigue. On an unknown date, the outcome of the chills, headache and muscle pain were recovered/resolved and the outcome of the nausea, injection site pain, weakness and fatigue were not recovered/not resolved. It was unknown if the reporter considered the chills, headache, muscle pain, nausea, injection site pain, weakness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left deltoid. The patient planned to follow-up with his physician on 10th December 2018. The reporter gave consent to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, headache, muscle pain, nausea, injection site pain, weakness and fatigue. On an unknown date, the outcome of the chills, headache and muscle pain were recovered/resolved and the outcome of the nausea, injection site pain, weakness and fatigue were not recovered/not resolved. It was unknown if the reporter considered the chills, headache, muscle pain, nausea, injection site pain, weakness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left deltoid. The patient planned to follow-up with his physician on 10th December 2018. The reporter gave consent to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Chills, Fatigue, Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 2nd dose of SHINGRIX. On 6th December 2018, immediately after receiving SHINGRIX, the patient experienced nausea, fever, chills, headache, restlessness, fatigue and jumpy. On 8th December 2018, the patient experienced hair loss. On an unknown date, the outcome of the nausea, fever, chills, headache, restlessness, fatigue, hair loss and jumpy were unknown. It was unknown if the reporter considered the nausea, fever, chills, headache, restlessness, fatigue, hair loss and jumpy to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm. Shortly after receiving SHINGRIX, she came down with nausea, fever, chills, headache, restlessness, fatigue and feeling very jumpy. The patient stated that she decided to wash her hair 2 days later and realized that huge chunks of her long red hair was falling out. The reporter gave consent to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Nervousness, Pyrexia, Restlessness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 2nd dose of SHINGRIX. On 6th December 2018, immediately after receiving SHINGRIX, the patient experienced nausea, fever, chills, headache, restlessness, fatigue and jumpy. On 8th December 2018, the patient experienced hair loss. On an unknown date, the outcome of the nausea, fever, chills, headache, restlessness, fatigue, hair loss and jumpy were unknown. It was unknown if the reporter considered the nausea, fever, chills, headache, restlessness, fatigue, hair loss and jumpy to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm. Shortly after receiving SHINGRIX, she came down with nausea, fever, chills, headache, restlessness, fatigue and feeling very jumpy. The patient stated that she decided to wash her hair 2 days later and realized that huge chunks of her long red hair was falling out. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Injection site swelling, Lymphadenopathy, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 70-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced sore throat, enlargement of lymph nodes, fever, swallowing difficult and injection site swelling. On an unknown date, the patient experienced red throat. On an unknown date, the outcome of the sore throat, enlargement of lymph nodes, fever, swallowing difficult, injection site swelling and red throat were recovered/resolved. It was unknown if the reporter considered the sore throat, enlargement of lymph nodes, fever, swallowing difficult, injection site swelling and red throat to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on unknown arm. By the evening the patient got the SHINGRIX vaccine her throat was very sore. The next day of the vaccination the lymph nodes in her throat were swollen, making it difficult to swallow, she had a 102 degree F fever and where she got the shot was swollen. The patient saw an Ear Nose Throat specialists (ENT) who said the whole back of her throat was extremely red. The patient took some antibiotics, which made her sick, but the symptoms resolved. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 70-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced sore throat, enlargement of lymph nodes, fever, swallowing difficult and injection site swelling. On an unknown date, the patient experienced red throat. On an unknown date, the outcome of the sore throat, enlargement of lymph nodes, fever, swallowing difficult, injection site swelling and red throat were recovered/resolved. It was unknown if the reporter considered the sore throat, enlargement of lymph nodes, fever, swallowing difficult, injection site swelling and red throat to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on unknown arm. By the evening the patient got the SHINGRIX vaccine her throat was very sore. The next day of the vaccination the lymph nodes in her throat were swollen, making it difficult to swallow, she had a 102 degree F fever and where she got the shot was swollen. The patient saw an Ear Nose Throat specialists (ENT) who said the whole back of her throat was extremely red. The patient took some antibiotics, which made her sick, but the symptoms resolved. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 57-year-old female patient who received BOOSTRIX (batch number 2774D, expiry date 9th March 2021) for prophylaxis. On 5th December 2018, the patient received BOOSTRIX. On 8th December 2018, 3 days after receiving BOOSTRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to BOOSTRIX. Additional details were reported as follows: The healthcare professional (HCP) states patient complained of an allergic reaction on her arm 3 days after receiving a BOOSTRIX vaccine. The HCP had no further information on this adverse event and did not want to be contacted regarding this adverse event. The reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Anxiety, Attention deficit/hyperactivity disorder, Disturbance in attention
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of attention deficit/hyperactivity disorder in a 60-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Co-suspect products included FLUCELVAX for prophylaxis. On 5th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and FLUCELVAX. On 5th October 2018, 30 min after receiving SHINGRIX, the patient experienced attention deficit/hyperactivity disorder, mental concentration difficult and anxiety. On an unknown date, the outcome of the attention deficit/hyperactivity disorder, mental concentration difficult and anxiety were recovered/resolved. It was unknown if the reporter considered the attention deficit/hyperactivity disorder, mental concentration difficult and anxiety to be related to SHINGRIX. Additional details were provided as follows: The reporter stated 30 minutes after receiving the 1st dose of SHINGRIX in right arm, the patient experienced ADHD-like symptoms, trouble concentrating and anxiety. The patient also received FLUCELVAX on the same day. It was unknown if the reporter considered the attention deficit/hyperactivity disorder, mental concentration difficult and anxiety to be related to FLUCELVAX as well.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 91-year-old female patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced mild soreness after vaccination with SHINGRIX.
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to BOOSTRIX. Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist said a patient told her that, her healthcare professional said she needed to get the vaccine again because there was a lump at the injection site. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Nasopharyngitis, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). On 7th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 9th June 2018, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced cold and product supply issue. On 13th June 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the cold was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the cold and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient experienced a bad reaction described as a flu like symptoms for about 4 days. The patient stated, more than 6 months had gone and till the time of reporting the patient did not receive the 2nd dose of SHINGRIX, due to availability issues. The patient reported that about a month before the date of reporting, a pharmacy had SHINGRIX in stock but she decided not to get the dose because she had a cold that day. The patient provided limited information.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had 5 to 8 times before receiving SHINGRIX). Previously administered products included ZOSTAVAX (received on an unknown date). On 23rd August 2018, the patient received SHINGRIX. On 24th August 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue and malaise. On an unknown date, the outcome of the fatigue and malaise were recovered/resolved. It was unknown if the reporter considered the fatigue and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown deltoid. The patient developed fatigue and malaise the following day after receiving SHINGRIX which lasted for 2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and injection site cellulitis. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and injection site cellulitis were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. Approximately 13 patients who received a dose of SHINGRIX. After vaccination, the patient experienced injection site reactions consistent with cellulitis, such as pain, redness and swelling. The reporter was not certain that any cases were confirmed cellulitis, but 3 of the patients did voluntarily seek treatment from a physician and the other 10 cases resolved spontaneously. The pharmacist reported the all events to VAERs. The call center representative advised to reporter, called to GlaxoSmithKline if had any future events. The clarification requested for case creation and event coding.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown deltoid. The pharmacist stated that the patient developed a case of the Shingles 2 months after receiving the a dose of SHINGRIX. The pharmacist consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 83-year-old female patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without any adverse event). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional information received as follows: The patient had no issue with the first dose of SHINGRIX. In 2018, the patient received the dose of SHINGRIX and experienced a severe headache. The reporter gave consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA (lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 65-year-old female patient received PREVNAR 13; (batch number unknown), via an unspecified route of administration on 06Dec2018 at 0.5 ml, single for immunization. The patient's medical history and concomitant medications were not reported. The patient's arm was really warm to touch and she had fever, and patient was still not feeling well in Dec2018. The outcome of the events arm was really warm to touch and had fever was unknown while patient was still not feeling well was not recovered. Information on the batch number has been requested.
Age: 0.17
Sex: F
Vaccine: PNC13, RV5
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 4-month-old female patient received the second dose of PREVNAR 13 (Suspension for injection; NDC number: 0005-1971-01, lot number: W33491, expiry date: Jun2020) at the age of 2 months, intramuscularly on 03Oct2018 at 0.5 mg, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of PREVNAR 13 on an unspecified date for immunisation. On 05Dec2018, the patient experienced high fever, nausea, and vomiting. It was reported that the patient had a possible adverse reactions of high fever and vomiting with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). It was reported that the product was directly ordered from Merck Vaccines, further reported as ordered directly from MerckVaccines.com. It was reported that the parents took the patient to the ER that night and the ER gave her TYLENOL suppository (treatment) and also ondansetron (treatment) for the nausea and vomiting. The outcome of the events was recovered on an unspecified date in Dec2018. The patient is completely better now.
Age: 0.17
Sex: F
Vaccine: PNC13, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 4-month-old female patient received the second dose of PREVNAR 13 (Suspension for injection; NDC number: 0005-1971-01, lot number: W33491, expiry date: Jun2020) at the age of 2 months, intramuscularly on 03Oct2018 at 0.5 mg, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of PREVNAR 13 on an unspecified date for immunisation. On 05Dec2018, the patient experienced high fever, nausea, and vomiting. It was reported that the patient had a possible adverse reactions of high fever and vomiting with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). It was reported that the product was directly ordered from Merck Vaccines, further reported as ordered directly from MerckVaccines.com. It was reported that the parents took the patient to the ER that night and the ER gave her TYLENOL suppository (treatment) and also ondansetron (treatment) for the nausea and vomiting. The outcome of the events was recovered on an unspecified date in Dec2018. The patient is completely better now.
Age: 34.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect route of product administration, Injection site irritation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported on behalf of a nurse that a 34-year-old female patient received PREVNAR 13 subcutaneous on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist called on behalf on nurse who inadvertently gave product subcutaneously instead of intramuscularly on an unspecified date. The patient experienced localized irritation at injection site. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discomfort, Injection site pain, Loss of personal independence in daily activities, Nuclear magnetic resonance imaging normal, Oral pain
Clinical narrative: This was a flu shot, but I do not have the type, etc. Did not feel the actual injection and told the nurse "you're good- Thanks"  That evening, started aching in the lower bicep area and gradually got worse as the week progressed. On 10/28, arm went "flaccid" and I couldn't move it for about 10 minutes. On 10/29, pain of 10/10 with a pulsing/aching/itchy pain. The worst pain I have ever had in my life. Unable to dress, complete ADL's etc. 10/29 Saw Dr. of ortho. Unable to assess at the time due to extreme pain. He ordered oral steroids. Returned to office 11/1/18. Consulted neurology and ordered MRI. Pain went down to 3-4 after 48hrs of steroids. Since then, pain has slowly gone down to 1-2 and just very uncomfortable in the bicep area and shoulder area. It is a slow "pulsing like" feeling and is still "itchy" on the inside. Mostly bothersome at this time. Also have a sensitivity in mouth as if I burned it only since having the flu shot/oral steroids.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Paralysis, Pruritus
Clinical narrative: This was a flu shot, but I do not have the type, etc. Did not feel the actual injection and told the nurse "you're good- Thanks"  That evening, started aching in the lower bicep area and gradually got worse as the week progressed. On 10/28, arm went "flaccid" and I couldn't move it for about 10 minutes. On 10/29, pain of 10/10 with a pulsing/aching/itchy pain. The worst pain I have ever had in my life. Unable to dress, complete ADL's etc. 10/29 Saw Dr. of ortho. Unable to assess at the time due to extreme pain. He ordered oral steroids. Returned to office 11/1/18. Consulted neurology and ordered MRI. Pain went down to 3-4 after 48hrs of steroids. Since then, pain has slowly gone down to 1-2 and just very uncomfortable in the bicep area and shoulder area. It is a slow "pulsing like" feeling and is still "itchy" on the inside. Mostly bothersome at this time. Also have a sensitivity in mouth as if I burned it only since having the flu shot/oral steroids.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain
Clinical narrative: PATIENT HAS BEEN EXPERIENCING MUSCLE PAIN AT SITE OF INJECTION, INJECTION SITE PAIN, AND SKIN SENSITIVITY SIMILAR TO HER EXPERIENCES OF HERPES OUTBREAKS.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blepharospasm, Blood test normal, Computerised tomogram head normal, Dehydration, Dizziness
Clinical narrative: Administered Hep A GARDASIL 9 vaccine. Within minutes patient became flushed. After about 45 seconds said felt dizzy and then passed out. Ammonia used. Patient was stabilized in chair she was in. Eye lids began to flutter and twitch rapidly. Patient then urinated large quantity onto floor. Postured and appeared to be seizing. B/P 88/ palp.  Lowered patient to floor and laid on side. Patient came to after ammonia used. Said she couldn't feel her body. Was able to tell me her name. After 3-4 minutes said feeling was back. within 5-6 min after start of reaction color improved. Mom sais "Well, she does pass out when has blood drawn, but never has with vaccines" mom says has never seen her have such a severe reaction. 911 called Squad responded. Assessed her and upon patient and moms agreement transported to ER. Patient was alert at time of transport.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Flushing, Loss of consciousness, Posturing, Seizure like phenomena, Sensory loss
Clinical narrative: Administered Hep A GARDASIL 9 vaccine. Within minutes patient became flushed. After about 45 seconds said felt dizzy and then passed out. Ammonia used. Patient was stabilized in chair she was in. Eye lids began to flutter and twitch rapidly. Patient then urinated large quantity onto floor. Postured and appeared to be seizing. B/P 88/ palp.  Lowered patient to floor and laid on side. Patient came to after ammonia used. Said she couldn't feel her body. Was able to tell me her name. After 3-4 minutes said feeling was back. within 5-6 min after start of reaction color improved. Mom sais "Well, she does pass out when has blood drawn, but never has with vaccines" mom says has never seen her have such a severe reaction. 911 called Squad responded. Assessed her and upon patient and moms agreement transported to ER. Patient was alert at time of transport.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urinary incontinence
Clinical narrative: Administered Hep A GARDASIL 9 vaccine. Within minutes patient became flushed. After about 45 seconds said felt dizzy and then passed out. Ammonia used. Patient was stabilized in chair she was in. Eye lids began to flutter and twitch rapidly. Patient then urinated large quantity onto floor. Postured and appeared to be seizing. B/P 88/ palp.  Lowered patient to floor and laid on side. Patient came to after ammonia used. Said she couldn't feel her body. Was able to tell me her name. After 3-4 minutes said feeling was back. within 5-6 min after start of reaction color improved. Mom sais "Well, she does pass out when has blood drawn, but never has with vaccines" mom says has never seen her have such a severe reaction. 911 called Squad responded. Assessed her and upon patient and moms agreement transported to ER. Patient was alert at time of transport.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site movement impairment, Injection site nerve damage, Scan abnormal
Clinical narrative: Patient called today (12/18/2018) to report since getting the 1st dose of SHINGRIX on 06/10/18 he had mobility issues. He said he had a scan done and a micrographic report showed that the vaccine had hit a nerve and that was the cause of the mobility issues.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe pain and limited range of motion in the rotator cuff area of shoulder. Onset was 5am the morning following the injection. Three and 1/2 weeks later, very little change.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia, Asthenia, Blood test normal, Blood urine present, Diarrhoea
Clinical narrative: Received the vaccine on Friday, by the next day or Sunday severe diarrhea started (4-5 times a day), dizzy, got weak, lost about 7 pounds, and felt like shaking inside/related to nervous system--like quivering. Went to clinic on 10/8, they did blood work, stool samples, and prescribed antibiotics--everything came back negative. Took results to doctor 10/15, told to stop antibiotics, given prescription IMODIUM for diarrhea. Medication helped but bowels still loose and has to take it periodically. Patient has never had problems with diarrhea in the past. Patient reports bad hair loss and weakness. On 10/26, during doctor visit, nurse found blood in urine and was given antibiotics; thyroid measurements were fine. Went to dermatologist to check scalp for hair loss. Both doctor, PCP and dermatologist mentioned problems related to the vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Stool analysis normal, Tremor, Weight decreased
Clinical narrative: Received the vaccine on Friday, by the next day or Sunday severe diarrhea started (4-5 times a day), dizzy, got weak, lost about 7 pounds, and felt like shaking inside/related to nervous system--like quivering. Went to clinic on 10/8, they did blood work, stool samples, and prescribed antibiotics--everything came back negative. Took results to doctor 10/15, told to stop antibiotics, given prescription IMODIUM for diarrhea. Medication helped but bowels still loose and has to take it periodically. Patient has never had problems with diarrhea in the past. Patient reports bad hair loss and weakness. On 10/26, during doctor visit, nurse found blood in urine and was given antibiotics; thyroid measurements were fine. Went to dermatologist to check scalp for hair loss. Both doctor, PCP and dermatologist mentioned problems related to the vaccine.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test, Ear pain, Eyelid ptosis, Facial paralysis, Headache
Clinical narrative: Patient states he started experiencing numbness on the roof of his month and in his tongue on the right hand side just after 5:00 pm on 12/15/18. Symptoms worsened through the night with addition of droopy right eye the morning of 12/16/18. The morning of 12/17/18 symptoms were worse along with right ear pain and right sided headache. Patient made a clinic appointment at 11:00 on 12/18/18. The clinic staff instructed him to go to the Emergency Department. He was seen by an ER physician. Patient could not recall last name of physician. Patient states they tested him for Lyme's Disease and Shingles. He states he was diagnosed with Bell's Palsy. He was also see by an ophthalmologist on 12/18/18, Dr., who told him he has no damage in his eye from condition on.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Herpes virus test, Hypoaesthesia oral
Clinical narrative: Patient states he started experiencing numbness on the roof of his month and in his tongue on the right hand side just after 5:00 pm on 12/15/18. Symptoms worsened through the night with addition of droopy right eye the morning of 12/16/18. The morning of 12/17/18 symptoms were worse along with right ear pain and right sided headache. Patient made a clinic appointment at 11:00 on 12/18/18. The clinic staff instructed him to go to the Emergency Department. He was seen by an ER physician. Patient could not recall last name of physician. Patient states they tested him for Lyme's Disease and Shingles. He states he was diagnosed with Bell's Palsy. He was also see by an ophthalmologist on 12/18/18, Dr., who told him he has no damage in his eye from condition on.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: My injection was about 6pm on 12/17/2018. I woke up the next morning, 12/18/2018, with soreness in the injection site, but no redness or swelling at the injection site. As the day wore on I felt more "spacey," tired and weak. By about 3 pm I had shivering and needed bedrest. By about 7pm I had a fever of 101 degrees and an elevated heart rate. I experienced no headache and no upset stomach. By bedtime the fever abated a little to 100.6 degrees. The fever abated during the night and I woke up with a temperature of 97.1 degrees. I have no "spacey" feeling as I write this (11am 12/19/2018).  However, I have a red rash on my left arm about the size of a tennis ball, about 2 inched below the injection site.  The rash is not blistering or peeling at this time, it does not actively hurt but is tender to the touch and is "warm" to the touch compared to the surrounding non-rash skin area. I had a mild reaction the first dose of SHINGRIX - a "uggy" feeling about a day or two after but my reaction to the second does was worse.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: My injection was about 6pm on 12/17/2018. I woke up the next morning, 12/18/2018, with soreness in the injection site, but no redness or swelling at the injection site. As the day wore on I felt more "spacey," tired and weak. By about 3 pm I had shivering and needed bedrest. By about 7pm I had a fever of 101 degrees and an elevated heart rate. I experienced no headache and no upset stomach. By bedtime the fever abated a little to 100.6 degrees. The fever abated during the night and I woke up with a temperature of 97.1 degrees. I have no "spacey" feeling as I write this (11am 12/19/2018).  However, I have a red rash on my left arm about the size of a tennis ball, about 2 inched below the injection site.  The rash is not blistering or peeling at this time, it does not actively hurt but is tender to the touch and is "warm" to the touch compared to the surrounding non-rash skin area. I had a mild reaction the first dose of SHINGRIX - a "uggy" feeling about a day or two after but my reaction to the second does was worse.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular, Rash pruritic, Skin abrasion
Clinical narrative: Excoriated papular pruritic rash that began in the midline upper chest and then spread to the midline upper back down to the midline lower back. Extremely pruritic. No reaction at vaccination site.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Had hives before vaccination. Day after the vaccination, left arm was swollen (the size of a grapefruit), red, hurt. Also had fever; took Tylenol. Went to bed because had bad joint aches (shoulders, knees, hip). After 6 hours fever resolved; next day felt tired but OK. Went to allergist because hives continued, by then felt ok with vaccine adverse events.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria, Vaccination complication
Clinical narrative: Had hives before vaccination. Day after the vaccination, left arm was swollen (the size of a grapefruit), red, hurt. Also had fever; took Tylenol. Went to bed because had bad joint aches (shoulders, knees, hip). After 6 hours fever resolved; next day felt tired but OK. Went to allergist because hives continued, by then felt ok with vaccine adverse events.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: GBS like symptoms presented 2 weeks after injection.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Dizziness, Immediate post-injection reaction, Limb discomfort, Nausea, Paraesthesia
Clinical narrative: Right after vaccination, she said she felt like her "arms were going to fall off". She woke up the following morning feeling nausea. She slept all day. When she woke up in the afternoon, she was dizzy and "felt tachycardic". She also felt tingling of her fingers. These symptoms subsided within 48 hours.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Somnolence, Tachycardia
Clinical narrative: Right after vaccination, she said she felt like her "arms were going to fall off". She woke up the following morning feeling nausea. She slept all day. When she woke up in the afternoon, she was dizzy and "felt tachycardic". She also felt tingling of her fingers. These symptoms subsided within 48 hours.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Shot given on Friday Dec 7th patient described numbness and pain in arm three days later. Is improving.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Presyncope, Syncope
Clinical narrative: Mother and Pt informed about what vaccines she was getting and advised to wait 15 min after. Immediately after giving vaccines (without problems) Pt started to faint fell off mother's legs-RN and mother placed her on exam table. Pt came to an vital signs assessed and provider evaluated. Pt recovered within 15 min.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Site soreness, swelling, fever, blisters on mouth and face, malaise, headache, 2 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Pyrexia
Clinical narrative: Site soreness, swelling, fever, blisters on mouth and face, malaise, headache, 2 days.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient complains of blistering rash along back 4 weeks after receiving SHINGRIX vaccine.