chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; patient received an improperly stored dose of PEDVAX.; This spontaneous report was received from a medical assistant, and refers to a 2 month old female patient. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 03-OCT-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R036177 with an expiration date in 08-OCT-2021), for prophylaxis (strength, dose and frequency were not provided), that underwent a temperature excursion of 46.5 degrees Fahrenheit during a time frame of 5 minutes. Digital data logger was involved, however no previous temperature excursion was reported. No adverse effects were reported.        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006584: US-009507513-1910USA006415: US-009507513-1910USA006562: US-009507513-1910USA006576: US-009507513-1910USA006268:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The physician is reporting that the patient recieved improperly stored vaccine; This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unknown date, the patient was vaccinated with an improperly dose (product storage error) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) one dose,  (route of administration was not reported). Administered dose of vaccine experienced the temperature excursion of 32.5 degrees Fahrenheit (°F) for 8 hours. Data logger was involved. There were no previous excursions reported.  The lot number S000757 and expiration date 27-SEP-2019 was pending for confirmation.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported; patient inadvertently received a second dose of VARIVAX at 15 months; This spontaneous report was received from a registered nurse referring to a 15 month old patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  In approximately July 2019, at 12 month old, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were not reported). On 10-OCT-2019, at 15 months, the patient inadvertently received a second dose  of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S006021 and expiration date on 27-FEB-2021, for prophylaxis (dose, route of administration and anatomical injection site were not reported) (wrong product administered). The vaccines were reconstituted with a sterile diluent(STERILE DILUENT). No adverse effects reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored doses administered; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (INFANRIX-IPV) and "FW".    On 19-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012981: US-009507513-1910USA012349: US-009507513-1910USA012350: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received on 16-OCT-2019, from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the patient's vaccination, he was treated by a physician for shingles. As a direct and proximate result of patient's vaccination with zoster vaccine live (ZOSTAVAX), he had and would continue suffering 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 included care for hospitalizations, physical care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life, quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of the report, the outcome of shingles was not recovered. The causality assessment was related.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; product storage error; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The patient had no illness at the time of vaccination. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV).   On an unknown date in 2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012240: US-009507513-1910USA012350: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012240:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; product storage error; This spontaneous report was received from a medical assistant, regarding a 4 year old female patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV) and "FW".   On 21-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012350: US-009507513-1910USA012352: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360: US-009507513-1910USA012981:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored doses of PROQUAD; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV).  On 27-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012351: US-009507513-1910USA012240: US-009507513-1910USA012349: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, No adverse event, Product label confusion
Clinical narrative: labeling of proquad should be much larger, a more obvious color differential, different font size and include the word "combination" on it; the unspecified 12 month old patient was inadvertently administered one dose of PROQUAD and one dose of VARIVAX; No adverse effects reported.; Information was received from a physician referring to a 12 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown.  On an unknown date, the patient was vaccinated inadvertently with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose detail, strength, route, lot#, expiration date were unknown) and one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose detail, strength, route, lot#, expiration date were unknown) for prophylaxis (accidental overdose). No adverse effects were reported.   The reporter stated that the labeling for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) should be much larger, a more obvious color differential, different font size and include the word 'combination' on it (product label issue).
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Product administered at inappropriate site
Clinical narrative: The patient´s arm then became swollen for the last few days; received PNEUMOVAX 23 simultaneously with an unspeciffied "flu" vaccine in the same arm; This spontaneous report was received from a consumer referring to his uncle, a male patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date (reported as few days ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis; simultaneously he was vaccinated with an unspecified flu vaccine in the same arm (dose, frequency, route, lot/batch # and expiration date were not provided) (product administered at inappropriate site). Then, the patient's arm became swollen for the last few days (peripheral swelling).  The outcome of peripheral swelling was unknown  The causality assessment between the event and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; multiple unspecified patients may have been administered improperly stored VARIVAX; This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported.  Since 27-SEP-2019, multiple unspecified patients may had been administered improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S019463 and expiration date 24-JUN-2021 (strength, dose, frequency and anatomical location were not provided) for prophylaxis. The administered doses of the vaccines were stored with the temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit (mainly at 8 degrees Fahrenheit) for 38 minutes. The previous temperature excursion was 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 40 minutes. There was a digital data logger involved. No adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; a patient was administered a improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 15-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)injection, subcutaneously, lot number S015460 with expiration date on 20-MAY-2021 (dosage schedule, and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of -11.5 degrees Celsius (C) for 76 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tired for a week; This case was reported by a nurse via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included food allergy and drug allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient was a registered nurse and reported adverse event experienced by herself. The age at vaccination was not reported. The patient was tired for a week after receiving Shingrix. The patient did not consent to follow-up and refused to provide any additional details, declined any future follow up or communication regarding this. This case has been linked to US2019188847, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain/stinging at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On 17th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The reporter mentioned that she gave 3 Shingrix vaccinations on day of reporting and all 3 patients had complained of pain/stinging during injection of the Shingrix dose. The reporter consent to follow up. This is 2 of the 3 linked cases reported by the same reporter. This case had been linked to the case US2019188954, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain/stinging at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On 17th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age at vaccination was captured as adult as per Shingrix indication. The reporter mentioned that she gave 3 Shingrix vaccinations on day of reporting and all 3 patients had complained of pain/stinging during injection of the Shingrix dose. The reporter consent to follow up. This is 3 of the 3 linked cases reported by the same reporter. This case had been linked to the case US2019188954, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gingival pain, Influenza like illness, Middle insomnia, Neuralgia
Clinical narrative: Bottom lip is tingly; Back hurting; Nerve pain in both her jaws; Both sides of her jaw hurt like throbbing nerve pain; Mouth pain was in the back by the molars; Flu like symptoms; Gums started feeling inflamed; Dry pain in the gum area; Left arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vaginal bleeding. Concomitant products included Herpes zoster (Shingrix).   On 6th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 6th October 2019, less than a day after receiving Shingrix, the patient experienced gingival inflammation and gum pain. On 7th October 2019, the patient experienced influenza-like symptoms. On 10th October 2019, the patient experienced back pain, nerve pain, jaw pain and oral pain. On 14th October 2019, the patient experienced tingling lips. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, gingival inflammation, gum pain and influenza-like symptoms were recovered/resolved and the outcome of the back pain, nerve pain, jaw pain, oral pain and tingling lips were unknown.   It was unknown if the reporter considered the pain in arm, gingival inflammation, gum pain, influenza-like symptoms, back pain, nerve pain, jaw pain, oral pain and tingling lips to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The patient stated that her left arm was sore for 2-3 days then resolved The patients gums started feeling inflamed as if she had eaten glass, gum pain. The patient stated that the pain was the gum area above the 4 top teeth and below the bottom 4 teeth. The patient had a flu-like symptoms. The patient had back hurting and also both sides of her jaw hurt like throbbing nerve pain. The mouth pain was in the back by the molars but they looked normal. The mouth pain was intermittent. The patient experienced the right side mouth jaw pain which woke her up in the middle of the night. The patient also felt that her bottom lip was tingly. Under her tongue and on the right side she is feeling a painful radiating nerve mouth pain on the upper and lower. The patient stated that the flossing helps the pain. The patient stated that she was not a hypochondriac. The patient do not go to the physician all the time but she already talked to her dentist about the events occurred  and was going to see the MD. The patient mentioned that something which consider to be medical history regarding one time she went to the doctor because she had vaginal bleeding and how it was good that she went to the MD because she ended up needing surgery on her uterus. This case has been linked with case US2019186112, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Noninfective gingivitis, Oral pain, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Bottom lip is tingly; Back hurting; Nerve pain in both her jaws; Both sides of her jaw hurt like throbbing nerve pain; Mouth pain was in the back by the molars; Flu like symptoms; Gums started feeling inflamed; Dry pain in the gum area; Left arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vaginal bleeding. Concomitant products included Herpes zoster (Shingrix).   On 6th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 6th October 2019, less than a day after receiving Shingrix, the patient experienced gingival inflammation and gum pain. On 7th October 2019, the patient experienced influenza-like symptoms. On 10th October 2019, the patient experienced back pain, nerve pain, jaw pain and oral pain. On 14th October 2019, the patient experienced tingling lips. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, gingival inflammation, gum pain and influenza-like symptoms were recovered/resolved and the outcome of the back pain, nerve pain, jaw pain, oral pain and tingling lips were unknown.   It was unknown if the reporter considered the pain in arm, gingival inflammation, gum pain, influenza-like symptoms, back pain, nerve pain, jaw pain, oral pain and tingling lips to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The patient stated that her left arm was sore for 2-3 days then resolved The patients gums started feeling inflamed as if she had eaten glass, gum pain. The patient stated that the pain was the gum area above the 4 top teeth and below the bottom 4 teeth. The patient had a flu-like symptoms. The patient had back hurting and also both sides of her jaw hurt like throbbing nerve pain. The mouth pain was in the back by the molars but they looked normal. The mouth pain was intermittent. The patient experienced the right side mouth jaw pain which woke her up in the middle of the night. The patient also felt that her bottom lip was tingly. Under her tongue and on the right side she is feeling a painful radiating nerve mouth pain on the upper and lower. The patient stated that the flossing helps the pain. The patient stated that she was not a hypochondriac. The patient do not go to the physician all the time but she already talked to her dentist about the events occurred  and was going to see the MD. The patient mentioned that something which consider to be medical history regarding one time she went to the doctor because she had vaginal bleeding and how it was good that she went to the MD because she ended up needing surgery on her uterus. This case has been linked with case US2019186112, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Bottom lip is tingly; Back hurting; Nerve pain in both her jaws; Both sides of her jaw hurt like throbbing nerve pain; Mouth pain was in the back by the molars; Flu like symptoms; Gums started feeling inflamed; Dry pain in the gum area; Left arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vaginal bleeding. Concomitant products included Herpes zoster (Shingrix).   On 6th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 6th October 2019, less than a day after receiving Shingrix, the patient experienced gingival inflammation and gum pain. On 7th October 2019, the patient experienced influenza-like symptoms. On 10th October 2019, the patient experienced back pain, nerve pain, jaw pain and oral pain. On 14th October 2019, the patient experienced tingling lips. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, gingival inflammation, gum pain and influenza-like symptoms were recovered/resolved and the outcome of the back pain, nerve pain, jaw pain, oral pain and tingling lips were unknown.   It was unknown if the reporter considered the pain in arm, gingival inflammation, gum pain, influenza-like symptoms, back pain, nerve pain, jaw pain, oral pain and tingling lips to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The patient stated that her left arm was sore for 2-3 days then resolved The patients gums started feeling inflamed as if she had eaten glass, gum pain. The patient stated that the pain was the gum area above the 4 top teeth and below the bottom 4 teeth. The patient had a flu-like symptoms. The patient had back hurting and also both sides of her jaw hurt like throbbing nerve pain. The mouth pain was in the back by the molars but they looked normal. The mouth pain was intermittent. The patient experienced the right side mouth jaw pain which woke her up in the middle of the night. The patient also felt that her bottom lip was tingly. Under her tongue and on the right side she is feeling a painful radiating nerve mouth pain on the upper and lower. The patient stated that the flossing helps the pain. The patient stated that she was not a hypochondriac. The patient do not go to the physician all the time but she already talked to her dentist about the events occurred  and was going to see the MD. The patient mentioned that something which consider to be medical history regarding one time she went to the doctor because she had vaginal bleeding and how it was good that she went to the MD because she ended up needing surgery on her uterus. This case has been linked with case US2019186112, reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number J225D, expiry date 22nd October 2021) for prophylaxis.   The patient's past medical history included dialysis.   On 10th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 9th October 2019, 60 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 case details were reported as follows: The patient received vaccine in left arm. The reporter on the line with a patient who received their first dose in August 2019 and then around 09th October 2019 developed shingles, which was ongoing. The reporter consent to follow up.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Hives around his neck and upper chest, then progressed down his upper arms and forearms; HIves itch; This case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (SEASONAL INFLUENZA VACCINE)) for prophylaxis.   Previously administered products included High dose flu vaccine (had received high dose vaccine in the past but never had reaction).   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th October 2019, the patient received FLUZONE (SEASONAL INFLUENZA VACCINE). In October 2019, 11 days after receiving Shingrix, the patient experienced hives and itchy rash. On an unknown date, the outcome of the hives and itchy rash were not recovered/not resolved.   The reporter considered the hives and itchy rash to be related to Shingrix.  Additional details were provided as follows: The reporter stated, she and her husband received the 1st Shingrix vaccine in left deltoid. After a week, they got a flu vaccine.  The reporter was fine but three days after the flu vaccine, the patient broke out in hives. The reporter said that, it might be a reaction from the Shingrix because they had the same high-dose flu vaccine in the past and never had this reaction.  The patient had hives which started around his neck and upper chest, then progressed down his upper arms and forearms. Thee hives itch when he took a hot shower and when he stated to get warm.  The hives were not cleared, was not resolving and therefore they went to see their dermatologist. The reporter did not grant permission to contact their healthcare provider about this event and did not consent to follow up. It was unknown if the reporter considered the hives and itchy rash to be related to Fluzone.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain/stinging at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. On 17th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age at vaccination was captured as adult as per Shingrix indication. The reporter mentioned that she gave 3 Shingrix vaccinations on day of reporting and all 3 patients had complained of pain/stinging during injection of the Shingrix dose. The reporter consent to follow up. This is 1 of the 3 linked cases reported by the same reporter. This case had been linked to the case US2019188954, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm about the size of a tennis ball; Fever; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced swelling arm, fever and chills. On an unknown date, the outcome of the swelling arm, fever and chills were unknown.   It was unknown if the reporter considered the swelling arm, fever and chills to be related to Shingrix.  Additional case details were reported as follows: The patient received a dose of Shingrix on the left arm. The patient experienced swollen arm about the size of a tennis ball, fever and chills.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: When I was given the 2 shots for shingles ( separately ) it gave me a headache like my head was full of broken glass for 3 days or more and that is exactly what it felt like.  The first shot really hurt and my arm swelled up and was very red for about 2 weeks.  The second shot was given by a different doctor.  He pointed the needle in a more downward position on the side of the shoulderand not that deep into the center of the tissue and this shot did not hurt or swell.  Just for your info.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Fever, Right deltoid edema
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: diffuse rash over torso, started approx. 10 days after immunization administration
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Cholinergic syndrome, Eye movement disorder, Immediate post-injection reaction, Muscle tightness, Seizure
Clinical narrative: The patient felt an immediate cholinergic cascade, like he was going to pass out.  Then his muscles tensed slightly, his eyes rolled back in his head, and he panicked and asked where he was.  He appeared to have had a 3-5 second seizure.  It took him 20-30 minutes to recover to a point where he could stand up without feeling like he would pass out.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Ataxia, Eyelid ptosis, Feeling drunk, Hypoaesthesia, Paraesthesia
Clinical narrative: Left sided facial numbness and tingling. Left eyelid drooping. Ataxic gate. "Feels drunk"
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site nerve damage, Injection site pain
Clinical narrative: Patient stated she had initial soreness from the flu vaccine for a couple of days, but then 10 days later she had severe pain in her arm that was keeping her awake.  She went to the emergency room and the doctor decided a nerve must have been hit at time of injection causing pain.
Age: 59.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Pyrexia, Rash, Respiratory symptom
Clinical narrative: 8 days after immunizations, fever, mild URI sxs, and as of rash
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Injection site pain, Nausea, Presyncope
Clinical narrative: Felt fine all day after shot, other than sore arm at injection site until about 5 p.m., a good 7 hours after shot.  Got light headed to the point of nearly fainting, violent feverish chills and nauseousness.  24 hours later, still dealing with heavy feverish sweating and nauseousness.  Not concerned, but wanted to note it for your records.  Info sent home with me noted 1 in 6 patients will see such a reaction, so simply assume I'm one of them.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Felt fine all day after shot, other than sore arm at injection site until about 5 p.m., a good 7 hours after shot.  Got light headed to the point of nearly fainting, violent feverish chills and nauseousness.  24 hours later, still dealing with heavy feverish sweating and nauseousness.  Not concerned, but wanted to note it for your records.  Info sent home with me noted 1 in 6 patients will see such a reaction, so simply assume I'm one of them.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Hemiparesis, Immediate post-injection reaction, Lethargy, Nausea
Clinical narrative: After injection, immediate burning down to hand. Developed extreme lethargy, nausea, rash, fever (25 hours post injection), right sided weakness, right sided pins and needles (from cheek to leg)
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia, Pyrexia, Rash
Clinical narrative: After injection, immediate burning down to hand. Developed extreme lethargy, nausea, rash, fever (25 hours post injection), right sided weakness, right sided pins and needles (from cheek to leg)
Age: 44.0
Sex: F
Vaccine: HEP, MMR, TDAP, UNK, VARCEL
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: CLIENT GOT HER VACCINES ON A FRIDAY. ON SUNDAY,HER LEFT ARM   WAS VERY SWOLLEN, RED, HOT AND  HARD TO TOUCH. SHE WENT TO THE ER AND THEY GAVE HER AN ANTIBIOTIC AND MARKED THE AREA WITH A PEN. TOLD CLIENT  THAT IF IT GETS BIGGER TO COME BACK. SHE  WENT TO HD TO GET WRM READ FROM PPD ON MONDAY.   SAW CLIENT TODAY ON 10/22/19, SHE SAID SHE WAS GOING OK AND SHE DID PUT COOL COMPRESSES ON IT ON SUNDAY. BUT DIDN'T TAKE ANYTHING FOR PAIN.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adeverse affects reported; patient "received her 3rd dose of GARDASIL 9 sooner than what was indicated." Nurse Prescriber stated that second dose was administered on 9/4/2019 and 3rd dose was received on 9/18/2019.; This spontaneous report was received from a nurse prescriber via a company representative referring to a 15 years old female patient. The patient's concurrent condition included migraine. Her medical history included migraine prior to injection. Concomitant medication and drug reactions/allergies were not reported.  On 04-SEP-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number reported as R032747) (expiration date and route of administration were unknown; strength and dose not reported) in left deltoid for prophylaxis. On 18-SEP-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number reported as 1621931) (expiration date and route of administration were unknown; strength and dose not reported) for prophylaxis (inappropriate schedule of product administration). The patient's mother told the medical assistant that the patient was here for flu vaccination and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination. The medical assistant administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to the patient-error caught immediately. The patient's mother was advised of error. No other injections were administered. The mother was advised to inform as soon as possible if any adverse effects occurred. The medical assistant then was educated after the incident-must look and verify injection due date prior to administration. The patient nor her family sometime was clear what was needed. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237, expiration date 04-JUL-2020 or lot # S005078, expiration date 19-FEB-2021 (the office did not know which lot was given to which patient, dose and route of administration were not reported). The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -14 to -10 (-9.74 degrees Celsius for an unknown time frame. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; the patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided.  On 07-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002874, expiration date 29-JAN-2021 (dose and route of administration were not reported) for prophylaxis. The sterile diluent (lot # N030413, expiration date 05-JUL-2020) used to reconstitute varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 7.64 degrees Fahrenheit for 20 minutes. Data logger was involved. There was previous temperature excursion of 19.34 degrees Fahrenheit for 34 minutes.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Oral shingles lesions; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 13th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th October 2019, 4 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 the first dose of Shingrix on the left deltoid. On 17Oct2019, the patient was seen by her dentist and was diagnosed with oral shingles (shingles in mouth). No treatment was prescribed at timeof reporting. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Blister, Exposure via skin contact, Pruritus
Clinical narrative: Some of the liquid got onto her right hand; Exposure via skin contact; Blisters on the right hand; Itchy; This case was reported by a nurse via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced blister and pruritus. On an unknown date, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the blister, pruritus, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The nurse was mixing a dose of Shingrix to administer to a patient, some of the liquid got onto her right hand, which led to inadvertent exposure to vaccine and exposure via skin contact. Afterwards, the patient developed blisters on the right hand and at the time of reporting the blisters had increased in number, although they remain localized.  At the time of reporting, some blisters were open, while others were closed. Blisters were on the crease of thumb and index finger and itchy.  The patient had not sought medical treatment and had not applied any treatment herself. No further details provided during the call. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 29th October 2021) for prophylaxis.   On 8th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient received the second dose of the Shingrix vaccine and experienced shingles. The reporter consented to follow up.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose increased, Condition aggravated, Diabetes mellitus
Clinical narrative: Sugar level jumped to 420; This is a spontaneous case from the United States, initially received from pharmacist via Med Communications (reference number: SEQ19-04655) on 14-Oct-2019, concerning a 31-year-old, female patient.   The patient's current condition included diabetes, while the patient's concomitant medications were not reported.   On 02-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid (left or right, as reported), batch number: P100100560, expiry date: May-2020] for an influenza prophylaxis.   On the same date, after vaccination, the patient's blood sugar jumped from 190 to 420 (units were not specified).The patient did not eat anything before receiving the flu shot, and had not taken any steroid shots as well, as reported.   At the time of initial reporting, the outcome of the event of diabetes mellitus aggravated was unknown.  The case was assessed as serious and the reporter did not provide causality assessment.  Company comment: The patient experienced diabetes mellitus aggravated, on the same date after vaccination with the suspect product, Afluria Quad. Chronology is plausible. Reportedly, the patient's blood sugar jumped from 190 to 420 (units were not specified). Causality was confounded by underlying medical history of diabetes mellitus. More information regarding therapy compliance, dietary regimen and physical activity is needed. Based on provided information, causal role of the suspect product is assessed as related.