chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPVX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis or with GARDASIL (strength, dosage, frequency, route, lot# and expiration date were not provided). The physician reported that the patient's mother stated that her daughter developed Guillain-Barre syndrome. It was unknown by the reporter if any treatment, laboratory diagnostics, studies or intervention to prevent serious criteria were performed regarding the event. The outcome of Guillain-Barre syndrome was unknown. The reporter did not provide causality assessment  between the events and the suspect therapies. Upon internal review the event was determined to be serious due to medically significant.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a 6 month old patient of unknown gander. The patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant medications were not reported. On an unknown date, the patient received a dose of ROTATEQ orally (lot # and expiration date were not reported) for prophylaxis. Afterwards, from 45 minutes to 1 hour after receiving the vaccine, the patient vomited. By the time of the report, the outcome of the event was unknown. The reporter's causality assessment between vomiting and ROTATEQ was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around January 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. In approximately 2016 [reported as shortly after receiving ZOSTAVAX], the patient suffered from shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the shingles was considered to be not recovered. Shingles was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Shingles after the first shot. The patient asked for how long she could wait to receive the 2nd dose. The patient left the chat, before any more information could be obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient still had sore arm, large reddish blue mark, slightly swollen arm from shingles vaccine, seems like muscle in arm was sore, hard to raise in certain positions. It was being two weeks since vaccine. The patient also had chills, fever, flu like symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient still had sore arm, large reddish blue mark, slightly swollen arm from shingles vaccine, seems like muscle in arm was sore, hard to raise in certain positions. It was being two weeks since vaccine. The patient also had chills, fever, flu like symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction and infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the adverse reaction and infection were recovered/resolved. It was unknown if the reporter considered the adverse reaction and infection to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient got 1st dose of SHINGRIX 3 months before the reporting time. The patient had a reaction that her doctor thought was an infection. The patient took antibiotics and got better. Caller disconnected before the patient could clarify what the reactions were she experienced. This case was 2 of the 2 cases, reported by the same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a patient who received BOOSTRIX (batch number 3YM7S, expiry date unknown) for prophylaxis. On an unknown date, the patient received BOOSTRIX. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reporting that, the patient had a reaction to BOOSTRIX vaccination and they were doing a VAERS report.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received SHINGRIX (batch number 9277N, expiry date unknown) for prophylaxis. On 29th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and experienced arm pain since the day of injection and continues to have this pain. This was especially present when lifting the arm. The batch number of Shingrix was reported as 9Z77N, which was corrected to 9277N as per sales data sheet.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness of arms in a 74-year-old female patient who received SHINGRIX (batch number 9277N, expiry date unknown) for prophylaxis. On 29th January 2019, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced weakness of arms and pain in arm. On an unknown date, the outcome of the weakness of arms and pain in arm were unknown. It was unknown if the reporter considered the weakness of arms and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient continued to have pain in the left arm, might be some weakness, when raising feels pain, pain seemed to be inside (not superficial, deeper in the tissue). The registered pharmacist did not had the expiry date of the vaccine. As per sales data sheet the batch number was changed from 9Z77N to 9277N.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient went on to receive the 2nd dose and reported no problems after 2nd dose. Limited information was available. The healthcare professional did not have lot or expiry.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Product supply issue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and product supply issue. On an unknown date, the outcome of the ophthalmic herpes zoster, shingles and product supply issue were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient developed a mild case of Shingles, which involved minimal eye involvement. The patient had missed second dose of SHINGRIX due to lack of availability.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Eczema infantile, Product storage error, Skin candida
Clinical narrative: This is a spontaneous report from a contactable healthcare professional  (HCP) and from a contactable other-HCP (Medical Assistant) on behalf of another Other-HCP. The other-HCP reported similar events for 7 patients. This report is 5th of 7 patients. A 4-month-old male patient received PREVNAR 13 (Batch/Lot # W11304, Expiry date 31May2020) intramuscularly at the left thigh, on 10Oct2018, 01:09, at 0.5 ml single dose on an unspecified date for immunization at a clinic. The patient had no medical history. Concomitant medications included first doses of diphtheria vaccine toxoid, hepatitis b vaccine, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP HEPB, lot number: H994T), hib vaccine (HIB, lot number: U1916AAA), and polio vaccine (POLIO); all intramuscular, on 10Oct2018, at single dose at the right thigh for immunization. Other concomitant medications included hydrocortisone 2.5% and nystatin; both on 10Oct2018 as a topical cream. On an unspecified date the patient received the vaccine after a temperature excursion occurred. On an unspecified date the vaccine was stored at 57 degrees Fahrenheit for approximately 4 hours. It was also reported that the patient experienced candidal dermatitis and infantile eczema on 10Oct2018. The patient recovered from the events, candidal dermatitis and infantile eczema on the same day of 10Oct2018. Follow-up (02Jan2019): New information from a contactable healthcare professional included: reporter details, patient details, suspect drug details, concomitant medication details and course of events. Follow-up (20Feb2019): New information from a contactable healthcare professional includes: new events (candidal dermatitis and infantile eczema), age of vaccination, route of vaccination, dose, administration date, time of vaccination, and anatomical location of the suspected vaccine, lot number for the concomitant vaccine, DTAP HEPB and HIB was updated (from H99HT and U196AAA), event onset of drug maladministration, and additional concomitant medications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018416194 different patient, same reporter/drug/event.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) at a single dose for immunization and morphine sulfate at an unspecified dose for an unspecified indication; both via an unspecified route of administration on an unspecified date. The patient's medical history and concomitant medications were not reported. It was reported that the patient had drug allergies on pneumococcal vaccine and morphine. The action taken in response to the event for morphine sulfate was unknown. Outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and morphine sulfate in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and morphine sulfate has submitted the same report to the regulatory authorities.
Sex: M
Vaccine: FLUX, PPV, TTOX
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways. Two contactable physicians reported that a 60-year-old male patient receive pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at a single dose for an immunization; erythromycin (manufacturer unknown) and clarithromycin, both via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for an unspecified indication; and influenza vaccine and tetanus vaccine toxoid (TETANUS VACCIN), both via an unspecified route of administrations on an unspecified date at an unspecified dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced drug allergies on an unknown date. The action taken in response to the event for erythromycin and clarithromycin and the outcome of the event were unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and erythromycin in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) and erythromycin has submitted the same report to the regulatory authorities.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old patient who received 0.25 ml dose, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included influenza vaccine from JUN-2015 to JUN-2016. The patient's past medical history, medical treatment(s) and family history were not provided. On 08-Feb-2019, the patient received a 0.25 dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. It was a case of medication error due to vaccine underdose. 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.
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 66 years old received vaccine FLUZONE HIGH DOSE which had a temperature excursion overnight. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Feb-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ051AB via unknown route in the left arm. It was a case of actual medication error due to incorrect product storage. It was unknown if adverse event was experienced. 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.
Sex: F
Vaccine: MNQ
Symptoms: Meningitis
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a female patient (age unknown) who experienced symptoms similar to meningitis, while she received vaccine MENACTRA. The patient's past vaccination(s) included a first dose of MENACTRA. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a serious symptoms similar to meningitis, following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient was hospitalized for this event. Other relevant tests were not reported. Final diagnosis was symptoms similar to meningitis. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none. Sender's Comments: This case concerns a female patient who presented with symptoms similar to meningitis after vaccination with MENACTRA. As with any vaccine, vaccination with MENACTRA may not protect 100% of susceptible individuals. The time to onset is unknown. Moreover, information regarding patient's medical condition at the time of vaccination and confirmatory lab tests ruling out alternate predisposing etiologies are required for complete assessment of the case and considering the cases as a vaccine failure. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 75 years old male patient who experienced pain at injection site, loss of mobility and burning sensation was radiating down to her left hand, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy received. On 06-Nov-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ043AB via unknown route in unknown administration site. On 06-Nov-2018, The patient developed a non-serious pain at injection site (vaccination site pain) <<immediately following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious loss of mobility (mobility decreased)following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious burning sensation was radiating down to her left hand (burning sensation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No  lab test reported. Final diagnosis was burning sensation was radiating down to her left hand, loss of mobility and pain at injection site. The patient was treated with MELOXICAM (MELOXICAM) and PARACETAMOL (TYLENOL [PARACETAMOL]). The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for pain at injection site, as Unknown for loss of mobility and as Unknown for burning sensation was radiating down to her left hand.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who received vaccine ADACEL instead of 4th dose of DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient also received ACTHIB and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) vaccines as concomitant therapy on unknown dates. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U589AA (expiry date: 30-Mar-2020) via unknown route in the left thigh. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was reported that no adverse event was experienced. 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. Follow-up information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. No new information was received. List of documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves patient of an unknown demographics who received vaccine ADACEL lot number not reported via unknown route in the gluteus instead of the deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. It was a case of actual medication error due to Vaccine administered at inappropriate site. It was unknown if any adverse event was 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a female patient (age unknown) who experienced large injection site reaction, while she received vaccine ADACEL. The patient's past medical history included was reaction to excipient allergy to a bovine component of ADACEL. The patient's past medical treatment(s), vaccination(s) and family history were not provided. In 1969, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a non-serious large injection site reaction (vaccination site reaction) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included no lab data.) Final diagnosis was large injection site reaction.It was not reported if the patient received a corrective treatment. The patient outcome was not reported for large injection site reaction. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adolescent was vaccinated with TWINRIX, an adult vaccine, instead of the pediatric Hepatitis A and Hepatitis B. No adverse reaction noted by patient.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient presented for varicella vaccine for work. Administered vaccine to patient and provided record of immunizations for work documentation. At the end of visit patient inquiring about pregnancy test. Clinic collected- positive pregnancy result. Advised pt of possible risk to fetus due to live vaccine administrating during first trimester of pregnancy. No pregnancy history GA: 6w0d EDD: 10/28/2019.
Age: 55.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD, TYP
Symptoms: Arthralgia
Clinical narrative: The client had severe joint pain starting two weeks after being vaccinated and continuing today.  The client states her knees and especially her hips hurt. The client looked this condition up on the internet and found reactive arthritis. The client is taking an over the counter anti-inflammatory which reduces the pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Started feeling a bit achy, then sluggish and tired. Had a fever 100.1 at 9 A. M. Chilled so wrapped up and laid down about 11:00 A. M. (Temp now 101.7) until 1:00 P. M. Got ready for an Ceremony (had a part in presentation). Kept having short throbs in my head. Never took temp again. Just very tired and achy. Did take ALEVE P. M. during the night to help with throbs. Sunday morning was much better. Slight aches and by noon was all gone.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Sluggishness
Clinical narrative: Started feeling a bit achy, then sluggish and tired. Had a fever 100.1 at 9 A. M. Chilled so wrapped up and laid down about 11:00 A. M. (Temp now 101.7) until 1:00 P. M. Got ready for an Ceremony (had a part in presentation). Kept having short throbs in my head. Never took temp again. Just very tired and achy. Did take ALEVE P. M. during the night to help with throbs. Sunday morning was much better. Slight aches and by noon was all gone.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever 102-103 for three days; rash with red spots (not raised bumps) for three days, with one day co-occurring with the fever.
Sex: U
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of unknown demography and reported that 3-4 drops had leaked out of the syringe but the patient had gotten more than half of the vaccine, while he/she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Typhoid VI Polysaccharide Vaccine (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to vaccine underdose. It was also case of syringe issue. (It was reported that 3-4 drops had leaked out of the syringe but the patient had gotten more than half of the vaccine). It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cardio-respiratory arrest, Death, Dyspnoea
Clinical narrative: This is a literature case, initially received on 19-Feb-2019, concerning a 70-year-old, elderly male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's medical history included chronic obstructive pulmonary disease and coronary artery disease. The patient had no hypersensitivities. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 258 minutes after the vaccination, the patient experienced anaphylactic reaction, difficulty in breathing and cardiopulmonary arrest. The documented cause of death was anaphylactic reaction (causality: related). It was unknown whether autopsy was performed or not. The author considered this case as serious (death). This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter's Comments: A 70-year-old, male patient with medical history (chronic obstructive pulmonary disease and coronary artery disease) developed difficulty in breathing and cardiopulmonary arrest, 258 minutes after administration of INN Flu Vaccine. The reported cause of death was anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events and lack of any alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, soreness at injection site 1 week after administration. Edema all around the injection site, warmth to the touch, tenderness upon palpation, painful to raise Rt arm above head.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pain, Pain in extremity
Clinical narrative: Swelling, redness, soreness at injection site 1 week after administration. Edema all around the injection site, warmth to the touch, tenderness upon palpation, painful to raise Rt arm above head.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cold sweat, Nausea
Clinical narrative: Two days after the vaccine I woke up in a cold sweat, clammy, nauseous. Felt very weak. Sat on the bathroom floor until the feeling passed, about 10-15 minutes. After that I had something to eat and felt ok.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Tenderness, erythema, edema and warmth over injection site of the L UE associated with chills/myalgias.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Tenderness, erythema, edema and warmth over injection site of the L UE associated with chills/myalgias.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient had a swollen, lumpy, red, painful, and itchy injection site. Pharmacist on duty instructed her to go to urgent care. Patient received BACTRIM DS for possible cellulitis. She had informed us at follow up that she was feeling much better by the following day (03/01/19).
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Tinnitus
Clinical narrative: Ringing in ears.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Blood test, Bradycardia, Hypotension, Syncope
Clinical narrative: Child fainted 15 minutes after receiving vaccines. He did have blood test also after vaccines were given.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test normal, Cyanosis, Electrocardiogram normal, Electroencephalogram normal, Fatigue
Clinical narrative: Pt experienced two seizures on 2/21/19. They were diagnosed as febrile seizures. The first occurred at approximately 3:50 PM and the second at approximately 6:00 PM. His temperature prior to the second seizure was measured at 101 degrees (F). Both seizures lasted around 2 minutes and consisted of whole body shaking. His lips appeared to turn slightly blue during the second seizure. No discoloration was noted during the first seizure. Both seizures resulted in pt falling asleep for a period of time, and he was pretty tired the rest of the day and into the next day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Somnolence, Tremor
Clinical narrative: Pt experienced two seizures on 2/21/19. They were diagnosed as febrile seizures. The first occurred at approximately 3:50 PM and the second at approximately 6:00 PM. His temperature prior to the second seizure was measured at 101 degrees (F). Both seizures lasted around 2 minutes and consisted of whole body shaking. His lips appeared to turn slightly blue during the second seizure. No discoloration was noted during the first seizure. Both seizures resulted in pt falling asleep for a period of time, and he was pretty tired the rest of the day and into the next day.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Credit card sized raised rash warm to touch lasted for 5-6 days.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Altered state of consciousness, Hypoaesthesia oral, Incoherent, Loss of consciousness, Seizure
Clinical narrative: Patient was administered the MENACTRA vaccine. Approximately 5 minutes after receiving vaccine patients aunt retrieved Pharmacist and stated niece was incoherent. When pharmacist approached patient she was unrespponsive and began to seize. Patient was moved to the floor and turned on side for approximately 1 minute, the duration of the seizure. Patient regained consciousness and stated she felt sleepy and that her lips were numb. 911 was contacted. They arrived at store and assessed patient and stated that she probably was stressed due to vaccination. Upon sitting in chair, patient again stated she felt like passing out. Family decided to have ambulance take patient to Emergency Room.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Patient was administered the MENACTRA vaccine. Approximately 5 minutes after receiving vaccine patients aunt retrieved Pharmacist and stated niece was incoherent. When pharmacist approached patient she was unrespponsive and began to seize. Patient was moved to the floor and turned on side for approximately 1 minute, the duration of the seizure. Patient regained consciousness and stated she felt sleepy and that her lips were numb. 911 was contacted. They arrived at store and assessed patient and stated that she probably was stressed due to vaccination. Upon sitting in chair, patient again stated she felt like passing out. Family decided to have ambulance take patient to Emergency Room.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Myalgia, Neck pain
Clinical narrative: Patient states she developed soreness from right side of neck, down entire length of arm with considerable muscular tenderness in right arm and without erythema, warmth or drainage at injection site, the day of/after the vaccine. On second day following immunization, patient continued to have myalgias in entire body and presented to clinic. Patient had 4" in diameter localized reaction at injection site which was red and warm. Patient did not present with fever or any other symptoms at that time. Per CDC, although rare, these sx can be associated with this particular vaccine. Advised patient would follow up with VAERS, explained this system to patient and had patient treat sx with NSAIDs, acetaminophen and ice. Patient to call clinic if any change or worsening sx. Discussed s/sx of infection with patient and any emergent s/sx.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient states she developed soreness from right side of neck, down entire length of arm with considerable muscular tenderness in right arm and without erythema, warmth or drainage at injection site, the day of/after the vaccine. On second day following immunization, patient continued to have myalgias in entire body and presented to clinic. Patient had 4" in diameter localized reaction at injection site which was red and warm. Patient did not present with fever or any other symptoms at that time. Per CDC, although rare, these sx can be associated with this particular vaccine. Advised patient would follow up with VAERS, explained this system to patient and had patient treat sx with NSAIDs, acetaminophen and ice. Patient to call clinic if any change or worsening sx. Discussed s/sx of infection with patient and any emergent s/sx.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Generalized soreness in muscles (arms, thighs) soreness in lower back and joint aches for 2-3 weeks.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation concerning a 51 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2017, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a healthcare provider. In March 2017, the patient was treated by a healthcare provider for pneumonia as a result of vaccination with ZOSTAVAX. The outcome was not provided. Upon internal review pneumonia was considered medically significant.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 22-FEB-2019 regarding a case in litigation concerning an approximately 54 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 30-MAR-2017, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. In May 2017, the patient was treated by a physician for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Mom reports just noticed last night that arm is red, hot and swollen. It also feels hand. She report seems more than normal side effect.
Age: 63.0
Sex: F
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation, Scratch, Skin injury, Vaccination site pustule
Clinical narrative: The following information was received from a study investigator on 19Feb2019. The subject is a 62 year old 208lb female subject without relevant medical history. She was previously vaccinated with smallpox  vaccine (immunization date not reported). On 09FEB2019 she received a 2.5mcL immunization percutaneously in the left arm with ACAM2000 (lot VV03-013-C expiry date 10FEB2019). On 19FEB2019 subject was seen by staff for day 12 site check subject explained when she was trying to remove band-aid subject scratched her skin multiple times not realizing she had broken the top layer of skin. It was observed 3 different pustule like formations. The subject has possible auto inoculated from the open wounds. The pustules are all 1-2 inches from vaccination site. Subject was provided further site care instructions and site care kit; contains 12 band aids and waterproof band aids. The outcome for the auto-inoculation is not resolved. The Investigator reported the autoinoculation as mild in severity, not serious and related to the ACAM2000.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a consumer who experienced received vaccine  FLUZONE QUADRIVALENT which did not have a working thermometer for three months 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 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. It was a case of actual medication error due to incorrect product storage. It was unknown whether adverse event was experienced. 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.