chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pain
Clinical narrative: Upset stomach; Tiredness; Body aches; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced upset stomach, tiredness and general body pain. On an unknown date, the outcome of the upset stomach, tiredness and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach, tiredness and general body pain to be related to Shingrix.  Additional deatils were provided as follows: The patient received dose of Shingrix at 10 am. After vaccination the patient experienced upset stomach, tiredness and body pain.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash vesicular, Urticaria
Clinical narrative: severe allergic reactions; Severe allergic reactions of hives; Breakout of rash; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2019).   In May 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 6 months after receiving Shingrix, the patient experienced allergic reaction, hives and vesicular rash. On an unknown date, the outcome of the allergic reaction, hives and vesicular rash were unknown.   It was unknown if the reporter considered the allergic reaction, hives and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient age was 59 years old at the time of vaccination. The patient received dose of Shingrix in May 2019 and experienced breakout of rash and hives since from October 2019. Till the time of reporting, the patient had 3rd occurence of breakout of rash and hives.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: numbness down her left side; This case was reported by a physician via sales rep and described the occurrence of numbness in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced numbness. On an unknown date, the outcome of the numbness was recovered/resolved.   It was unknown if the reporter considered the numbness to be related to Shingrix.  Additional details were provided as follows: The patient stated that getting the vaccine at a pharmacy in left deltoid and soon thereafter, experienced numbness down her left side.  It lasted a couple of weeks but then completely subsided.  She was hesitant to get the 2nd dose based on her reaction if even related to the 1st dose.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema
Clinical narrative: red lines on arms and legs; This case was reported by a physician via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received Shingrix at an unknown dose and Tdap Vaccine at an unknown dose. On an unknown date, 2 weeks after receiving Shingrix and Tdap Vaccine, the patient experienced erythema. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix and Tdap Vaccine.  Additional details were provided as follows: The patient received Tdap and Shingrix in separate arms and presented approximately 2 weeks later with red lines on arms and legs.  The patient was treated with yeast infection medications and steroids.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 101.5 temperature; This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 2nd dose of Shingrix. On 7th February 2020, 1 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fever.  The patient treated with Ibuprofen tablets.  The reporter asked what should we expect from here.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes outbreak; This case was reported by a consumer via call center representative and described the occurrence of herpes zoster 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, unknown after receiving Shingrix, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient experienced herpes zoster after receiving 1st dose of Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: has been dealing with side effects from Shinglix vaccination; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. In August 2019, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The patients friend was the reporter.  The age at vaccination was not reported. The patient experienced side effects after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Fatigue
Clinical narrative: side effects; Tired; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event and tiredness. On an unknown date, the outcome of the adverse event and tiredness were unknown.   It was unknown if the reporter considered the adverse event and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced typical side effects and tiredness after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivers; This case was reported by a consumer via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 6th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced shivers. On an unknown date, the outcome of the shivers was unknown.   It was unknown if the reporter considered the shivers to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced Shiver after receiving 2nd dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at the sight; swelling at the sight; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received Shingrix. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced redness and swelling at the sight after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. All patient experienced flu like symptoms who received Shingrix. This case is linked with US2020022431, reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: rash emanating from the injection site and down the arm; feeling arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on unknown date).   On 5th February 2020, the patient received the 2nd dose of Shingrix. On 5th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the pain in arm and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. After receiving the 2nd dose the patient reported feeling arm soreness after the injection.  The patient reported a rash emanating from the injection site and down the arm for about 4 and a half inches. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Myalgia, Walking aid user
Clinical narrative: body muscle problems; had severe reaction; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and adverse event. On an unknown date, the outcome of the muscle pain and adverse event were recovering/resolving.   It was unknown if the reporter considered the muscle pain and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the 2nd dose of Shingrix the patient experienced severe reaction, body muscle problems where had used a cane. The patient had been dealing with the issues over a year or longer but was improving. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Experienced shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number J352N, expiry date 11th December 2021) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix. In November 2019, 20 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Bumps around the injection site; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date unknown) for prophylaxis.   On 23rd January 2020, the patient received Shingrix. On 28th January 2020, 5 days after receiving Shingrix, the patient experienced injection site swelling and pruritus. On an unknown date, the outcome of the injection site swelling and pruritus were unknown.   It was unknown if the reporter considered the injection site swelling and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient developed bumps around the injection site and itching. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: rash on injection site; itchiness on right side of face; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2020, the patient received the 2nd dose of Shingrix. On 5th February 2020, immediately after receiving Shingrix, the patient experienced injection site rash and pruritus facial. On an unknown date, the outcome of the injection site rash and pruritus facial were unknown.   It was unknown if the reporter considered the injection site rash and pruritus facial to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 68 years or 69 years. The patient experienced rash on injection site and itchiness on right side of face right after receiving Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Syncope
Clinical narrative: fainting; chills; fever; This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st February 2020, 1 days after receiving Shingrix, the patient experienced chills and fever. On 2nd February 2020, the patient experienced fainting (serious criteria GSK medically significant). On 2nd February 2020, the outcome of the fainting was recovered/resolved. On an unknown date, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the fainting, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 58 or 59 years old at time of vaccination. The patient received Shingrix on left arm and experienced chills and fever. She fainted for a couple of seconds two days after getting the first dose of Shingrix. The patient was concerned about whether she should get the 2nd dose, The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash
Clinical narrative: PT came into the clinic w/ rash on arms, chest, and back. over the weekend moved to legs. use calamine lotion. Pt came to the clinic on 01/13/2020 Provider gave cetirizine tablets
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Headache, Injection site pain, Nausea
Clinical narrative: At approximately 24 hr post-vaccination, patient developed a severe headache, nausea, and diarrhea. These symptoms continued for approximately 5 hours before she fell asleep at about 10pm, at which point the symptoms began to improve. Patient also had extreme soreness at and near the injection site for approximately 48 hr post-vaccination.
Age: 70.0
Sex: U
Vaccine: UNK
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Box 17 - Shingrix   1st dose - 3/2019. Exact date unknown. Adverse event began the following day. 100 fever for two days. Chills.  2nd dose - 02/12/2020. Adverse event began 2/13/2020  Three inch circumference redness and swelling, hard knot and soreness at injection site. Lasted 6 days. Injection site is not pink, but not as hard. No plans to seek medical attention.   Box - Flu vaccine
Age: 70.0
Sex: U
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Box 17 - Shingrix   1st dose - 3/2019. Exact date unknown. Adverse event began the following day. 100 fever for two days. Chills.  2nd dose - 02/12/2020. Adverse event began 2/13/2020  Three inch circumference redness and swelling, hard knot and soreness at injection site. Lasted 6 days. Injection site is not pink, but not as hard. No plans to seek medical attention.   Box - Flu vaccine
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: patient called on 02/11/20 , 1 day after getting shot, that she could not lift her arm. she was advised that it should sub-side in a day or 2. patient called back again on 02/17/20, she still could not raise her arm. and it was only 10% better than what it was on 02/11/20 when she called on it 1st time. patient has reached out to there md and awaiting respone
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Acoustic stimulation tests, Audiogram, Ear discomfort, Tinnitus
Clinical narrative: Almost immediately after receiving the Rabavert vaccine both ears began ringing. I asked the pharmacist if I should be concerned about it, and she said that ringing in the ears was not listed as a side effect so she let me go home. Hours later my ears had a burning sensation inside. An urgent care doctor prescribed me with a Steroid medication and I have since been seen by my E.N.T. but the ringing has not stopped. I am still experiencing tinnitus in both ears constantly.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 3-4 days after vaccine patient said she experienced swollen and painful lymph nodes in neck.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: I had my first shingles Shingrix vaccine injection (50 mcg) on 2/4/20 in the afternoon. It was administered at Pharmacy. The treatment was prescribed by my physician. My arm became sore within 2 hours. I began using cold compresses and 200 mg ibuprofen tablets. That evening my arm was in pain. I could not sleep lying down so I had to sit up in a chair overnight. My arm stiffened and I could not raise my arm or elbow more than 50% of the normal range. Pain and stiffness of that arm continued for a full 3 days even with icing and ibuprofen, although I was able to sleep horizontally. At that point, I decided to use a TENS machine to stimulate the muscle in my upper arm. In 15 minutes, my arm felt relieved of most pain and my arm movement was greatly enhanced. I used the TENS machine a few times after that and stopped icing and stopped ibuprofen. After a full week, I still had some soreness in my arm where the injection occurred. I resumed physical workouts on the 8th day. It is now 13 days and most of the soreness has abated and the range of motion for that arm is ca. 90% of what it had been.  I wish someone had recommended trying a TENS treatment for relief from pain and stiffness following the Shingrix injection. Feb 17, 2020
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash breakout on upper trunk and wrists.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 2 cases of shingles; 2 cases of shingles; This spontaneous report as received from a pharmacist, who was informed by her aunt, refers to an unspecified female patient of an unknown age. No information regarding patient's pertinent medical history, drug reactions or allergies and concomitant medications was reported.  On an unknown date, reported as "years ago", the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On an unknown dates, the patient experienced 2 cases of shingles after receiving the zoster vaccine live (ZOSTAVAX). The outcome of the events was reported as recovered on an unspecified dates.  The relatedness between the events and the suspect vaccine was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The patient was administered an improperly stored dose of VARIVAX; This spontaneous Non-valid report was received from a medical assistant referring to a patient of an unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided.  On unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S021926, expiration date on 15-JUL-2021 (strength, dose number, route and frequency were not provided). In addition, it was mentioned that the sterile diluent (manufacturer unknown) used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. All therapies were used for prophylaxis.  The vaccines were improperly stored at a temperature of -14°C to -10°C during a time frame of 41 minutes. No previous temperature excursions and the call was because of a data logger.
Sex: F
Vaccine: HPV9
Symptoms: Colitis ulcerative, Condition aggravated, Inappropriate schedule of product administration
Clinical narrative: First dose of Gardasil on June 2017/Second dose of Gardasil on October 2017/On 2020 the consumer called inquiring for the third dose administration; Consumer inquired if the patient could receive the third dose of Gardasil 9 if the patient was experiencing an "ulcerative colitis flare up"; This spontaneous report was received from a consumer reporting on her daughter, a 21-year-old female patient. The patient's concurrent conditions included colitis ulcerative. Information regarding the patient's pertinent medical history, past drug reactions/allergies, and concomitant medications was not reported.  On an unspecified date in June 2017, 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) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  In October 2017, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).   On an unspecified date in October 2017, the patient experienced ulcerative colitis flare up. The reporter wanted to know if the patient could receive a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  The outcome of colitis ulcerative was unknown.    The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event occurrence was not reported.   Upon internal review, the event colitis ulcerative was determined to be medically significant.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: itching over her chest, both upper arms, stomach, and back; a slight rash on both upper arms , chest, back, and stomach; This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's concurrent conditions included asthma, seasonal allergies and allergy to cats. Her concomitant therapies included unknown medication for high blood pressure and unknown medication for acid reflux. On an unknown date in September 2019 (reported as: at the end of September 2019 or in the beginning of October 2019), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneously (exact dose, lot # and expiry date were not reported) for prophylaxis (reported as: prevention of shingles). Other suspect therapies included sterile diluent (STERILE DILUENT) (exact dose, lot # and expiry date were not reported). On an unspecified date in October 2019 (also reported as: around 2 or 3 weeks later), the patient experienced itching over her chest, both upper arms, stomach, and back. She was also experiencing a slight rash on both upper arms, chest, back, and stomach. She stated that she took fexofenadine hydrochloride (ALLEGRA) for these symptoms and the rash and the itching came and went. The patient did not seek medical attention. The outcome of itching and rash was reported as not recovered/not resolved. The causality assessment was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Muscle spasms, Pain, Swelling
Clinical narrative: Patient complained of swelling and tenderness (to the touch) of the neck and shoulder on the same side as the vaccine was given.  No reaction seen on other side of neck or shoulder.  Also complained about back muscles seizing up while shopping.  The pain and swell went away within 2 days, but was still tender (not as drastically as before) on the 17th of February
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Patient complained of swelling and tenderness (to the touch) of the neck and shoulder on the same side as the vaccine was given.  No reaction seen on other side of neck or shoulder.  Also complained about back muscles seizing up while shopping.  The pain and swell went away within 2 days, but was still tender (not as drastically as before) on the 17th of February
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea haemorrhagic, Nausea
Clinical narrative: Seen in the ED for nausea, bloody diarrhea.  Possible intussusception.   Patient transferred to hospital.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Onset of seizure, hospitalized, stabilized, seizure return, given Keppra, stabilized, returned again
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Feeling abnormal, Impaired work ability, Pain, Paraesthesia
Clinical narrative: Patient had an exposure and when checking to verify hep b  series completed and immune it was noted she had not received dose #3. That was give on date of exposure 12/22/19. At 6weeks it showed she was not immune so# 2nd series started with the new heplisav. The morning the vaccine was given the employee said within 1-2  hours after shot she severe deep joint pain and pain all over her body and a mixture of itching with pins a needles all over my body. It progressively became worse requiring her to go to bed and taking Benadryl and another antihistamine. She then felt still to bad to work  the next evening and called and stayed in bed with more Benadryl. Felt better the next day.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Patient had an exposure and when checking to verify hep b  series completed and immune it was noted she had not received dose #3. That was give on date of exposure 12/22/19. At 6weeks it showed she was not immune so# 2nd series started with the new heplisav. The morning the vaccine was given the employee said within 1-2  hours after shot she severe deep joint pain and pain all over her body and a mixture of itching with pins a needles all over my body. It progressively became worse requiring her to go to bed and taking Benadryl and another antihistamine. She then felt still to bad to work  the next evening and called and stayed in bed with more Benadryl. Felt better the next day.
Age: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Pt states that shot hurt "way more than normal" on injection. Stated that it was "black and blue and painful for 6 weeks. No swelling. After 6 weeks the pain diminished and he began to lose mobility in the arm. Today he has no pain but now limited range of motion in his shoulder / upper arm."  Pt went to physician for other complaint and mentioned his shoulder issue to provider. Provider could see nothing on exam; ordered x-ray. Nothing remarkable on x-ray. Provider suggested MRI. Pt concerned that numbness / immobility may be permanent or long time recovery.
Age: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Skin discolouration, X-ray normal
Clinical narrative: Pt states that shot hurt "way more than normal" on injection. Stated that it was "black and blue and painful for 6 weeks. No swelling. After 6 weeks the pain diminished and he began to lose mobility in the arm. Today he has no pain but now limited range of motion in his shoulder / upper arm."  Pt went to physician for other complaint and mentioned his shoulder issue to provider. Provider could see nothing on exam; ordered x-ray. Nothing remarkable on x-ray. Provider suggested MRI. Pt concerned that numbness / immobility may be permanent or long time recovery.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: redness, swelling 4cmx4cm
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient forgot to come back in for Gardasil 9 #2 injection, so patient was given dose #2 today; This spontaneous report was received from a healthcare worker and refers to an adult male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided. On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). It was reported that the patient forgot to come back for the second dose of vaccine and it was administered to him on 10-JUL-2019 (reported as today).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a licensed practical nurse 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 14-FEB-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis, lot # N035940 and expiration date reported as 18-DEC-2019 (dose, strength, frequency, and route of administration were not reported). It was reported that the sterile diluent used to reconstitute varicella virus vaccine live (oka/merck)(VARIVAX) was not expired.  No additional adverse events were reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bone pain, Breast pain, Musculoskeletal pain, Nausea
Clinical narrative: Nausea; lower back aches; pain in her right arm; pain in her right arm and right shoulder; it spread to her collar bone to the top of her breast.; collar bone pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of dermatitis contact (On 12th March 2019, 1st dose received. 1st dose recieevd on 12th March 2019, refer case id US2020021631).   In February 2020, the patient received the 2nd dose of Shingrix. On 4th February 2020, less than 3 months after receiving Shingrix, the patient experienced bone pain. On an unknown date, the patient experienced nausea, back pain, pain in arm, shoulder pain and breast pain. The patient was treated with cefixime (Flexeril (Cefixime)) and paracetamol (Tylenol). (Dechallenge was positive). On an unknown date, the outcome of the nausea, back pain, pain in arm, shoulder pain, breast pain and bone pain were unknown.   It was unknown if the reporter considered the nausea, breast pain and bone pain to be related to Shingrix. The reporter considered the back pain, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced after receiving the 2nd dose, she experienced nausea and lower back aches.  The patient experienced less than a week after receiving the 2nd dose of Shingrix, she developed pain in her right arm and right shoulder and it spread to her collar bone to the top of her breast.  The patient was wondering if this pain might be related to the Shingrix vaccine.  The patient went to see her doctor for this pain and she was at the time of report taking Flexeril and Tylenol. The reporter consented to follow up. Emergency room visit required
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Nausea; lower back aches; pain in her right arm; pain in her right arm and right shoulder; it spread to her collar bone to the top of her breast.; collar bone pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of dermatitis contact (On 12th March 2019, 1st dose received. 1st dose recieevd on 12th March 2019, refer case id US2020021631).   In February 2020, the patient received the 2nd dose of Shingrix. On 4th February 2020, less than 3 months after receiving Shingrix, the patient experienced bone pain. On an unknown date, the patient experienced nausea, back pain, pain in arm, shoulder pain and breast pain. The patient was treated with cefixime (Flexeril (Cefixime)) and paracetamol (Tylenol). (Dechallenge was positive). On an unknown date, the outcome of the nausea, back pain, pain in arm, shoulder pain, breast pain and bone pain were unknown.   It was unknown if the reporter considered the nausea, breast pain and bone pain to be related to Shingrix. The reporter considered the back pain, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced after receiving the 2nd dose, she experienced nausea and lower back aches.  The patient experienced less than a week after receiving the 2nd dose of Shingrix, she developed pain in her right arm and right shoulder and it spread to her collar bone to the top of her breast.  The patient was wondering if this pain might be related to the Shingrix vaccine.  The patient went to see her doctor for this pain and she was at the time of report taking Flexeril and Tylenol. The reporter consented to follow up. Emergency room visit required
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Rash, Skin warm
Clinical narrative: Patient received prevnar 13 and the next afternoon patient started to with rash spreading down towards her elbow, warm to touch and 5/10 discomfort.  Patient was treated with Cephelexin 500 mg twice a day for 10 days.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Computerised tomogram, Constipation, Diarrhoea, Gastrointestinal motility disorder, Pain
Clinical narrative: Severe constipation for greater than 2 weeks, had pain which reminded her of her history of cecal volvulus pain, resulting in emergency room visit 2/10/2020.  Dx with UTI and constipation.  Prescribed antibiotics at that time and advised to take Miralax and docusate.   Patient has had small "mushy" BMs since then but continues to feel that she has not fully evacuated her bowels.   Scheduled to see gastroenterologist 3/11/2020.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Scan with contrast, Urinary tract infection
Clinical narrative: Severe constipation for greater than 2 weeks, had pain which reminded her of her history of cecal volvulus pain, resulting in emergency room visit 2/10/2020.  Dx with UTI and constipation.  Prescribed antibiotics at that time and advised to take Miralax and docusate.   Patient has had small "mushy" BMs since then but continues to feel that she has not fully evacuated her bowels.   Scheduled to see gastroenterologist 3/11/2020.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: SORE ARM PAINFUL TO LIFT SEND IS DOING A LITTLE BETTER
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Acute myeloid leukaemia, Biopsy bone marrow abnormal, Blast cell count increased, Blood test, Chemotherapy
Clinical narrative: My husband had lymphoma in 2016 and went through six cycles of chemo including rchop and even did the spinal chemo.  He was all clear as of 8 20 2019 pet scans clear and blood normal.  He received a flu shot 9 27 2019 although this date it was administered in a home of friend pharmacist who works for pharmacy here.  After 9 27 2019 my husbands health declined he seemed to have cold symptoms October and November.  He was getting worse by December and on December 30 2019 had horrible lip cold sore then mouth infection local urgent care sent him home after flu test and pneumonia normal.  On January 3 2020 we went to clinic ER we were put on antibiotics and blood work showed 20% blasts we were admitted and bone marrow biopsy and formal diagnosis of treatment related acute myeloid leukemia on Jan 5 2020 and 7 + 3 chemo started on Jan 6 2020.  We spent one month in patient and now have genetic results he has an inversion on chromosome 16 so we are now doing four cycles of cytarabine chemotherapy in patient for six days then home for three weeks in between cycles. I am convinced this is triggered by the flu shot and suspect underlying virus or retrovirus.  I also suspect the flu shot triggered the inversion on chromosome 16.  Patient's family  history of cancer - viral infection among family members passed to next generation infected with virus or latent retrovirus Dad passed away from non Hodgkin lymphoma at 64 on Feb 2 2005 Mom at 60 breast cancer at 74 diagnosed CLL living Sister at 48 diagnosis Brest cancer living
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Cytogenetic analysis abnormal, Influenza virus test negative, Laboratory test abnormal, Nasopharyngitis, Oral herpes
Clinical narrative: My husband had lymphoma in 2016 and went through six cycles of chemo including rchop and even did the spinal chemo.  He was all clear as of 8 20 2019 pet scans clear and blood normal.  He received a flu shot 9 27 2019 although this date it was administered in a home of friend pharmacist who works for pharmacy here.  After 9 27 2019 my husbands health declined he seemed to have cold symptoms October and November.  He was getting worse by December and on December 30 2019 had horrible lip cold sore then mouth infection local urgent care sent him home after flu test and pneumonia normal.  On January 3 2020 we went to clinic ER we were put on antibiotics and blood work showed 20% blasts we were admitted and bone marrow biopsy and formal diagnosis of treatment related acute myeloid leukemia on Jan 5 2020 and 7 + 3 chemo started on Jan 6 2020.  We spent one month in patient and now have genetic results he has an inversion on chromosome 16 so we are now doing four cycles of cytarabine chemotherapy in patient for six days then home for three weeks in between cycles. I am convinced this is triggered by the flu shot and suspect underlying virus or retrovirus.  I also suspect the flu shot triggered the inversion on chromosome 16.  Patient's family  history of cancer - viral infection among family members passed to next generation infected with virus or latent retrovirus Dad passed away from non Hodgkin lymphoma at 64 on Feb 2 2005 Mom at 60 breast cancer at 74 diagnosed CLL living Sister at 48 diagnosis Brest cancer living
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Oral infection
Clinical narrative: My husband had lymphoma in 2016 and went through six cycles of chemo including rchop and even did the spinal chemo.  He was all clear as of 8 20 2019 pet scans clear and blood normal.  He received a flu shot 9 27 2019 although this date it was administered in a home of friend pharmacist who works for pharmacy here.  After 9 27 2019 my husbands health declined he seemed to have cold symptoms October and November.  He was getting worse by December and on December 30 2019 had horrible lip cold sore then mouth infection local urgent care sent him home after flu test and pneumonia normal.  On January 3 2020 we went to clinic ER we were put on antibiotics and blood work showed 20% blasts we were admitted and bone marrow biopsy and formal diagnosis of treatment related acute myeloid leukemia on Jan 5 2020 and 7 + 3 chemo started on Jan 6 2020.  We spent one month in patient and now have genetic results he has an inversion on chromosome 16 so we are now doing four cycles of cytarabine chemotherapy in patient for six days then home for three weeks in between cycles. I am convinced this is triggered by the flu shot and suspect underlying virus or retrovirus.  I also suspect the flu shot triggered the inversion on chromosome 16.  Patient's family  history of cancer - viral infection among family members passed to next generation infected with virus or latent retrovirus Dad passed away from non Hodgkin lymphoma at 64 on Feb 2 2005 Mom at 60 breast cancer at 74 diagnosed CLL living Sister at 48 diagnosis Brest cancer living
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Autism spectrum disorder, Disability
Clinical narrative: DISABILITY FOR LIFE. IS NOW AUTISTIC
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Pain, Thrombosis
Clinical narrative: PATIENT REPORTS THAT THE DAY FOLLOWING HER INJECTION HER ARM WAS PAINFUL AT THE INJECTION SITE. PT REPORTS THAT SORENESS LINGERING FROM THE INJECTION IS LIMITING MOVEMENT AND CAUSES PAIN WHEN LIFTING HER ARM SEVERAL WEEKS FOLLOWING INJECTION. PATIENT STATES THAT SHE SAW HER DR IN THE DAYS FOLLOWING THE VACCINATION AND WAS TOLD IT APPEARED A CLOT HAD FORMED AT THE INJECTION SITE.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: PATIENT WAS GIVEN 3 DOSES INSTEAD OF THE RECOMMENDED 2 DOSES OF SHINGRIX. THE ADMINISTRATION ERROR WAS DISCOVERED AFTER PATIENT REQUESTED A YEARLY REPORT AND SHE SAW 3 DOSES OF SHINGRIX. THE PATIENT SAID SHE REMEMBERED A SORE ARM AFTER THE INJECTION.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, warmth, and edema to right deltoid area
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Dizziness, Erythema, Fall
Clinical narrative: Headache - felt like a migraine, last 4 days with improvement each day Dizziness / falling / tripping Fever / chills - did not measure Severe swelling at injection site pain in the other arm first 2 days Face / left ear red and burning hot
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Injection site swelling, Migraine, Pain in extremity
Clinical narrative: Headache - felt like a migraine, last 4 days with improvement each day Dizziness / falling / tripping Fever / chills - did not measure Severe swelling at injection site pain in the other arm first 2 days Face / left ear red and burning hot
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache - felt like a migraine, last 4 days with improvement each day Dizziness / falling / tripping Fever / chills - did not measure Severe swelling at injection site pain in the other arm first 2 days Face / left ear red and burning hot
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site bruising, Injection site erythema
Clinical narrative: Patient developed severe bruising and redness both at the injection site and in another spot below the injection site.
Age: 72.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Dizziness, Eructation, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: patient immediately got light headed and basically passed out, unresponsive, nauseousness and belching
Age: 72.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Unresponsive to stimuli
Clinical narrative: patient immediately got light headed and basically passed out, unresponsive, nauseousness and belching
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: REDNESS, INFLAMMATION AND ITCHING AT SITE AND AROUND AREA OF ADMINISTRATION. PATIENT OBSERVED THIS REACTION AFTER 6 DAYS OF VACCINE ADMINISTRATION. PATIENT APPLIED BENADRYL CREAM TO SOOTHE THE AREA. PATIENT WILL CONSULT WITH HER PRIMARY CARE PHYSICIAN ON 02/18/2020
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Lymph node pain, Lymphadenopathy, Malaise
Clinical narrative: I was given a TDAP vaccine - unknown name or brand in the left arm intramuscularly. The description in my patient summary only describes it as "TDAP Vaccine Age 7+ IM".  I also received a flu shot listed in the patient summary as "Influenza Vaccine Quadrivalent Age 3 Yrs Plus + IM" on my right arm. I began to feel malaise hours after receiving the vaccines. When I woke up morning (2/17/20) - 3 days after receiving the vaccines, I  felt a lymph node on the inside of my upper arm -near the armpit crease swollen/hard and tender to the touch. When I got up I looked in the mirror and noticed that the skin over the lymph was hot pink in color. There was also stiffness in the muscles of the upper arm. This has persisted all day and into the evening.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: I was given a TDAP vaccine - unknown name or brand in the left arm intramuscularly. The description in my patient summary only describes it as "TDAP Vaccine Age 7+ IM".  I also received a flu shot listed in the patient summary as "Influenza Vaccine Quadrivalent Age 3 Yrs Plus + IM" on my right arm. I began to feel malaise hours after receiving the vaccines. When I woke up morning (2/17/20) - 3 days after receiving the vaccines, I  felt a lymph node on the inside of my upper arm -near the armpit crease swollen/hard and tender to the touch. When I got up I looked in the mirror and noticed that the skin over the lymph was hot pink in color. There was also stiffness in the muscles of the upper arm. This has persisted all day and into the evening.