chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. The reporter stated that on 15-JUN-2018, the patient inadvertently received a dose of M-M-R II rHA, lot # N019615, expiration date 09-JUL-2019, subcutaneously concomitant with PROQUAD rHA, lot # R004438 and expiration date 12-AUG-2019, subcutaneously for prophylaxis. The nurse states the patient received the doses separately in each thigh. The possible diluent information for one or both vaccines that were administered was sterile diluent (MERCK) Lot number N027625, expiration date 19-MAY-2019. "There was no report about information on vial". It was also reported that the patient was not experiencing any adverse effects and was doing fine. The patient did not sought medical attention or received any treatment.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (route, dose, and lot # not provided). The vaccine "did" function as intended [considered meant the vaccine did not function as intended] and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Incorrect route of drug administration, No adverse event, Product administered at inappropriate site, Wrong drug administered
Clinical narrative: Initial unsolicited report received from a Nurse on 25-Jun-2018. This case involves a 16-year-old male patient who was treated with 0.5 ml TUBERCULIN TEST [TUBERSOL] (lot number: C5474BA, expiry date: 29-oct-2018) via intramuscular in right deltoid instead of 0.1 ml dose of MENACTRA (Batch number, expiration date, dose and site of administration was not reported) on 25-Jun-2018. The patient's medical history was not reported. The patient's concomitant vaccines included TRUMENBA and MENACTRA injected intramuscularly in the left deltoid. It was an actual medication error due to wrong vaccine administered, vaccine administered at inappropriate site and overdose. No adverse effects had been noted. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Incorrect route of drug administration, Insomnia
Clinical narrative: Based upon follow up report received from a nurse on 27-Jun-2018, this case becomes medically confirmed. Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 22 years old male patient who experienced increased anxiety and received Tdap (caller states that it was manufactured by Sanofi) intravenously on Saturday, Tdap is not to be given IV, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Jun-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6092BA, expiry date - 21-Aug-2020 via IV NOS route in deltoid site. The patient developed a non-serious increased anxiety following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of actual medication error due to Inappropriate route of vaccination. (Other relevant tests included No lab data). Final diagnosis was received Tdap (caller states that it was manufactured by Sanofi) intravenously on Saturday, Tdap is not to be given IV and increased anxiety. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for increased anxiety and as Not Applicable for received Tdap (caller states that it was manufactured by Sanofi) intravenously on Saturday, Tdap is not to be given IV. 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. Follow up report received from a nurse on 27-Jun-2018. On 23-Jun-2018, the patient was also vaccinated with a dose of ADACEL (Lot number, expiry date, dose, dose in series was not reported) via intramuscular route in the deltoid. On an unknown date, the patient had anxiety (for 10-15 minutes after receiving the Tdap) and has had a hard time sleeping. It was reported that the patient didn't exhibit any skin changes at the IV site and IM site where the injection was administered. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Child patient who experienced pentacel vaccine where patient was given the dtap-ipv but not the hib part, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to inappropriate reconstitution technique. (Other relevant tests included No lab data.) Final diagnosis was pentacel vaccine where patient was given the dtap-ipv but not the hib part. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for pentacel vaccine where patient was given the dtap-ipv but not the hib part. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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
Sex: M
Vaccine: RAB
Symptoms: Product label confusion, Syringe issue
Clinical narrative: Initial information received on 28-Jun-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves male (age not reported) patient who had an event reported as nurse was unable to administer IMOVAX Rabies to a male patient because it was leaking. This is actual medication error case due to Product issues. No medical history no concomitant therapies were reported. On 27-Jun-2018, the patient received a 1 ml dose of suspect IMOVAX Rabies lot N1G40, exp date: 31-July-2019, via unknown route in unknown administration site. Pharmacist reported that nurse was unable to administer IMOVAX Rabies to a male patient because it was leaking. Pharmacist states that the nurse probably had never given the IMOVAX before and wasn't sure if it was nursing error or product issue. Pharmacist got the Nurse to explain event details. Nurse reports that I had never given Rabies vaccine, put the needle on, was not sure if it loosened up in process, put sterile water into powder and then tried tightening the needle both needle and then when it was drawn up, it was leaking. The leaking was coming from the syringe at the top. Nurse states that she removed the cap and the piece on the syringe kept turning. After looking at the syringe with the Pharmacist, it was decided to use another IMOVAX. Nurse diluted it with 1cc of sterile water. It was unclear how to take the cap off the syringe because it has two pieces and the bottom one got loose and spun. Caller mentioned that it was difficult to remove the cap off the sterile water initially. Pharmacist/Nurse stated several times that the instructions were not clear on the PI and no administration instructions were included in the box of how to reconstitute the product/attach the needle. This needs to be clear. Pharmacist reports that the patient received the Imovax after they reconstituted/prepared the second syringe. First syringe was unused. But his injection was delayed due to this issue. Caller states that numerous rabies vaccines have been administered at the hospital and they have never seen anything like this before. Date of event: 27Jun2018 Account Number: 70074468 Product Lot: N1G40 Exp: July 2019; Diluent Lot: Exp: was discarded; no Lot/Exp available Carton Lot Lot: N1G402M Exp: July 2019 NDC: 49281-0250-51 How purchased: Wholesaler; Ameris Number of units affected: one Was dose used or not used: not uses Available for return: vial Only. It was not reported if the patient experienced any adverse event. 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. Documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Initial information received on 28-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who experienced burning, burning and MENACTRA vaccine on 20-Jun-2018 in the left arm subcutaneously instead of IM, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Jun-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via subcutaneous route in the left arm. The patient developed a non-serious burning following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient developed a non-serious burning following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was also a case of actual medication error due to inappropriate route of vaccination. (Other relevant tests included No lab data). Final diagnosis was MENACTRA vaccine on 20Jun2018 in the left arm subcutaneously instead of IM, burning and burning. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for burning, as Unknown for burning and as Not Applicable for MENACTRA vaccine on 20Jun2018 in the left arm subcutaneously instead of IM. 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.
Age: 47.0
Sex: U
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 47 years old patient who received 0.5 ml expired dose of vaccine TYPHIM VI (lot M1287-1, expiry date- 01-Jun-2018 via unknown route) in unknown administration site on 29-Jun-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 unknown if 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 holder's 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. Document held by sender: None.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 33 years old female patient who experienced an expired ADACEL injection was given on 19-Jun-2018, while she received vaccine ADACEL. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Jun-2018, the patient received a once 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5271AA, expiry date- 10-Feb-2018 via intramuscular route in unknown administration site. It was a case of actual medication error due to expired vaccine used. Other relevant tests included No lab data. Final diagnosis was an expired ADACEL injection was given on 19-Jun-2018. The patient has had no complaints of any adverse reactions. 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.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old female patient who experienced injection site numbness and injection site tingling, while she received vaccine TYPHIM VI. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Jun-2018, the patient received 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported via intramuscular route in the left arm. The patient developed a non-serious injection site numbness and injection site tingling Unknown latency following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. Other relevant tests included No lab data. Final diagnosis was injection site tingling and injection site numbness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site numbness and for injection site tingling. List of documents held by sender: none.
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a other health professional.(medical assistant). Linked cases: 2018SA182256, 2018SA182252, 2018SA182253, 2018SA182254, 2018SA182255 (same reporter). This case involves female Infant patient who experienced vaccine reached 52.8f, for 43 minutes, while he/she received vaccine IPV (VERO) [IPOL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 04-Jun-2018, the patient received a  dose of suspect IPV (VERO) lot N1K931M, via intramuscular route. It was a case of actual, medication error due to product storage error. Reported that vaccine reached 52.8 F, for 43 minutes and on 04-Jun-2018, product reached 48.2 F for greater than 30 minutes. It was not reported whether adverse event occurred or not. The patient outcome is reported as Not Applicable. This case involves unknown number of patients who were vaccinated with a dose of REVAXIS (Batch number, expiry date, dose, dose in series, route and site of administration were unknown) on unknown dates (reported as one Revaxis vaccine was given on 09-May-2017, three were given on 10-May-2017 and other there were given with no details available).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a two-months-old (reported as two months and nine days old) female patient, who was vaccinated with an expired dose of PENTACEL (Batch number: C5401AA, expiration date: 24-Jun-2018, dose in series and route of administration were not reported) in the thigh on 29-Jun-2018. The patient's past medical history, medical treatment, vaccination and family history were not provided. It was a case of actual medication error due expired vaccine used because the patient was administered an expired dose of PENTACEL. 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: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves 18 years old female patient who received expired 0.5 ml dose of MENACTRA (batch number U5567AA, expiry date 17 June 2017) intramuscularly in left arm on 27 June 2018. Patient had not received any other vaccines. It was actual medication error due to Expired vaccine used as an Expired MENACTRA vaccine was administered to a patient on 27Jun2018. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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 information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient (age and gender not reported) who was vaccinated with an expired dose of MENACTRA (batch number, expiry date, dose, route and site of administration were not reported). 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 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: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling that involved entire upper right arm to elbow.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Rash pruritic
Clinical narrative: PNEUMOVAX had a large redness and swelling where shot given. SHINGRIX was tender but not as much. Then rash on both thighs itchy rash.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site mass
Clinical narrative: Chills, then at 2am she was excessively shivering for hours. Mild HA, upset stomach, tiredness the following day. Shivering in 96 degree water the following day (6/28/18). Brief chills/shivering afterwards. Itching and a lump at the site of administration. All symptoms lasted 4-5 days but much milder after the first day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Chills, then at 2am she was excessively shivering for hours. Mild HA, upset stomach, tiredness the following day. Shivering in 96 degree water the following day (6/28/18). Brief chills/shivering afterwards. Itching and a lump at the site of administration. All symptoms lasted 4-5 days but much milder after the first day.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: He received his ADACEL, HPV and meningococcal conjugate vaccine. Very early on Saturday morning, he was covered in hives. BENADRYL given. By 4 PM, he was so covered in hives that it was on his face, neck, ears, and over 80% of his body. Urgent care told us to use BENADRYL every 4-6 hours. I have been giving him BENADRYL every 4 hours because if it goes to 5 hours, he breaks out in a horrible, itchy rash. We are still giving BENADRYL every 4 hours and it has been 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Patient reported rash that was diagnosed as chicken pox at an office on 7-7-18. Patient is seeing her primary care doctor on 7-9-18 to confirm diagnosis and determine course of treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Inflammation, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient reported rash that was diagnosed as chicken pox at an office on 7-7-18. Patient is seeing her primary care doctor on 7-9-18 to confirm diagnosis and determine course of treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Patient reported rash that was diagnosed as chicken pox at an office on 7-7-18. Patient is seeing her primary care doctor on 7-9-18 to confirm diagnosis and determine course of treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash papular, Varicella
Clinical narrative: Patient reported rash that was diagnosed as chicken pox at an office on 7-7-18. Patient is seeing her primary care doctor on 7-9-18 to confirm diagnosis and determine course of treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: I developed blisters filled with fluid. They were very itchy.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Inflammation, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: I developed blisters filled with fluid. They were very itchy.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: I developed blisters filled with fluid. They were very itchy.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash papular, Varicella
Clinical narrative: I developed blisters filled with fluid. They were very itchy.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 25-JUN-2018, the patient was vaccinated with VAQTA injection, strength 25/0.05 (units not provided), dose 0.5 ml, once, intramuscular, lot# R009822 and expiration date reported as 12-JUN-2019 for prophylaxis. The nurse stated that the patient inadvertently received dose of pediatric VAQTA on that day. No adverse effects being reported. No further information provided.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a currently 25-year-old female patient referring to herself. The patient was allergic to SULFA. She had no pertinent medical history. On 17-NOV-2017, the patient was vaccinated with the first dose and on 17-JAN-2018, with the second dose of GARDASIL 9 0.5 ml suspension for injection, in upper arm with a dosing schedule as 0, 2 and 6 months, for human papillomavirus (HPV) protection (exact dose, lot # and expiration date were not reported). Concomitant therapies included unspecified prenatal vitamins and venlafaxine hydrochloride ER. The patient became pregnant with last menstrual period (LMP) of 11-APR-2018 and estimated delivery date (EDD) of 16-JAN-2019. The LMP and EDD were calculated based on the number of weeks of pregnancy at the time of reporting. The pregnancy outcome was pending. The patient sought medical attention and visited an obstetrician-gynecologist (OB/GYN). There were no lab diagnostic tests performed. There was no treatment given. The patient was scheduled to receive her last injection of GARDASIL 9 on 17-JUL-2018.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date in 2018 (reported as a recent date), while in the hospital the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date in 2018 (reported as "8 days after the first dose" after discharge), the patient was vaccinated with another dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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 medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-DEC-2015, the patient was treated by a Dermatologist for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  She was prescribed valacyclovir for management of her painful symptoms and chronic pain. 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 considered related. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17-year-old female patient receive the first dose of TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for Prevention of Meningitis. The patient's medical history and concomitant medications were not reported. The patient got the shot, the one initial, the first dose of meningococcal group b rlp2086, when the patient got back, on 02Jul2018, the patient had chills, headache, nauseous and body ache. The outcome of the events was unknown. The information on the batch number has been requested.
Age: 0.17
Sex: F
Vaccine: PNC13, RV1
Symptoms: Crying, Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse.  An 8-week-old female patient received PREVNAR 13 (lot number: T78675 and expiration date: 01Mar2020) intramuscular in the left thigh on 05Jul2018 12:10 at 0.5 ml, single for routine vaccination. The patient had no relevant medical history and no known allergies. Family medical history was unknown. The patient had no vaccinations within 4 weeks prior to the administration of  pneumococcal 13-valent conjugate vaccine. Concomitant medication included the first dose of ROTARIX (lot number: HS35D and expiration date: 17Oct2019) oral, also given on 05Jul2018 for immunization. It was reported that they first gave the rotavirus vaccine live oral 1v, orally, and then they gave the pneumococcal vaccine in the left leg. Immediately after the injection on 05Jul2018, the patient experienced swelling and bleeding at injection site and was crying. Severity of the swelling and bleeding at injection site was unknown. They showed the doctorand he said no more injections for now. They called the parents back about 3 hours later and stated that the patient didn't cry for long, and they applied ice to the swelling, and it went down. The patient fell asleep on the way home and had no fevers. The events did not require and emergency room or physician office visit. No other concomitant medications, medical history, or relevant testing or investigations were provided at the time of the report. Outcome of the events was recovered on the same day, 05Jul2018. The reporter wanted to know if there were any recommendations for future vaccinations.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature, Diarrhoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: Came in to have Tdap since new Baby in family given RUA and later in the evening her arm was sore, swollen and she had diarrhea, vomiting and temp. with bad headache. This went on for the whole next day and then the arm started with the above symptoms. Today still red and warm to touch, and painful.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Came in to have Tdap since new Baby in family given RUA and later in the evening her arm was sore, swollen and she had diarrhea, vomiting and temp. with bad headache. This went on for the whole next day and then the arm started with the above symptoms. Today still red and warm to touch, and painful.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Patient became lightheaded after receiving this vaccine. He was revived with ammonia capsule, after it was placed under the nose. He was given water to drink. Vitals were taken BP 120/70, P 68, R 16. Patient stated that he felt fine, no longer dizzy or lightheaded. He was made to sit for about 20 minutes. He refused to lay down and stated he was fine.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Complement factor, Condition aggravated, Double stranded DNA antibody, Headache
Clinical narrative: 12 hours post vaccine, low grade fever, muscle aches, headache, joint aches, malaise for approx 48 hours. Within 5-6 days, moderate/severe flare of Rheumatoid Arthritis, with every joint affected in terms of pain, and several joints with swelling, tendon involvement of swollen Achilles in both feet, severe fatigue and malaise. Increasing dose of prednisone was ineffective in reducing flare, and flare continuously became worse over course of 2 months post vaccine. Patient started Xeljanz June 14 and this has been effective in reducing flare. Lab work showed abnormal levels of anti-ds DNA and low Complement C3c and C4c, indicative of lupus-like reaction. It is possible that adjuvant QS-21 that is used in SHINGRIX vaccine may be contraindicated for persons with autoimmune disease, as QS-21 is a powerful immunostimulant.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Lupus-like syndrome, Malaise, Myalgia, Pyrexia
Clinical narrative: 12 hours post vaccine, low grade fever, muscle aches, headache, joint aches, malaise for approx 48 hours. Within 5-6 days, moderate/severe flare of Rheumatoid Arthritis, with every joint affected in terms of pain, and several joints with swelling, tendon involvement of swollen Achilles in both feet, severe fatigue and malaise. Increasing dose of prednisone was ineffective in reducing flare, and flare continuously became worse over course of 2 months post vaccine. Patient started Xeljanz June 14 and this has been effective in reducing flare. Lab work showed abnormal levels of anti-ds DNA and low Complement C3c and C4c, indicative of lupus-like reaction. It is possible that adjuvant QS-21 that is used in SHINGRIX vaccine may be contraindicated for persons with autoimmune disease, as QS-21 is a powerful immunostimulant.
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 medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2015, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of 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.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Insomnia, Loss of consciousness
Clinical narrative: This case was reported by a nurse via other and described the occurrence of passed out in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 26th June 2018, the patient received SHINGRIX .5 ml. On 26th June 2018, several hours after receiving SHINGRIX, the patient experienced chills, headache and insomnia. On 27th June 2018, the patient experienced passed out (serious criteria GSK medically significant and other: as per reporter), nausea, light headedness, fainting and fever. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the passed out, chills, headache, insomnia, nausea, light headedness, fainting and fever were unknown. The reporter considered the passed out, chills, headache, insomnia, nausea, light headedness, fainting and fever to be probably related to SHINGRIX. Additional details were provided as follows: The vaccine was not discontinued. The patient took product in the morning and that night experienced chills, headache and insomnia. On 27th June 2018, 1 day after vaccination, the patient woke up around 7 am, nauseated and lightheaded, went to throw up and passed out. On the same day the patient visited the nurse's office and was dressed too warmly and had temperature of 102 degree F. The patient had to take more medications to control fever (given Tylenol and Ibuprofen). The patient was also advised to increase fluids and rest. The details of the pharmacy was provided. The other seriousness criteria's (death, hospitalization, disabling, congenital anomaly, and life-threatening) were not associated with the reported events.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Syncope
Clinical narrative: This case was reported by a nurse via other and described the occurrence of passed out in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 26th June 2018, the patient received SHINGRIX .5 ml. On 26th June 2018, several hours after receiving SHINGRIX, the patient experienced chills, headache and insomnia. On 27th June 2018, the patient experienced passed out (serious criteria GSK medically significant and other: as per reporter), nausea, light headedness, fainting and fever. The patient was treated with paracetamol (Tylenol) and ibuprofen. On an unknown date, the outcome of the passed out, chills, headache, insomnia, nausea, light headedness, fainting and fever were unknown. The reporter considered the passed out, chills, headache, insomnia, nausea, light headedness, fainting and fever to be probably related to SHINGRIX. Additional details were provided as follows: The vaccine was not discontinued. The patient took product in the morning and that night experienced chills, headache and insomnia. On 27th June 2018, 1 day after vaccination, the patient woke up around 7 am, nauseated and lightheaded, went to throw up and passed out. On the same day the patient visited the nurse's office and was dressed too warmly and had temperature of 102 degree F. The patient had to take more medications to control fever (given Tylenol and Ibuprofen). The patient was also advised to increase fluids and rest. The details of the pharmacy was provided. The other seriousness criteria's (death, hospitalization, disabling, congenital anomaly, and life-threatening) were not associated with the reported events.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Dizziness, Loss of consciousness, Muscle twitching, Unresponsive to stimuli
Clinical narrative: Patient felt light headed after the vaccine was given. She then became unresponsive in the chair for about 15 seconds. During this time she was twitching. When she came to she was still light headed.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dysstasia, Feeling abnormal, Gait disturbance
Clinical narrative: Patient stated that the morning after receiving the immunization she woke up feeling "like she lost her mind". She felt foggy and disoriented, and needed assistance standing and walking. The next morning she felt fine.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Red and swollen on left arm and pain in left arm. Unable to move it easily the first day. It is improving at this time, able to move her arm easily, but there is still some pain at the site. Did not take any OTC medication.
Age: 0.67
Sex: F
Vaccine: DTAP, RV1
Symptoms: Condition aggravated, Gross motor delay, Hypotonia
Clinical narrative: Hypotonia and delayed gross motor skills. Patient had difficulty meeting infant milestones, such as rolling over, sitting up, crawling, and walking. Average delay was 6 months, as patient started crawling at around 11 months and started walking at 18 months.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient received vaccination on 7/2/18 without any reactions. On 7/5, patient states that small area around site of injection is red. From 7/5-7/9, area got progressively red, warm/hot with mild pain from neck to arm. Patient does not experience any itchiness.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Body temperature, Crying, Irritability, Vaccination complication
Clinical narrative: Mother said severe reaction to the ROTATEQ given to child later in the day. He was crying, pulling up his legs  and abdominal  tightness. Mom said she took him to emergency room where they kept child overnight. He was fussy and ran temp for several days and she said doctor thought it was reaction to this vaccine and requested that child receive no further doses.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Autism spectrum disorder, Developmental delay, Epilepsy, Pyrexia, Respiratory disorder
Clinical narrative: We delayed the vaccines she would normally receive at 4 months to a week before she was 6 months. At this point shortly after the shots she developed a fever. Then March 2nd the day she turned 6 months she went into a grand mal seizure. We have continued the scheduled vaccinations with her pediatricians and now she is diagnosed with intractable epilepsy, autism, severe developmental delay, and a number of respiratory issues.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Seizure
Clinical narrative: We delayed the vaccines she would normally receive at 4 months to a week before she was 6 months. At this point shortly after the shots she developed a fever. Then March 2nd the day she turned 6 months she went into a grand mal seizure. We have continued the scheduled vaccinations with her pediatricians and now she is diagnosed with intractable epilepsy, autism, severe developmental delay, and a number of respiratory issues.
Age: 22.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Musculoskeletal stiffness, Nausea
Clinical narrative: Patient complained of arm soreness bilaterally. Rt side soreness worse than Lt. Patient took Ibuprofen and said it wore off at 10pm 7/3/18. She then states she had feeling of weakness, nausea, increased heart rate and SOB "like a panic attack". She did not seek treatment. She took more ibuprofen and went to bed. She felt better in AM except residual arm pain to Rt side which consists of pain, stiffness and "shooting pains" requiring the use of ibuprofen still on 7/9/18. She then contacted the health dept and was encouraged to contact her primary care physician.
Age: 22.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Pain, Pain in extremity, Panic attack
Clinical narrative: Patient complained of arm soreness bilaterally. Rt side soreness worse than Lt. Patient took Ibuprofen and said it wore off at 10pm 7/3/18. She then states she had feeling of weakness, nausea, increased heart rate and SOB "like a panic attack". She did not seek treatment. She took more ibuprofen and went to bed. She felt better in AM except residual arm pain to Rt side which consists of pain, stiffness and "shooting pains" requiring the use of ibuprofen still on 7/9/18. She then contacted the health dept and was encouraged to contact her primary care physician.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain in extremity, Skin reaction, Skin warm
Clinical narrative: Large red induration about 4 inches across and 6 inches down the arm. Red, painful and hot to the touch. Resolved after 4 to 5 days.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Myalgia
Clinical narrative: Pt with fevers, chills, localized redness, swelling, vomiting, diarrhea, myalgias, arthralgias.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Pt with fevers, chills, localized redness, swelling, vomiting, diarrhea, myalgias, arthralgias.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Somnolence
Clinical narrative: Extreme sleepiness. Awake for 1-2 hours and sleep for 3-5 hours all day long. Slept through night from around 9:30pm-7am. Woke up with horrible headache behind eyes following day. Feeling more normal on third day following vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain of skin
Clinical narrative: Severe shivering, low grade fever and chills. Muscle pain lasting more than twenty four hours (shoulders, back, hips, wrist, neck, thighs). Exhaustion, and headache. Skin tender to touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe shivering, low grade fever and chills. Muscle pain lasting more than twenty four hours (shoulders, back, hips, wrist, neck, thighs). Exhaustion, and headache. Skin tender to touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait inability, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: This was a second dose. With the first dose I experienced a VERY sore arm for a week. With this dose I vigorously exercised the arm. During the night following the vaccination I awoke with a very high fever and quaking chills - so much so that I could not even walk. I had someone bring me 2 TYLENOL which I took. Over the period of about an hour, the symptoms dissipated. The arm was sore for nearly a week and did itch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Muscle aches all over, extreme in shoulders, hips and back. Headache and low grade fever. Nausea. Exhaustion and skin tender to touch. Arm with injection site still quite sore (painful to even raise the arm) muscle aches and tired 48 hrs after vaccine. Much improved after 36 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain of skin, Pyrexia
Clinical narrative: Muscle aches all over, extreme in shoulders, hips and back. Headache and low grade fever. Nausea. Exhaustion and skin tender to touch. Arm with injection site still quite sore (painful to even raise the arm) muscle aches and tired 48 hrs after vaccine. Much improved after 36 hours.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling, pain L lateral thigh today. Dr. dx as inflammatory reaction.