chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; On 11-FEB-2020 patient received a dose of improperly stored ROTATEQ.; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 11-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 14-OCT-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  On 18-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error). The nurse reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 hours, as recorded by the data logger. There were not any other temperature excursions.   No adverse effects were reported for the patient.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA005831: US-009507513-2003USA005908:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; Patient received a dose of improperly stored ROTATEQ; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 18-OCT-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (lot number 1660112 has been verified to be a valid number; expiration date reported and validated as 18-OCT-2020) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  On 20-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error). The nurse reported that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 hours, as recorded by the data logger. There were not any other temperature excursions.   No adverse effects were reported for the patient.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2003USA005831: US-009507513-2003USA005901:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions and allergies was not reported.  On 04-MAR-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, orally (concentration  and vaccination scheme frequency were not reported; lot number 1660942 and expiration date 06-FEB-2021) as prophylaxis. No adverse effects were reported for the patient.  According to the reporter, the multiple temperature excursion was below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; On 13-FEB-2020 patient received a dose of improperly stored ROTATEQ.; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 13-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; On 25-FEB-2020 patient received a dose of improperly stored ROTATEQ.; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 25-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 20-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1660112 and expiration date 18-OCT-2020, orally, for prophylaxis (dose, strength and frequency were not reported).    No adverse effects were reported. It was reported that rotavirus vaccine, live, oral, pentavalent(ROTATEQ) suffered multiple excursions of below 2°C (1.28C) for 2 hours and 30 hours. No previous temperature excursions were reported. Digital data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored ROTATEQ; No adverse event; This spontaneous report was received from a registered nurse, refers to an unspecified patient of unknown gender and age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dose, which had Lot number 1660112, with expiry date on 18-OCT-2020 (strength and route were not reported) for prophylaxis, however no adverse effects reported.   It was reported that the vaccines were exposed to temperature Mmltiple excursions: below 2 grade centigrade range for a time frame of 2 hours and 30 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.  This is one of the several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: patient received a dose of improperly stored ROTATEQ; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 02-MAR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1660112 exp date 18-OCT-2020), orally. There was a data logger issue involved. There were multiple temperature excursions below 2°C (1.28 °C) for a time frame of 2 hours and 30 minutes. There was no previous temperature excursion.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB powder from the Pentacel diluted with sterile water, no AE; Initial information received on 06-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two month old patient who received 0.5 ml of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] via intramuscular route in the left thigh on 05-Mar-2020 for prophylactic vaccination, where ActHIB powder from the Pentacel was diluted with sterile water. The ActHIB was from lot UJ127AAA, Exp. Date 03-Nov-2020, and DTaP/IPV lot U6469AA, Exp. Date 03-Nov-2020 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination on 05-Mar-2020.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of reporting, no adverse reactions were 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  contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 months old Male was given the Fluzone High Dose Quad in error/No AE; 6 months old Male was given the Fluzone High Dose Quad in error/No AE; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a six month old male patient who was given INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination in error (inappropriate age at vaccine administration and overdose).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of 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 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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expied Daptacel vaccine was administered with no AE; Initial information received on 09-Mar-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp (Office Staff).  This case involves a patient of unknown demographics who received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Lot- unknown, expiration date- 30-Jan-2020) via an unknown route at an unknown administration site on 05-Mar-2020, for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Laboratory details were not reported.  It was an actual medication error due to expired vaccine administered.  Patient had no adverse reactions 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 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 is requested.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient was exposed on 12Jan2020. He received two doses outside the country of unspecified rabies vaccine on 13Jan2020 and 16Jan2020, no adverse event; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an adult male (approximately 40 years old) patient who had inappropriate schedule of product administration while receiving RABIES VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. The patient had exposure on 12-Jan-2020.  On 13-Jan-2020, and on 16-Jan-2020 the patient received first and second dose of RABIES VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for post exposure immunization outside the country.  On 18-Feb-2020 and on 03-Mar-2020 the patient received the third and fourth dose of RABIES VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for post exposure immunization in country.  It was an actual medication error case due to inappropriate schedule of vaccine administered as the vaccination started one day after exposure. The patient wanted to know if he should receive a fifth dose or start the entire series over. He received two doses outside the country and then two doses in the country  At the time of report, no adverse events were 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: 5.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a nurse inadvertently administered Adacel to a 5 year old instead of Daptacel, No AE; a nurse inadvertently administered Adacel to a 5 year old instead of Daptacel, No AE; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a five years old patient (gender unknown) who was inadvertently administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] by a nurse (lot number and expiration date  not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment, vaccination  and family history were not provided.   It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of 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.  Information on the lot number was requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering an expired ACTHib to a patient/no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old patient who was administered an expired ACTHIB to a patient (expired product administered), while he/she received vaccine HIB (PRP/T) VACCINE [ActHIB].  Medical history, medical treatment, vaccination and family history were not provided.    On 25-Feb-2020, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI916AA expiry date 19-Nov-2019 via intramuscular route in unknown administration site for prophylactic vaccination.  This is a case of actual medication error due to expired product administered.  At the time of this 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 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: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Viral upper respiratory tract infection
Clinical narrative: Family would like reported that 4 days after vaccinations she had swelling of right thigh. She was evaluated by her doctor and told this was low risk local swelling. No intervention was needed. Several days later she was singing Christmas carols out of season. It just seemed weird to father. Then over the next winter she had 6 viral upper respiratory infections, none of which required treatment. At each stage they have discussed with pcp and been told normal. Dad is concerned that because they have been told these things are normal and no reports have been generated that we do not understand that this is a side effect and would like the entire course reported to VAERS.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Extreme, achey pain in the left shoulder (received the injection) that radiated down to the wrist. Very difficult to raise arm above head. Pain has abated after sleep.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Migraine, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Migraine-type headache; neck stiffness and shoulder soreness occurred a few days after vaccine per patient.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Rash pruritic
Clinical narrative: Patient stated he woke up the next day and had an itchy full body rash.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Starting on 3/14 had fever (101-102) for 2 days, reaction at the injection site on thigh and faint red spotty rash
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Fatigue, Headache, Hypersensitivity
Clinical narrative: I had a severe allergic reaction to the vaccination I was given at Pharmacy.  I fell ill within a day and a half and did not recover for a week and a half.  My symptoms included bad headache, tiredness, physical weakness, runny nose, constant mucus drainage, persistent cough, and sore throat.  The vaccination info is Fluarix Qiv PFS 2019-2020 INJ 0.5ml (3FS25 Glaxo 06/30/20) (NDC: 58160-0896-52).
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Oropharyngeal pain, Rhinorrhoea, Secretion discharge
Clinical narrative: I had a severe allergic reaction to the vaccination I was given at Pharmacy.  I fell ill within a day and a half and did not recover for a week and a half.  My symptoms included bad headache, tiredness, physical weakness, runny nose, constant mucus drainage, persistent cough, and sore throat.  The vaccination info is Fluarix Qiv PFS 2019-2020 INJ 0.5ml (3FS25 Glaxo 06/30/20) (NDC: 58160-0896-52).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Vascular test
Clinical narrative: severe cold feet no evidence of Raynauds. No neuropathy per NCV
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Asthenia, Chills, Condition aggravated, Feeling cold
Clinical narrative: upon waking at normal time of 5:00 AM - aches from head to toe, total body weakness, chills - cannot get warm, swelling of fingers aggravating arthritis in both hands, flushing of the face as if I had a fever. checked fever with a traditional mercury thermometer twice within 2 hours of each other and fever was normal both times - NO FEVER as of 11:00 AM, 3/17/2020.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Impaired work ability, Pain, Peripheral swelling
Clinical narrative: upon waking at normal time of 5:00 AM - aches from head to toe, total body weakness, chills - cannot get warm, swelling of fingers aggravating arthritis in both hands, flushing of the face as if I had a fever. checked fever with a traditional mercury thermometer twice within 2 hours of each other and fever was normal both times - NO FEVER as of 11:00 AM, 3/17/2020.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Anaphylactic reaction, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: pt was given proquad on 3/9/2020; early morning of 3/11/2020, mother called that patient has a fever and a rash; c/o itchiness; she gave him tylenol; was concern about chicken pox since he had the shot 2 days before. she was  advised to give  benadryl and will see him during office hour. he came at 9:00 a.m. at that time pt had no rash. mother showed a picture and the rash looked like hives. he was not on any respiratory distress. she was advised to continue with benadryl. 2 1/2 hours later, she called and wants the patient to be seen again since he developed the rash again. he was seen . he had the hives on  his torso, few on the forehead and ears. not having shortness of breath or any respiratory distress. he was prescribed prednisolone 15mg daily x 3 days and told to continue with benadryl. later that day, he again had the rash and the on call doctor advised her to give a second dose of the prednisolone. it calmed down a bit. it came back that evening and patient was brought to Hospital ER. pt was not in any respiratory distress, no swelling of the mouth or tongue.  he was given epinephrine and  was told that he had an anaphylaxis but not sure if it was from the vaccine or the egg. he was sent home and advised to continue with benadryl. was again seen at ER the following night,  3/13/20. was given Decadron at that visit and epipen prescription. spoke to mother on 3/14/2020 and the rash finally went away as well as the fever. patient is doing better. pt will be seen for follow up next month per mom's request
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Musculoskeletal discomfort, Urinary tract infection
Clinical narrative: Developed UTI 3 days after vaccination. Having back, kidney area discomfort. Treated with antibiotic
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Gave the Hep A instead of Hep B.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, shivering, tiredness, pain at injection site
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Swelling
Clinical narrative: Client calls Health Department at 11:00 a.m. on 03/17/2020 and states that the location (right arm SQ) where she received her Varicella #2 vaccine on 03/16/2020 is "itchy and swollen". Advised client to come in to the Health Department for evaluation. Client arrives at Health Department at approximately 11:15 A.M. This nurse evaluated clients right arm where vaccine was administered.  This nurse observed a raised, reddened area about the size of a half dollar present on the back of the clients right arm. Client states that the "area is extremely itchy. I asked client if she has any areas of redness or itchiness anywhere else on her body. Client states "no". I advised client to apply an ice pack to the area to help reduce swelling and to take 50mg of Benadryl PO when she gets home. Also advised client that Benadryl could make her drowsy so be sure not to drive or operate heavy machinary while under the influence of this medication. Instructed client to return to clinic if these measures do not help and the area of inflammation gets worse. Client verbalized understanding and is agreeable with treatment  plan at this time. RN.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MMR, VARCEL
Symptoms: Erythema, Mobility decreased, Rash, Swelling
Clinical narrative: Client presented ( 2 days post-vaccine)  c/o limited motion in arm, redness,swelling and small bumps.  Instruction to ice and take ibuprofen per nursing.  Client was seen by N.P., and provided an RX for skin rash.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: This was second dose. I have been experiencing chills, nausea, headache, body aches. pain at injection site for past 20+ hours. I also noticed a burning sensation during the injection.   I did not have any pain or reaction to the first dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient experienced a tingling/numb sensation in her jaw a day after the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Rash
Clinical narrative: day after vaccine: rash on face, neck;                            headache, woozy;                            redness at injection site
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This third dose was actually due in January.; This spontaneous report was received from a healthcare professional regarding a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.    On unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  The patient had two doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and needed the third to complete the course. The reporter did not have Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) available in Trade, for him to purchase. The third dose was due in January 2020.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A pediatric dose of VAQTA on 3/5/2020 in error.; This spontaneous report as received from a license practical nurse, and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not provided.  On 05-MAR-2020, in error, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) lot number reported as "S023449" with expiration date on 24-AUG-2020 (dose number, route of administration and anatomical location were not reported) for prophylaxis.  Lot number S023449 is an invalid lot number for hepatitis a vaccine, inactivated.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue, Product use issue
Clinical narrative: 4 month-old child received the DTap-IPV portion of Pentacel vaccine received without the lypolized ActHIB portion/no AE; 4 month-old child received the DTap-IPV portion of Pentacel vaccine received without the lypolized ActHIB portion/no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old patient who received single second dose of only DTAP-IPV portion of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on 06-Mar-2020 without the lypolized ActHIB portion for prophylactic vaccination via intramuscular route in the left vastus lateralis(product preparation issue), (product use issue) [batch number and expiry date of Pentacel not reported; for ACT-HIB batch number UJ258AA  and expiry date 04-APR-2021; for DTAP- IPV batch number UJ315AA and expiry date 04-APR-2021 respectively]  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (no dosing details reported for both vaccines).  It was of actual medication error case due to inappropriate reconstitution technique and product use issue.  It was also reported that Patient will be re-immunized with Act-HIB from that 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 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: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Swelling of eyelid
Clinical narrative: Approximately 24 hours after the injection, my eyes began to itch and swell shut.  This was the exact same reaction as last year, however, I had a different flu injection last year - the one recommended for seniors.  I went to the ER as that was the only doctor available, who gave me a prescription for dexAMETHasone, which I took for two days and my eyes returned to normal.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed swelling and redness to the injection site  the day of vaccination.  This increased both in extent and redness over the next  3 days.  He did not have any other associated symptoms: no fever, generalized rash, difficulty breathing, swelling of the lips or tongue, or difficulty ambulating.  At its largest, the redness measured approximately 9 x 10cm.  Eight days after the injection his left thigh measured 2.5 cm larger in circumference compared to the right.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: MOM STATES PATIENT HAD SWELLING AND REDNESS TO INJECTION SITE STARTING ON 3/16/2020. DR. INSTRUCTED FAMILY TO CONTINUE WARM COMPRESS AND TO RTC IF IT DOES NOT IMPROVE OR GETS WORSE.  MOM HAD CALLED BACK LATER 3/16/2020 PATIENT HAD VOMITED X2 AND HAD 1 EPISODE OF DIARRHEA, DR. PRESCRIBED ZOFRAN.  SPOKE WITH MOM 3/17/2020, PER MOM PATIENT IS DOING BETTER, NO REDNESS OR SWELLING, VOMITING/ DIARRHEA HAS RESOLVED.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: MOM STATES PATIENT DEVELOPED SITE REDNESS AND SWELLING 3/12/2020, SHE WAS SEEN IN OFFICE BY DR. 3/12/2020, SHE STARTED HER ON CEPHALEXIN FOR CELLULITIS. SPOKE WITH MOM TODAY AND SYMPTOMS HAVE RESOLVED 3/17/2020.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE REDNESS AND SWELLING
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain
Clinical narrative: sore left side of neck ,pain with trying to turn head approximately 5 and half hours later.applied hea ting pad to left side of neck during the night approximately 10  to 12 hrs.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: tiredness on Day 2 and Day 3, much of the day chills on Day 2 and Day 3, but only occasionally subnormal temp 97.5 F on day 3,  Possibly on day 2 as well but didn't check actual temp.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Contraindication to vaccination
Clinical narrative: Prevnar 13 should have been administered first, then Pneumovax 23 due to patient taking a medication that may suppress her immune system (Tecfidera).
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Valor?s right shoulder has swollen up, there is about a 3 in circle of raised red tissue.  The tissue and muscle feels tight/hard and it is hot to the touch.  We noticed this about 24 hours after the vaccine was given.   I have called  Dr. office to report the Adverse reaction to the vaccination. They said to come in if it is not better by tomorrow.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Muscle tightness, Vaccination complication
Clinical narrative: Valor?s right shoulder has swollen up, there is about a 3 in circle of raised red tissue.  The tissue and muscle feels tight/hard and it is hot to the touch.  We noticed this about 24 hours after the vaccine was given.   I have called  Dr. office to report the Adverse reaction to the vaccination. They said to come in if it is not better by tomorrow.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Impaired work ability, Influenza like illness
Clinical narrative: Next morning developed welts/blotches on both arms.  Called doctor who recommended Benadryl; Benadryl helped. Next day neck and back pain started; ached all over like if had the Flu.  Thursday had to leave work early because was so achy. On Sunday, spoke to doctor on call since pain and achiness continued; doctor specified he had the same problems with the vaccine and recommended stretching/exercising and alternating 2 Naproxen with 2 Tylenol.  As of today, neck still is aching; it felt like the gripe/bad case of flu.  Patient has headaches sporadically and fatigue.   Pain level has not changed since Sunday. Recovery is at 80%.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Rash macular, Urticaria
Clinical narrative: Next morning developed welts/blotches on both arms.  Called doctor who recommended Benadryl; Benadryl helped. Next day neck and back pain started; ached all over like if had the Flu.  Thursday had to leave work early because was so achy. On Sunday, spoke to doctor on call since pain and achiness continued; doctor specified he had the same problems with the vaccine and recommended stretching/exercising and alternating 2 Naproxen with 2 Tylenol.  As of today, neck still is aching; it felt like the gripe/bad case of flu.  Patient has headaches sporadically and fatigue.   Pain level has not changed since Sunday. Recovery is at 80%.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Nasopharyngitis
Clinical narrative: Erythema (palm sized), chills, cold-like symptomes for 2 days
Age: 50.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash, Rash erythematous
Clinical narrative: the patient had a warm, swollen, red widespred rash that extended from the site of injection down to her elbow and up to her neck
Age: 50.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Skin warm, Swelling
Clinical narrative: the patient had a warm, swollen, red widespred rash that extended from the site of injection down to her elbow and up to her neck
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Decreased activity, Fatigue, Gait disturbance
Clinical narrative: Day of vaccine arm was very sore and next day was even worse; used cold pack.  Next day felt extremely ill, had slight fever, joint muscle pain was so severe that could hardly walk to the kitchen.  It felt like it was the worst case of flu you can have and she has never had.  Patient felt fatigued and was sleeping most of the timealmost bed ridden. Patient had limited activities for 2 days; felt fatigued and sleeping most of time almostwas bedridden.  Monday patient felt better but could not drive, felt too lethargic and sleepy.  For the pain, patient took Tylenol but also current medicine is supposed to help with pain.  On Saturday morning, patient contacted pharmacy to see what type of compresses to use. On Monday, contacted pharmacy again reporting that vaccine area was very red like a pale strawberry; there was a rash and swelling.  Monday afternoon felt alert enough to drive to grocery store.  By Monday night, arm was swollen and fiery red; rash was extreme. Patient did not contact the doctor on Monday.  Next day patient contacted pharmacist and was told to give it a few more days.  On Tuesday, rash was so bad, itchy and swollenarea expanded 3 inches from vaccination site; patient was using Cortaid.  In terms of progression, first, area was sore, then it was sore/rash, and then sore/rash/itch--as itch came rash came down.  On 3/10, patient went to dermatologist because of rash and sent back to her doctor.  Dermatologist concerned that there was an infection because symptoms were going backwards; since patient had been on antibiotics recently doctor checked for other things. The medicine the dermatologist prescribed did not work as well as doctors.  Next day 3/11, patient went to doctor, and rash had subsided quite a bit.  Patient told that if there is no improvement to call back.  Yesterday, was the first day that there was a tiny itch, continues to use Cortaid and energy came back.  Today still has itch, small red area and still using Cortaid.   Per internist, it is not unusual with 2nd shot to get rash while dermatologist said it was.  Patient had Zostavax vaccine with no problems.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Impaired driving ability, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Day of vaccine arm was very sore and next day was even worse; used cold pack.  Next day felt extremely ill, had slight fever, joint muscle pain was so severe that could hardly walk to the kitchen.  It felt like it was the worst case of flu you can have and she has never had.  Patient felt fatigued and was sleeping most of the timealmost bed ridden. Patient had limited activities for 2 days; felt fatigued and sleeping most of time almostwas bedridden.  Monday patient felt better but could not drive, felt too lethargic and sleepy.  For the pain, patient took Tylenol but also current medicine is supposed to help with pain.  On Saturday morning, patient contacted pharmacy to see what type of compresses to use. On Monday, contacted pharmacy again reporting that vaccine area was very red like a pale strawberry; there was a rash and swelling.  Monday afternoon felt alert enough to drive to grocery store.  By Monday night, arm was swollen and fiery red; rash was extreme. Patient did not contact the doctor on Monday.  Next day patient contacted pharmacist and was told to give it a few more days.  On Tuesday, rash was so bad, itchy and swollenarea expanded 3 inches from vaccination site; patient was using Cortaid.  In terms of progression, first, area was sore, then it was sore/rash, and then sore/rash/itch--as itch came rash came down.  On 3/10, patient went to dermatologist because of rash and sent back to her doctor.  Dermatologist concerned that there was an infection because symptoms were going backwards; since patient had been on antibiotics recently doctor checked for other things. The medicine the dermatologist prescribed did not work as well as doctors.  Next day 3/11, patient went to doctor, and rash had subsided quite a bit.  Patient told that if there is no improvement to call back.  Yesterday, was the first day that there was a tiny itch, continues to use Cortaid and energy came back.  Today still has itch, small red area and still using Cortaid.   Per internist, it is not unusual with 2nd shot to get rash while dermatologist said it was.  Patient had Zostavax vaccine with no problems.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Lethargy, Malaise, Myalgia
Clinical narrative: Day of vaccine arm was very sore and next day was even worse; used cold pack.  Next day felt extremely ill, had slight fever, joint muscle pain was so severe that could hardly walk to the kitchen.  It felt like it was the worst case of flu you can have and she has never had.  Patient felt fatigued and was sleeping most of the timealmost bed ridden. Patient had limited activities for 2 days; felt fatigued and sleeping most of time almostwas bedridden.  Monday patient felt better but could not drive, felt too lethargic and sleepy.  For the pain, patient took Tylenol but also current medicine is supposed to help with pain.  On Saturday morning, patient contacted pharmacy to see what type of compresses to use. On Monday, contacted pharmacy again reporting that vaccine area was very red like a pale strawberry; there was a rash and swelling.  Monday afternoon felt alert enough to drive to grocery store.  By Monday night, arm was swollen and fiery red; rash was extreme. Patient did not contact the doctor on Monday.  Next day patient contacted pharmacist and was told to give it a few more days.  On Tuesday, rash was so bad, itchy and swollenarea expanded 3 inches from vaccination site; patient was using Cortaid.  In terms of progression, first, area was sore, then it was sore/rash, and then sore/rash/itch--as itch came rash came down.  On 3/10, patient went to dermatologist because of rash and sent back to her doctor.  Dermatologist concerned that there was an infection because symptoms were going backwards; since patient had been on antibiotics recently doctor checked for other things. The medicine the dermatologist prescribed did not work as well as doctors.  Next day 3/11, patient went to doctor, and rash had subsided quite a bit.  Patient told that if there is no improvement to call back.  Yesterday, was the first day that there was a tiny itch, continues to use Cortaid and energy came back.  Today still has itch, small red area and still using Cortaid.   Per internist, it is not unusual with 2nd shot to get rash while dermatologist said it was.  Patient had Zostavax vaccine with no problems.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Day of vaccine arm was very sore and next day was even worse; used cold pack.  Next day felt extremely ill, had slight fever, joint muscle pain was so severe that could hardly walk to the kitchen.  It felt like it was the worst case of flu you can have and she has never had.  Patient felt fatigued and was sleeping most of the timealmost bed ridden. Patient had limited activities for 2 days; felt fatigued and sleeping most of time almostwas bedridden.  Monday patient felt better but could not drive, felt too lethargic and sleepy.  For the pain, patient took Tylenol but also current medicine is supposed to help with pain.  On Saturday morning, patient contacted pharmacy to see what type of compresses to use. On Monday, contacted pharmacy again reporting that vaccine area was very red like a pale strawberry; there was a rash and swelling.  Monday afternoon felt alert enough to drive to grocery store.  By Monday night, arm was swollen and fiery red; rash was extreme. Patient did not contact the doctor on Monday.  Next day patient contacted pharmacist and was told to give it a few more days.  On Tuesday, rash was so bad, itchy and swollenarea expanded 3 inches from vaccination site; patient was using Cortaid.  In terms of progression, first, area was sore, then it was sore/rash, and then sore/rash/itch--as itch came rash came down.  On 3/10, patient went to dermatologist because of rash and sent back to her doctor.  Dermatologist concerned that there was an infection because symptoms were going backwards; since patient had been on antibiotics recently doctor checked for other things. The medicine the dermatologist prescribed did not work as well as doctors.  Next day 3/11, patient went to doctor, and rash had subsided quite a bit.  Patient told that if there is no improvement to call back.  Yesterday, was the first day that there was a tiny itch, continues to use Cortaid and energy came back.  Today still has itch, small red area and still using Cortaid.   Per internist, it is not unusual with 2nd shot to get rash while dermatologist said it was.  Patient had Zostavax vaccine with no problems.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient reports reddish, pink spots appeared on her left arm the day after her injection. One spot around injection site, one down by her forearm, and one near the wrist. The spots became very itchy, then turned into blisters that lasted for 2 weeks after injection. She reports a fever of 101 degrees F off an on throughout the 2 weeks after injection. Additional pink spots appeared bilaterally on her arms, legs, stomach, and breasts. She estimates during the 2 week period post-vaccination she had about 20 spots that turned into blisters. All were extremely itchy, but otherwise not problematic.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Patient reports reddish, pink spots appeared on her left arm the day after her injection. One spot around injection site, one down by her forearm, and one near the wrist. The spots became very itchy, then turned into blisters that lasted for 2 weeks after injection. She reports a fever of 101 degrees F off an on throughout the 2 weeks after injection. Additional pink spots appeared bilaterally on her arms, legs, stomach, and breasts. She estimates during the 2 week period post-vaccination she had about 20 spots that turned into blisters. All were extremely itchy, but otherwise not problematic.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Myalgia
Clinical narrative: DELTOID MUSCLE PAIN COMES AND GOES, LIMITED ARM MOBITLITY AT 5 MONTHS AFTER VACCINE