chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Pain
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from Other health care professional (Medical assistant). This case involves a 61 years old male patient who experienced left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store, he does need help lifting up his arm to place on steering wheel, left upper arm weakness and sore left deltoid region where ADACEL was given, while he received vaccine ADACEL. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 09-Aug-2018, the patient received a 0.5ml dose of suspect ADACEL lot U5979AA, expiry date 13 Jun 2020 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store (pain in extremity) with unknown latency following the administration of ADACEL. On an unknown date, the patient developed a non-serious he does need help lifting up his arm to place on steering wheel (injected limb mobility decreased) with unknown latency following the administration of ADACEL. On an unknown date, the patient developed a non-serious left upper arm weakness (muscular weakness) with unknown latency following the administration of ADACEL. On an unknown date, the patient developed a non-serious sore left deltoid region where ADACEL was given (vaccination site pain) with unknown latency following the administration of ADACEL. He does need help lifting up his arm to place on steering wheel and has weakness and pain. It does not hurt with internal rotation. He has no loss of strength or feeling in his hand. There is no marking at the injection site and no fever. He was doing pretty good the other day he was in and he still requires the other arm to lift the affected arm onto the steering wheel. Lab data was not provided. Final diagnosis was sore left deltoid region where ADACEL was given, left upper arm weakness, he does need help lifting up his arm to place on steering wheel and left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered/Not Resolved on an unknown date for sore left deltoid region where ADACEL was given, as Not Recovered/Not Resolved on an unknown date for he does need help lifting up his arm to place on steering wheel, as Not Recovered/Not Resolved on an unknown date for left upper arm weakness and as Not Recovered / Not Resolved on an unknown date for left upper pain, feels like a tear, has pain with forward flexion of the arm, with adduction, still store. List of documents held by sender- none.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 42 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number: UI9758AC and expiry date: 30-Jun-2019) (dose, dose in series, route and site of administration were not reported) on 04Sep2018 instead of a dose of Shingles vaccine. Patent was already vaccinated with FLUZONE HIGH DOSE in August. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to Wrong vaccine administered. It was unknown if any adverse event was occurred or not following the vaccination. 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 the sender: None.
Sex: U
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA252194, 2018SA252181 and 2018SA252204 (same reporter). This case involves patient (age and gender not provided), who was given expired vaccine PENTACEL (lot number: C5384AA and expiry date: 30-JUN-2018) (dose, dose in series and route of administration were not reported) in the left leg on 13-Jul-2018. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (Lot number, dose, route and site of administration not provided) on an unknown date. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Product preparation issue, Wrong technique in product usage process
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 month old female patient who received vaccine PENTACEL as two injections. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medication includes FLUZONE QUADRIVALENT, PREVNAR 13, and ROTATEQ Oral vaccine (Lot number, expiry date, dose, route not provided) on an unknown date. On 05-Sep-2018, the patient received 0.5 ml Dtap-IPV, 0.7 ml diluent + Hib dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5409AA and lot C5552AA via intramuscular route in the left thigh. It was an actual medication error due to inappropriate reconstitution technique and wrong injection technique. It was reported that patient was given PENTACEL vaccine as 2 injections. Hib component diluted with sterile water and given separate from DTaP-IPV component. 0.5 ml Dtap-IPV, 0.7 ml diluent + Hib was given 1 inch apart. The patient did not experience any reported symptoms or need for treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: DTAPIPVHIB, FLU4, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from physician on 05-Sep-2018. This case involves a 6 months old male patient who was vaccinated with a first 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (Batch number, expiration date : UI182AB, 30-Jun-2018 site of administration: thigh, route was not reported) on 01-Sep-2018. The patients concomitant medications included was PENTACEL and PREVNAR 13. The patients medical history were not reported. It was a case of actual medication error due to expired vaccine used (vial that was injected turned out to be expired). It was unknown whether patient experienced any adverse event following vaccination but it was also reported that medical assistant informed him that there would not be an adverse effect in the child. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 2 months old female patient who experienced expired PENTACEL vaccination was given, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; HEPATITIS B VACCINE for Immunisation; and ROTATEQ for Immunisation on an unknown date (Batch number, expiry date, dose, dose in series, route and site of administration were not reported). On 04-Sep-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: C5418AA, Diluent: C5230AA and expiry date: 02-Sep-2018) via intramuscular route in the left thigh. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: DTAP, HEPA, IPV, PNC13, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a three years old patient (gender was not reported) who received IPOL two months before his fourth birthday. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included - HEPATITIS A VACCINE and PREVNAR, VARICELLA VACC. and DAPTACEL. On 08-May-2017, the patient received a fourth dose of 0.5 ml suspect IPOL (lot number: 975970, expiry date: 23-JUN-2019) via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was unknown if 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.
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA255269 (same reporter). This case involves an 18 months old female patient who received a 0.25 mL first dose of FLUZONE QUADRIVALENT (lot number, expiry date, route and site of administration were not reported) on 30-aug-2018 and second dose (lot UT6259JA, expiry date: 30-Jun-2019, via intramuscular route in the left thigh) on 06-sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Age: 42.0
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA255147 and 2018SA254040 (same reporter). This case involves a 42 years old patient (gender not reported) who received a 0.5 mL expired dose of FLUZONE QUADRIVALENT, lot UI826AC via intramuscular route in the left deltoid on 06-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: FLU4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA254717 (same reporter). This case involves an 18 months old female patient who received a 0.25 mL first dose of FLUZONE QUADRIVALENT (lot number, expiry date, route and site of administration were not reported) on 30-Aug-2018 and second dose (lot UT6259JA, expiry date: 30-Jun-2019, via intramuscular route in the left thigh) on 06-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Pain, Pollakiuria, Pyrexia
Clinical narrative: Fever chills Aches started at 10pm on 9-10-2018. Lasted the night and started to improve the next morning. Patient missed one day of work. Patient also complained of frequent urination on the morning of 9-12-18. And feels that it may be related, but was not sure. Patient reports that all symptoms have resolved by 9-13-18.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Hypersensitivity, Rash, Rash pruritic
Clinical narrative: 2 days after vaccine administration and she developed a painful pruritic rash on the right upper back and since then she has continued to develop similar rashes on different parts of her body lasting for up to 2 weeks.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Intensive care, Sneezing, Swelling face
Clinical narrative: After waiting 15 minutes patient started sneezing he looked good we let him leave. Mom called us back face started swelling up she gave him oral BENADRYL. He returned to clinic around 2:30 we gave him BENADRYL IM. He was admitted into the hospital for 23 hour observation in the ICU department.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Impetigo, Vaccination site reaction
Clinical narrative: Impetigo surrounding inferior and superior border of vaccination site. 10-day course of Cephalexin 500mg twice per day.
Age: 49.0
Sex: M
Vaccine: ANTH, JEV1
Symptoms: Discomfort, Erythema, Pain
Clinical narrative: The Patient is a 50 year old male. He reported: Encounter Background information: - Patient, industrial Hygienist, contacted the Immunization Healthcare Branch with concerns about anthrax vaccine. He is due for annual booster this month. Patient reports receipt of many anthrax vaccine doses in the past. Record documents receipt on: 08 Apr 2008, 28 Apr 2008, 16 Sep 2008, 24 Feb 2016, 31 Aug 2016, and 12 Sep 2017, Patient also recalls receipt of anthrax vaccine prior to employment in 2001-2002 while working for lab at Health Dep; he received 1 or 2 doses in this era. Ow deltoid region, but not to elbow. Redness and pain also noted, and he missed one day of work due to discomfort. He self-treated with MOTRIN and did not seek medical care. Symptoms resolved in 5-6 days. No problems noted with any other vaccines, including JE-VC received in right arm on same day as last anthrax vaccine. NKDA or other allergies. Takes MOTRIN regularly for joint pains and ortho challenges; no other OTC or Rx meds. He is concerned about maintaining protection against anthrax but wants to avoid repeat local reaction. He expresses no general vaccine hesitancy concerns.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain in extremity
Clinical narrative: Very sore arm with red spots.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Mother states symptoms started about 1:45 pm after returning home after receiving the vaccine. Child began to cry excessively and was inconsolable until 5:00pm. No fever was noticed just major crying. She states that "none of her other children acted this way after shots." She did not give the child TYLENOL for this just lathered him down in lavender oil according to mother's statement. Child finally stopped crying around 5:00pm and has been acting fine since this. Child is playing today 9/13/18 and acts his normal self-according to the mother.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Pt reported a red bump at the injection site and some swelling in the arm extending down to the elbow.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm very swollen and red. Patient sent to MD. Outcome to be decided.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Diarrhoea, Imaging procedure, Laboratory test, Nausea, Systemic inflammatory response syndrome
Clinical narrative: Patient received Influenza (High Dose) 3 valent vaccine and Pneumo Conj 13-V (2010 and after) and was then hospitalized "Nausea, Vomiting, Diarrhea with SIRS - Possible Acute Reaction to Vaccines".
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Vomiting
Clinical narrative: Patient received Influenza (High Dose) 3 valent vaccine and Pneumo Conj 13-V (2010 and after) and was then hospitalized "Nausea, Vomiting, Diarrhea with SIRS - Possible Acute Reaction to Vaccines".
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Hypoaesthesia, Paraesthesia oral, Sensation of foreign body, Slow speech
Clinical narrative: Approx 30-45 after immunization c/o left arm numbness, SOB, tingling around mouth, pt states difficulty in speech , states it is hard to talk, states " it feels like there is oatmeal in my mouth), denies numbness or tingling to throat. Speech is slow but clear.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: Approx 30-45 after immunization c/o left arm numbness, SOB, tingling around mouth, pt states difficulty in speech , states it is hard to talk, states " it feels like there is oatmeal in my mouth), denies numbness or tingling to throat. Speech is slow but clear.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Headache, Malaise
Clinical narrative: Beginning approximately 11 hours post injection, headache (mild). Headache persisted throughout the day and then approximately 22 hours post injection, general feeling of malaise, feeling cold, feeling like I was running a fever (temporal thermometer read 98.8 degrees) and basically feeling ill began and has persisted since that time. Took naproxyn OTC, Benadryl, and nasal spray listed in meds earlier and went to bed.
Age: 65.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Cellulitis, Injection site reaction, Rash, Rash erythematous, Skin warm
Clinical narrative: Red rash surrounding injection site and up/ down the left arm from the PNEUMOVAX 23 vaccine.  Rash was warm to touch and painful. Patient reported to Urgent Care center for evaluation and was prescribed oral prednisone and doxycycline as a precaution for cellulitis.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: Patient states she can not move arm.
Sex: F
Vaccine: HPVX
Symptoms: Skin striae, Varicose vein
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a 13-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL lot# L038917 (exact dose, route and site of administration and expiration date were not reported) for prophylaxis. Reporter reported GARDASIL with lot # L038917 which was not valid for GARDASIL. However, lot #L038917 was valid for GARDASIL 9. On an unknown date, the patient was vaccinated with a second dose of GARDASIL lot# L040164, expiration date: 20-FEB-2018 (exact dose, route and site of administration were not reported) for prophylaxis. Reporter reported GARDASIL with lot # L040164 which was not valid for GARDASIL. However, lot #L040164 was valid for GARDASIL 9. On an unknown date, the patient was vaccinated with a third dose of GARDASIL lot# M011840 (exact dose, route and site of administration and expiration date were not reported) for prophylaxis.  On 13-JUN-2018 (reported as after receiving GARDASIL, the patient "received stretch marks and varicose veins". The patient sought unspecified medical attention. There was no treatment given for the events. The outcome of stretch marks and varicose veins was reported as not recovered. The outcome of product lot number issue was unknown. The relatedness between GARDASIL and the events was not provided.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months of 2018. The patient was 1 year old male. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1809USA004058:US-009507513-1809USA004059: US-009507513-1809USA004060: US-009507513-1809USA004057: US-009507513-1809USA004061: US-009507513-1809USA004055: US-009507513-1809USA004055.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from the patient's husband, referring to a 76 year old female patient. The patient did not have any historical drugs, medical history, drug reactions/allergies or concurrent conditions. The patient's concomitant therapies included statins. On an unknown date in August 2006, the patient was vaccinated with PNEUMOVAX 23 dose reported as multiple revaccinations, injection in the right arm, for avoid pneumococcal disease (strength, frequency, lot # and expiration date were not reported). On August 2011, the patient was revaccinated with PNEUMOVAX 23 dose reported as multiple revaccinations, injection in the right arm, for avoid pneumococcal disease (strength, frequency, lot# and expiration date were not reported). On an unknown date in 2015, the patient was vaccinated with PREVENAR 13 (strength, dose, route, frequency, lot# and expiration date were not reported). On 28-AUG-2018 (reported as "yesterday"), the patient was revaccinated with PNEUMOVAX 23 dose reported as multiple revaccinations, injection in the right arm, for avoid pneumococcal disease (strength, frequency, lot# and expiration date were not reported) and on the same date, the patient experienced injection-site pain that grew worse during the day in her right arm where she received PNEUMOVAX 23 revaccination. The patient sought medical attention with the nurse and received TYLENOL as treatment for the pain. The patient continued with pain in the injection-site arm but the pain was fading. The reporter said the patient did not have pain this bad after receiving the prior PNEUMOVAX 23 vaccinations. The reporter confirmed that the patient never had pneumonia since received the vaccinations and had not been hospitalized. At the time of reporting, the outcome of injection site pain was reported as recovering. Additionally, the causality assessment between injection site pain with PNEUMOVAX 23 and PREVENAR 13 was not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated intramuscularly rather than subcutaneously with M-M-R II albumin status: recombinant human albumin (rHA), lot # N024698, expiration date: 08-SEP-2019 (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, referring to her son, a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history. On an unknown date, the patient was vaccinated with a dose of PROQUAD that had been stored in the refrigerator for an unspecified amount of time (reported as "at least a week"), for prophylaxis via intramuscular route (dosage, lot number and expiration date were not reported). There was no adverse effect reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. It was reported that on 06-SEP-2018, the patient was vaccinated with an expired dose of VAQTA (dosage, route, and anatomical location were not provided) lot # N019924, expiration date on 02-SEP-2018, for prophylaxis. No adverse effect was reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates the unspecified patients received doses of improperly stored PROQUAD (rHA) (strength, dose, frequency, route were not reported, lot # N031929, expiry date 12-MAY-2019) for prophylaxis. Concomitant therapy included sterile diluent (lot # and expiry date were unknown). Sterile diluent used to reconstitute PROQUAD was stored properly. The temperature and time frame were unknown. There were no previous excursions reported. The call was because of a data logger. No adverse effects were reported. Follow up information was received on 05-SEP-2018 from the nurse and later from the physician. The reporters stated that three female children and five male children between the ages of 1 year and 4 years received doses of PROQUAD on an unspecified date in the past 3 months (in approximately 2018). The patient was 4 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. There had been no adverse events following the administration of the improperly stored PROQUAD vaccinations. This was just temperature issue where temperature reached -12 Celsius degree. Sender's Comments: US-009507513-1809USA004056: US-009507513-1809USA004057: US-009507513-1809USA004058: US-009507513-1809USA004058: US-009507513-1809USA004060: US-009507513-1809USA004061: US-009507513-1808USA010810.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 20-FEB-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician at a family practice for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-JAN-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at an Urgent Care for the onset of a vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: This initial 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 concomitant medications, concurrent conditions or medical history. On or about 26-OCT-2012, the patient was inoculated with ZOSTAVAX by a certified medical assistant at a primary care office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 27-SEP-2013, the patient was treated at the same primary care office for a vesicular outbreak which was diagnosed as herpes zoster. On or about 27-APR-2015, she sought subsequent treatment at the primary care office for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed prednisone for management of her painful symptoms and chronic pain. On or about 12-OCT-2016, she sought additional treatment at the primary care for a vesicular outbreak which was diagnosed as herpes zoster. She was prescribed VALTREX for management of her painful symptoms and chronic pain. On or about 28-JUL-2017, the patient sought further treatment from the primary care for a vesicular outbreak that was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial 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 concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial 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 concomitant medications, concurrent conditions or medical history. In 2008, the patient was inoculated with ZOSTAVAX at a family practice as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended. On or about 12-JUL-2016, the patient was treated by a physician at the same family practice for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2011 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles by a physician assistant. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 20-MAR-2012 the patient was treated at a health center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, 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, pain, suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Malaise, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender started to receive TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stiff neck and felt ill on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: FLU3, RAB
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient has itchy red rash around injection site and mild pain. Patient has been counseled to take BENADRYL, TYLENOL and use a cold compress.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Rash
Clinical narrative: Mother of child states child had a rash on her neck, chest, back, arms and legs when she was picked up from daycare yesterday around 4 pm. Child was taken to family Dr on 9/13/18. Dr seen child with no further treatment. As of 9/13/18 rash is unchanged.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle
Clinical narrative: A boil (wart type) erupted on one of my toes.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neck pain, Pain in extremity, Swelling
Clinical narrative: Big 4" swelling next morning. The 2nd day in the morning much worse, by evening expanded, whole arm and neck sore. reaction site about 10 X 4". I have pictures if I can upload.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: Big 4" swelling next morning. The 2nd day in the morning much worse, by evening expanded, whole arm and neck sore. reaction site about 10 X 4". I have pictures if I can upload.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: Patient experienced swollen red arm and flu like symptoms that began after receiving vaccine and lasted approximately 3 days. She did not seek medical treatment and recovered without the use of medication.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Erythema and swelling of arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. showed me her arm. There was a 2.5 inch in diameter swollen red site upon injection that had prgressivly gotten worse over night.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: The vaccine started to burn right after injection. Fatigue set in later that afternoon, and my arm hurt. This morning, I have muscle aches, fatigue (although I got a good night's sleep), and a headache, and the injection site is swollen, red, and painful.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: The vaccine started to burn right after injection. Fatigue set in later that afternoon, and my arm hurt. This morning, I have muscle aches, fatigue (although I got a good night's sleep), and a headache, and the injection site is swollen, red, and painful.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Dizzy, both legs felt heavy and not able to ambulate well, fever, right arm injection site was red, warm, swollen. The size of the reaction site was 6mm in length and 4.5 mm in width. The patient came back to the clinic on 9/13/2018 to complain about the symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pyrexia
Clinical narrative: Dizzy, both legs felt heavy and not able to ambulate well, fever, right arm injection site was red, warm, swollen. The size of the reaction site was 6mm in length and 4.5 mm in width. The patient came back to the clinic on 9/13/2018 to complain about the symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a doctor's office for the onset of a vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a family care center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 29-DEC-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician at a medical facility for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial 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 concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a severe vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 related. Additional information has been requested.