chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site nodule, Pain, Pyrexia
Clinical narrative: Suspected Vaccination failure; Shingles rash; Pain; Knot at injection site; REDNESS at injection site; FEVER; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 30th April 2020) for prophylaxis.   The patient's past medical history included shingles.   On 25th December 2018, the patient received the 1st dose of Shingrix. On 25th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On 26th April 2019, not applicable after receiving Shingrix and 1 days after receiving Shingrix, the patient experienced injection site nodule, injection site erythema, fever and pain. In July 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was not recovered/not resolved and the outcome of the shingles and pain were unknown and the outcome of the injection site nodule, injection site erythema and fever were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site nodule, injection site erythema, fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose in left arm. The day after the patient received her 2nd dose of Shingrix she experienced a large knot the size of a small basketball that was very red at the injection site. This resolved after 4 days. A fever also presented the day after the 2nd vaccination that lasted 3 days. Last week before the date of reporting a shingles rash presented on the back of her legs just below the buttocks. The patient stated that the Shingrix shots were painful. She had bad reaction from the shot. The patient wanted the money back. The patient was very dissatisfied. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles rash; Pain; Knot at injection site; REDNESS at injection site; FEVER; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 30th April 2020) for prophylaxis.   The patient's past medical history included shingles.   On 25th December 2018, the patient received the 1st dose of Shingrix. On 25th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On 26th April 2019, not applicable after receiving Shingrix and 1 days after receiving Shingrix, the patient experienced injection site nodule, injection site erythema, fever and pain. In July 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was not recovered/not resolved and the outcome of the shingles and pain were unknown and the outcome of the injection site nodule, injection site erythema and fever were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the injection site nodule, injection site erythema, fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose in left arm. The day after the patient received her 2nd dose of Shingrix she experienced a large knot the size of a small basketball that was very red at the injection site. This resolved after 4 days. A fever also presented the day after the 2nd vaccination that lasted 3 days. Last week before the date of reporting a shingles rash presented on the back of her legs just below the buttocks. The patient stated that the Shingrix shots were painful. She had bad reaction from the shot. The patient wanted the money back. The patient was very dissatisfied. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain and swelling at vaccine site, redness 1 and 1/2 inches in diameter, headache day after vaccine, itching on day of vaccine
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Device connection issue, Underdose
Clinical narrative: Upon administering the vaccination to the patient, some of the dose was lost. We believe it was due to a faulty connection between the syringe and needle. I contacted the manufacture and the CDC. The CDC recommended to revaccinate the patient. The patient has been contacted and will come in to receive the dose.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth to the area
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: Area of injection was very sore about 6 hours after injection; Extreme tiredness about 11 hours after injection; Severe chills 13 hours after injection that lasted for three hours. No fever but took 2 Tylenol and went to sleep.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Balance disorder, Blood glucose normal, Chills, Cold sweat, Gait disturbance
Clinical narrative: Yesterday at 1030 patient  received his second dose of Menactra at his 16 year WCC.  1.5 hours later developed chills, shaking, 10 episodes NBNB emesis, "room spinning sensation",  difficulty with balance.  Returned to office, physical exam: pale/yellow skin coloring, clammy/cool skin, nystagmus of eyes, worse with lateral EOM, unable to balance well without support. Blood glucose 97, VS stable, afebrile.  Unable to obtain UA or urine drug screen from patient.  Zofran given in office. Sent to ED,  physical exam: notable nystagmus on right lateral gaze, somewhat unsteady with toe and heel gait but not ataxic. Dx with vertigo vs. labyrinthitis. Given IVF, zofran and PO meclizine. After treatment patient felt significantly better, discharged home, follow up with PCP.   Of note, patient was up until 2am the night before playing video games at friends house.  Only had a cookie for breakfast, nothing to drink all morning. Denies alcohol, marijuana or drug use.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Labyrinthitis, Nystagmus, Pallor, Tremor, Vertigo
Clinical narrative: Yesterday at 1030 patient  received his second dose of Menactra at his 16 year WCC.  1.5 hours later developed chills, shaking, 10 episodes NBNB emesis, "room spinning sensation",  difficulty with balance.  Returned to office, physical exam: pale/yellow skin coloring, clammy/cool skin, nystagmus of eyes, worse with lateral EOM, unable to balance well without support. Blood glucose 97, VS stable, afebrile.  Unable to obtain UA or urine drug screen from patient.  Zofran given in office. Sent to ED,  physical exam: notable nystagmus on right lateral gaze, somewhat unsteady with toe and heel gait but not ataxic. Dx with vertigo vs. labyrinthitis. Given IVF, zofran and PO meclizine. After treatment patient felt significantly better, discharged home, follow up with PCP.   Of note, patient was up until 2am the night before playing video games at friends house.  Only had a cookie for breakfast, nothing to drink all morning. Denies alcohol, marijuana or drug use.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting, Yellow skin
Clinical narrative: Yesterday at 1030 patient  received his second dose of Menactra at his 16 year WCC.  1.5 hours later developed chills, shaking, 10 episodes NBNB emesis, "room spinning sensation",  difficulty with balance.  Returned to office, physical exam: pale/yellow skin coloring, clammy/cool skin, nystagmus of eyes, worse with lateral EOM, unable to balance well without support. Blood glucose 97, VS stable, afebrile.  Unable to obtain UA or urine drug screen from patient.  Zofran given in office. Sent to ED,  physical exam: notable nystagmus on right lateral gaze, somewhat unsteady with toe and heel gait but not ataxic. Dx with vertigo vs. labyrinthitis. Given IVF, zofran and PO meclizine. After treatment patient felt significantly better, discharged home, follow up with PCP.   Of note, patient was up until 2am the night before playing video games at friends house.  Only had a cookie for breakfast, nothing to drink all morning. Denies alcohol, marijuana or drug use.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: I administered 3 immunizations HPV, TDAP and Menveo. After I administered all three injections, I was wiping away a little bit of blood when the patient started to lean forward and pass out. I caught the patient and then I helped lower her to the ground with another nurse. When patient came to we had her stay seated on the floor for a couple of minutes. I stayed with the patient while the other nurse went and got the patient some crackers and juice. We stayed with the patient 15-20 minutes after shots (they are required to stay that amount of time). Then the other nurse took patient's vital signs all within normal limits. BP 110/74, P 80, SPO2 98%. Patient verbalized that she was feeling normal again after the 20 minutes. After which we waked patient and her father to check out and told them if there is any more problems to call the clinic and let us know. The physician's assistant that saw patient was notified of the event.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Around 7 P.M. that night, I noticed I felt a hard knot in my right arm, about where the shot was given - halfway beween my shoulder and elbow.  The right arm was also swollen from the shoulder to the elbow and became painful as the hours went by.  There was also reddening and the skin was very warm to touch.  My face also swelled by the next day for 2 days after.  I took an Advil and applied ice to the outside of the right arm from the shoulder to the elbow intermittently for the next 2 or 3 days.  The Advil made me feel too sick and nauseous to go to the Emergency Room, but the pain decreased somewhat.  I had to spend the next 3 days resting with the ice on.  Any movement of my arm hurt so it was best to lie flat in bed.  I switched to aspirin the day after the Advil and slowly started feeling better.  After 4 days, all the adverse symptoms were gone.  I called Dr.'s office to report it.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Malaise, Nausea, Pain, Swelling face
Clinical narrative: Around 7 P.M. that night, I noticed I felt a hard knot in my right arm, about where the shot was given - halfway beween my shoulder and elbow.  The right arm was also swollen from the shoulder to the elbow and became painful as the hours went by.  There was also reddening and the skin was very warm to touch.  My face also swelled by the next day for 2 days after.  I took an Advil and applied ice to the outside of the right arm from the shoulder to the elbow intermittently for the next 2 or 3 days.  The Advil made me feel too sick and nauseous to go to the Emergency Room, but the pain decreased somewhat.  I had to spend the next 3 days resting with the ice on.  Any movement of my arm hurt so it was best to lie flat in bed.  I switched to aspirin the day after the Advil and slowly started feeling better.  After 4 days, all the adverse symptoms were gone.  I called Dr.'s office to report it.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain lower, Abdominal pain upper, Back pain, Blood test, Diarrhoea
Clinical narrative: 11:00 am , nausea and lower abdominal pain 1:30 pm Epigastic pain radiating to mid  back pain , nausea and diarrhea 9:00 pm Epigastric , mid back pain, nausea,  diarrhea shortness of breath
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Electrocardiogram, Nausea, Pain, X-ray
Clinical narrative: 11:00 am , nausea and lower abdominal pain 1:30 pm Epigastic pain radiating to mid  back pain , nausea and diarrhea 9:00 pm Epigastric , mid back pain, nausea,  diarrhea shortness of breath
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt states she got large red area at injection site location
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: put her down; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery (had her 2nd breast cancer surgery 5 weeks before receiving Shingrix), lymph node dissection (was a breast cancer survivor and has had her lymph nodes removed) and breast cancer (Breast cancer survivour).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient was a friend of the reporter.  The age at vaccination was not reported. The patient stated that the shot put her down for a day or two.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: large red area @ injection site
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Headache, Injection site pain, Injection site warmth
Clinical narrative: fatigue, nausea, headache, fever 100.9, all over muscle achiness, shakiness, stomach pain, pain and heat at site of shot. They started when I woke up at 6 a.m. the day after but at this time I don't know how long they will last because it's only been one day.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Tremor
Clinical narrative: fatigue, nausea, headache, fever 100.9, all over muscle achiness, shakiness, stomach pain, pain and heat at site of shot. They started when I woke up at 6 a.m. the day after but at this time I don't know how long they will last because it's only been one day.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis in lower deltoid area, closer to bicep. She was seen at an urgent care center and was prescribed cephalexin 500mg four times daily for 7 days, which was dispensed on 7/22/2019
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Pain, Swelling
Clinical narrative: Severe redness at injection site that lasted approximately 2 weeks.  Patient had pain and swelling and experience flu like symptoms.
Age: 46.0
Sex: F
Vaccine: TYP
Symptoms: Electrocauterisation, Epistaxis
Clinical narrative: 7/15/19: Dose #1 of Vivotif at bedtime,  7/16/19: 2pm nose bleed,  7/23/19: afternoon nosebleed,  7/17/19: Evening nosebleed, Dose #2 Vivotif at bedtime,  7/18/19: Afternoon nosebleed, called primary care physician and 2 urgent care facilities and referred to ER. Had nose cauterized at local ER 7/19/19: 3rd dose Vivotif at bedtime, NO nosebleed this day (possibly from cauterization of nose on previous day) 7/20/19: 8:30pm nosebleed, visited ER from 9pm-midnight and was told there was nothing they could do and didn't want to risk another nosebleed with cauterization. Advised to stop taking Vivotif. Use humidifier and vaseline in nasal cavity. Make appointment with ENT 7/21/19: evening nosebleed...DID NOT take last dose of Vivotif 7/22/19: 6:00am nosebleed. Scheduled appoint with ENT for 8/5/19 7/23/19: Nothing. No symptoms of nosebleed 7/24/19: Nothing. No symptoms of nosebleed  ****I've never had a nosebleed in my entire life.****
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acute kidney injury, Hyponatraemia, Pyrexia, Rash, Sepsis
Clinical narrative: Started with Hives/Diffuse rash day 2 post vaccination given Hydroxyzine 25mg prednisone 20mg Day 3 was admitted to Hospital with Fever Diagnosed with Sepsis, Acute Renal failure and Hyponatremia released 7-22-19
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Started with Hives/Diffuse rash day 2 post vaccination given Hydroxyzine 25mg prednisone 20mg Day 3 was admitted to Hospital with Fever Diagnosed with Sepsis, Acute Renal failure and Hyponatremia released 7-22-19
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Intensive care, Renal failure, Sepsis
Clinical narrative: Started with Hives/Diffuse rash day 2 post vaccination given Hydroxyzine 25mg prednisone 20mg Day 3 was admitted to Hospital with Fever Diagnosed with Sepsis, Acute Renal failure and Hyponatremia released 7-22-19
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 61 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 16-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a two physicians for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 19-APR-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Malaise, Myalgia
Clinical narrative: Feeling pretty achy; muscle aches; Flu like symptoms; Soreness at injection site; felt crummy; felt like she was coming down with something; This case was reported by a other health professional via call center representative and described the occurrence of pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had an active case of shingles at 35 years old), skin lesion (had right sided might be the L4-L5 S1 dermatome skin lesions), abdominal pain (Deep right lower abdomen pain), appendicitis and neuralgia (post neuralgia pain). Previously administered products included Acyclovir.   On 31st January 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain, muscle pain, influenza-like symptoms, injection site pain, feeling bad and feeling unwell. On an unknown date, the outcome of the pain, muscle pain, influenza-like symptoms, injection site pain, feeling bad and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pain, muscle pain, influenza-like symptoms, injection site pain, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: Following 1st dose of the vaccine, the patient felt pretty achy, had muscle aches, flu like symptoms, soreness at the injection site, felt crummy and felt like she was coming down with something.  The patient experienced this for 24 to 48 hours and then resolved. The patient received 2nd dose and experienced some adverse events, for tolerance refer the case US2019124837.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Feeling pretty achy; muscle aches; Flu like symptoms; Soreness at injection site; felt crummy; felt like she was coming down with something; This case was reported by a other health professional via call center representative and described the occurrence of pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had an active case of shingles at 35 years old), skin lesion (had right sided might be the L4-L5 S1 dermatome skin lesions), abdominal pain (Deep right lower abdomen pain), appendicitis and neuralgia (post neuralgia pain). Previously administered products included Acyclovir.   On 31st January 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain, muscle pain, influenza-like symptoms, injection site pain, feeling bad and feeling unwell. On an unknown date, the outcome of the pain, muscle pain, influenza-like symptoms, injection site pain, feeling bad and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the pain, muscle pain, influenza-like symptoms, injection site pain, feeling bad and feeling unwell to be related to Shingrix.  Additional details were provided as follows: Following 1st dose of the vaccine, the patient felt pretty achy, had muscle aches, flu like symptoms, soreness at the injection site, felt crummy and felt like she was coming down with something.  The patient experienced this for 24 to 48 hours and then resolved. The patient received 2nd dose and experienced some adverse events, for tolerance refer the case US2019124837.
Sex: F
Vaccine: MENB
Symptoms: Apparent death, Meningitis, Seizure, Vaccination failure
Clinical narrative: meningitis; seizures; almost lost life; Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), seizure (serious criteria hospitalization and GSK medically significant) and near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the meningitis, seizure and near death experience were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, meningitis, seizure and near death experience to be related to Bexsero.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. It was reported that the patient almost lost her life with meningitis and she was up to date in all her vaccinations. It caused her to have seizures and to be hospitalized for 2 months.  It was reported 10 people that died from the same bacterial infection. The patient was the only one that made it out alive.  The patient was breathing normally. This case was considered as suspected vaccination failure, since the details regarding the time to onset and dose number was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Vaccine positive rechallenge
Clinical narrative: felt sick; vaccine hurt; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on unknown date refer case US2019AMR131615).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that he felt sick for a couple days after receiving Shingrix. He also said that the vaccine hurt and he would like us to make it hurt less.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: vaccine hurt; felt sick; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult 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 injection site pain and feeling unwell. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site pain and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that he felt sick for a couple days after receiving a dose of Shingrix. He also said that the vaccine hurt and he would like us to make it hurt less. The reporter did not agree to be followed up. For tolerances of 2nd dose refer case US2019AMR131609, reported by same reporter for the same patient.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness postural, Fall, Peripheral coldness, Tremor
Clinical narrative: Patient described her side effects started in the evening after receiving her vaccination.   She reported as having shaking, cold hands; and an overall sensation of chills that entire evening.   Upon standing after she had been resting for some time, she became very dizzy to the point of her falling  in her kitchen. She reported no injuries as a result of the fall.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: LOCALIZED RXN, SWELLING AND REDNESS AT SITE.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: per patient "flu-like symptoms, feel really bad has been going on for 3 weeks and still feel like that today"
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Headache, Nausea, Nodule, Sensation of foreign body
Clinical narrative: Nausa, headache, back pain and knot on ear lob, feeling of something is stuck in her throat
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Papule, Rash, Rash pruritic
Clinical narrative: Patient developed rash to face, scalp, chest, and bilateral arms about 12-13 days after receiving vaccination.  Rash is itchy.  Patient presented with scattered papules and vesicles on erythematous base.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pruritus, Rash
Clinical narrative: Rash on left arm, itchy, painful, burning.  -patient states that she took antihistamines(cetirizine) which were not helpful -
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site haematoma, Injection site haemorrhage, Injection site pain, Underdose
Clinical narrative: I gave the patient 2 immunizations, Pneumovax 23 and Shingrix, in the same arm.  While injecting the Pneumovax 23, it felt like I hit something going in so I slightly withdrew the syringe.  A very small amount of vaccine (clear solution) squirted out.  The patient started bleeding immediately after I withdrew the syringe.  About 30-60 minutes later, the patient's daughter called and stated she had a hematoma the size of a quarter.  Patient did receive some Tylenol for her slight pain and has been putting cold compresses on the site.  No other adverse reaction were noted.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Influenza, Pain in extremity
Clinical narrative: PATIENT STATES SHE FELT LIKE SHE HAD FLU SYMPTOMS AND ARM WAS PAINFUL AND RED
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Arthralgia, Burning sensation, Groin pain, Injection site pain, Musculoskeletal stiffness
Clinical narrative: EMPLOYEE HAD STIFFNESS TO NECK AND SHOULDERS THE FOLLOWING DAY, 2 DAYS AFTER INJECTION PAIN IN RIGHT SHOULDER, RIGHT GROIN, AND MEDIAL RIGHT KNEE, THE THIRD DAY AFTER THE INJECTION RASH DEVELOPED TO RIGHT BUTTOCK, STARTED ABOUT A QUARTER SIZE AND PROGRESSED TO THE SIZE OF AN ORANGE OVER A TWO DAY TIME FRAME. STATES THE RASH BURNS WHEN TOUCHED.SORENESSS TO GLUTEAL MUSCLE AND RADIATES AROUND TO THE GROIN.
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Myalgia, Rash
Clinical narrative: EMPLOYEE HAD STIFFNESS TO NECK AND SHOULDERS THE FOLLOWING DAY, 2 DAYS AFTER INJECTION PAIN IN RIGHT SHOULDER, RIGHT GROIN, AND MEDIAL RIGHT KNEE, THE THIRD DAY AFTER THE INJECTION RASH DEVELOPED TO RIGHT BUTTOCK, STARTED ABOUT A QUARTER SIZE AND PROGRESSED TO THE SIZE OF AN ORANGE OVER A TWO DAY TIME FRAME. STATES THE RASH BURNS WHEN TOUCHED.SORENESSS TO GLUTEAL MUSCLE AND RADIATES AROUND TO THE GROIN.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives started local approximately 1 1/2 hours after vaccine given.  Spread down arm, legs, bottom, & feet.  Gave Benadryl the evening of 07/23/19.  Itching.  Dr. advised to continue Benadryl and watch.  At this time not resolved.  Parent to call if persists or worsens.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Musculoskeletal disorder, Peripheral swelling
Clinical narrative: Swollen arm (could not use for 5 days), no redness Shiver/fever next morning Overnight vomitting and diarrhea for 2.5 days Extra fatigue
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Swollen arm (could not use for 5 days), no redness Shiver/fever next morning Overnight vomitting and diarrhea for 2.5 days Extra fatigue
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Generalised erythema, Injection site pain, Migraine
Clinical narrative: Pt experienced fatigue, migraine, and soreness in arm where injected the day after administering the vaccine.  2 days after administration, pt stated experiencing redness all over body from shoulder downs (spoke to pt over the phone)
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Myopathy, Nerve conduction studies abnormal, Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Pain, muscle weakness in right arm, confirmed by Dr. via nerve conduction studies.  Little improvement since onset.  Diagnosis of Parsonage Turner Syndrome / Brachial Myopathy.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Myocardial infarction
Clinical narrative: Before being administered the  Shringrix , patient had suffer a car incident. So the origin is uncleared about what cause the heart attack.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Fibromyalgia, Headache
Clinical narrative: Extreme pain all over body. Patient received dose with 650mg APAP in system. Redosed APAP 8 hours after original AM dose. Arthritic pain flare, fibromyalgia pain flared, extreme headache pain as well. Even tried using tramadol she had on hand and that did not even touch the pain level she was experiencing. Nausea occurred but no vomiting. Chills occurred but no temperature taken to determine if she had a fever. Extreme fatigue as well. Patient had to call a family member to care for her elderly and ill husband because she could not perform any activities of daily living. The symptoms started about 8 hours after administration and lasted for about 24 hours. Patient treated symptoms with rest and 650mg Tylenol. Patient was counseled on the likelihood of these adverse events prior to vaccination but feels the reaction was so severe it needed to be reported.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: Extreme pain all over body. Patient received dose with 650mg APAP in system. Redosed APAP 8 hours after original AM dose. Arthritic pain flare, fibromyalgia pain flared, extreme headache pain as well. Even tried using tramadol she had on hand and that did not even touch the pain level she was experiencing. Nausea occurred but no vomiting. Chills occurred but no temperature taken to determine if she had a fever. Extreme fatigue as well. Patient had to call a family member to care for her elderly and ill husband because she could not perform any activities of daily living. The symptoms started about 8 hours after administration and lasted for about 24 hours. Patient treated symptoms with rest and 650mg Tylenol. Patient was counseled on the likelihood of these adverse events prior to vaccination but feels the reaction was so severe it needed to be reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: July 22, 2019 5:00 pm injection of Shingrix.  July 23, 2019 8:00 am Extreme headache, nausea, chills, very tired, redness and swelling at injection site (left arm). July 24, 2019 3:00 pm still have same symptoms but mild.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: July 22, 2019 5:00 pm injection of Shingrix.  July 23, 2019 8:00 am Extreme headache, nausea, chills, very tired, redness and swelling at injection site (left arm). July 24, 2019 3:00 pm still have same symptoms but mild.
Age: 24.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient became lightheaded and diaphoretic after vaccines. VS at 1045 BP 95/62 O2 sat 99 Pulse 65 R 14 VS at 1052 BP 95/68 O2 sat 100 Pulse 64 R 16
Age: 38.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Pain in extremity, Rash macular, Skin warm
Clinical narrative: Patient called on 7/20/19 to see if her reaction was normal. She stated she had 3 red blotches on the side of her arm when asked if they were hot to the touch, she said " no but it is hard to tell because it is just so hot outside anyways". She were there when she woke up. When asked if as series of questions (is it hot to the touch, red and streaky, is it at the injection site, are you having any trouble breathing, is there any swelling) she replied no. She said they are just 3 splotches about a quarter size and her arm is hurting "pretty bad". I told her it is best to go to an urgent care center since it is the weekend and have it looked at. I left a message for her on 7/21/19 to check on her. I called again today 7/24 to see how she was. She said she went to urgent care center They were not sure what it was they had two scenarios 10 could be some kind of infection or 2) and unrelated allergy. They could not say it was the vaccines given the red areas were no where near the injection sites, but was warm to the touch. She was given antibiotics and Benadryl to be on the safe side and cover both scenarios.  She said the Benadryl did not do much to improve the red blotches. She has an appointment with her PCP and Allergist in the next week to help find if she could possibly have an allergy or if it is in an infection. She did say it is getting much better and looks better but not completely gone
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Cyanosis, Headache, Malaise, Pyrexia, Tremor
Clinical narrative: Vaccine was administered on 7/24/19 at 11:39 a.m.  Around 1:30 p.m. patient was out shopping with her mother when she suddenly did not feel well. She started with a fever, headache, shaking and fingertips were cyanotic.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: shingles; Information was received from a lawyer concerning a case in litigation regarding a female patient, age and history not provided.  On or about 06-APR-2012 the patient received zoster vaccine live (ZOSTAVAX) for prevention of shingles.  As a direct result of the vaccine the patient suffered a shingles outbreak in addition to chronic pain, rash and lesions to various parts of the body.  She did not have a shingles outbreak until 17-JUN-2017.  As a direct result of the vaccine she suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition.  As a result of zoster vaccine live (ZOSTAVAX) the patient suffered severe progressive, permanent and incurable  injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.    Shingles was considered to be disabling.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 85 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 18-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HIBV, IPV
Symptoms: Product storage error
Clinical narrative: patients who have received vaccines that were previously exposed to temperatures below 32 degrees F/No AE; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA192700, 2019SA193109, 2019SA193112, 2019SA193111, 2019SA193113, 2019SA193107, 2019SA193106, 2019SA193110, 2019SA192698 and 2019SA192699. (Same reporter).  This case involves a 5 months old female patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) and IPV (VERO) [IPOL] (lot PIA461M, expiry date- 03-May-2020) via intramuscular route in unknown administration site, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: patients who have received vaccines that were previously exposed to temperatures below 32 degrees F.; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2019SA193105, 2019SA193107, 2019SA193109, 2019SA193110, 2019SA193111, 2019SA193112, 2019SA193113, 2019SA192698, 2019SA192699 and 2019SA192700 (Same reporter).  This case involves a 7 years old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] (lot PIA461M, expiry date: 03-May-2020 via intramuscular route in unknown administration site) on 28-Jun-2019, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patients who have received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months and 26 days old female patient who received a 0.5 ml dose of vaccine IPV (VERO) (lot: PIA461M and expiry date: 03-May-2020) via intramuscular route in unknown administration site, On 28-Jun-2019.  Patient medical history, vaccinations, family history not reported.   No other vaccine was given.  It is an actual medication error due to incorrect product storage.   It was reported that patient received vaccines that were previously exposed to temperatures below 32 degrees F.  At the time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: patients who have received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2019SA193105, 2019SA193107, 2019SA193106, 2019SA193110, 2019SA193111, 2019SA193112, 2019SA193113, 2019SA192698, 2019SA192699 and 2019SA192700 (Same reporter).  This case involves a 1 years old male patient who received 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date: 04-Apr-2020 via intramuscular route in unknown administration site) on 28-Jun-2019, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Patient received vaccines that were previously exposed to temperatures below 32 degrees F, no adverse event; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192700, 2019SA193109, 2019SA193112, 2019SA193111, 2019SA193113, 2019SA193107, 2019SA193106, 2019SA193105, 2019SA192698 and 2019SA192699. (Same reporter).  This case involves a 12 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) via intramuscular route in unknown administration site, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: patients who have received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2019SA193105, 2019SA193107, 2019SA193106, 2019SA193110, 2019SA193111, 2019SA193109, 2019SA193113, 2019SA192698, 2019SA192699 and 2019SA192700 (Same reporter).  This case involves a 2 months old male patient who received a dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date: 04-Apr-2020 via unknown route in unknown administration site) on an unknown date (visit date: 28-Jun-2019), which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.