chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMR, UNK
Symptoms: Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: The titers came back positive for measles and rubella but negative for mumps/mumps was below 9 AU per milliliter; Antibody test negative; the patient's father has expressed doubt on if the vaccine was actually administered/ lot number and expiration date he looked up and found as diluent; This spontaneous report as received from a consumer refers to his 3-year-old son. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 17-MAY-2019, the patient should be vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) to prevent measles, mumps, and rubella but instead he received only sterile diluent, in the right deltoid, lot # M034781 has been verified to be a valid lot number, expiration date reported as 29-APR-2020, but upon internal validation established as 11-APR-2019 (dose, frequency and route of administration were not reported). On 18-MAY-2019, the father took the patient to a different physician. At the appointment, it was noted that there was "no indication that any vaccine had been administered". On 29-MAY-2019, the patient had blood drawn to check for titers. The reporter stated that "all titers were flat out negative." On 17-JUN-2019, the patient had had blood drawn to check for titers for the second time and the results were negative. On the same visit, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, route of administration, lot# and expiration date was not reported) for prophylaxis. On 12-JUL-2019, the patient had blood drawn to confirm the titers and the result was: measles 268 arbitrary unit per milliliter (positive), mumps below 9 arbitrary unit per milliliter (negative) and rubella 4.24 index (unit not provided)(positive). The outcome of the events and causality assessment between suspect therapies and the events was not provided.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: a patient received his second dose of PNEUMOVAX 23 on 12/10/2019 and "a couple hours after the injection" started experiencing "pain, swelling and redness at the injection site in the right triceps area down to the patients right elbow."; a patient received his second dose of PNEUMOVAX 23 on 12/10/2019 and "a couple hours after the injection" started experiencing "pain, swelling and redness at the injection site in the right triceps area down to the patients right elbow."; a patient received his second dose of PNEUMOVAX 23 on 12/10/2019 and "a couple hours after the injection" started experiencing "pain, swelling and redness at the injection site in the right triceps area down to the patients right elbow."; This spontaneous report was received from a nurse referring to a 78 years old male patient. Concomitant therapies included metformin, rosuvastatin and metoprolol.  Concurrent conditions included diabetes and hypertension. No drug reaction/allergy.  On 26-NOV-2014, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) for prophylaxis. On 10-DEC-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S029916, expiration date 12-JUN-2021; strength and vaccine dosage detail were not reported) intramuscularly in the right tricep for prophylaxis.  On the same day, a couple hours after the injection the patient started experiencing pain, swelling and redness at the injection site in the right triceps area down to the patient's right elbow. The patient came back to the office to seek medical attention on 11-DEC-2019. No treatment, lab diagnostics or intervention was given for the events. No product quality complaint (PQC) was involved in this case. The outcome of the events was not recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: he developed a pins and needles sensation in the same arm; This spontaneous report was received from a male patient of unknown age who refers to himself. No information regarding the patient's current condition, medical history and concomitant medication was provided.   On unspecified date in December 2019 (reported as two and a half weeks ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, in the right arm (dose, strength, route of administration, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). On unspecified date in December 2019 (reported as the following day), the patient developed a "pins and needles" sensation in the same arm.   The outcome of the event was reported as not recovered. The relatedness between the event and the vaccine was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Administered dose of Proquad underwent a temperature excursion; No known adverse effects; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # S017255 and expiration date 01-DEC-2020) (dose, frequency and route of administration was not reported) for prophylaxis. On an unknown date, the patient administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) that underwent a temperature excursion on 27-DEC-2019 prior to being administered to one patient on 30-DEC-2019. There was no temperature excursion occurred previously. The call was because of data logger of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) which was stored at a temperature -12.94 Celsius for 90 minutes. Product quality complaint was not involved in the case.
Sex: F
Vaccine: TD
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd dose hasn't been given after 8 yrs of the original dose, no adverse event; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non health care professional.  This case involves a 13 years old female patient for whom it was reported that 2nd dose hasn't been given after 8 yrs of the original dose while she received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] via unknown route and site of administration, on an unknown date.  The patient's past medical history, medical treatments, and family history were not provided. The patient had received a first dose of Tenivac in past. It was a case of actual medicaiton error due to inappropriate schedule of product administration.  The reporter was not sure if the patient was going to be administered Adacel or Tenivac but she believed that it was not being administered the way the package insert states. Caller states that the insert states that the 2nd dose has not been given after 8 yrs of the original dose. The patient was undergoing catchup vaccination, and the stated officials are saying the interval between the first and second dose of Td or Tdap is 4 weeks apart, can they administer it sooner than the interval listed in the PI.  At the time of reporting, no adverse event was reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  Information on batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Dysgeusia, Injection site pain, Pain in extremity, Paraesthesia oral
Clinical narrative: slurring her words; tongue started tingling; couldn't speak; tongue swelled up; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old patient who received an unknown dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was reported that the patient received fluone HD and she had any reaction aside from a sore arm, pain at the injection site, and a fever. She stated that she went home and had dinner and she was talking to a friend on the phone when her tongue started tingling and then she was slurring her words. She accepted a call back and/or paperwork from Agency but states that she would be out of town for quite a while for the holidays but she could check her phone message remotely. She stated that they gave her epinephrine, steroids, and Benadryl in the emergency room. She recently had cataracts surgery so she had given herself her eye drops and she was suspecting this had something to do with the eye drops. She stated that one eye drop was Prednisolone, and one was an antibiotic and the other was an antiinflammatory. She stated that she had checked with her eye after her cataract surgery if she could get the flu shot and he told her it was ok. She stated that her tongue started swelling half an hour after she administered her eye drops and 3-4 hours after the flu shot. She stated that they wanted her to take prednisone for 5 days but it made her very sick and stayed in her system for more than a month. She stated that she was now getting back to normal. She stated that her eye drops usually drain into her sinus passage and she experienced a bitter taste on her tongue. This was all the information she provided.  At the time of reporting, the patient had adverse event.  The batch number information was requested.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: slurring her words; tongue started tingling; couldn't speak; tongue swelled up; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old patient who received an unknown dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was reported that the patient received fluone HD and she had any reaction aside from a sore arm, pain at the injection site, and a fever. She stated that she went home and had dinner and she was talking to a friend on the phone when her tongue started tingling and then she was slurring her words. She accepted a call back and/or paperwork from Agency but states that she would be out of town for quite a while for the holidays but she could check her phone message remotely. She stated that they gave her epinephrine, steroids, and Benadryl in the emergency room. She recently had cataracts surgery so she had given herself her eye drops and she was suspecting this had something to do with the eye drops. She stated that one eye drop was Prednisolone, and one was an antibiotic and the other was an antiinflammatory. She stated that she had checked with her eye after her cataract surgery if she could get the flu shot and he told her it was ok. She stated that her tongue started swelling half an hour after she administered her eye drops and 3-4 hours after the flu shot. She stated that they wanted her to take prednisone for 5 days but it made her very sick and stayed in her system for more than a month. She stated that she was now getting back to normal. She stated that her eye drops usually drain into her sinus passage and she experienced a bitter taste on her tongue. This was all the information she provided.  At the time of reporting, the patient had adverse event.  The batch number information was requested.
Sex: U
Vaccine: RAB
Symptoms: Burning sensation, Cardiac monitoring, Hyperhidrosis, Palpitations, Pyrexia
Clinical narrative: burning; she had an allergic reaction to Imovax; It started under my armpits and moved to my heart. I had a rash under my armpits; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 65 years old patient who received a unknown dose of vaccine RABIES VACCINE [IMOVAX VACCINE], via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was reported that having like burning inside. It started under my armpits and moved to my heart, had a rash under armpits. Doctor did not think that it was related to the vaccine. Had a fever of 99.2 which was a fever for me. My heart was palpitating and I went to the ER and they put me on a heart monitor for 2 weeks. Going to have an echocardiogram to see if the heart was damaged. Still had heat in heart and armpits that was not to the same degree as it was 3 months ago, but it was still there. Three months in after getting my last shot at while at a physical (on 25-Sep-2019) temperature was 99.2 and then it would go down to 98.6 or 98 point something and began breaking a little. Normal body temperature was in the 97 degree range. Under arm pits and between the arm pits and back was really hot and that was where my heart was. This area was still really. Have to wear hair in a bun and off neck because it would start sweating there if hair touched it. Had no treatment for this. Have not had Tylenol or Ibuprofen.  At the time of reporting, the patient had adverse event.  The batch number information was requested.
Sex: U
Vaccine: RAB
Symptoms: Rash, Skin warm
Clinical narrative: burning; she had an allergic reaction to Imovax; It started under my armpits and moved to my heart. I had a rash under my armpits; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 65 years old patient who received a unknown dose of vaccine RABIES VACCINE [IMOVAX VACCINE], via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was reported that having like burning inside. It started under my armpits and moved to my heart, had a rash under armpits. Doctor did not think that it was related to the vaccine. Had a fever of 99.2 which was a fever for me. My heart was palpitating and I went to the ER and they put me on a heart monitor for 2 weeks. Going to have an echocardiogram to see if the heart was damaged. Still had heat in heart and armpits that was not to the same degree as it was 3 months ago, but it was still there. Three months in after getting my last shot at while at a physical (on 25-Sep-2019) temperature was 99.2 and then it would go down to 98.6 or 98 point something and began breaking a little. Normal body temperature was in the 97 degree range. Under arm pits and between the arm pits and back was really hot and that was where my heart was. This area was still really. Have to wear hair in a bun and off neck because it would start sweating there if hair touched it. Had no treatment for this. Have not had Tylenol or Ibuprofen.  At the time of reporting, the patient had adverse event.  The batch number information was requested.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: administered Fluzone Quadrivalent into the gluteal of an adult female/no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves female patient (age not reported) who was vaccinated with vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled Syringe  0.5 ml (lot UJ295AA and expiry date: 30-Jun-2020) via intramuscular route in administration gluteal site on 02 Dec 2019.  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 Vaccine administered at inappropriate site. It was reported that new employee accidentally administered Fluzone Quadrivalent into the gluteal of an adult female patient.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 113.0
Sex: F
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: uncontrollable shivering and chills; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 113 years old female patient who experienced shivering (chills), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Dec-2019, the patient received a one dose (0.5 mL) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (frequency once) lot UJ293AA and expiry date 15-Jun-2020 via unknown route in the right deltoid.  On an unknown date, the patient experienced a non-serious shivering (chills) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was chills.  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received on on 9/11 and the other on 11/11 shingles vaccine and a Fluzone HD, no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ292AB and expiry date:10-Jun-2020) via unknown route in the right arm, on 11-Nov-2019.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient received concomitant therapy with VARICELLA ZOSTER VACCINE (SHINGLES VACCINE) on 11-Sep-2019 and 11-Nov-2019.  It was also a case of actual medication error due to extra dose administered. It was reported that patient received two shots of Fluzone HD in two months. The patient received one shot on 11-Sep-2019 and the other on 11-Nov-2019.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient receiving FluLaval on 16Sep2019 and Fluzone Quadrivalent 0.5 mL on 11Nov2019, no AE; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 48 years old male patient who received 0.5 ml dose vaccines  INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLULAVAL) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via intramuscular route in the right deltoid, on 16-Sep-2019 and 11-Nov-2019 respectively.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was as actual medication error case due extra dose administered. It was reported that patient receiving FluLaval on 16-Sep-2019 and Fluzone Quadrivalent 0.5 mL on 11-Nov-2019 due to the consumer asked for a influenza vaccination on a subsequent clinic visit and the consumers record was not checked before administering the second vaccine.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 13.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: 13 year old kid was given Fluzone Quadrivalent subcutaneously instead of intramuscular, no AE.; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a physician (doctor).  This case involves a 13 years old patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiration date and other dosing details not reported) via subcutaneous route in unknown administration site.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate route of vaccination (PT: incorrect route of product administration).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number was requested.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered
Clinical narrative: gave the Pentacel that included the extra IPV, No AE; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare.  This case involves a 12 months old male patient who received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ196ABA and expiry date 02-Mar-2021 via intramuscular route in the right thigh and fourth dose of IPV (VERO) [IPOL] lot U6615AA and expiry date 02-Mar-2021 via intramuscular route in the right thigh on 10-dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) Lot UJ196AB, Expiry Date 02-Mar-2021 for Immunisation; DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE) U6615AA, Expiry Date 02-Mar-2021 for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunization.  It was a case of actual medication error due to extra dose administered. It was reported that an extra Polio Vaccine (fourth dose) was given since Pentacel that included the extra IPV was administered to the patient.   At the time of reporting, it was not reported if the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 month old child getting the Fluzone Quadrivalent 0.5 mL injection, no AE; Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a five months old male patient who was vaccinated with a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6695MA, expiry date: 30-June-2020 via unknown route in unknown administration site on 17-Dec-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that a five month old child getting the Fluzone Quadrivalent 0.5 mL injection due to the parents ordering the vaccine and the office being kind of busy and not realize the age.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: she had given a patient a double dose of polio vaccine with giving IPOL and Quadracel, no AE; Initial information received on 18-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who received received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and expiry date: not reported) not reported via unknown route in unknown administration site, on an unknown date and IPV (VERO) [IPOL] (lot P1A43 and expiry date: not reported) via intramuscular route in the right deltoid, on 17-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  It was a case of actual medication error due to extra dose administered. It was reported that patient a double dose of polio vaccine with giving IPOL and Quadracel on the same visit  At the time of reporting, no adverse event was reported.  Information on batch number requested for QUADRACEL.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Muscle rigidity
Clinical narrative: rigid; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who received a unknown dose of vaccine INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE], via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was reported that the patient became very rigid after receiving a Fluzone HD vaccine. She did not want to give me additional details as she cited confidentiality.  At the time of reporting, the patient had an adverse event.  The batch number information has been requested.
Age: 33.0
Sex: M
Vaccine: IPV
Symptoms: Wrong product administered
Clinical narrative: .1cc of Ipol administered instead of Tubersol to a patient intradermally like it was a TB skin test/ no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  It was reported that 33 years old male patient received .1cc of Ipol  instead of tubersol intradermally like it was a TB skin test/ no AE (wrong product administered) of vaccine IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Dec-2019, the patient received a 0.1 ml of suspect IPV (VERO) lot number not reported via intradermal route in the left forearm.  On 19-Dec-2019, TUBERSOL (TUBERCULIN TEST) 0.1 mL administered intradermally (with an unknown batch number) in place of the accidental Ipol administration.  It was a case of actual medication error due to wrong vaccine administered.   It was unknown whether adverse event was experienced by patient 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.  The information on the batch number was requested.
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14-year-old female patient received the Flublok Quadrivalent prefilled syringe rather than the Fluzone Quadrivalent prefilled syringe, No AE; 14-year-old female patient received the Flublok Quadrivalent prefilled syringe rather than the Fluzone Quadrivalent prefilled syringe, No AE; Initial information received on 20-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old female patient who was vaccinated with 0.5 ml of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] QFAA1929 and expiry date 30-Jun-2020 via intramuscular route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6686KA and expiry date 30-Jun-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Fatigue, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Parents report that patient developed itchy rash about 6 hours after receiving vaccine , not like hives/did not come and go, mostly on arms and face.  Some fatigue and mild congestion per parents but no swelling or resp difficulty, no other sxs, no new contacts. Seen in office the following day 12/19/2019 with scattered erythematous macular patches on face and arms, not-urticarial, otherwise nl exam.  No clear etiology. Returned for f/u  12/23,  rash persists with scattered mildly erythematous macules and papules mostly on face and arms, some rough/excoriated, no wheals, not urticarial.  Family leaving next day for extended out of town travel, so no further follow up known.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Respiratory tract congestion
Clinical narrative: Parents report that patient developed itchy rash about 6 hours after receiving vaccine , not like hives/did not come and go, mostly on arms and face.  Some fatigue and mild congestion per parents but no swelling or resp difficulty, no other sxs, no new contacts. Seen in office the following day 12/19/2019 with scattered erythematous macular patches on face and arms, not-urticarial, otherwise nl exam.  No clear etiology. Returned for f/u  12/23,  rash persists with scattered mildly erythematous macules and papules mostly on face and arms, some rough/excoriated, no wheals, not urticarial.  Family leaving next day for extended out of town travel, so no further follow up known.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Language disorder, Obsessive-compulsive disorder, Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection, Tic
Clinical narrative: Parents reported verbal and behavioral tics, previously not demonstrated by this child.  The tics began 2-3 days following administration of DTaP.  Examples of tics include repeatedly speaking the phrase "One more time" while raising a forefinger.  Another example is obsessively and ritually touching both sides of a  playground slide before descending.   A provisional diagnosis of new onset tic disorder and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS) was considered as a possible cause.  A 5 day course of azithomycin was prescribed beginning 7 days after the tics started.   Initially the patient's tic behaviors did not decrease, however at the time, however at a follow up visit 5 weeks following, the tic behaviors had decreased, but additional OCD-like door-shutting  behaviors had developed.  Parents also felt that language skills had regressed, although they were age-appropriate at the time of the visit.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Magnetic resonance imaging abnormal, Skin warm, Swelling
Clinical narrative: Left shoulder pain localized over site of vaccination.  Started with week of immunization, associated with inflammatory symptoms, feeling warm, looking swollen and red
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site pain
Clinical narrative: Left shoulder pain localized over site of vaccination.  Started with week of immunization, associated with inflammatory symptoms, feeling warm, looking swollen and red
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Therapy non-responder, Vaccination failure
Clinical narrative: non responsive to Hepatitis B vaccine; This information has been received from the authors of the published literature article. This report was regarding a female medical resident of unknown age. Her medical school records noted that she was a non-responder to Hepatitis B vaccine (HBsAg status was not assessed).   On unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dosage, route, anatomical location, lot # and expiration date were not provided) for prophylaxis in order to meet criteria as the patient was a healthcare personnel (HCP). She had been evaluated by Occupational Health Service (OHS) at initiation of her residency.  On unspecified date, the medical resident was tested by her obstetrician and was found to be HBsAg positive, subsequently she was referred to our Occupational Health Service (OHS). Later, she was referred to hepatology for further evaluation and treatment. The student health department at her medical school was contacted, and current Centers for Disease Control and Prevention (CDC) and Advisory Committee on Immunization Practices (ACIP) guidelines for prevention of hepatitis B in HCP were provided. The authors considered that patient fail to respond to a complete HBV vaccine series (vaccination failure). The authors considered that the patient failed to respond to a complete HBV vaccine series (vaccination failure). At the reporting time, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1912USA012702:Original Case : 1912USA011716 US-009507513-1912USA012700:Original Case : 1912USA011716 US-009507513-1912USA012700:Original Case : 1912USA011716
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: The patient received a fifth dose of Gardasil 9; The patient received a fourth dose of Gardasil 9; The patient received a total of 5 doses of Gardasil 9 on 7/16/2015, 11/19/2015, 1/18/2016, 8/23/2019 and 12/30/2019; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 16-JUL-2015, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot number L001312, expiration date 24-FEB-2017 for prophylaxis (anatomical location and route of administration were not reported).  On 19-NOV-2015, the patient was vaccinated with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot number L000610, expiration date 31-JAN-2017 for prophylaxis (anatomical location and route of administration were not reported) (inappropriate schedule of product administration).  On 18-JAN-2016, the patient was vaccinated with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 dose, lot number L000610, expiration date 31-JAN-2017 for prophylaxis (anatomical location and route of administration were not reported).  On 23-AUG-2019, the patient received the fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively, 1 dose, lot number 1621929, expiration date 06-DEC-2021 for prophylaxis (anatomical location and route of administration were not reported) (overdose).  On 30-DEC-2019, the patient received the fifth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) respectively, 1 dose, lot number R028386, expiration date 27-APR-2021 for prophylaxis (anatomical location and route of administration were not reported) (overdose).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Initially felt typical post vaccine flu like symptoms but including more severe shaking chills & extreme tiredness, so took a few day off regular daily activities and wor ; night of day three about 15 minutes after going to bed my back, both sides and then shoulders began to itch uncontrollably & got red. I was unable to relive it with cortisone creme or itch X so orally took 25 mg Benadryl but a half hour later itching still bad so took a second oral .25 Benadryl & finally a third .25 oral dose on the hour . After a total of 75mg Benedryl & a third topical itch x, application I was able to sleep.  This occurred night of day four  also -same topical treatment plus .50 mg benadryl got me to sleep. Day five  again same topical  treatment and only .25 Benadryl. Day six  .25 mg Benadryl also. Saw PCP  about 4 days later and we agreed I must stop all famvir or similar drugs to see if this would lessen this effect. Additionally from day four on,  if I took a shower even with cool water my arms & legs where water hit itched & burned badly as if many needles being jammed into my skin.  I remain off all famvir type meds but now  12.31.2019 a lukewarm to cool shower made arms burn itch & tun so red I had to get out of shower &rinse off with pitcher slowly in tears from pain & itching.  I am  unable to resume all normal daily activities  due to generalized itching on neck arms back & legs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Skin burning sensation, Tremor
Clinical narrative: Initially felt typical post vaccine flu like symptoms but including more severe shaking chills & extreme tiredness, so took a few day off regular daily activities and wor ; night of day three about 15 minutes after going to bed my back, both sides and then shoulders began to itch uncontrollably & got red. I was unable to relive it with cortisone creme or itch X so orally took 25 mg Benadryl but a half hour later itching still bad so took a second oral .25 Benadryl & finally a third .25 oral dose on the hour . After a total of 75mg Benedryl & a third topical itch x, application I was able to sleep.  This occurred night of day four  also -same topical treatment plus .50 mg benadryl got me to sleep. Day five  again same topical  treatment and only .25 Benadryl. Day six  .25 mg Benadryl also. Saw PCP  about 4 days later and we agreed I must stop all famvir or similar drugs to see if this would lessen this effect. Additionally from day four on,  if I took a shower even with cool water my arms & legs where water hit itched & burned badly as if many needles being jammed into my skin.  I remain off all famvir type meds but now  12.31.2019 a lukewarm to cool shower made arms burn itch & tun so red I had to get out of shower &rinse off with pitcher slowly in tears from pain & itching.  I am  unable to resume all normal daily activities  due to generalized itching on neck arms back & legs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin exfoliation, Swelling
Clinical narrative: red, swelling, itching, peeling of the skin
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Increasing chills as it became evening. Fatigue. Headache (mild but consistent). Nausea constantly during the night. 5:10 a.m., severe sweating, attempt by body to vomit, mild headache, 100.5 fever. I went to bed 3 hours early. So chilled I wore mittens to bed. Did not sleep much. 12/31/2019 after 10 a.m. dozing on the couch. Much improved, but not myself at all.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pyrexia
Clinical narrative: Increasing chills as it became evening. Fatigue. Headache (mild but consistent). Nausea constantly during the night. 5:10 a.m., severe sweating, attempt by body to vomit, mild headache, 100.5 fever. I went to bed 3 hours early. So chilled I wore mittens to bed. Did not sleep much. 12/31/2019 after 10 a.m. dozing on the couch. Much improved, but not myself at all.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Gait disturbance, Headache, Injection site bruising
Clinical narrative: Patient reporting adverse reaction to Shingle shot series: Received first shot on 09/17/2019:  - reporting sore arm, redness and  bruising at injection site and felt tired after shot. Received second shot 11/19/2019 administered:  - reporting a pounding headache the day after receiving the shot -Body aches, muscle and tendons tightness and pain, had trouble moving due to the body aches and pain. -Pain then moved to just the right hip and leg, injection site still sore. -Patient consulted with Doctors, Chiropractors and Massage therapists to get relief from the pain and tightness in his right hip and leg. Walking with a limp due to tightness in his muscles and experiencing shooting pains in his nerves as of today 12/31/2019. -Patient states that he just started feeling a tingling sensation in his right leg today, 12/31/2019
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Muscle tightness, Myalgia, Neuralgia
Clinical narrative: Patient reporting adverse reaction to Shingle shot series: Received first shot on 09/17/2019:  - reporting sore arm, redness and  bruising at injection site and felt tired after shot. Received second shot 11/19/2019 administered:  - reporting a pounding headache the day after receiving the shot -Body aches, muscle and tendons tightness and pain, had trouble moving due to the body aches and pain. -Pain then moved to just the right hip and leg, injection site still sore. -Patient consulted with Doctors, Chiropractors and Massage therapists to get relief from the pain and tightness in his right hip and leg. Walking with a limp due to tightness in his muscles and experiencing shooting pains in his nerves as of today 12/31/2019. -Patient states that he just started feeling a tingling sensation in his right leg today, 12/31/2019
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Tendon pain
Clinical narrative: Patient reporting adverse reaction to Shingle shot series: Received first shot on 09/17/2019:  - reporting sore arm, redness and  bruising at injection site and felt tired after shot. Received second shot 11/19/2019 administered:  - reporting a pounding headache the day after receiving the shot -Body aches, muscle and tendons tightness and pain, had trouble moving due to the body aches and pain. -Pain then moved to just the right hip and leg, injection site still sore. -Patient consulted with Doctors, Chiropractors and Massage therapists to get relief from the pain and tightness in his right hip and leg. Walking with a limp due to tightness in his muscles and experiencing shooting pains in his nerves as of today 12/31/2019. -Patient states that he just started feeling a tingling sensation in his right leg today, 12/31/2019
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling in left foot
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Dysphonia, Stomatitis
Clinical narrative: Within one day patient complaining of oral irritation, metallic taste in mouth and hoarse voice.  Has persisted for 3-4 weeks
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pain
Clinical narrative: Discomfort and pain with range of motion  in upper arm and shoulder with intermittent numbness in lower arm. Was given steroid dose pack and NSAID in December.
Age: 41.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dizziness, Feeling hot, Flushing, Presyncope
Clinical narrative: Patient became lightheaded and flushed and warm. Vasovagal reaction with no loss of consciousness. Patient has a history of reacting to injections.