chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Tremor
Clinical narrative: Chills, shaking, muscle soreness starting approximately 10PM and lasting for 4-5 hours
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Was given adult dose instead of pediatric dose
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: extreme pain/stiffness in injection arm  lasted 2 days diarrhea lasted 3 days so far persistent head ache  lasted 3 days so far pain in injection  arm pit 3 days after shot lasted 1 day severe chills started first day  lasted 3 days extreme fatigue  started second day  lasted 3 days so far
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: extreme pain/stiffness in injection arm  lasted 2 days diarrhea lasted 3 days so far persistent head ache  lasted 3 days so far pain in injection  arm pit 3 days after shot lasted 1 day severe chills started first day  lasted 3 days extreme fatigue  started second day  lasted 3 days so far
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Lethargy, Vomiting
Clinical narrative: vomiting, droopy-acting , constantly crying
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was here for Pentacel vaccine.  Was only given the Dtap and IPV components,   The Hib component was not given.   The liquid part of the vaccine was not mixed with the powder part.   No adverse effects.  Patient returned on 7/2/19 for a Hib vaccine.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Severe body ache, left are around injection site is swollen around the injection site, swelling is spreading to lower arm. upper part of arm is swollen, hot and red. patient reported that she had fever and nausea.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Severe body ache, left are around injection site is swollen around the injection site, swelling is spreading to lower arm. upper part of arm is swollen, hot and red. patient reported that she had fever and nausea.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient described that a rash started on her face on 06/27/19 in the evening. The rash spread to her left arm and to her calves. Her injection site was red, swollen, and warm to the touch.  Patient reported the rash to the health department on 07/01/19. She stated it no longer appears to be spreading, and she planned to make a doctor appointment on 07/01/19.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pyrexia, Skin discolouration, Tenderness
Clinical narrative: Pt came into the office to have his 1st  PPD of a 2-step placed for school. The pt's mother made me aware that the pt was seen in the office on 6/20/19 for a 18yr WCC and was given a Bexsero(2nd round) in his right deltoid and the pt had a reaction about 6-8 hr later. It started with redness in the deltoid area that grew larger, he was running a fever of 99.6, he was given ibuprofen and Motrin for the fever at home, he slept a lot the next day(roughly 15-16 hours) and his his arm still has a yellow discoloration and tenderness to it. He was not taken to the ER because the mother states "he has had a reaction previously and was told by the office that she was doing what needed to be done". I made Dr aware of the situation and he accessed the pt and gave the order to place the PPD step 1 and we made the pt and mother aware if he had any unusual reaction to this placement to please make us aware and for the pt to return on Friday morning to have it read.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Pain in extremity
Clinical narrative: Have not seen doctor or reported to my doctor but shivering early this morning around 5am to 6.30am, then sweating (mostly in the face), then stomach ache from 8.30am onward (currently 10.30am and still have stomach ache).  Also had sudden pain in both legs while in a cold cafeteria and had to bend over to endure it.  Lasted only a minute.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: zoster keratitis; Zoster iridocyclitis of the left eye; Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a painful rash on the left side of his face, forehead and in his eye. He presented to his medical provider and was diagnosed with herpes zoster, zoster keratitis, and zoster iridocyclitis of the left eye. Despite receiving treatment, the patient continued suffering from herpes zoster, zoster Keratitis and zoster iridocyclitis of the left eye (not recovered). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experiences 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. The events were considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events zoster Keratitis and zoster iridocyclitis of the left eye were determined to be medically significant. The events zoster Keratitis and zoster iridocyclitis of the left eye and herpes zoster were considered to be disabling.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Migraine, Pain, Pallor, Pyrexia
Clinical narrative: fever of 102 degrees Fahrenheit; chills; body aches; turned pale; migraine; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of adverse reaction (1st dose received on an unknown date, refer case US2019AMR118220).   On 11th June 2019, the patient received the 2nd dose of Bexsero (intramuscular). On 11th June 2019, 1 hr 30 min after receiving Bexsero, the patient experienced fever, chills, general body pain, pallor and migraine. On 12th June 2019, the outcome of the fever, chills, general body pain, pallor and migraine were recovered/resolved.   It was unknown if the reporter considered the fever, chills, general body pain, pallor and migraine to be related to Bexsero.  Additional details were provided as follows: The patient received a dose of Bexsero on the right deltoid. About 1.5 hours after vaccination, the patient experienced a fever of 102 degree F, chills, body aches, turned pale, and a migraine. On the next day, the patient was feeling fine. The outcome of fever, chills, general body pain, pallor and migraine were reported as recovered/resolved, however in source document, it was mentioned as recovered/resolved with sequel. This was all the information the sales representative had to report.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching in arm of injection; This case was reported by a pharmacist via call center representative and described the occurrence of itchy upper limbs in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 10th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced itchy upper limbs. On an unknown date, the outcome of the itchy upper limbs was recovered/resolved.   It was unknown if the reporter considered the itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient had itching in arm of injection for one week after receiving Shingrix.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthma, Chills, Condition aggravated, Injection site swelling
Clinical narrative: Symptoms began about 4 hr after injection. Not feeling well, then chills/fever, then joints aching and swollen lymph in armpit. Used tylenol/ibuprofen. Arm swollen at injection site. Asthma exacerbated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Symptoms began about 4 hr after injection. Not feeling well, then chills/fever, then joints aching and swollen lymph in armpit. Used tylenol/ibuprofen. Arm swollen at injection site. Asthma exacerbated.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Posture abnormal, Seizure
Clinical narrative: After admin of Tdap, patient sat well for PPD test. 5 seconds aftger admin of ppd, patient said "Whoa", fell to her R side  and seized. Lasted ~7 seconds. Pt. said she has "passed out" in the pat, felt similar to this, but with no witnesses.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Loss of personal independence in daily activities, Pain, Sluggishness, Thinking abnormal
Clinical narrative: Unusual sluggishness and tiredness, some aching, inability to function, take care of grandkids, and think, effectively. As of today, 20 some hours after the vaccine, the symptoms are lessening, but are clearly still present.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Headache, Local reaction, Rash erythematous, Rash generalised
Clinical narrative: The patient reported to ER with c/o generalized  rash on June 30, 2019.   Patient had received Smallpox and Anthrax vaccines on June 20, 2019.  Patient reported Headache, fatigue, and localized symptoms following injection, however, on the morning of June 30 , noticed a pimply red rash to back, arms, chest, neck, and head.  Lesions were erythematous and pustular < or = approx. 0.5 cm, no vesicles, or active discharge was appreciated.  He was treated with Motrin and Benadryl.  As of July 2 when contacted for follow up, patient stated he was gradually improving.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash pustular, Skin lesion
Clinical narrative: The patient reported to ER with c/o generalized  rash on June 30, 2019.   Patient had received Smallpox and Anthrax vaccines on June 20, 2019.  Patient reported Headache, fatigue, and localized symptoms following injection, however, on the morning of June 30 , noticed a pimply red rash to back, arms, chest, neck, and head.  Lesions were erythematous and pustular < or = approx. 0.5 cm, no vesicles, or active discharge was appreciated.  He was treated with Motrin and Benadryl.  As of July 2 when contacted for follow up, patient stated he was gradually improving.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nasopharyngitis, Pruritus, Urticaria
Clinical narrative: Redness and hives around neck area - front and back and upper chest, also itching.  Also had cold-like symptoms.  Lasted from Wednesday, June 19 til June 23.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Pain
Clinical narrative: Patient reported that a day after receiving MMR on right arm subcutaneously, he experienced pain with right elbow extension and supination.  He is point tender only over the right lateral epicondyle but no swelling, erythema, or warmth is noted on exam.  He has been taking ibuprofen as needed (2-3 times per week), resting, and applying a muscle rub.  He is still able to work despite the pain.  He has not followed-up with anyone regarding this.  He states that his pain has remained stable despite his self treatment.  He denies doing anything strenuous around the time of vaccination that could have precipitated the pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Welt at injection site. Started very red about quarter size, grew to about 3 1/2 inches in diameter, quite painful. Not as red today, but noticable and sore (7/2/2019)
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: HAD THE VACCINE ON 5/28/2019 AT 4:20 pm. WOKE UP AT MIDNIGHT, SEVERE PAIN IN LEFT ARM. 5/29/2019 ARM STARTED SWELLING & TURNING RED. PAIN CONTINUED & SWELLING & SEVERE REDNESS FROM THE INJECTION SITE TO ELBOW. THE SITE WAS HOT TO THE TOUCH. IT CLEARED UP IN 5 DAYS REPORTED SITUATION TO DR.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: HAD THE VACCINE ON 5/28/2019 AT 4:20 pm. WOKE UP AT MIDNIGHT, SEVERE PAIN IN LEFT ARM. 5/29/2019 ARM STARTED SWELLING & TURNING RED. PAIN CONTINUED & SWELLING & SEVERE REDNESS FROM THE INJECTION SITE TO ELBOW. THE SITE WAS HOT TO THE TOUCH. IT CLEARED UP IN 5 DAYS REPORTED SITUATION TO DR.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Abdominal pain upper
Clinical narrative: Mother states that 7/1/19 in the evening patient reported stomach ache only.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 08-DEC-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) by a pharmacist for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): shingles. The outcome of the event was unknown.    Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a currently 74-year-old female patient. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. In 2013, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route, vaccination site, lot # and expiry date were not specified) by a pharmacist for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by a physician for the following injuries resulting from use zoster vaccine live (ZOSTAVAX): shingles. The outcome of the event was unknown.   Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; improperly stored dose of Varivax was reconstituted with a non-Merck diluent; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 27-JUN-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R003301, expiration date 01-FEB-2020, (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion from -9 degrees Celsius to 8 degrees Celsius for 5 days. There were no previous excursions reported. Data logger was not involved. Concomitant therapies included sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 09-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019, one dose for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, frequency, route, lot/batch#, expiration date were unknown) for prophylaxis. No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R018140  and expiry date 25-JUN-2020, (strength, dose and route were not reported) for prophylaxis and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 20-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R018140  and expiry date 25-JUN-2020)  for prophylaxis and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 05-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R018140  and expiry date 25-JUN-2020) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 28-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R018140  and expiry date 25-JUL-2020) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 17-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R018140  and expiry date 25-JUL-2020) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 22-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported) for prophylaxis. There were no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.
Sex: F
Vaccine: UNK
Symptoms: Death
Clinical narrative: Death NOS; This case was reported in a literature article and described the occurrence of unknown cause of death in a 12-year-old female subject who received HPV vaccine unknown for prophylaxis.   On an unknown date, several hours after receiving HPV vaccine unknown, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the investigator considered the unknown cause of death to be related to HPV vaccine unknown.  Additional information was provided.  This case was reported in a literature article and described the death NOS in a 12-year-old female who was vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) case for prophylaxis.  The patient was a part of the study that employed the Twitter data to understand content characteristics and the patterns of content flow of the conversations about the HPV vaccine debate. [In this study, Twitter activity related to HPV vaccination was collected in one-week period datasets, started from 20th September 2016 for ten weeks]. No information on patient's medical or family history or concurrent condition or concomitant medication was provided.  On an unspecified date, the patient received the injection of unspecified HPV vaccine (administration site and route unspecified; dosages unknown; batch number not provided).  On an unspecified, hours after vaccination, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed.  The authors did not comment on the relationship between the event of death NOS' and unspecified HPV vaccine.  The authors stated, "Our findings show that positive emotion is positively correlated with cluster density, an indicator of strong ties and rapid information flow. In the case of negative emotion, we found that anger is a significant negative predictor for graph density. We also found a correlation between certainty and tentativeness; both at cluster as well as at tweet level, suggesting that clusters bring together people who are sure about the HPV vaccine and people who are exploring for answers."  The article corresponding to this case is not available for regulatory submission due to copyright restriction.  This is 1 of the 3 valid cases reported in the same literature article.; Reported Cause(s) of Death: Unknown cause of death
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: sore/achy; muscle pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019 11:00, the patient received the 1st dose of Shingrix. On 20th June 2019, several hours after receiving Shingrix, the patient experienced pain and myalgia upper extremities. On an unknown date, the outcome of the pain and myalgia upper extremities were recovering/resolving.   It was unknown if the reporter considered the pain and myalgia upper extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient received the vaccine and a couple of hours later the muscle in her arm started to ache. Till the reporting time, it was 50 % better but was sore.  The reporter did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Fatigue,muscle and joint aches started 1-2 days after vaccination. Lasted 24-48 hrs
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient expressed redness at the injection site along with swelling, and a warm pain.  This redness encompassed most of the deltoid region of her upper arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site reaction, Blindness unilateral, Chills, Erythema, Fatigue
Clinical narrative: Immediately that afternoon arm was sore. Next day, woke up shivering, fever was 101, headache, arm was sore/swollen and had very distinct red blotch at administration site--about 2 inches in diameter. Arm did continue to get larger, redder and circle got larger by evening.  Felt exhausted like if hit by a truck. Took Tylenol but did not seem to make difference.   By 4/26, fever was 99.2, arm was quite swollen still/sore, 4-inch red circle on arm and arm was very itchy.   Symptoms continued 4/27 and 4/28.  On 4/29 fever was gone, arm tender still, had red circle, and still itchy.   Called the pharmacy and PCP (Dr) who recommended to continue ice packs and lotion.   By 4/30, arm symptoms beginning to subside and feeling better.  By 5/1, arm issues resolved.  On 5/23 woke up and could not see on left eye.  When to ophthalmologist and diagnosed with shingles on eye. Patient given prescription of steroid eye drops Durezol and prescription for Valacyclovir.  Patient went back to ophthalmologist 1 week later and vision had cleared.  Doctor started weaning patient off steroid eye drops; last drops were on 6/17.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Ophthalmic herpes zoster, Pain in extremity, Peripheral swelling
Clinical narrative: Immediately that afternoon arm was sore. Next day, woke up shivering, fever was 101, headache, arm was sore/swollen and had very distinct red blotch at administration site--about 2 inches in diameter. Arm did continue to get larger, redder and circle got larger by evening.  Felt exhausted like if hit by a truck. Took Tylenol but did not seem to make difference.   By 4/26, fever was 99.2, arm was quite swollen still/sore, 4-inch red circle on arm and arm was very itchy.   Symptoms continued 4/27 and 4/28.  On 4/29 fever was gone, arm tender still, had red circle, and still itchy.   Called the pharmacy and PCP (Dr) who recommended to continue ice packs and lotion.   By 4/30, arm symptoms beginning to subside and feeling better.  By 5/1, arm issues resolved.  On 5/23 woke up and could not see on left eye.  When to ophthalmologist and diagnosed with shingles on eye. Patient given prescription of steroid eye drops Durezol and prescription for Valacyclovir.  Patient went back to ophthalmologist 1 week later and vision had cleared.  Doctor started weaning patient off steroid eye drops; last drops were on 6/17.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash macular, Tenderness
Clinical narrative: Immediately that afternoon arm was sore. Next day, woke up shivering, fever was 101, headache, arm was sore/swollen and had very distinct red blotch at administration site--about 2 inches in diameter. Arm did continue to get larger, redder and circle got larger by evening.  Felt exhausted like if hit by a truck. Took Tylenol but did not seem to make difference.   By 4/26, fever was 99.2, arm was quite swollen still/sore, 4-inch red circle on arm and arm was very itchy.   Symptoms continued 4/27 and 4/28.  On 4/29 fever was gone, arm tender still, had red circle, and still itchy.   Called the pharmacy and PCP (Dr) who recommended to continue ice packs and lotion.   By 4/30, arm symptoms beginning to subside and feeling better.  By 5/1, arm issues resolved.  On 5/23 woke up and could not see on left eye.  When to ophthalmologist and diagnosed with shingles on eye. Patient given prescription of steroid eye drops Durezol and prescription for Valacyclovir.  Patient went back to ophthalmologist 1 week later and vision had cleared.  Doctor started weaning patient off steroid eye drops; last drops were on 6/17.
Age: 46.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: I received the shot of Trumemba on the morning of June 11th. I felt well in the evening so I went out playing tennis. When I came back, I developed body chills and high fever. My whole body was shaking and I couldn?t control it. I recovered the next day morning with a light headache.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Rash generalised
Clinical narrative: TOTAL BODY RASH IMMEDIATELY AFTER VACCINES GIVEN NO OTHER ADVERSE REACTION
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: headache, chills, weakness, feverish
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Muscle tenderness over injection site/minimal red/NO induration/not hot over area.  Normal ROM, muscle strength. Diphenhydramine and Ibuprofen prescribed at time of visit for immunization reaction.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13, TDAP, VARZOS
Symptoms: Arthralgia
Clinical narrative: SEVERE DIFFUSE ARTHRALGIAS
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Induration, Inflammation, Mobility decreased
Clinical narrative: I had problem to move the arm. It hurt, I had inflammation and pain skin like and orange. (The painful area was hot, red and hard.) Red skin, First, up and later, Down Body temperature 99.7 the arm was hot and hard. below the place the vaccine was given The vaccine had been given to me in the past without any adverse reaction. The first in July 2015-I have been visiting my doctor once a year since then for controls. I visited three doctors, The second one indicated antibiotics. It was treated as a cellulitis too. The last one determined that it was adverse reaction and indicated some allergic tests.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Skin warm, Vaccination site induration, Vaccination site warmth
Clinical narrative: I had problem to move the arm. It hurt, I had inflammation and pain skin like and orange. (The painful area was hot, red and hard.) Red skin, First, up and later, Down Body temperature 99.7 the arm was hot and hard. below the place the vaccine was given The vaccine had been given to me in the past without any adverse reaction. The first in July 2015-I have been visiting my doctor once a year since then for controls. I visited three doctors, The second one indicated antibiotics. It was treated as a cellulitis too. The last one determined that it was adverse reaction and indicated some allergic tests.
Age: 0.33
Sex: M
Vaccine: UNK, UNK, DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Crying, Death, Endotracheal intubation, Malaise
Clinical narrative: He had gotten his 2 month old shots because he was behind due to a 10 week stay in the hospital. That night i he was crying. I thought it had to do with vaccines. I gave him tylenol like the drs had said. It cintinued thru the night. Next morning I went to his gi Dr. Told her he was pulling. She said its normal when they are sick. I went home. Took a nap w9ke up to him crying. I called his drs office and said he had to be seen. I drive there. And as I took him out of his car seat. He stopped breathing. They did cpr but werent successful. Paramedic arrived and incubated him. Went to the er where they pronounced he was dead
Age: 0.33
Sex: M
Vaccine: UNK, UNK, DTAPHEPBIP, HIBV, PNC13
Symptoms: Respiratory arrest, Resuscitation
Clinical narrative: He had gotten his 2 month old shots because he was behind due to a 10 week stay in the hospital. That night i he was crying. I thought it had to do with vaccines. I gave him tylenol like the drs had said. It cintinued thru the night. Next morning I went to his gi Dr. Told her he was pulling. She said its normal when they are sick. I went home. Took a nap w9ke up to him crying. I called his drs office and said he had to be seen. I drive there. And as I took him out of his car seat. He stopped breathing. They did cpr but werent successful. Paramedic arrived and incubated him. Went to the er where they pronounced he was dead
Age: 0.33
Sex: M
Vaccine: UNK, UNK, DTAPHEPBIP, HIBV, PNC13
Symptoms: Dyspnoea, Endotracheal intubation, Human rhinovirus test positive, Infantile apnoea, Resuscitation
Clinical narrative: He had gotten his 2 month old shots because he was behind due to a 10 week stay in the hospital. That night i he was crying. I thought it had to do with vaccines. I gave him tylenol like the drs had said. It cintinued thru the night. Next morning I went to his gi Dr. Told her he was pulling. She said its normal when they are sick. I went home. Took a nap w9ke up to him crying. I called his drs office and said he had to be seen. I drive there. And as I took him out of his car seat. He stopped breathing. They did cpr but werent successful. Paramedic arrived and incubated him. Went to the er where they pronounced he was dead
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Discomfort, Irritability, Measles post vaccine, Morbillivirus test positive, Rash generalised
Clinical narrative: Rash from head to toe that looked like the measles. Extremely fussy and uncomfortable. Did blood work and levels were high and doctor confirmed that the vaccine gave him the measles.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Rash from head to toe that looked like the measles. Extremely fussy and uncomfortable. Did blood work and levels were high and doctor confirmed that the vaccine gave him the measles.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction, Skin lesion
Clinical narrative: Rash and lesion developed at injection site, having pain and itching
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: About  11 hours after receiving the injection, I experienced shivering and fever. The shivering lasted about 5-6 hours but the fever continued into the next day. Also experienced fatigue for about 48 hours.
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Inappropriate schedule of product administration
Clinical narrative: On 07-DEC-2018 the patient was vaccinated with the first dose of GARDASIL 9 and on 19-JUN-2019 she received the second dose.; The patient was diagnosed with Bell's Palsy; This spontaneous report was received from a nurse practitioner via a company representative, referring to a 11-year-old female patient. The patient did not had any medical history, current conditions, concomitant medications, drug reactions or allergies.   On 07-DEC-2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular, for human papillomavirus prevention (HPV) (dose, strength, site of administration, lot # and expiration date were not reported).   On 19-JUN-2019, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular, for human papillomavirus prevention (HPV) (lot# R017624, expiration date on 17-MAR-2021 (also reported as 27-MAR-2021) (inappropriate schedule of vaccine administered) (dose, strength and site of administration were not provided).   On 22-JUN-2019, the patient started to feel symptomatic and was seen in the emergency room. Consequently, the patient was diagnosed with Bell's Palsy (facial paralysis). There was no laboratories or studies performed. It was reported that the patient received treatment for the event (unspecified).   At the time of this report, the patient was recovering. The causality assessment between the vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and facial paralysis, was not reported.   Upon internal review, the event facial paralysis was considered to be medically significant.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-OCT-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 15-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 29-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.   This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 09-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found  This is one of the several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 11-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 27-MAR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-OCT-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # N020016 and expiry date 17-JUL-2019) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC).
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # S000132 and expiry date 02-JAN-2021) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2019) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 21-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2019) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.