chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Tongue ulceration
Clinical narrative: canker sore under my tongue; This case was reported by a consumer and described the occurrence of tongue aphtha formation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tongue aphtha formation. On an unknown date, the outcome of the tongue aphtha formation was unknown.   It was unknown if the reporter considered the tongue aphtha formation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and got a canker sore under my Tongue. The reporter asked was that a side effect.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Red around her band aid; around her band aid and it's sore; This case was reported by a consumer and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema and pain localized. On an unknown date, the outcome of the localized erythema and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the localized erythema and pain localized to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for her aunt. The age at vaccination was not reported. The patient received Shingrix and it was red around her band aid and it was sore and reporter wanted to know was this a side effect of the vaccine.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after receiving the second dose; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient develpoed shingles after receiving 2nd dose. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Incorrect route of product administration, Injection site bruising, Injection site pruritus, Injection site swelling
Clinical narrative: pre anaphylactic reaction; injection site was bruised; wheel" formed under the vaccine site / area felt raised; wheel" formed under the vaccine site / area felt raised; area felt raised and was little itchy; muscle fatigue; malaise; isn't sure it was given IM / unsure if the needle ever reached the muscle; used a  5/8 in 25 gauge needle; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of muscle fatigue (received 1st dose on March 2020, refer Case ID:US2020AMR108337).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue, malaise, intramuscular formulation administered by other route and wrong technique in device usage process. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Inhaler (Nos)). On an unknown date, the outcome of the anaphylactic reaction, injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue, malaise, intramuscular formulation administered by other route and wrong technique in device usage process were unknown.   It was unknown if the reporter considered the anaphylactic reaction, injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was received the first dose of Shingrix in March of 2020. The patient received the 2nd dose on 18th June 2020, in the left arm but was not sure it was given intramuscular.  The reporter said it was a quick injection without resistance. The pharmacist used a 5/8 in 25 gauge needle so she was unsure if the needle ever reached the muscle. Within four to five hours later on the same day, the patient noticed the injection site was bruised , and the wheel was formed under the vaccine site. It was more oblong in shape and began to spread until it was three to four inches vertical and two inches horizontally. The area felt raised and was little itchy. She also had a pre anaphylactic reaction so she took Benadryl and used an inhaler. The patient had some muscle fatigue as well as malaise. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Malaise, Muscle fatigue, Wrong technique in device usage process
Clinical narrative: pre anaphylactic reaction; injection site was bruised; wheel" formed under the vaccine site / area felt raised; wheel" formed under the vaccine site / area felt raised; area felt raised and was little itchy; muscle fatigue; malaise; isn't sure it was given IM / unsure if the needle ever reached the muscle; used a  5/8 in 25 gauge needle; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of muscle fatigue (received 1st dose on March 2020, refer Case ID:US2020AMR108337).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue, malaise, intramuscular formulation administered by other route and wrong technique in device usage process. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Inhaler (Nos)). On an unknown date, the outcome of the anaphylactic reaction, injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue, malaise, intramuscular formulation administered by other route and wrong technique in device usage process were unknown.   It was unknown if the reporter considered the anaphylactic reaction, injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was received the first dose of Shingrix in March of 2020. The patient received the 2nd dose on 18th June 2020, in the left arm but was not sure it was given intramuscular.  The reporter said it was a quick injection without resistance. The pharmacist used a 5/8 in 25 gauge needle so she was unsure if the needle ever reached the muscle. Within four to five hours later on the same day, the patient noticed the injection site was bruised , and the wheel was formed under the vaccine site. It was more oblong in shape and began to spread until it was three to four inches vertical and two inches horizontally. The area felt raised and was little itchy. She also had a pre anaphylactic reaction so she took Benadryl and used an inhaler. The patient had some muscle fatigue as well as malaise. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle tightness
Clinical narrative: Left Knee Pain; Left calf tightness; This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received Shingrix (intramuscular). On 18th June 2020, 1 days after receiving Shingrix, the patient experienced knee pain and muscle tightness. On an unknown date, the outcome of the knee pain and muscle tightness were unknown.   It was unknown if the reporter considered the knee pain and muscle tightness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had left calf tightness and left knee pain.  The patient stated she had also worked in her yard. All information was not obtained.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Vaccination failure
Clinical narrative: Believes the current rash following dose two of Shingrix could be shingles/ Suspected vaccination failure; Could be shingles/ current rash following dose two of Shingrix could be shingles; Rash was flat and red; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown and the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, red rash and rash to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a rash prior to receiving dose two of Shingrix but the rash was flat and red and resolved quickly.  The patient believesdthe current rash following dose two of Shingrix could be shingles. No additional details provided. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Blister, Burning sensation, Erythema, Pain, Peripheral swelling
Clinical narrative: Pain; Allergic reaction/ allergy to Thimerosal; It burned going in; left arm was swollen, fevered, and red; left arm was swollen, fevered, and red; Swollen arms/the left arm was swollen; her arm was really swollen and blistered and the blisters popped immediately; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) intramuscularly on left arm on 11Jun2020 at a single dose for immunization, and also received unspecified products with thimerosal via an unspecified route of administration on an unspecified date at an unspecified dose for an unspecified indication. Medical history was none. Concomitant medications were not reported. The patient ran a fever in Jun2020 and her arm was really swollen and blistered and the blisters popped immediately on 11Jun2020. The patient was wondering if this was one of the common side effects or adverse reactions and if so, does Pfizer know what ingredients were in it that she would be allergic to. Not uncommon for her, she had allergy to thimerosal and stays away from things/vaccines that contain it. They were not worse and just now clearing up, but she had a few blisters to completely resolve. They started from the shoulder half way down to the forearm. Could tell right away that she was going to have a problem with the vaccine when it went it because it burned on 11Jun2020 and the fever also started right away. Right afterwards the left arm was swollen, fevered, and red right away (on 11Jun2020). The next day it was twice as big, it was huge and she looked like she had Popeye's arm. It was really, really swollen and so she went to the pharmacist to talk about it and was encouraged to contact her doctor. First found out about allergy to thimerosal as a teenager and trying out contact lenses. The solution contained this product. Used paracetamol (TYLENOL) to treat the fever, pain, and swelling and used it for 3 days. For the blistering it stung, but after they popped they didn't sting anymore. Had blisters that started right after vaccine administration and popped immediately, it burned, caused swollen shoulder halfway down to forearm. The outcome of event fever was resolving, of blistered and the blisters popped immediately was not resolved, and of other events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Pyrexia
Clinical narrative: Pain; Allergic reaction/ allergy to Thimerosal; It burned going in; left arm was swollen, fevered, and red; left arm was swollen, fevered, and red; Swollen arms/the left arm was swollen; her arm was really swollen and blistered and the blisters popped immediately; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) intramuscularly on left arm on 11Jun2020 at a single dose for immunization, and also received unspecified products with thimerosal via an unspecified route of administration on an unspecified date at an unspecified dose for an unspecified indication. Medical history was none. Concomitant medications were not reported. The patient ran a fever in Jun2020 and her arm was really swollen and blistered and the blisters popped immediately on 11Jun2020. The patient was wondering if this was one of the common side effects or adverse reactions and if so, does Pfizer know what ingredients were in it that she would be allergic to. Not uncommon for her, she had allergy to thimerosal and stays away from things/vaccines that contain it. They were not worse and just now clearing up, but she had a few blisters to completely resolve. They started from the shoulder half way down to the forearm. Could tell right away that she was going to have a problem with the vaccine when it went it because it burned on 11Jun2020 and the fever also started right away. Right afterwards the left arm was swollen, fevered, and red right away (on 11Jun2020). The next day it was twice as big, it was huge and she looked like she had Popeye's arm. It was really, really swollen and so she went to the pharmacist to talk about it and was encouraged to contact her doctor. First found out about allergy to thimerosal as a teenager and trying out contact lenses. The solution contained this product. Used paracetamol (TYLENOL) to treat the fever, pain, and swelling and used it for 3 days. For the blistering it stung, but after they popped they didn't sting anymore. Had blisters that started right after vaccine administration and popped immediately, it burned, caused swollen shoulder halfway down to forearm. The outcome of event fever was resolving, of blistered and the blisters popped immediately was not resolved, and of other events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Rash, Skin warm
Clinical narrative: Rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site; Rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site; Rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site; This is a spontaneous report from a contactable nurse. This nurse reported similar reports for two patients. This is the 2nd of two reports. A 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot number: CK0842, expiry date: 28Feb2022), intramuscular into left arm on 19Jun2020 at 09:06 at 0.5 mL, single for preventative. There were no medical history or concomitant medications. The patient experienced rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site in Jun2020, occurred several days after receiving the pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020248405 Same reporter/drug/event, different patient
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Haematology test, Hyperaesthesia, Swelling
Clinical narrative: Went medical center on 6-27-20 for redness, swelling and sensitivity was administered Keflex for possible cellulitis. Went back to medical center on 6-28-20 for follow up. Arm is looking better per Physician. Swelling has subsided, smaller than original outline of marker.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Tremor
Clinical narrative: PATIENT REPORTED AN INCREASED SHORTNESS OF BREATH, OVERALL CHEST HEAVINESS AND GENERALIZED SHAKINESS WHILE RETURNING HOME FROM GETTING THE VACCINE. PATIENT WAS TRANSPORTED TO THE ED AND RECEIVED ALBUTEROL, PREDNISONE, BENADRYL AND CETIRIZINE. PATIENT DISCHARGED HOME SAME DAY.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Screaming
Clinical narrative: 2month old had vaccines at 0800 apt. She began non-stop crying shortly after we got home about 0930. Crying was inconsolable, whaling open mouth. We tried breastfeeding, holding, bottle feeding, bath, pacifier,  rocking, nothing calmed her.  Called nurses line, they handled poorly and gave no help besides what I'd already tried. No fever was present. Finally infant calmed skin to skin on her belly to mother and slept in a very light state for the rest of the day until a little before 4pm. If i even moved a little while she reared on me she would began screaming and crying again. Infant wouldnt eat while dealing with this adverse reaction all day.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Paranasal sinus discomfort, Tenderness
Clinical narrative: dose left arm 06/09, left sided headache 06/13; headache worsening 06/14, took 650 Tylenol x2 that day, more intense headache 06/15, called PCP office to report headache & questioning  RN re side effect of shingrex shot, wasn't able to R/O but to monitor & call back if worse; 06/17 noticed 'pink' cheek, tenderness under left eyebrow & pressure left sinus area & thought maybe I was having a dental/sinus issue > exam & xrays  by dentist proved negative to the symptoms I was describing but he gave me amoxicillin 500mg po tid: if pain was better then it was probably an underlying dental problem but if pain persists then recall PCP. 06/17 nite I had terrific headache & pain left forehead which necessitated tylenol/ibuprofen doses + ice pack to affected area. I 'knew' 06/18 AM that I had shingles ? 'bumpy' painful left forehead, swelling under  brow, & lesions thru-ought scalp; went to local Urgent Care where PA diagnosed me with Shingles & prescribed Acyclovir 1GM tid x7days. Within 36 hrs relief was felt.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray dental normal
Clinical narrative: dose left arm 06/09, left sided headache 06/13; headache worsening 06/14, took 650 Tylenol x2 that day, more intense headache 06/15, called PCP office to report headache & questioning  RN re side effect of shingrex shot, wasn't able to R/O but to monitor & call back if worse; 06/17 noticed 'pink' cheek, tenderness under left eyebrow & pressure left sinus area & thought maybe I was having a dental/sinus issue > exam & xrays  by dentist proved negative to the symptoms I was describing but he gave me amoxicillin 500mg po tid: if pain was better then it was probably an underlying dental problem but if pain persists then recall PCP. 06/17 nite I had terrific headache & pain left forehead which necessitated tylenol/ibuprofen doses + ice pack to affected area. I 'knew' 06/18 AM that I had shingles ? 'bumpy' painful left forehead, swelling under  brow, & lesions thru-ought scalp; went to local Urgent Care where PA diagnosed me with Shingles & prescribed Acyclovir 1GM tid x7days. Within 36 hrs relief was felt.
Age: 24.0
Sex: M
Vaccine: UNK
Symptoms: Dehydration, Vomiting
Clinical narrative: Patient reports vomiting and went to ER. Diagnosed with dehydration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5/21/20 - "oreo-size redness" at injection site on left upper arm. Then Redness spread to entire left upper arm from proximal shoulder area to elbow area with mild swelling  in a matter of 2 days. Anticipatory guidance given that this is a known reaction to DTaP and occurs 2-3% of time per Red Book and should resolve on its own.
Age: 1.58
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VARIVAX on 6/16/2020, that had been improperly stored; This spontaneous report has been received from a nurse, referring to a 19 months old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 16-JUN-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S028925 with expiration date: 16-SEP-2021; dose, strength and route were unknown) for prophylaxis, that had been improperly stored (product storage error). The lot of varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). No additional adverse event.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 7.2 degrees Fahrenheit (F) for 30 minutes. On 05-JUN-2020, the previous temperature excursion was 6F to 14F for 1 hour and 15F to 46F for 4 hours. On 08-JUN-2020, the previous temperature excursion was 6F to 14F for 1 hour 50 minutes. On 15-JUN-2020, the previous temperature excursion was 6F to 14F for 20 minutes. The digital data logger was involved to capture the temperature excursion.
Sex: M
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: No other adverse effects were reported; a patient received a partial dose of Proquad because the patient moved his arm during administration of the vaccine; a patient received a partial dose of Proquad because the patient moved his arm during administration of the vaccine; This spontaneous report was received from a nurse and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 22-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with a sterile diluent (STERILE DILUENT) 0.5 ml, injection.   The patient received a partial dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), because he moved his arm during the administration. The patient did not experience any additional adverse events.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 06-FEB-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at a practice for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; On June 10, 2020 her daughter was administered an improperly stored varivax; This spontaneous report was received from a registered nurse referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 10-JUN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S038175, expiry date: 26-NOV-2021; lot # S035125, expiry date: 04-NOV-2021; lot # S012036, expiry date: 17-APR-2021; lot # R019237, expiry date: 04-JUL-2020 and lot # S024366, expiry date: 06-AUG-2021) (strength, route and anatomical location not provided) for prophylaxis (product storage error). The sterile diluent (lot number and expiration date not reported) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. It was reported that, the nurse did not know which lot was administered to the patient. The temperature excursion reported as -9 degree Celsius to 8 degree Celsius (-9 degree Celsius) for 45 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse events were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Oropharyngeal pain
Clinical narrative: flu like symptoms; sore throat; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced influenza-like symptoms and sore throat. On an unknown date, the outcome of the influenza-like symptoms and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and sore throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked how long do the flu like symptoms usually last. The patient received Shingrix and had sore throat and continued for 5 days. The reporter asked was this a side effect or a new problem.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Inappropriate schedule of product administration, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: slightly later than 6 months after the first one; Neck pain; Shoulder pain; Arm pain; Ear pain; Welts on skin; Irritation on neck; Irritation on neck with 3 bumps; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose 6 months ago).   On 15th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th June 2020, 4 days after receiving Shingrix, the patient experienced neck pain, shoulder pain, pain in arm, ear pain, welts, skin irritation and papular rash. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the neck pain, shoulder pain, pain in arm, ear pain and welts were recovering/resolving and the outcome of the skin irritation was not recovered/not resolved and the outcome of the papular rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the neck pain, shoulder pain, pain in arm, ear pain, welts, skin irritation and papular rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the wife of the patient. The patient received Shingrix slightly later than 6 months after the first one which led to drug dose administration interval too long. On 19th June 2020, the patient experienced neck, shoulder, arm and ear pain, welts on his skin and irritation on his neck with three bumps in a line. Advised reporter to have patient follow up with his health care professional. Reporter did not consent to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, Skin irritation, Urticaria
Clinical narrative: slightly later than 6 months after the first one; Neck pain; Shoulder pain; Arm pain; Ear pain; Welts on skin; Irritation on neck; Irritation on neck with 3 bumps; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose 6 months ago).   On 15th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th June 2020, 4 days after receiving Shingrix, the patient experienced neck pain, shoulder pain, pain in arm, ear pain, welts, skin irritation and papular rash. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the neck pain, shoulder pain, pain in arm, ear pain and welts were recovering/resolving and the outcome of the skin irritation was not recovered/not resolved and the outcome of the papular rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the neck pain, shoulder pain, pain in arm, ear pain, welts, skin irritation and papular rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the wife of the patient. The patient received Shingrix slightly later than 6 months after the first one which led to drug dose administration interval too long. On 19th June 2020, the patient experienced neck, shoulder, arm and ear pain, welts on his skin and irritation on his neck with three bumps in a line. Advised reporter to have patient follow up with his health care professional. Reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Low grade fever; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on February 2020).   On 22nd June 2020, the patient received the 2nd dose of Shingrix .5 ml. On 22nd June 2020, 6 hrs after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and approximately 6 hours after receiving his injection, he developed a low grade fever, of which he did not provide the temperature and a headache.   The reporter requested to know how long these side effects would last.  Information provided per Shingrix PI in Content.   The medical disclaimer given to caller and PI offered to be mailed to caller. The reporter did not consent to follow up. The reporter did not know who administered his injection of Shingrix, only the name and address where he received it.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Rash down arm and itching/Experienced rash, itching, at the injection site; Rash down arm and itching/Experienced rash, itching, at the injection site; Experienced rash, itching, and warmth at the injection site; This is a spontaneous report from a contactable nurse. This nurse reported for three patients. This is 1st of three reports. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, strength: 0.5 ml, Batch/lot number: CK0842, NDC number: 0005-1971-02, Expiry date: 28Feb2022), intramuscular in the left arm on 19Jun2020 13:20 at 0.5 mL, single dose for prevention of pneumonia. Medical history was none. There were no concomitant medications. Pneumococcal 13-val conj vac (dipht crm197 protein) was given to the patient who then experienced rash, itching, and warmth at the injection site on an unspecified date of Jun2020. The patient experienced rash down arm and itching on 24Jun2020. Additional vaccines administered on the same date of the pfizer suspect was none. Events requiring a visit to emergency room or physician office was no. Prior Vaccinations (within 4 weeks) was none. Family medical history relevant to events was none. No relevant tests. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020248408 same reporter/drug/event, different patient
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Sunburn, Swelling
Clinical narrative: Patient reported that a painful spot, approximately 6 x 3 inches, appeared on the inside of his vaccinated (left) upper arm later in the evening following vaccination.  He reported the spot was red, warm to the touch, and was sore and swollen when pressed upon.  He called the pharmacy to report as it was different than the usual response after having vaccines here previously (described the area as "more pronounced" than the usual small spot right at site of vaccination).  Patient reported having to take two Tylenol 500mg the Sunday night of vaccination, 2 tabs AM and 2 tabs PM on Monday, and 2 tabs AM on Tuesday (he called Tuesday afternoon).  At that point he described the spot as a mild sunburn and was getting somewhat better.  I counseled him to continue with the Tylenol regimen as it seemed to be helping and to ice the area in 15-minute intervals to help with further swelling and discomfort.  He was instructed to report any further reactions to his primary care physician and the pharmacy.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: SkinRash & UrticarialPruritus
Age: 62.0
Sex: M
Vaccine: DTP, FLU4, PPV
Symptoms: Purpura, Rash
Clinical narrative: Rash & Purpura
Age: 84.0
Sex: M
Vaccine: FLUX
Symptoms: Blood immunoglobulin G, Cough, Productive cough, SARS-CoV-2 test
Clinical narrative: Green Phlem Cough +; for month +, first time ever.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Urticaria
Clinical narrative: I woke up the morning after the injection with small welts under my buttocks. Within a day I had swollen lips and large welts all over the upper part of my body. I started on a regimen of prednisone that proved inadequate. Then took a larger dose - cleared up in 2 days.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Lymphadenopathy, Rash morbilliform
Clinical narrative: - Rash that looks like measles all over the body. - Not itchy - 2 knots (lymph nodes) in Bilateral inguinal areas. - No fevers.  - Tx - supportive care - Avoid close contact with Immunocompromised individuals
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. In 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a healthcare provider at the medical clinic, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. No information was received regarding the pt's medical history, concurrent conditions and concomitant medications. On or about 02-OCT-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; The nurse reports that patient received improperly stored PEDVAXHIB; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not the reported.  On 19-JUN-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, as prophylaxis (lot number S023646 which has been verified to be valid, expiration date reported and validated as 31-MAR-2022) (dose, route of administration, vaccination scheme and anatomical site of injection were not reported). The administered dose of the vaccine experienced a temperature total time and highest temperature above 47 degrees Fahrenheit (F)/9 degrees Celsius (C) 9.15 C, during a time frame of 15 minutes, as recorded by a data logger. There was a previous temperature excursion with total time and highest temperature above 47 F/9 C 8.62 C, during a time frame of 11 minutes. No additional adverse effect reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 24-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) by a health care provider (HCP) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a HCP at a clinic for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore; This case was reported by a dentist via call center representative and described the occurrence of cold sores in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2020, the patient received Shingrix. On 22nd June 2020, 51 days after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. On 22nd June 2020, the patient experienced cold sore 2 hours prior to the time of reporting.  The patient had never had the cold sore before.  The reporter consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Menactra was accidentally given to a patient/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional.  This case involves a 12 years old female patient who was mistakenly vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was already expired (batch number U6219BA, dosing details 0.5 ml and expiry date 16-JUN-2020) via intramuscular route in the right deltoid on an unknown date for prophylactic vaccination(Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Menactra was accidentally given to a 12 month old instead of MMR/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a twelve months old male patient who was mistakenly vaccinated with  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number U6486AD, dosing details 0.5 ml and expiry date 16-JAN-2021) instead MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] via intramuscularly at the left leg on 23-JUN-2020 for prophylactic vaccination (Wrong product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX II) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of an actual medication error due to wrong vaccine administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.