chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Skin irritation
Clinical narrative: Broke out in shingles; Itching; Irritation; Blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles year ago and aware of the appearances and feeling itching, difficulty wearing clothes) and pruritus.   On 15th June 2020, the patient received the 2nd dose of Shingrix. On 16th June 2020, 1 days after receiving Shingrix, the patient experienced shingles, pruritus, skin irritation and blister. On an unknown date, the outcome of the shingles, pruritus, skin irritation and blister were recovered/resolved.   It was unknown if the reporter considered the shingles, pruritus, skin irritation and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and broke out in shingles and they are still bothering me and reported several times to the VA and took pictures of the breakout.  The reporter stated his condition was minor but subsiding, itching and irritation. The patient was breaking out, there are no new blisters.  The reporter stated he had spoken to his healthcare provider but she had not seen them. He states that, because of fact that they are not all in same vicinity, his HCP doubts it was shingles. The reporter consented to follow up. No additional details were available.  Attempted callback but had to leave voicemail message.  The customer called back while filling out AE report and was patient not HCP.   HCP information for his HCP was provided in form.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity, SARS-CoV-2 test negative, Sitting disability
Clinical narrative: shooting pain down the arm, the pain spread to the; pain  "all over" the consumer's body; pain is so severe in the buttocks; cannot tolerate sitting; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number 2437H, expiry date 28th March 2022) for prophylaxis.   Concurrent medical conditions included arthritis and carpal tunnel syndrome.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, general body pain, buttock pain and sitting disability. On an unknown date, the outcome of the pain in arm, general body pain, buttock pain and sitting disability were unknown.   It was unknown if the reporter considered the pain in arm, general body pain, buttock pain and sitting disability to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had tested for COVID and COVID antibodies which were negative. The patient received Shingrix at a pharmacy in the left arm and within one week of receiving had shooting pain down the arm that received the injection.  The pain spread to the other arm and was all over to the body.  The pain was so severe in the buttocks, the patient cannot tolerate sitting.  The patient has been to several doctors regarding these symptoms without success. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash macular, Rash vesicular
Clinical narrative: pain in her left arm after the dose; breakout described as breaking out on her left wrist that looked like shingles; outbreak described as two spots; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 occurance prior to receiving Shingrix vaccine).   In February 2020, the patient received the 1st dose of Shingrix. In March 2020, less than 2 months after receiving Shingrix, the patient experienced rash vesicular. In April 2020, the patient experienced rash macular. On 3rd July 2020, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, rash vesicular and rash macular were recovered/resolved.   It was unknown if the reporter considered the pain in arm, rash vesicular and rash macular to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. After receiving Shingrix, the patient experienced pain in her left arm.  Sometime after 13th March 2020, the patient reported first breakout described as breaking out on her left wrist that was 3 by 3 in area that looked like shingles but not as painful as shingles although pain was associated with this outbreak.  The patient reported the outbreak was not extended like previous cases of shingles and was localized to the left wrist. Outbreak reportedly lasted approximately 3 weeks.  The patient reported a second outbreak occurred approximately one month later sometime in April 2020.  Second outbreak described as two spots on patient's right thigh that also lasted for approximately three weeks. For the tolerance of 2nd dose, refer linked case US2020AMR127069.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR127069:same patient, 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: injection site pain; body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Shingrix. On 9th July 2020, 1 days after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experiencing body aches and injection site pain. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness; Hot to the touch; Swelling; second dose on 06Jul2020 and a first dose on 19Dec2019.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix administered on 19th December 2019.).   On 6th July 2020, the patient received the 2nd dose of Shingrix. On 6th July 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site swelling and drug dose administration interval too long. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: After receiving the 2nd dose if Shingrix the patient experienced, redness, swelling and hot to the touch sensation at the site of injection. The events had persisted over 3 days. On 6th July 2020, the patient received 2nd dose of Shingrix, which led to which led to lengthening of the vaccination schedule. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Headache, Impaired work ability, Inflammation
Clinical narrative: Cellulitis; Inflammation; interrupting his ability to work; Headache as pretty painful / interrupting his ability to work; This case was reported by a physician via call center representative and described the occurrence of cellulitis in a male 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 cellulitis (serious criteria GSK medically significant), inflammation, headache and inability to work. On an unknown date, the outcome of the cellulitis, inflammation and inability to work were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the cellulitis, inflammation, headache and inability to work to be related to Shingrix.  Additional details were p[rovided as follows: The age at vaccination was not reported. The reporter stated that, the patient experienced cellulitis, inflammation, headache and inability to work following dose 1 of Shingrix administration. The reporter stated that, the patient received another vaccine at the same time (name was not provided). The patient had headache as pretty painful, which lasted for 4 days. No additional details were provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 7th July 2020, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated she received 2 doses of Shingles vaccine 5 years ago. The patient believed the vaccine was Shingrix that she received, and stated "what else would I get that was two shots?" When further asked if she remembered when she received these doses, the patient stated she had no idea. On 7th July 2020, the patient diagnosed with Shingles. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided. The patient was unable to provide any additional details or information. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: swelling in the throat; difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a 73-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced throat swelling and difficulty breathing. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the throat swelling and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the throat swelling and difficulty breathing to be related to Influenza vaccine.  Additional details were provided as follows: The patient received an unknown flu vaccine 6 years ago and experienced swelling in the throat and difficulty breathing.  The patient was also taking an unspecified antibiotic at the time. The reporter consented to follow up. The pharmacist would be reaching out to the patient's doctor's office to determine which flu vaccine was administered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2737P, expiry date 22nd January 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th March 2020).   On 7th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 8th July 2020, 1 days after receiving Shingrix, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm and fever the next day.   The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Halo vision, Photophobia, Visual impairment, Vitreous floaters
Clinical narrative: halo in both eyes; spots in both the eye which comes and goes; difficulty for him to see or drive; feels like he is seeing at a bright lights directly; This case was reported by a pharmacist via call center representative and described the occurrence of vision halo in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On 8th July 2020 12:00, the patient received the 2nd dose of Shingrix. On 8th July 2020, 4 hrs after receiving Shingrix, the patient experienced visual impairment and eyes sensitive to sunlight. On 8th July 2020 04:00, the patient experienced vision halo and eye floaters. On an unknown date, the outcome of the vision halo, eye floaters, visual impairment and eyes sensitive to sunlight were unknown.   It was unknown if the reporter considered the vision halo, eye floaters, visual impairment and eyes sensitive to sunlight to be related to Shingrix.  Additional details were reported as follows: The patient received second dose in his left arm at around 12 pm and around 4 pm he started to experience spots in both the eye which comes and goes and also halos in both the eyes which comes and goes. When there were halos in the eyes, it makes it difficulty for him to see or drive, as he felt like he was seeing at a bright lights directly or like seeing the sun directly.  He had this experience on 8th and 10th July 2020. He did not have any halos or spots in his eyes on  9th July 2020. On 10th July 2020, the patient again experienced halos in both the eyes after he did his workout. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Feeling hot, Injection site pain, Insomnia
Clinical narrative: felt feverish; TIRED; feels cold; soreness at the injection site/ sore arm; felt hot; ACHY; TROUBLE SLEEPING; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included thyroxine sodium (Levothyroxine).   On 9th July 2020 12:00, the patient received the 1st dose of Shingrix. On 9th July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 10th July 2020, the patient experienced fever, tiredness and feeling cold. In July 2020, the patient experienced feeling hot, pain and difficulty sleeping. On an unknown date, the outcome of the fever, feeling hot, pain, tiredness and feeling cold were unknown and the outcome of the difficulty sleeping was recovered/resolved and the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the fever, feeling hot, pain, difficulty sleeping, tiredness, feeling cold and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose in left arm at 12:00 pm.  The soreness at the injection site presented that evening.  It was better at the time of reporting.  On 10th July 2020, in early morning around 2:00 am other symptoms represented. She felt hot, achy and had trouble sleeping. After getting up in the morning, she felt feverish and took her temperature which read 99.4 degree fahrenheit. She was tired and felt cold although the house was warm. She had to put a sweater on. The outcome for event trouble sleeping was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case. The TTO for events felt hot , trouble sleeping and achy should be 14 hours as per event onset time. The reporter consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: felt feverish; TIRED; feels cold; soreness at the injection site/ sore arm; felt hot; ACHY; TROUBLE SLEEPING; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included thyroxine sodium (Levothyroxine).   On 9th July 2020 12:00, the patient received the 1st dose of Shingrix. On 9th July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 10th July 2020, the patient experienced fever, tiredness and feeling cold. In July 2020, the patient experienced feeling hot, pain and difficulty sleeping. On an unknown date, the outcome of the fever, feeling hot, pain, tiredness and feeling cold were unknown and the outcome of the difficulty sleeping was recovered/resolved and the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the fever, feeling hot, pain, difficulty sleeping, tiredness, feeling cold and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose in left arm at 12:00 pm.  The soreness at the injection site presented that evening.  It was better at the time of reporting.  On 10th July 2020, in early morning around 2:00 am other symptoms represented. She felt hot, achy and had trouble sleeping. After getting up in the morning, she felt feverish and took her temperature which read 99.4 degree fahrenheit. She was tired and felt cold although the house was warm. She had to put a sweater on. The outcome for event trouble sleeping was reported as recovered/resolved with sequel however it was captured as recovered/resolved in the case. The TTO for events felt hot , trouble sleeping and achy should be 14 hours as per event onset time. The reporter consent to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Rash, Skin irritation
Clinical narrative: Shingles; Burning sensation; Itching; Rash; Irritation; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included chickenpox.   On 28th March 2020, the patient received the 1st dose of Shingrix. On 19th June 2020, 83 days after receiving Shingrix, the patient experienced shingles, burning sensation, pruritus, rash and skin irritation. On an unknown date, the outcome of the shingles, burning sensation, pruritus, rash and skin irritation were not recovered/not resolved.   It was unknown if the reporter considered the shingles, burning sensation, pruritus, rash and skin irritation to be related to Shingrix.  Additional details were reported as follows: The patient got shingles after receiving the 1st dose of Shingrix. He experienced a burning sensation, itching, irritation, and a rash about 3 weeks ago. Adverse events have not resolved. The reporter stated that his healthcare prefessionla was aware of events and still recommended to receive 2nd dose. The outcomes for events were reported as recovering in source document however it was captured as not recovered as per description. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever up to 101.3F; Chills; Pounding headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date unknown) for prophylaxis.   On 20th June 2020, the patient received the 2nd dose of Shingrix. On 20th June 2020, immediately after receiving Shingrix, the patient experienced fever, chills and pounding in head. On 23rd June 2020, the outcome of the fever, chills and pounding in head were recovered/resolved.   It was unknown if the reporter considered the fever, chills and pounding in head to be related to Shingrix.  Additional details were reported as follows: The patient received the dose of Shingrix and shortly after that experienced fever up to 101.3 degrees fahrenheit, chills and pounding headache that continued up to 23rd June 2020. The pharmacist also reported that this patient has recovered from this symptoms. The reporter consented to follow up. The batch number was reported as AJ9N5 however it was captured as KJ9N5 as per sales data sheet.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020127743:same reporter
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 22-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA651B, expiry date 20th March 2023) for prophylaxis.   Co-suspect products included LIVE VARICELLA VIRUS VACCINE (CHICKEN POX VACCINE) for prophylaxis.   On 23rd June 2020, the patient received the 2nd dose of RabAvert. On 22nd June 2020, the patient received CHICKEN POX VACCINE. On an unknown date, less than 3 weeks after receiving RabAvert, 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 RabAvert.  Additional details were provided as follows: The reporter stated that, the patient received pre-exposure schedule for Rabavert and experienced flu-like symptoms. The patient received  dose of a chicken pox vaccine just the day before receiving Rabavert 2nd dose. It was unknown if the reporter considered the influenza-like symptoms to be related to Chicken pox vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Product supply issue, Vaccination failure
Clinical narrative: vaccination failure; Shingles; Second dose 7 months after the first dose; Shingrix vaccine was not available from GSK; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and 1 year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, drug dose administration interval too long and product supply issue. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, drug dose administration interval too long and product supply issue were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated, he had his 1st Shingrix vaccine dose about 1 and half year ago from the date of reporting. The patient stated, he could not get his 2nd dose of Shingrix vaccine because it was not available from GlaxoSmithKline.  The patient stated, he had his 2nd dose 7 months after the 1st dose which led to drug dose administration interval too long. The patient reported, he had his first symptoms of shingles a year after his 2nd vaccine dose.  The patient reported, he had shingles 3 times after his Shingrix vaccine series.  The patient stated, it did not work.  A lack of drug effect was reported as the patient experienced shingles after both injections of Shingrix. Till the time reporting, the patient stated his symptoms had resolved like a month ago. The patient reported, he had a total of 37 episodes of shingles including the 3 episodes after Shingrix vaccination.  The patient stated that if he did not take Acyclovir, he would have shingles again. All information was not available. The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Chills, Erythema, Influenza like illness, Pain
Clinical narrative: Fever; Flu-like Symptoms; Aching; Chills; Insect Bites; Redness; Itchiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, influenza-like symptoms, pain, chills, insect bite nos, erythema and pruritus. On an unknown date, the outcome of the fever, influenza-like symptoms, pain, chills and erythema were recovered/resolved and the outcome of the insect bite nos and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, influenza-like symptoms, pain, chills, insect bite nos, erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever, flu-like symptoms, aching, chills, insect bites, redness, and itchiness. The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Fever; Flu-like Symptoms; Aching; Chills; Insect Bites; Redness; Itchiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, influenza-like symptoms, pain, chills, insect bite nos, erythema and pruritus. On an unknown date, the outcome of the fever, influenza-like symptoms, pain, chills and erythema were recovered/resolved and the outcome of the insect bite nos and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, influenza-like symptoms, pain, chills, insect bite nos, erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever, flu-like symptoms, aching, chills, insect bites, redness, and itchiness. The reporter was consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Severely sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of male patients who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patients had severe sick after vaccination with 1st dose of shingrix. The health care professional information was not obtained.
Age: 0.17
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Irritability, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was administered Shingrix instead of HEB; was administered Shingrix instead of HEB; has been fussy; experiencing sleep regression; This case was reported by a consumer via call center representative and described the occurrence of irritability in a 2-month-old male patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   On 13th July 2020, the patient received Shingrix .5 ml. On 13th July 2020, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. In July 2020, the patient experienced irritability and difficulty sleeping. On an unknown date, the outcome of the irritability was recovering/resolving and the outcome of the difficulty sleeping, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the irritability and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: A two month old baby was administered Shingrix in thigh instead of Heb vaccine at his two month visit which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient was in leap two and had been fussy and experiencing sleep regression where he would not let his mother put him down to sleep. The reporter stated that she had to hold him which was not like him.  No other events were reported. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Anxiety, Arthralgia, Chills, Headache, Hypoaesthesia
Clinical narrative: chills, body aches, headache, joint pains, anxiety, numbness in arms briefly
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: chills, body aches, headache, joint pains, anxiety, numbness in arms briefly
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pain in extremity
Clinical narrative: Arm pain, flu like symptoms (chills, body aches, nausea) lasting for approximately 24 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: Patient had swelling and red areas of inflammation close to but not attached to injection site
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain, Tenderness
Clinical narrative: The patient was given her vaccine in the right deltoid at 8:50am on 07/17/2020. Later that evening around 8pm, the patient noticed soreness in her shoulder. The next day, she noticed tenderness to palpation of the medial, upper arm as well as in the right axillary region. She checked her arm and noticed some swelling at the injection site and some erythema distally to the injection site. Today (07/20/2020) she presented for evaluation in the clinic and states the area of erythema has grown since she first noticed it. Her shoulder is sore and she remains having areas of tenderness to palpation including the injection site, the erythematous area distal and medial to this as well as her anterior axillary region.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Underdose
Clinical narrative: The patient experienced no symptoms; a patient received an incomplete dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's current condition included reflux and vocal cord paralysis. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On 06-JUL-2020, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1676327, expiration date: 19-APR-2021, orally for prophylaxis. The patient's parent was concerned that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) might be too thin for the baby to ingest safely and requested that administration of the dose be stopped before it was complete. The patient experienced no symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: a fairly significant goose egg red and itchy hot swelling (3") on upper arm at the site of the shingles shot. Also last evening had about 3-4 hours of chills and all over nasty feeling. (1 day post shot). Took Tylenol and went to bed early. Ok in the morning and better this evening. (2 Days after). Swelling not down yet but doesn't feel as bad.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling of injection site with in 2 hours, fatigue within 2 hours. headache, chills, body ache, mild fever (100.5) wihin 12 hours, OTC med helped with headache and chills. Milder symptoms of the same persisted for 24 hours, mild pain at injection site for 48 hours
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain and swelling of injection site with in 2 hours, fatigue within 2 hours. headache, chills, body ache, mild fever (100.5) wihin 12 hours, OTC med helped with headache and chills. Milder symptoms of the same persisted for 24 hours, mild pain at injection site for 48 hours
Age: 17.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: pt has not and did not have any reactions Mom, patient and provider all notified wrong immunization was given (should have been Meningoccal B). Next time we will triple check with a 3rd person to prevent form happening again
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abnormal faeces, Culture stool, Haematochezia, Mucous stools, Occult blood positive
Clinical narrative: Patient developed a low grade fever around 30 hours following the vaccines. Her stool changed from seedy and normal liquid based to extremely seedy and thick. At 48 hours she developed significant mucus in her stool and we followed up with a pediatrician. When her symptoms did not improve or resolve by the following week we provided a stool sample and she tested positive for rotavirus as well as blood in her stool. The pediatrician advised that patient may have a dairy or egg allergy. She is exclusively breastfed and I, the mother, am consuming an entirely vegan diet and patient has not shown any improvement at this time. We met with a lactation consultant on May 21st (prior to her being vaccinated) and she was diagnosed with mild GERD but they were confident after examining her and her stool that she did not have any food allergies. My husband and I are confident that her symptoms are a direct result of the rotavirus vaccine and are extremely discouraged that we have not been able to get her well.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Rotavirus test positive
Clinical narrative: Patient developed a low grade fever around 30 hours following the vaccines. Her stool changed from seedy and normal liquid based to extremely seedy and thick. At 48 hours she developed significant mucus in her stool and we followed up with a pediatrician. When her symptoms did not improve or resolve by the following week we provided a stool sample and she tested positive for rotavirus as well as blood in her stool. The pediatrician advised that patient may have a dairy or egg allergy. She is exclusively breastfed and I, the mother, am consuming an entirely vegan diet and patient has not shown any improvement at this time. We met with a lactation consultant on May 21st (prior to her being vaccinated) and she was diagnosed with mild GERD but they were confident after examining her and her stool that she did not have any food allergies. My husband and I are confident that her symptoms are a direct result of the rotavirus vaccine and are extremely discouraged that we have not been able to get her well.
Age: 20.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Arthralgia, Myalgia
Clinical narrative: feelings of muscle aching and joint pain for the past 10 days. Noticed that shortly after he received varicella vaccine and hepatitis B vaccine. He denies any fevers. Denies any recent change in his activity level. Denies recent nutritional change. Denies any recent illness. He has not had any rash or fever. Has been taking Advil with only slight improvement. Has not had any giving out of joints. Denies any syncopal episodes. States he notices involvement of both upper and lower extremities. Denies change in his sleeping pattern
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 09-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001779: US-009507513-2007USA001780: US-009507513-2007USA001782: US-009507513-2007USA001783: US-009507513-2007USA001778: US-009507513-2007USA001777: US-009507513-2007USA001781:
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a registered nurse and refers to a 9-week-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-JUL-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S023646, expiration date: 31-MAR-2022 (exact dose, injection site and route of administration were not provided) for prophylaxis. The administered dose experienced a temperature excursion of above 47 degrees Fahrenheit: 57.39 degrees Fahrenheit for 6 hours. The digital data logger was involved in regards the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptoms; an expired dose of VAQTA was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # S018419, expiration date 12-JUL-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Myalgia
Clinical narrative: chills/shivering; fatigue; malaise; myalgia; This case was reported by a consumer via interactive digital media and described the occurrence of chills 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 chills, fatigue, malaise and myalgia. On an unknown date, the outcome of the chills, fatigue, malaise and myalgia were unknown.   It was unknown if the reporter considered the chills, fatigue, malaise and myalgia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experinced chills, fatigue, shivering, malaise and myalgia. The reporter asked should not had the second dose in 2 months.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: pain on the arm where I got the shot; chills; body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (did not remember any pain after the 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, chills and general body pain. On an unknown date, the outcome of the pain in arm, chills and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had pain on the arm where got the shot, chills and body aches. The reporter wanted to know how long do the side effects last. The reporter would check with doctor if it does not get better in 24 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Crying, Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: cannot even use my arm; arm hurts so bad / painful injection; I want to cry; can't sleep.; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2020, the patient received the 1st dose of Shingrix. On 15th July 2020, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm, crying and insomnia. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, crying and insomnia were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, crying and insomnia to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and was very painful injection and arm hurts so bad that want to cry. The patient cannot even use arm and cannot sleep.  The pain mention in list of side effects was very downplayed.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain in arm; This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th July 2020, the patient received Shingles vaccine. In July 2020, less than a week after receiving Shingles vaccine, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and had muscle pain in arm. The reporter asked was it ok to take Tylenol for the muscle pain in arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: red indurated rash at the injection site; red  rash at the injection site; indurated at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th March 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st April 2020, 21 days after receiving Shingrix, the patient experienced injection site erythema, injection site rash and injection site induration. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and reporting a red indurated rash at the injection site that began 3 weeks post vaccination and has not resolved.  The vaccination was given at a local pharmacy.  Limited information available.  Lot and expiration date unavailable. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: episodes of shingles; one dose of Shingrix approximately in March 2019; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had multiple episodes of shingles (prior to Shingrix)) and chemotherapy.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose of vaccine. The patient had chemotherapy and multiple episodes of shingles prior to Shingrix vaccination.  This patient received one dose of Shingrix approximately in March 2019 and told that he was not informed he needed a second dose. Also, patient continued having episodes of shingles after 1st dose. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination.