chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLUR4, HEPA, HPV9, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flublok given to a 13 year old in error.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site for five days. Large ?golf ball? sized lump. Hot to the touch and painful.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pain in extremity, Pruritus, Skin warm, Urticaria
Clinical narrative: Allergic reaction to flu shot.  Large hive located on bicep with pain, warmth and some itching.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Arthralgias, myalgias - persistent Treated with prednisone 20mg PO daily x 5 days - starting today, outcome TBD
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient described having a tingly/numbness in her arm to her fingers after the shot was given.  Patient described that this lasted 3 days.  Patient is no longer experiencing the tingling or numbness.
Age: 66.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Chills, Insomnia, Nausea
Clinical narrative: Spoke with pt, he states he wanted to report the reaction he got to the vaccines. He read the literature given to him from the office and states he wanted do his civic duty and report his side effects.  He states that the first shingrix shot made him tired for about 24 hours  But this second one with the flu, he got nausea, shivering, frequency and was unable to sleep Friday night .  He denies any symptoms now. States that he recovered on Sunday.
Age: 1.0
Sex: F
Vaccine: MMRV, HEPA, MMR
Symptoms: Full blood count, Immune thrombocytopenic purpura
Clinical narrative: ITP
Age: 1.0
Sex: F
Vaccine: MMRV, HEPA, MMR
Symptoms: Contusion, Differential white blood cell count, Full blood count, Immune thrombocytopenic purpura, Petechiae
Clinical narrative: ITP
Age: 1.0
Sex: F
Vaccine: MMRV, HEPA, MMR
Symptoms: Platelet count decreased
Clinical narrative: ITP
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Patient sent photo of red area over injection site in right thigh that developed on night of flu vaccine. She has egg allergy but had no other swelling or symptoms.  She has no sign of pain at the site. Recommended applying ice, motrin if needed for pain and call/returning if no resolution in two days.
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Cellulitis, Drug hypersensitivity, Erythema, Impaired work ability, Injection site erythema
Clinical narrative: Employee present on 10/10/19 with 3 raised red areas on her left deltoid and 1 raised area to her left cheek. . denies shortness of breath, trouble breathing or other respiratory issues. employee stated she noted the reaction the previous day while in the shower. Declined medical attention at this time and was asked to call facility if medical attention was required.  On 10/11/19 the employee went to health Center for worsened reaction. she was seen by provider. she was diagnosed with Left arm flu shot reaction  (T80.69XD) and cellulitis of the left upper limb (L03.114). she was given Benadryl 25 mg every 6 hours until next evaluation and Claritin. the employee was also given PCN for which she stated she took 1 dose and had an allergic reaction. The employee stated she had red raised marks on her entire body and her right hand was swollen, after the PCN. She stopped taking  the PCN and returned to NP on 10/15/19 at this time she was told to remain out of work until her follow up on 10/17/19 and to continue the Benadryl 25 MG every 6 hours .
Age: 53.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site swelling, Peripheral swelling, Swelling, Swelling face
Clinical narrative: Employee present on 10/10/19 with 3 raised red areas on her left deltoid and 1 raised area to her left cheek. . denies shortness of breath, trouble breathing or other respiratory issues. employee stated she noted the reaction the previous day while in the shower. Declined medical attention at this time and was asked to call facility if medical attention was required.  On 10/11/19 the employee went to health Center for worsened reaction. she was seen by provider. she was diagnosed with Left arm flu shot reaction  (T80.69XD) and cellulitis of the left upper limb (L03.114). she was given Benadryl 25 mg every 6 hours until next evaluation and Claritin. the employee was also given PCN for which she stated she took 1 dose and had an allergic reaction. The employee stated she had red raised marks on her entire body and her right hand was swollen, after the PCN. She stopped taking  the PCN and returned to NP on 10/15/19 at this time she was told to remain out of work until her follow up on 10/17/19 and to continue the Benadryl 25 MG every 6 hours .
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site reaction, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Patient went to school by 10:30 am and then complained of sore fat arm, redness and itchy arm.  Patient was taken to the nurses office and then the mother was called about the reaction.  I was notified at 11:45 am that this had happened and I told the mother that she should ice the area to help limit the swelling, and confirmed that there was no airway breathing difficulty.  I then told the mother to contact the child's pediatrician to get further direction.  The mother contacted me around 4pm on 10/7/19 to state that she had taken her son to the doctor and that the doctor stated this was an injection site reaction.  The swelling had gone down quite a bit from icing and the md recommended to ice and use Benadryl.  The md also recommended that next year's flu shot should be done at the pediatrician's office
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Felt tired a day after the first shot for a day and felt tired for 3 days after the second shot.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Prior to receiving injection, I consulted w/clinic staff  to determine whether the vaccine contains gelatin/ animal products due to alpha gal allergy.   It was determined that vaccine should be okay for me.  Within an hour of  receiving vaccination, red and warm area appeared; about 3 " across.  A few hours later,  it had doubled in size and was red, warm and itching.  I visited Occupational Medicine.  Given Allegra and ice pack, and left work early.  By evening, the area had spread further up/down (about 9 ") and around (about 8 ") upper arm; fingers were slightly numb  --felt like tourniquet at elbow. Took  Benadryl and marked perimeter of itching/redness.  In the  morning, the area had spread further down to my elbow and around upper arm.  It was still red, itching and warm.  My doctor's office had no appointments available and advised that I visit ER/Urgent care.   I went to local ER,  and was given prescription and first dose of Prednisone, Benadryl and Pepsid.  By the third day (10/12/19) the itching had stopped, and the redness was fading.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Injection site erythema, Injection site inflammation, Pyrexia, Wheezing
Clinical narrative: Fever, cough, wheezing, redness/inflammation to injection site
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Electroencephalogram abnormal, Petit mal epilepsy
Clinical narrative: 48 HOURS AFTER INJECTIONS, PATIENT STARTED WITH ABSENCE SEIZURES  DIAGNOSED WITH EEG
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: PATIENT REPORTS ARM IS SWOLLEN  AND ITCHING. INJECTION SITE IS SWOLLEN. REDNESS AROUND THE INJECTION SITE EXTENDING DOWN TO THE ELBOW.  PATIENT HAS APPOINTMENT WITH PRIMARY CARE TO FOLLOW UP AND RECEIVE TREATMENT IF NECESSARY.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Autoimmune disorder, Autoimmune thyroiditis, Fatigue, Fibromyalgia, Muscle spasms
Clinical narrative: Starting in Aug/Sept 2003 Chronic sore throats, tonsillitis, strep throat, swollen tonsils, rhinitis, on antibiotics for months with no resolution, bacteria was resistant. Ended up having a tonillectomy in April 2004.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Myalgia, Oropharyngeal pain, Pharyngitis streptococcal, Rheumatoid arthritis, Rhinitis
Clinical narrative: Starting in Aug/Sept 2003 Chronic sore throats, tonsillitis, strep throat, swollen tonsils, rhinitis, on antibiotics for months with no resolution, bacteria was resistant. Ended up having a tonillectomy in April 2004.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Streptococcus test, Tonsillar hypertrophy, Tonsillectomy, Tonsillitis
Clinical narrative: Starting in Aug/Sept 2003 Chronic sore throats, tonsillitis, strep throat, swollen tonsils, rhinitis, on antibiotics for months with no resolution, bacteria was resistant. Ended up having a tonillectomy in April 2004.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Consciousness fluctuating, Dizziness, Feeling cold, Hyperhidrosis
Clinical narrative: I received the flu shot around 9:15 am. I felt fine afterwards, just had some pain at the injection site. Within 30 minutes, I started to feel light-headed, my vision started to lessen, and I felt extremely nauseous. I sat down and let a pharmacist know that I felt like I was going to pass out. She commented on how I had no color in my face; I was really pale. It felt like my whole body was going numb and that I could vomit at any moment. I vomited once and felt better after doing so. Within seconds I had another round of lightheadedness and almost passed out, but vomited 5-6 times right after that feeling. It felt like I was going in and out of consciousness. My forehead was sweaty and my body felt cold. A pharmacist got me a glass of water to drink after the nausea went away, which was right after the last time I vomited. I proceeded to sit for at least the next hour and a half while drinking Pepsi. I also tried walking around, but I still felt lightheaded. I called my mom during that time to find out if I actually have received the flu shot before; I thought I had received it before. She told me she has never allowed me to have the flu shot, so this would've been the first dose of the flu vaccine I've ever received. I also talked with my dad about the incident and he said in the 1980s when he received the flu shot, he experienced nausea and vomiting as well, but stated that he no longer experiences nausea or vomiting after receiving the shot. I am reporting this very soon after the incident. It is almost 11:30 am and I still feel light-headed and not ready to walk around.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Nausea, Pallor, Visual impairment
Clinical narrative: I received the flu shot around 9:15 am. I felt fine afterwards, just had some pain at the injection site. Within 30 minutes, I started to feel light-headed, my vision started to lessen, and I felt extremely nauseous. I sat down and let a pharmacist know that I felt like I was going to pass out. She commented on how I had no color in my face; I was really pale. It felt like my whole body was going numb and that I could vomit at any moment. I vomited once and felt better after doing so. Within seconds I had another round of lightheadedness and almost passed out, but vomited 5-6 times right after that feeling. It felt like I was going in and out of consciousness. My forehead was sweaty and my body felt cold. A pharmacist got me a glass of water to drink after the nausea went away, which was right after the last time I vomited. I proceeded to sit for at least the next hour and a half while drinking Pepsi. I also tried walking around, but I still felt lightheaded. I called my mom during that time to find out if I actually have received the flu shot before; I thought I had received it before. She told me she has never allowed me to have the flu shot, so this would've been the first dose of the flu vaccine I've ever received. I also talked with my dad about the incident and he said in the 1980s when he received the flu shot, he experienced nausea and vomiting as well, but stated that he no longer experiences nausea or vomiting after receiving the shot. I am reporting this very soon after the incident. It is almost 11:30 am and I still feel light-headed and not ready to walk around.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: I received the flu shot around 9:15 am. I felt fine afterwards, just had some pain at the injection site. Within 30 minutes, I started to feel light-headed, my vision started to lessen, and I felt extremely nauseous. I sat down and let a pharmacist know that I felt like I was going to pass out. She commented on how I had no color in my face; I was really pale. It felt like my whole body was going numb and that I could vomit at any moment. I vomited once and felt better after doing so. Within seconds I had another round of lightheadedness and almost passed out, but vomited 5-6 times right after that feeling. It felt like I was going in and out of consciousness. My forehead was sweaty and my body felt cold. A pharmacist got me a glass of water to drink after the nausea went away, which was right after the last time I vomited. I proceeded to sit for at least the next hour and a half while drinking Pepsi. I also tried walking around, but I still felt lightheaded. I called my mom during that time to find out if I actually have received the flu shot before; I thought I had received it before. She told me she has never allowed me to have the flu shot, so this would've been the first dose of the flu vaccine I've ever received. I also talked with my dad about the incident and he said in the 1980s when he received the flu shot, he experienced nausea and vomiting as well, but stated that he no longer experiences nausea or vomiting after receiving the shot. I am reporting this very soon after the incident. It is almost 11:30 am and I still feel light-headed and not ready to walk around.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; the patient was anadvertently administered a dose of Proquad, that had been improperly stored; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (exact dose and route of administration were not reported) for prophylaxis. There were two lot numbers involved: - lot # R030805, expiration date 22-APR-2020, therapy type recombinant human albumin (rha), - lot # S003326, expiration date 02-AUG-2020, therapy type rha. Concomitant therapies included sterile diluent, which was properly stored. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. Administered dose of vaccine experienced the temperature excursion of 27.1 degrees Fahrenheit for 40 minutes.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix
Clinical narrative: patient was diagnosed as HPV positive; This spontaneous report was received from a physician, via company representative, referring to a 24-year-old female patient. The aptietns pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were unknow by the reporter.  On an unspecified date in 2010 (also reported as "9 years ago") the patient was vaccinated with a 3 dose regimen of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), intramuscular for prevention of human papilloma virus (HPV) (strength, dose, frequency, anatomical injection site, lot number and expiration date were not reported). It was reported that the patient was diagnosed as being HPV positive (human papilloma virus test positive). It was reported that the patient did not received treatment due to this event, and her laboratory diagnostics included a routine Pap smear (performed on an unknown date) but no results were provided for this exam.  At the time of this report, the outcome of human papilloma virus test positive was unknown.  The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARlVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-SEP-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237 with an expiration date on 04-JUL-2020 or lot # S005078 with an expiration date on 19-FEB-2021 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of -14 degrees Celsius to -10 degrees Celsius (-9.74 degrees Celsius) (timeframe was not reported). The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARlVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237 with an expiration date on 04-JUL-2020 or lot # S005078 with an expiration date on 19-FEB-2021 (exact dose, injection site and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK) injection (exact dose, injection site, route of administration, indication, lot # and expiration date were not provided). Administered dose experienced the temperature excursions of -14 degrees Celsius to -10 degrees Celsius (-9.74 degrees Celsius) (timeframe was not reported). The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: My arm is still red about 4 inches down from the injection site; Arm  a little itchy; This case was reported by a consumer via sales rep and described the occurrence of erythema of extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities and itchy upper limbs were unknown.   It was unknown if the reporter considered the erythema of extremities and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient stated that the arm about 4 inches down from the injection site was red and little achy but patient was concerned that till the time of reporting the arm was red.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 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, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient in her 60's received the 1st dose of vaccine and experienced severe arm pain. The reporter did not agree to the follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Injection site pain and soreness; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced injection site pain and soreness for 3 days after vaccination. The reporter did not agree to the follow up.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Periarthritis, Pyrexia
Clinical narrative: Fever; Chills; Frozen shoulder in the arm of the injection; This case was reported by a consumer and described the occurrence of fever in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills and frozen shoulder. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the frozen shoulder was unknown.   It was unknown if the reporter considered the fever, chills and frozen shoulder to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in an unknown arm. The patient experienced fever and chills. The patient took tylenol and side effects went away. The patient developed a frozen shoulder in the arm of the injection and now under going physiotherapy treatments. The patient was due for second follow up injection and woul not receive it in that same arm. The patient asked would they recommend another larger muscle (like the thigh) besides the one in the other arm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hypersomnia, Injection site pain, Pyrexia
Clinical narrative: chills; fever/ fever was 102; pain at injection site; fatigue; slept all day; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on 11th April 2019, refer case US2019177121).   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 5th September 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, injection site pain, fatigue and sleepiness. Rechallenge with Shingrix was positive. On 28th September 2019, the outcome of the chills, fever, injection site pain, fatigue and sleepiness were recovered/resolved.   It was unknown if the reporter considered the chills, fever, injection site pain, fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows The patient received his Shingrix second dose on and that same day he experienced all the adverse reactions. The fatigue was described as exhausted and slept all day. The fever was 102. The patient was laid up again for a day and a half before the symptoms resolved. Injection site pain again lasted a few days.  On 14th September 2019, the same symptoms presented including the injection site pain and lasted a day before resolving. On 28th September 2019, all of the same symptoms presented and again resolved within a day and a half.  The patient only had the two injections on those two dates.  The reporter Consented to follow up. This case has been linked with US2019177136 having same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Vaccine positive rechallenge
Clinical narrative: chills; fever/ fever was 102; pain at injection site; fatigue; slept all day; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on 11th April 2019, refer case US2019177121).   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 5th September 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, injection site pain, fatigue and sleepiness. Rechallenge with Shingrix was positive. On 28th September 2019, the outcome of the chills, fever, injection site pain, fatigue and sleepiness were recovered/resolved.   It was unknown if the reporter considered the chills, fever, injection site pain, fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows The patient received his Shingrix second dose on and that same day he experienced all the adverse reactions. The fatigue was described as exhausted and slept all day. The fever was 102. The patient was laid up again for a day and a half before the symptoms resolved. Injection site pain again lasted a few days.  On 14th September 2019, the same symptoms presented including the injection site pain and lasted a day before resolving. On 28th September 2019, all of the same symptoms presented and again resolved within a day and a half.  The patient only had the two injections on those two dates.  The reporter Consented to follow up. This case has been linked with US2019177136 having same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered too low / Vaccine may not have been administered into deltoid region, but it was administered further down; Mild cellulitis reaction; Redness at injection site/ Erythematous; Slightly swollen; Edematous; Warm to Touch; This case was reported by a nurse via call center representative and described the occurrence of injection site cellulitis in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 2nd October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 2nd October 2019, unknown after receiving FluLaval Tetra 2019-2020 season, the patient experienced vaccine administered at inappropriate site. In October 2019, the patient experienced injection site cellulitis, injection site erythema, injection site swelling, injection site edema and injection site warmth. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema, injection site swelling, injection site edema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site swelling, injection site edema and injection site warmth to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient was approximately in her 40s, and that the vaccine was administered yesterday in the hospital between 1-3 PM Mountain time. The reporter was registered nurse who reports an employee of the hospital may have had Flulaval vaccine administered too low.  The nurse reports vaccine may not had been administered into deltoid region, but it was administered further down, which led to vaccine administered at inappropriate site. The reporter stated that reaction as mild and described as redness at injection site, slightly swollen, and mild cellulitis reaction approximately 3.5 cm by 4cm. It was erythematous, edematous, and warm to touch. The nurse mentioned reaction resembles several local reactions seen with prior unspecified flu vaccine and it does not appear atypical. The reporter was consented to follow up. This was 1 of the 2 cases reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine administered too low / Vaccine may not have been administered into deltoid region, but it was administered further down; Mild cellulitis reaction; Redness at injection site/ Erythematous; Slightly swollen; Edematous; Warm to Touch; This case was reported by a nurse via call center representative and described the occurrence of injection site cellulitis in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 2nd October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 2nd October 2019, unknown after receiving FluLaval Tetra 2019-2020 season, the patient experienced vaccine administered at inappropriate site. In October 2019, the patient experienced injection site cellulitis, injection site erythema, injection site swelling, injection site edema and injection site warmth. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema, injection site swelling, injection site edema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site swelling, injection site edema and injection site warmth to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient was approximately in her 40s, and that the vaccine was administered yesterday in the hospital between 1-3 PM Mountain time. The reporter was registered nurse who reports an employee of the hospital may have had Flulaval vaccine administered too low.  The nurse reports vaccine may not had been administered into deltoid region, but it was administered further down, which led to vaccine administered at inappropriate site. The reporter stated that reaction as mild and described as redness at injection site, slightly swollen, and mild cellulitis reaction approximately 3.5 cm by 4cm. It was erythematous, edematous, and warm to touch. The nurse mentioned reaction resembles several local reactions seen with prior unspecified flu vaccine and it does not appear atypical. The reporter was consented to follow up. This was 1 of the 2 cases reported by same reporter.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain, Pyrexia
Clinical narrative: body aches; headache; fever; sick to her stomach; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. In October 2019, 12 hrs after receiving Shingrix, the patient experienced general body pain, headache, fever and stomach discomfort. On an unknown date, the outcome of the general body pain, headache, fever and stomach discomfort were not recovered/not resolved.   The reporter considered the general body pain, headache, fever and stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The patient had the first dose of Shingrix, twelve hours later, she was sick to her stomach, has body aches, headache and a fever of 102.6F. The reporter consented to follow up. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the argus it was reported as not recovered/ not resolved.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Bump fluid filled; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 79-year-old male patient who received Herpes zoster (Shingrix) (batch number E523B, expiry date 5th November 2021) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. In October 2019, 3 days after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was not recovered/not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient experienced a bump on the left elbow following a dose of Shingrix. The bump was described as fluid filled. The health care professional reported that the bump developed approximately 72 hours after the dose of Shingrix was administered. The bump has not worsened or improved since it developed. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Lethargy, Pain in extremity, Paraesthesia
Clinical narrative: Tingling in left arm / Head felt tingly on the left side; lethargic; sore arm; Felt lousy; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 23rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced feeling bad, tingling, lethargy and pain in arm. On an unknown date, the outcome of the feeling bad, lethargy and pain in arm were recovered/resolved and the outcome of the tingling was unknown.   It was unknown if the reporter considered the feeling bad, tingling, lethargy and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient felt lousy the first few days, tingling in her left arm, lethargic, sore arm, and her head felt tingly on the left side. At the time of reporting patient still had tingling on the left side of her head. The patient was concerned because this was similar to her shingles experience from the past. The patient consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Rash vesicular
Clinical narrative: vesicular rash; small vesicles that became dry; small vesicles that became dry; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date 5th October 2021) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 2 days after receiving Shingrix, the patient experienced vesicular rash, vesicles and dry skin. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved and the outcome of the vesicles and dry skin were unknown.   It was unknown if the reporter considered the vesicular rash, vesicles and dry skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on right deltoid and 2 days after receiving the vaccine, patient developed a vesicular rash on the inner part of her right arm. The reporter stated that there were multiple small vesicles that became dry and one of the vesicles has popped. Emergency visit was Required. The reporter was in a rush and needed to get off of the phone to see patients. Therefore, reporter did not provide vaccination date or dose number.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: arm  was so swollen; it was swollen, it was red, it had a big red area on it; arm  was so swollen; it was swollen, it was red, it had a big red area on it; Nauseated; patient had her second pneumonia shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (brother in law and herself). This is first of two reports. A 66-year-old female patient received the 2nd dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer unknown, lot number and expiration date: unknown), via an unspecified route of administration on an unspecified date in 2019 (reported as this year) at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patent was previously administered the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in 2018 at an unspecified age for immunization. The patient reported that she had her second pneumonia shot and she do not know what's it called. Patient further stated that she got her first one last year and her last one this year. The patient also reported that in that afternoon (unspecified date), her arm was so swollen at the top where the shot was, it was swollen, it was red, it was (incomprehensible word) and it had a big red area on it and it stayed there for 5 days just like that, and she also got real nauseated. Outcome of events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019434230 same reporter and drug, similar event, different patient
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Arm was so swollen; it was swollen, it was red, it had a big red area on it; arm was so swollen; it was swollen, it was red, it had a big red area; Nauseated; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (patient and reporter). This is the second of two reports. A male patient (brother-in-law of reporter) of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (unknown manufacturer), via an unspecified route of administration from an unspecified date to an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient went in one time at day and reporter went into a different time to take the shot. The reporter stated that her arm was so swollen at the top where the shot was; it was swollen and it was red, it was (incomprehensible word) and it had a big red area on it. It stayed there for 5 days. She got really nauseated and reported that the patient had the same results. Outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019434226 same reporter and drug, similar event, different patient
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Joint dislocation, Loss of personal independence in daily activities, Muscle discomfort
Clinical narrative: He was not able to function so he stayed in bed; Extreme muscle discomfort in every muscle; Joint discomfort; Pain at the injection site the first 2-3 days; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain at the injection site the first 2-3 days, extreme muscle discomfort in every muscle, joint discomfort, muscle and joint pain and he was not able to function so he stayed in bed. The patient recovered from vaccination site pain; while clinical outcome of the other adverse events was unknown at time of this report.  The information on the lot number has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: He was not able to function so he stayed in bed; Extreme muscle discomfort in every muscle; Joint discomfort; Pain at the injection site the first 2-3 days; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain at the injection site the first 2-3 days, extreme muscle discomfort in every muscle, joint discomfort, muscle and joint pain and he was not able to function so he stayed in bed. The patient recovered from vaccination site pain; while clinical outcome of the other adverse events was unknown at time of this report.  The information on the lot number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Muscle fatigue, Wrong product administered
Clinical narrative: Fatigue/Tiredness; Chills; Muscle tiredness; Got dose of Trumenba accidentally; This is a spontaneous report from a non-contactable consumer (mother). An 11-year-old male patient received meningococcal group b rlp2086 (TRUMENBA suspension for injection, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The mother reported that her son (patient who was 11years old) got dose of meningococcal group b rlp2086 accidentally and was asking what will happen to her son. The mother also reported that her son (patient) reported fatigue, chills and muscle tiredness, tiredness. The mother was asking if her son should get a second or third dose and when, since her son got a dose of meningococcal group b rlp2086 accidentally. The mother was asking what to do. The mother stated that a doctor told them to wait till her son was 16 and then get vaccinated with meningococcal group b rlp2086. The HCP was aware that the vaccine was given by mistake. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Chills, Confusional state, Pyrexia, Tremor
Clinical narrative: chills; fever; Shaking; confusion; This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative.  A male patient of an unspecified age (in his late 60's or early 70's) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose and influenza vaccine, both on the same date, in different arms, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccinations, the patient experienced chills, fever, shaking, and confusion. The patient went to the emergency room (ER) for testing and was discharged the next day with antibiotics. Clinical outcome of the adverse events was unknown at time of this report.  The information on the lot number has been requested.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Influenza like illness
Clinical narrative: Experienced flu like symptoms for 2 days from receiving Prevnar 13 and flu together; This is a spontaneous report from a contactable Pharmacist, via a sales representative, who reported similar events for three patients. This is the first of three reports. This Pharmacist reported for a patient that: A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), at single dose and influenza vaccine (FLU) both via an unspecified route of administration on the same unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms for 2 days on an unspecified date with outcome of recovered.    No follow-up attempts are possible. No further information is expected, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019438282 same reporter, same product, same event, and different patient;US-PFIZER INC-2019438281 same reporter, same product, same event, and different patient
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for three patients. This is the second of three reports. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiry date unknown) and influenza vaccine (FLU), both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patient experienced side effects from receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and flu together on an unspecified date. The patient experienced flu like symptoms for 2 days. The outcome of the event was unknown.  No follow up attempts are possible, information on the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019438279 same reporter, same product, same event, and different patient;US-PFIZER INC-2019438282 same reporter, same product, same event, and different patient