chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a nurse on 18 May 2018. This case involves a six year old patient (gender was not reported) who was vaccinated with of ADACEL (batch number, expiry date, route and site of administration were not reported) as the fourth dose of ADACEL on an unspecified date. It was a case of actual medication error due as product use in unapproved population, Inappropriate age at vaccine administration and Wrong vaccine administered. No adverse event 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 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. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from a Nurse (LPN) on 21-May-2018. This case involves a patient (age and gender was not reported), who was vaccinated with an expired dose of ADACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to expired vaccine used because one expired dose was given to the patient. No adverse event 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 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. Documents held by sender: none
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 21 May 2018. This is an invalid case as no patient identifiers were reported. This case involves vaccination with an expired dose of MENACTRA on an unspecified date. It is a case of actual medication error as expired vaccine was used. No adverse event 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 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. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial unsolicited report received from office person medical assistant on 22 May 2018. This case involves a child patient (age and gender not reported) who was vaccinated with first dose of ADACEL instead of Dtap (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered. No adverse event 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 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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from an office person medical assistant on 23-May-2018. This case involves a child patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was explained that this was not a valid dose since the child was given ACTHIB mixed with sterile water. No adverse event was not 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 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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a Nurse on 23-May-2018. This case involves a four-month-old patient (gender not reported) who was vaccinated with a DTAP/IPV portion of PENTACEL (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. It was a case of actual medication error due to wrong technique in product usage process. No adverse event 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 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. Documents held by sender: none.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Blister, Erythema, Feeling abnormal, Skin plaque
Clinical narrative: Erythematous plaque within 20 min of injection followed by 2cm Bulla developed 18-20 hrs post injection. No fever or chills. Pt felt bad. No Tx.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Sinusitis
Clinical narrative: Pt reports- She received SHINGRIX yesterday and today she woke up feeling like she has a sinus infection, also has some joint pain, headache, some pain at site.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Pain at injection site, Joint pain. Headache. Fatigue. Dizziness. Fever. Symptoms persisted for 48 hours. Treatment: Extra sleep and ADVIL every 4-6 hours.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at injection site, Joint pain. Headache. Fatigue. Dizziness. Fever. Symptoms persisted for 48 hours. Treatment: Extra sleep and ADVIL every 4-6 hours.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Haemorrhage, Oral herpes
Clinical narrative: At first I thought I was having a "fever blister" on my lip (get them a lot) so I started taking 400 mg twice daily of acyclovir and using ZOVIRAX CREAM, the meds didn't seem to have any effect and the blister got bigger and doesn't seem to be healing yet though I am close to healing as it bleeds quite often. As a side note when I got the original shingles vaccine some years ago I got a large blister (like chicken pox) on the top of one finger.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: Swelling under right armpit, no redness. No treatment at this time.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I developed Shingles 10 days after the shot was administered.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Myalgia
Clinical narrative: Muscle soreness at injection site and surrounding muscles, neck and back.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: A few hours after her PNEUMOVAX booster (received 1 around age 60, she was 67 with this one) her left arm started to swell, get red, and was very painful.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Heart rate increased, Hyperhidrosis, Injection site pain
Clinical narrative: At time of injection, felt it go straight down my arm (toward my elbow). About two hours later, had headache starting from the bottom back right side of my neck up into the back right side of my head.  In the middle of the night (15 hours after injection), I woke up with chills an quick pulse and had both for about 1 hour. I took 2 TYLENOL at that time. On hour later, I woke up with my clothes wet as when a fever breaks. It is now 22 hours after the injection, and I still have the same headache in the same location described above, plus in general feel achy all over.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain
Clinical narrative: At time of injection, felt it go straight down my arm (toward my elbow). About two hours later, had headache starting from the bottom back right side of my neck up into the back right side of my head.  In the middle of the night (15 hours after injection), I woke up with chills an quick pulse and had both for about 1 hour. I took 2 TYLENOL at that time. On hour later, I woke up with my clothes wet as when a fever breaks. It is now 22 hours after the injection, and I still have the same headache in the same location described above, plus in general feel achy all over.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Influenza like illness
Clinical narrative: Side Effects from 2nd dose of GSK SHINGRIX vac: temp. 100.4. No appetite. Cold chills + total body aches + Flu-like. Very sore arm. Very tired / on my back for 24 hrs. Flu-like. Night sweats on night 1 and 2. While these Side Effects are discussed as "possible" on GSK's SHINGRIX literature,  please note: (a)  I did not experience these effects from dose #1  after which I had sore arm + some body ache and tiredness (b) My general health & fitness is excellent (e.g. bike, walk, run daily).
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats, Pain, Pain in extremity
Clinical narrative: Side Effects from 2nd dose of GSK SHINGRIX vac: temp. 100.4. No appetite. Cold chills + total body aches + Flu-like. Very sore arm. Very tired / on my back for 24 hrs. Flu-like. Night sweats on night 1 and 2. While these Side Effects are discussed as "possible" on GSK's SHINGRIX literature,  please note: (a)  I did not experience these effects from dose #1  after which I had sore arm + some body ache and tiredness (b) My general health & fitness is excellent (e.g. bike, walk, run daily).
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Headache, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 22-OCT-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient began to experience shooting pains around her temple, and a feeling of itchiness and discomfort throughout her body. In response to these complaints, on 27-OCT-2016, the patient presented to a physician and was diagnosed as suffering from shingles. Thereafter, on 18-NOV-2016, she returned to physician for a follow up appointment and was diagnosed as suffering from post-herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 22-OCT-2016, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient began to experience shooting pains around her temple, and a feeling of itchiness and discomfort throughout her body. In response to these complaints, on 27-OCT-2016, the patient presented to a physician and was diagnosed as suffering from shingles. Thereafter, on 18-NOV-2016, she returned to physician for a follow up appointment and was diagnosed as suffering from post-herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial unsolicited report received from a nurse on 22-May-2018. This case involves an 11-year-old patient (gender not reported) who was vaccinated with first and second 0.5 ml dose of MENACTRA (batch number: U4817AA, expiry date: 30-Jun-2019, dose, dose in series, route and site of administration were not reported) via intramuscular route on an unknown dates. It was a case of actual medication error due to inappropriate age at vaccine administration. Patient was given the second dose of MENACTRA injection at 11 years old and 6 Months. Frequency: 1st dose was given at 11 yrs and 2 months of age second dose 11 yrs and 6 months. Route was IM via the left deltoid. It was unknown whether adverse event occurred or not. 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. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from a nurse on 22-May-2018. This case involves a patient (age and gender not reported) who was vaccinated with an expired vaccine of MENACTRA (batch number, expiry date: 12-MAR-2018, dose, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medication not reported. It was a case of actual medication error due to Expired vaccine used. It was unknown whether adverse event occurred or not. 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. Documents held by sender: none.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial unsolicited report received from a nurse on 21 May 2018. This was an invalid case as no patient identifiers were reported. This case involves two dose of IPOL (batch number, expiry date, route and site of administration were not reported) vaccinated on an unspecified date. It was a actual medication error due to incorrect product storage, as two doses of product were inadvertently given after excursion. No adverse event 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 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse on 23 May 2018. This case involve a child (age and gender not reported) who received only Dtap/IPV portion of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of Inappropriate reconstitution technique. No adverse event 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 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. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse on 23 May 2018. This case involve a child (age and gender not reported) who received only Dtap/IPV portion without first reconstituting the ACTHIB component of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a actual medication error due to inappropriate reconstitution technique. No adverse event 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 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. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from a nurse on 24 May 2018. This case involves an adult patient (age and gender not reported) who was vaccinated with expired dose of ADACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date (reported as one month ago). It was a case of actual medication error as expired vaccine used. No adverse event 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 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. Documents held by sender: none.
Age: 10.0
Sex: F
Vaccine: MENB
Symptoms: Feeling hot, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a physician via regulatory authority and described the occurrence of injection site oedema in a 10-year-old female patient who received BEXSERO (batch number 16E221, expiry date unknown). Additional patient notes included Medical history: insignificant. On 10th November 2017, the patient received BEXSERO (intramuscular) .5 ml. On 10th November 2017, less than a day after receiving BEXSERO, the patient experienced injection site oedema (serious criteria other: serious as per reporter), injection site pain (serious criteria other: serious as per reporter), extremities hot feeling of (serious criteria other: serious as per reporter) and subfebrile. On 13th November 2017, the outcome of the subfebrile was recovered/resolved. On 18th November 2017, the outcome of the injection site oedema, injection site pain and extremities hot feeling of were recovered/resolved. It was unknown if the reporter considered the injection site oedema, injection site pain, extremities hot feeling of and subfebrile to be related to BEXSERO. Initial information was received from a physician via regulatory authority on 30th May 2018: Subfebrile, vaccination site oedema, site of vaccination painful, hot feeling of upper extremity.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Redness and swelling at injection site. Fever, total body aches.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: RN administered DTaP instead of TDaP. INFANRIX should be given 6 weeks through 6 years. Child was 8 years old.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: SHINGRIX given to a 47 yr old male at office visit. No treatment needed. No adverse effect thus far.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Vertigo
Clinical narrative: Pt. had vertigo for 3 days, had to stay in bed. Extremely inflamed at injection site, area size of her hand.
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination, Injected limb mobility decreased
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injected limb mobility decreased in a female patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced injected limb mobility decreased (serious criteria disability) and incomplete course of vaccination. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. The reporter considered the injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported, however, it could 16 or 17 years old. The patient received unknown concomitant medication. The patient received BEXSERO on an unknown arm, 1 year before the date of reporting. The patient could not move her arm for 1 week after the 1st dose of BEXSERO, so she refused to receive the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of BEXSERO, which led to incomplete course of vaccination.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: Patient presented on 6/4/2018 with symptoms of rash, swelling, pain and heat in the left arm. She said her arm hurt all the way down and when she raised it. I told her to put ice on it and take Benadryl by mouth or apply topically and to call her doctor first thing in the morning. She stated the reaction started a couple days ago.
Age: 77.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Soreness and stiffness at the site of each injection. Applying wet heat and taking two ibuprofen tablets helped reduce the stiffness and soreness over the next several hours. Both symptoms lessened overnight and became more localized by the next morning. No other adverse effects to report.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Flushing, Urticaria
Clinical narrative: Parent called the office 2 days later, states that sx started same day between the hours of 5pm -7pm. Face flushed and then later hives. Used BENADRYL with relief. Sx reoccurring on face. Today states hives on face, neck, chest and both arms. BENADRYL still helps sx.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache, tired, sore arm.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Catheterisation cardiac normal, Chest pain, Choking sensation, Hyperhidrosis, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 67-year-old male patient who received SHINGRIX. Concurrent medical conditions included aortic aneurysm repair (in 2014), coronary stent placement (in 2012 and 2014) and shoulder replacement (on 19th November 2016). Concomitant products included ADVAIR, Aspirin, PLAVIX, Magnesium, Probiotic, Calcium, TENORMIN, SINGULAIR, COMBIVENT, fish oil, isosorbide and SOLU-MEDROL. On 21st May 2018, the patient received the 2nd dose of SHINGRIX. On 23rd May 2018, 2 days after receiving SHINGRIX, the patient experienced chest pain (serious criteria hospitalization), choking sensation (serious criteria hospitalization), nausea (serious criteria hospitalization) and diaphoresis (serious criteria hospitalization). The patient was treated with Nitroglycerin and oxycodone. On 24th May 2018, the outcome of the chest pain, choking sensation, nausea and diaphoresis were recovered/resolved. The reporter considered the chest pain, choking sensation, nausea and diaphoresis to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of the patient who was a Catheterization Technician. On Wednesday, in the morning, the patient experienced severe chest pain on the left side, diaphoresis, nausea, and choking sensation. The patient took up to 6 nitroglycerin tablets that did not resolve the pain and then went to the Emergency room at around 10 am that morning. The patient was then admitted to hospital for possible myocardial infarction and was given oxycodone for the pain. On 24th May 2018, the patient underwent cardiac Catheterization on which ruled out myocardial infarction and patient was discharged on the same day in the evening. The reporter was unable to provide full demographics for hospital where the patient received SHINGRIX or for the prescriber.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: On May 25, 2018 while at Dialysis getting my treatment, I started with chills, vomiting, and fever of 101.3. Chills vomiting lasted until after treatment was over and fever lasted until about 6:00pm (started 7:30 AM).
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: One and 1/2 days after vaccination (L) arm red and swollen from shoulder to elbow, no pain, able to move freely, itchy. Doctor notified. Mom brought child to health dept. to report reaction, child took MOTRIN and BENADRYL. Redness and swelling greatly reduced 5 days after vaccination. Child afebrile entire course of episode.
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a 40 year old female patient. The patient had no drug reactions or allergies. No information about the patient's pertinent medical history and concomitant medications was provided. On an unknown date, the patient became pregnant with the unknown last menstrual period (LMP), estimated date of delivery (EDD) and gestation period. On 24-APR-2018, the patient was inadvertently vaccinated with unspecified dose of GARDASIL 9 intramuscularly, lot # N026812, expiration date 22-JUN-2020 (exact dose was not reported) instead of DTaP, while being pregnant. No adverse effects were noted. No information about trimester of exposure and prenatal tests or results was provided. No treatment was given for the events and no laboratory diagnostics or studies were performed. The events did not cause any significant disability or incapacity. The patient was not hospitalized and the events were not life threatening. At the time of the report, the outcome of pregnancy and fetal outcome were unknown.
Age: 1.5
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from an administrator referring to a 18 month old patient (no gender reported). No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 22-FEB-2018, the patient was vaccinated with a dose of PROQUAD, lot# N022954, expiration date 19-FEB-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The reporter stated that on 29-MAY-2018, the patient received another dose of PROQUAD lot # N034561, expiration date 03-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Other suspect therapies included sterile diluent (MRK) (dose, frequency, route of administration, lot# and expiration date were not provided) for prophylaxis. No adverse events were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Gait disturbance, Gait inability, Herpes zoster, Pain
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-JUL-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient began to experience pain, loss of strength in his left leg, and difficulty walking. There after the patient lost the ability to walk. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Lost the ability to walk was considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Scar
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient began to experience post herpetic nerve pain. Thereafter, the patient was diagnosed with a shingles outbreak on both of his legs and on his back, which lead to significant scarring. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician, reported for himself, via Pfizer sales representative. A male patient of unspecified age and ethnicity received PREVNAR 13 at single dose on unknown date for immunization. Relevant medical history and concomitant medications were not reported. On unknown date the patient developed cellulitis. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, such as lack of medical history, concomitant medications, concurrent illness and especially event details description including the location of cellulitis and the time lag between the onset of the event and vaccination date of PREVENAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Fatigue, Infectious mononucleosis, Lymph node pain, Mononucleosis heterophile test negative, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's father). A 17-year-old female patient received TRUMENBA lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization and an unspecified vaccine with unspecified route of administration, therapy dates, drug posology and indication. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine and been experiencing body aches, low grade fever, fatigue, soreness around lymph nodes and had symptoms of mononucleosis virus since unspecified dates. It was mentioned that her doctor thought it was mono and the test was performed on an unspecified date and came back negative. The patient was going back to be tested again because the doctor said it could take some time for the mono test to be positive. It was stated that patient also received other vaccines on the same day and was trying to get an understanding of what the drug companies know about their vaccines. Outcome of the adverse events was unknown. Information on batch number has been requested.
Age: 17.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's father). A 17-year-old female patient received TRUMENBA lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for immunization and an unspecified vaccine with unspecified route of administration, therapy dates, drug posology and indication. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine and been experiencing body aches, low grade fever, fatigue, soreness around lymph nodes and had symptoms of mononucleosis virus since unspecified dates. It was mentioned that her doctor thought it was mono and the test was performed on an unspecified date and came back negative. The patient was going back to be tested again because the doctor said it could take some time for the mono test to be positive. It was stated that patient also received other vaccines on the same day and was trying to get an understanding of what the drug companies know about their vaccines. Outcome of the adverse events was unknown. Information on batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician (parent) via a Pfizer sales representative. A female patient of unknown age received on an unknown date (15 years before this report) a single dose of PREVNAR 13 for immunization. Medical history was none. Concomitant medications were not reported. The patient at the time received the shot and had a severe reaction including proximal and purple swirly discoloration at the injection site and was red and swollen up. Outcome was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Headache, sweating, 12 red itchy spots on left leg and foot, 8 red itchy spots on right leg and foot, 4 itchy red spots on left forearm, 6 itchy red spots on right arm and shoulder. The spots looked similar to flea bites in size about the size of a notebook hole. Treated with BACTINE Spray and Calamine lotion. The left injection site arm was extremely sore for three days. Sleeping was difficult with the sore arm but extreme tiredness was experienced and slept for 10 hours straight the day after having the shot. Some residual very small scabs remain from the original spots after three days everything seems to be back to normal.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Scab
Clinical narrative: Headache, sweating, 12 red itchy spots on left leg and foot, 8 red itchy spots on right leg and foot, 4 itchy red spots on left forearm, 6 itchy red spots on right arm and shoulder. The spots looked similar to flea bites in size about the size of a notebook hole. Treated with BACTINE Spray and Calamine lotion. The left injection site arm was extremely sore for three days. Sleeping was difficult with the sore arm but extreme tiredness was experienced and slept for 10 hours straight the day after having the shot. Some residual very small scabs remain from the original spots after three days everything seems to be back to normal.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Pt reported later that day feeling fever, chills joint pain, headache, nausea and fatigue. Pt called md and was advised to take benadryl and ibuprofen. she feels better today (2 days later) but not completely.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt reported later that day feeling fever, chills joint pain, headache, nausea and fatigue. Pt called md and was advised to take benadryl and ibuprofen. she feels better today (2 days later) but not completely.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness around injection sites. No itchiness. Hurts upon palpitation.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine given to patient- Parent notified that patient will need a additional dose due to the expired vaccine not being a valid dose.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Client noted to have redness, minimal swelling, warmth to touch, and mild discomfort to injection site. Area noted to be oval in shape, redness the size of an egg surrounding injection site.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose Hep A given to pediatric patient.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1 day after injection pt. developed redness, pain, and swelling at injection site. Went to Dr. got an antibiotic still has some pain at site.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Decreased appetite, Fatigue, Hypersomnia, Malaise
Clinical narrative: 2nd dose of SHINGRIX given 5/21/18. On 5/24/18, pt reports loss of appetite, extreme tiredness (slept all day next day), fever approximately 100.5 F. Follow up w/pt 5/25/18, pt is still sick w/fever approximately 100.5-101 F w/cough and sore throat.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: 2nd dose of SHINGRIX given 5/21/18. On 5/24/18, pt reports loss of appetite, extreme tiredness (slept all day next day), fever approximately 100.5 F. Follow up w/pt 5/25/18, pt is still sick w/fever approximately 100.5-101 F w/cough and sore throat.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site reaction, Local reaction, Pallor
Clinical narrative: (L) upper arm-large area of redness, blanching and irregular in contour, no pain (Local reaction to immun-no treatment given).
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema
Clinical narrative: Redness measured 2" diameter around injection site. No fever, pain or temp. Went away in a couple days. No other symptoms.
Age: 12.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: 2 Min post injections Pt became pale, dizzy, and complained of nausea. No LOC, no vomiting. Alert and oriented x3. Reclined in chair. Cool cloth applied to forehead and neck. Monitored x20 min post reaction. 9:32am BP: 103/66, P:89; 9:44am BP: 107/71, P:89; 9:56am: BP 111/74, P:81 cleared by Dr. to go, color returned and no dizziness.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: No symptoms for first 24 hours, but removed Band Aid from Rt deltoid at 24hrs significant redness and swelling with decreased range of motion. Looks better 6/1/18 am.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema, Eye movement disorder, Screaming
Clinical narrative: Abnormal eye movement: Event occurred approx 2-3 hours after receiving 2 month immunizations. Patient was laying in blanket on couch. Had been asleep and started stirring so MOC went over to him. He opened his eyes and made his typical "asleep cry" and then looked at MOC and eyes went from side to side and then eye rolled back "as if falling asleep"- total of 20 seconds of eye movement including rolling. Description most consistent with horizontal nystagmus. Then "woke up" and started screaming. At that time appeared red. Rectal temp was 98. Changed his diaper, then breastfed- seemed like a normal feed, then put him down to sleep. With eye movement event-no associated color or respiratory change or abnormal body movements. No post-ictal period. Seen in clinic approximately 3 hours after and was afebrile and well appearing on exam.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chest discomfort, Chills, Dysphagia, Fatigue, Headache
Clinical narrative: 1 1/2 - 2 hours after receiving first BEXSERO developed headache, chills, upper body aches and neck pains. Mild soreness at injection site. Then shortly after felt tired and throat felt "funny" with difficulty swallowing. No lip or face swelling but his chest felt a little tight. Similar to a past reaction to Motrin for which he has an epi-pen. He did not take epi-pen but did take Benadryl and Tylenol.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Neck pain, Pain, Throat irritation
Clinical narrative: 1 1/2 - 2 hours after receiving first BEXSERO developed headache, chills, upper body aches and neck pains. Mild soreness at injection site. Then shortly after felt tired and throat felt "funny" with difficulty swallowing. No lip or face swelling but his chest felt a little tight. Similar to a past reaction to Motrin for which he has an epi-pen. He did not take epi-pen but did take Benadryl and Tylenol.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site discomfort, Injection site erythema, Injection site warmth, Malaise
Clinical narrative: Nausea, fatigue, malaise, low grade temperature for one day. Discomfort, redness, heat at injection site for 3 days (continuing today).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, fatigue, malaise, low grade temperature for one day. Discomfort, redness, heat at injection site for 3 days (continuing today).
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient experienced shoulder pain down the arm the same day of vaccination. She has experienced a partially frozen shoulder in the past and the symptoms were similar. Therefore, she self-treated with exercises used for the frozen shoulder but the symptoms did not improve. She did not visit a physician because another resident at the community experienced a similar reaction and treatment through a doctor was not successful.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Dysacusis, Headache, Tinnitus
Clinical narrative: Very bad headache 30 minutes after vaccine. The next morning had hearing issues with ringing in ears and echoing, especially of my young child's voice.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Limb discomfort, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Heavy feeling, throbbing feeling from elbow down. Tingling in left arm. Is totally relieved by laying it down flat. But when getting up it goes to throbbing/heavy feeling pain again.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash all over body with itching started on 06/05/2018 on legs. Mother instructed to give BENADRYL for rash.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood culture negative, Chest X-ray normal, Electroencephalogram normal, Febrile convulsion, Full blood count normal
Clinical narrative: Two generalized, tonic-clonic seizures while febrile on 5/1/2018, several hours apart. He was admitted overnight for observation after the second febrile seizure.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Generalised tonic-clonic seizure, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Laboratory test normal
Clinical narrative: Two generalized, tonic-clonic seizures while febrile on 5/1/2018, several hours apart. He was admitted overnight for observation after the second febrile seizure.