chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; the patient was administered expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 29-JAN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R000555 and expiration date 08-JAN-2020 (expired product administered), for prophylaxis (dose strength, frequency, and route of administration were not reported). Sterile diluent, lot# N032755 and expiration date 04-AUG-2020 was used to reconstitute the vaccine.  The patient experienced no adverse events.
Sex: F
Vaccine: HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: she did cut her finger on the syringe; syringe that was broken "around the top where plunger is"; This spontaneous report was received from a nurse, who is also the female patient of unknown age referring to herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 17-JAN-2020, reported as 2 weeks ago, the nurse was trying to attach the needle to the pre-filled syringe of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9)  lot # S008151 expiration date on 20-NOV-2021, when she noticed that the syringe was broken "around the top where plunger was". As result, the nurse did cut her finger (wound) on the syringe. Subsequently, she put a "Band Aid on the wound and kept on working". There were no symptoms reported. It was reported that the patient did not seek medical attention and no treatment was given for the event.  The outcome of wound was reported resolved on an unknown date in January 2020. The causality between the event and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was unknown.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; aches; tiredness; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix. On 24th January 2020, less than a day after receiving Shingrix, the patient experienced fever, pain, tiredness and headache. On an unknown date, the outcome of the fever, pain, tiredness and headache were unknown.   It was unknown if the reporter considered the fever, pain, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received the shot of the shingles vaccine and developed a fever, aches, tiredness, headache. The patient told that his physician's office this reactions like that would not happened that soon after the shot.  The reporter wanted to know, what was the average time period for symptoms to appear after a shingles shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: discomfort from the shot; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site discomfort in a adult 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 injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were reported as follows: The age vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient received Shingrix vaccine and experianced discomfort. The patient ask for advil as a treatment for discomfort.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: developed a large red spot not at the injection site; This case was reported by a other health professional and described the occurrence of localized erythema in a adult 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 localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   It was unknown if the reporter considered the localized erythema to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient experianced large red spot after every shigrix vaccination . The large red spot not at the site of administration but red spot at few inches from site of administration.  The patient was fine but think about red spot which are not at site of administration. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site reaction, Rash papular
Clinical narrative: raised red spot at injection site; tender spot at injection site; raised spot where the vaccine was given; raised spot where the vaccine was given; 1st dose of Shingrix subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site tenderness, raised rash, injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site tenderness, raised rash, injection site reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site erythema, injection site tenderness, raised rash and injection site reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient, received the dose of Shingrix subcutaneously on an unknown date, which led to incorrect route of vaccine administration The patient developed a large, raised, red tender spot where the vaccine was given about 5 inch by 3 inch in size.  The reporter consented to follow up.  The HCP did not have the vaccination information (date, lot number, expiration date, etc).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure / he received the Shingrix 2-shot series and his shingles outbreaks were less severe for a little while but now they are back to full-blown outbreaks again; shingles outbreaks; Severe pain; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (constantly had major shingles outbreaks for years and was in a lot of pain).   In March 2019, the patient received the 1st dose of Shingrix. In May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix 2nd shot series and his shingles outbreaks were less severe for a little while but at the time of reporting they were back to full blown outbreaks again (Patient said he was back to square one again). The patient was calling because he wanted to see if he could get the 2nd shot series again because it was not effective. The patient was back to having full shingles outbreaks again. The patient was in severe pain and he had to sit on a heating pad to get any kind of relief. The patient stated that he took pills (unspecified) for shingles but they did not do any good. The patient was upset during the call and ended the call abruptly. The reporter provided limited information. The permission to follow up was denied. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. This case had been linked to the case US2020015877, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure / had the Shingrix shot(s) is "still has outbreaks" so he guesses our product isn't very effective; had the Shingrix shot(s) is "still has outbreaks"; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 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.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter did not know if the patients had a prior history of shingles or not. The reporter knew that everyone's, who had the Shingrix shot(s) was still had outbreaks so reporter guessed that GSK  product was not very effective. The reporter did not specify the number of persons or their gender or if they had received both doses in the series. The reporter stated that he did not know if they had a prior history of shingles or not. The reporter provided limited information. The permission to follow up was denied. This case had been linked to the case US2020015873, reported by same reporter. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, laboratory test confirmation and time to onset for the event was unknown at the time of reporting.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: developing a rash this morning covering both sides of his chest, his neck, his head and scalp and below his eye.; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received the 1st dose of Shingrix. On 30th January 2020, 3 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were received as follows: The patient developed rash covering both sides of his chest, his neck, his head and scalp and below his eye after vaccination. The patient reported that the rash was red but not raised and was not itchy. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Rash, Urticaria
Clinical narrative: hives; rash on the left side of the body including at the injection site; pain on the left side of the body; This case was reported by a consumer via call center representative and described the occurrence of hives in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced hives, rash and pain. On an unknown date, the outcome of the hives, rash and pain were resolved with sequelae.   It was unknown if the reporter considered the hives, rash and pain to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's husband. The age at vaccination was not reported but could be 65 or 66 years. The reporter stated that the patient received the 1st dose of Shingrix and developed a rash on the left side of her body including at the injection site. The patient developed pain on the left side of her body and used a topical botanical gel for the pain as recommended by a pharmacist and the pain lasted approximately 7 to 10 days before going away. The patient also developed hives on her body. The reporter did not consent to follow up. This case has been linked to US2020017550, reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at and around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th December 2019, the patient received the 1st dose of Shingrix. In December 2019, 1 week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient received the first dose of Shingrix vaccine and about a week later he started experiencing soreness at the injection site. The soreness was still the same and it was present in 5 inches by 5 inches of area at and around injection site on left arm. The patient consented to follow up.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called after leaving the office after only about an hour and half with swelling and induration at injection site.  Patient states that it was very hot to touch and painful.  The size of induration was about 3-4 cm round.   We advised patient to take Benadryl,, Tylenol.  Dr. also prescribed Doxycycline 100mg  BID for 7 days. Patient is coming back into the office today for re-evaluation
Age: 71.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthralgia, Erythema, Fatigue, Migraine, Pyrexia
Clinical narrative: Dose1 of Shingrix: given in left arm at Pharmacy on 9-20-19. Within 6 hours after the vaccine I had disabling arthralgias and myalgias and developed 102 temp. which lasted for four days.  On the second night after the vaccine I was awakened by a pounding migraine-like headache,which slowly responded to Tylenol.  My left arm became red and swollen over the deltoid muscle.  I could just barely getup to use the bathroom and had to collapse back into bed. I called the pharmacist, who reassured me that this could be a normal strong reaction. The pharmacy sent my vaccine information and lot number, etc. to my primary MD.   The second dose finally became available and we were called to our Pharmacy, off of their waiting list.  I discussed with the pharmacist my rather harsh first dose reaction, and he assured me that I should get the second dose.   Within 6 hours of gettin the second dose I felt like a truck had run me over again:  myalgias and arthralgias that sent me to bed; fever for two days; no horrible headache this time; huge swollen left deltoid muscle and blotchy redness below the deltoid to three inches above my elbow. Pharmacy also faxed the lot number and vaccine information to my primary MD.   Boy! if this vaccine were a three dose vaccine I certainly would NOT have appeared for a third dose!
Age: 71.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Rash macular, Swelling
Clinical narrative: Dose1 of Shingrix: given in left arm at Pharmacy on 9-20-19. Within 6 hours after the vaccine I had disabling arthralgias and myalgias and developed 102 temp. which lasted for four days.  On the second night after the vaccine I was awakened by a pounding migraine-like headache,which slowly responded to Tylenol.  My left arm became red and swollen over the deltoid muscle.  I could just barely getup to use the bathroom and had to collapse back into bed. I called the pharmacist, who reassured me that this could be a normal strong reaction. The pharmacy sent my vaccine information and lot number, etc. to my primary MD.   The second dose finally became available and we were called to our Pharmacy, off of their waiting list.  I discussed with the pharmacist my rather harsh first dose reaction, and he assured me that I should get the second dose.   Within 6 hours of gettin the second dose I felt like a truck had run me over again:  myalgias and arthralgias that sent me to bed; fever for two days; no horrible headache this time; huge swollen left deltoid muscle and blotchy redness below the deltoid to three inches above my elbow. Pharmacy also faxed the lot number and vaccine information to my primary MD.   Boy! if this vaccine were a three dose vaccine I certainly would NOT have appeared for a third dose!
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Patient went vasal bagel in the waiting room post receiving the 2 above mentioned vaccines during a routine office visit. Pt was alert at the time of the fall and assisted to the floor by mother from my understanding as I did not witness the event.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Ear pain, Hypoaesthesia eye, Pain
Clinical narrative: Patient developed a rash on the right side of her body notably on the scalp and facial area(forehead). Also, she had a throbbing earache(right side), stabbing pains in the stomach,  diarrhea, fever, numbness  in the right eye.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Patient developed a rash on the right side of her body notably on the scalp and facial area(forehead). Also, she had a throbbing earache(right side), stabbing pains in the stomach,  diarrhea, fever, numbness  in the right eye.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, PNC13, RV5
Symptoms: Cardiac arrest, Death
Clinical narrative: Patient passed away on 2/1/2020 ED diagnosis- cardiac arrest
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chest discomfort, Flushing, Injection site pain, Insomnia
Clinical narrative: Chest feels like there is pressure Unable to sleep due to body pain Nerve pain throughout body Extreme pain in whole left arm Weakness  Flushed skin
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: Chest feels like there is pressure Unable to sleep due to body pain Nerve pain throughout body Extreme pain in whole left arm Weakness  Flushed skin
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: sneezing & runny nose for about a week
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Fatigue, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: after waiting 15 minutes in office and being discharged without any issues, the patient returned to the office within 10 minutes with mild swelling of the right middle finger.  Pt also stated that is was tingling.  Pt also had a red mark on the inside of his elbow.  After watching patient for another 10 minutes he stated that his right arm was beginning to tingle and feel numb in some places.  Vital signs were stable.  Pt was given 50mg of Benadryl by  mouth.   After another 10 minutes, it was noted that pt  had a small hive on the right middle finger and that he was feeling a little "fuzzy headed".  Pt was rechecked after another 15 minutes and was noted to be feeling just tired, likely from the benadryl.  He no longer felt 'fussy headed" and the hive which was still present was no longer red and was beginning to fade away.  Pt remained in office for another 10 minutes or so.  Patient's vitals were stable and he seemed to no longer be reacting so he was discharged home.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: after waiting 15 minutes in office and being discharged without any issues, the patient returned to the office within 10 minutes with mild swelling of the right middle finger.  Pt also stated that is was tingling.  Pt also had a red mark on the inside of his elbow.  After watching patient for another 10 minutes he stated that his right arm was beginning to tingle and feel numb in some places.  Vital signs were stable.  Pt was given 50mg of Benadryl by  mouth.   After another 10 minutes, it was noted that pt  had a small hive on the right middle finger and that he was feeling a little "fuzzy headed".  Pt was rechecked after another 15 minutes and was noted to be feeling just tired, likely from the benadryl.  He no longer felt 'fussy headed" and the hive which was still present was no longer red and was beginning to fade away.  Pt remained in office for another 10 minutes or so.  Patient's vitals were stable and he seemed to no longer be reacting so he was discharged home.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Rash, Urticaria
Clinical narrative: mild case of rash and hives on chest.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a nurse, also the medical assistant, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 15-JAN-2020, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, orally, lot number S004399, expiration date on 06-NOV-2020, as prophylaxis (concentration, dosage, and frequency were not reported), that had been improperly stored in a temperature below 36 Fahrenheit degrees (16.7 Fahrenheit degrees) for 2 hours and 30 minutes and below 24 Fahrenheit degrees (16 Fahrenheit degrees) for 1 hour and 30 minutes; 1 cycle. No symptoms and no additional adverse events were reported. There was not previous temperature excursion and the temperature was recorded by a data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Dizziness, Ear congestion, Ear pain
Clinical narrative: ear fullness, associated with a dull aching sensation, tinnitus and dizziness / diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and vertigo; ear fullness, associated with a dull aching sensation, tinnitus and dizziness / diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and vertigo; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not provided. On or around 12-MAY-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its indented purpose: the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving the vaccine, the patient suffered ear fullness, associated with a dull aching sensation, tinnitus and dizziness. The patient was diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and with vertigo. As a direct and proximate result of the suspect vaccine, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of these malfunctions, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX). The events were considered to be disabling. Upon internal review, the event of sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus, Vertigo
Clinical narrative: ear fullness, associated with a dull aching sensation, tinnitus and dizziness / diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and vertigo; ear fullness, associated with a dull aching sensation, tinnitus and dizziness / diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and vertigo; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not provided. On or around 12-MAY-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its indented purpose: the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). Shortly after receiving the vaccine, the patient suffered ear fullness, associated with a dull aching sensation, tinnitus and dizziness. The patient was diagnosed with sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear and with vertigo. As a direct and proximate result of the suspect vaccine, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of these malfunctions, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered. The lawyer felt the events were related to zoster vaccine live (ZOSTAVAX). The events were considered to be disabling. Upon internal review, the event of sensorineural hearing loss of the right ear with unrestricted hearing of contralateral ear was determined to be medically significant.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse effect; Pharmacy Intern reports that on 1/27/2020, the dose ofMMR II was inadvertently administered by the intramuscular route instead of the subcutaneous route; This spontaneous report was received from pharmacy technician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 27-JAN-2020, the patient was inadvertently administered by intramuscular route instead of the subcutaneous a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number S014429 and expiration date on 09-MAY-2021, for prophylaxis (dose, dose number, and  anatomical injection site were not reported); which was reconstituted with sterile diluent (strength, dose, frequency, indication, lot number and expiration date were not reported) (incorrect route of product administration). No additional adverse effect.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no aditional adverse effect; A female 16 year old patient inadvertently was administered PROQUAD; This spontaneous report has been received from a registered nurse referring to a 16 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On 27-JAN-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was diluted with sterile diluent. No adverse events were reported.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passed out; syncope / syncopal episode; This spontaneous report was received from a physician via a company representative and refers to a 17-year-old female patient. The patient had none pertinent medical history or concomitant medications and there were no drug reactions or allergies known.  On approximately 08-JAN-2020 (reported as three weeks ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On the same day, the patient was vaccinated with three other unspecified vaccines.  On the same day, after receipt of the vaccines, the patient passed out, experiencing syncope. Syncopal episode resolved and the patient went home the same day. The patient did not seek medical attention and received no treatment for the events. None lab diagnostics or studies were performed.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the events of passed out and syncope were considered to be medically significant.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events; received 4th dose of gardasil 9; This spontaneous report was received from a physician via company representative regarding a male patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The reported described that on an unspecified date in 30-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 4 (extra dose administered) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Im running 101 fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced fever (101 degree C) on next day after receiving Shingrix. The reporter asked if would have the same side effects with the 2nd dose of Shingrix. The patient did not usually get side effects with vaccines.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Inappropriate schedule of product administration, Pruritus
Clinical narrative: Redness after first dose; Itching after dose; had been greater than 6 months since first dose; This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a female 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 not applicable after receiving Shingrix, the patient experienced erythema, pruritus and drug dose administration interval too long. On an unknown date, the outcome of the erythema, pruritus and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the erythema and pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist called to report that patient experienced redness and itching after first dose. Also that it had been greater than 6 months since first dose, which led to lengthening of the vaccination schedule. The reporter consented to follow up.  Caller did not have lot and expiration date of Shingrix at time of call.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had an active case of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date unknown) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix. In January 2020, less than 3 months 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 information was provided as follows: The patient received Shingrix and had an active case of Shingles a couple of days before the day of reporting. The reporter called to inquired how to proceed with 2nd dose of Shingrix. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: her titers in 2019 and had no immunity; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 35-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, between 1 and 2 years after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional information was provided as follows: The caller did not want to provide her complete address. The patient received 3 doses of Engerix B. The patient checked her titers in 2019 and had no immunity, the patient rechecked it again and had no immunity. The patient ended up getting a booster dose in October 2019. The reporter did not consent to follow up. No further details were provided.
Age: 83.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: itching; swelling at the injection site, left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site itching and injection site swelling. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced itching and swelling at the injection site, left arm. It had been now resolved. The patient had recently received her second Shingrix injection and did not experience any side effects. The reporter declined in providing her physician's contact information. The reporter did not consented to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Blister, Headache, Herpes zoster, Pain, Rash
Clinical narrative: itching; swelling at the injection site, left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site itching and injection site swelling. On an unknown date, the outcome of the injection site itching and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient experienced itching and swelling at the injection site, left arm. It had been now resolved. The patient had recently received her second Shingrix injection and did not experience any side effects. The reporter declined in providing her physician's contact information. The reporter did not consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: his left arm started to hurt severely; the back of his neck is also hurting.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and neck pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.  Additional details were received as follows: The patient received the first dose of the Shingrix vaccine and left arm started to hurt severely in the middle of the night. The patient stated that the left arm was very sore and took Tylenol for the pain. The patient stated that the back of his neck was also hurting. The patient consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: Swelling; Rash on her arm; This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative.  A female patient of an unspecified age received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, in Jan2020, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jan2020, the patient experienced swelling and rash on her arm. Steroids were administered. Clinical outcome of the adverse events was unknown at time of this report.   The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Headache, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Arm soreness; Diarrhea; Itching of scalp and limbs; Headache; tenderness and swelling at injection site; tenderness and swelling at injection site; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A 62-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included diabetes, blood pressure and cholesterol, all from an unknown date and unknown if ongoing. Concomitant medications include many medications (unspecified) for diabetes, blood pressure and cholesterol, all from an unknown date and unknown if ongoing. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and reported the following adverse events the following day: diarrhea, itching of scalp and limbs, headache, tenderness and swelling at injection site as well as arm soreness. The patient had not recovered from the arm soreness at the time of reporting; while recovered for the rest of the events.  Information on the batch number has been requested.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and heat at site that subsequently spread from upper arm to wrist. Tender to touch. Hot/cold therapy. Ibuprofen for pain. Spoke to MD over the phone, medical attention sought as of yet.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Redness, swelling and heat at site that subsequently spread from upper arm to wrist. Tender to touch. Hot/cold therapy. Ibuprofen for pain. Spoke to MD over the phone, medical attention sought as of yet.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Acne, Emotional disorder, Irritability, Pruritus, Sleep terror
Clinical narrative: First sign was a pimple/welt on hand. Next day there were itchy, raised,  welts all over her body. She was extremely irritable for about 3 weeks, very emotional, and having night terrors. Benadryl was recommended and hydrocortisone cream was prescribed by the doctor.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: First sign was a pimple/welt on hand. Next day there were itchy, raised,  welts all over her body. She was extremely irritable for about 3 weeks, very emotional, and having night terrors. Benadryl was recommended and hydrocortisone cream was prescribed by the doctor.
Age: 25.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Back pain, Groin pain, Muscle spasms
Clinical narrative: Started with Right hip pain Moved to right side and Right knee, then to groin and into Left back pain. Whole body muscle spasms.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: patient states after the vaccine was given she had a lot of pain at the site. Patient then began to notice redness & swelling at the site a couple of days later. patient states body aches, fatigue, and cramping & diarrhea.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Pain
Clinical narrative: patient states after the vaccine was given she had a lot of pain at the site. Patient then began to notice redness & swelling at the site a couple of days later. patient states body aches, fatigue, and cramping & diarrhea.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Within 2 hours after receiving Shingrix vaccine, had ringing in ears that grew increasingly louder until the 4th hour after vaccine, and have had chronic tinnitus ever since.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: UPPER RIGHT ARM RED AND SWOLLEN
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: t cell reaction per allergist
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Impaired driving ability, Insomnia, Pain in extremity
Clinical narrative: First Shingrix Vaccine was given on Oct. 9, 2019. The only side effect was the severe, severe pain on left arm going down to fingers. Very painful that couldn't even sleep at night & was suffering so much thru entire arm. Second shingrix Vaccine was given on 12/06/2019. This time I asked to inject on the other arm (Right arm.) Same thing; soon after the injection, the pain started. Severe pain on that side from shoulder to hand & fingers & unable to sleep and same as first one it lasted 2 days. On December 10, 2019 I experienced redness & itching on my both palms & forearms up to elbow. half of my both palms at the same time going up on inner side of the arm. My palms were itching so badly, redness, pain was hurting so much gradually. Half of my palms on each side became very Sensitive & painful. I couldn't touch the skin at all, couldn't hold any object & was unable to drive. The pain & rashes and the scaring look of rashes on both arms and both thighs made me go to Emergency Room at Hospital. Was there for hours & they told me it could have been the side effects of the vaccination. While waiting, they gave me the following shot & medications: dexamethasone (DECADRON) 4mg/mL injection 10mg Intramuscular); diphenhydAMIN (BENADRYL) capsule 25mg; famotidine (PEPCID) tablet 20mg. They also did lab test. Was told to use cream & Benedryl at home & prescribing methylPREDNISolone (MEDROL DOSEPAK) 4mg tablet for a week at home. The appearance of these spot on my thighs was so bad, to me looked close to a shingle. If the skin was reacting like that, how the internal organs were affected? For days, I was dealing with it & while the arms & thighs were getting better, my both shins started to show rashes & again spreading to my calf and were so itchy & painful.