chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Burning sensation, Chills, Feeling abnormal, Malaise, Muscle rigidity
Clinical narrative: This is a spontaneous report from a contactable nurse (mother).  A 17-year-old female patient received the first dose TRUMENBA (lot number S85201; expiration date: 30Dec2019), via an unspecified route of administration on 19Jul2018 at a single dose for Meningitis B. The patient's medical history and concomitant medications were not reported. The mother stated that she had identical twins 17 year old daughters and were pretty small for their age only like a 100 pounds. It was stated that the mother and her daughter's went to their pediatrician on 19Jul2018 (Thursday) and had the meningococcal group b rlp2086 first shot given to them of the vaccines for the meningitis B. It was mentioned that the patient (one of the reporter's daughter) don't feel well (Jul2018). The patient stated that she had chills and nausea. The mother thought that the patient was going to faint as she was coming down the stairs with thought she going to faint. The patient came on the couch and then she was kinda caught up in bond. The patient was very rigid and very tense and very stiff. The mother then asked if what's going on in the patient's body but can't explain it. The patient described it that it just feel like there's poison running through her body. The mother just freaked out and ended up calling the pediatrician back but didn't hear back from them. The mother then drove to their office and spoke to the nurse. The nurse mentioned that she doesn't think that it was a side effect. The mother then narrated that the patient actually ate a good dinner later and she was starting to feel a little bit better and then she went to bed. The patient then woke up and stated that it was all kind of coming back. The mother then asked what it feels like. The patient then stated that she was like a burning. The patient later elaborated that she woke up with the high fever. The mother didn't check the temperature because she just wanted to bring the patient right over to the pediatrician but she felt warm like probably like 101, 102 so the mother bought her to the doctor's office. The doctor later stated that he mother probably just "chalking up to patient" kind of being like a perfect storm in her body. The patient later stated that like her body was going to start a period or hormones like all this stuff was going on and she said maybe if she wasn't going to start a period she would only have the two symptoms like her twin sister. So the mother kind of left with the feeling like a little more comfortable thinking alright perfect storm in patient body she maybe she would have just have had what her twin sister had if she haven't been starting her periods. The outcome of the adverse events was unknown.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal stiffness, Nausea, Pyrexia, Tension
Clinical narrative: This is a spontaneous report from a contactable nurse (mother).  A 17-year-old female patient received the first dose TRUMENBA (lot number S85201; expiration date: 30Dec2019), via an unspecified route of administration on 19Jul2018 at a single dose for Meningitis B. The patient's medical history and concomitant medications were not reported. The mother stated that she had identical twins 17 year old daughters and were pretty small for their age only like a 100 pounds. It was stated that the mother and her daughter's went to their pediatrician on 19Jul2018 (Thursday) and had the meningococcal group b rlp2086 first shot given to them of the vaccines for the meningitis B. It was mentioned that the patient (one of the reporter's daughter) don't feel well (Jul2018). The patient stated that she had chills and nausea. The mother thought that the patient was going to faint as she was coming down the stairs with thought she going to faint. The patient came on the couch and then she was kinda caught up in bond. The patient was very rigid and very tense and very stiff. The mother then asked if what's going on in the patient's body but can't explain it. The patient described it that it just feel like there's poison running through her body. The mother just freaked out and ended up calling the pediatrician back but didn't hear back from them. The mother then drove to their office and spoke to the nurse. The nurse mentioned that she doesn't think that it was a side effect. The mother then narrated that the patient actually ate a good dinner later and she was starting to feel a little bit better and then she went to bed. The patient then woke up and stated that it was all kind of coming back. The mother then asked what it feels like. The patient then stated that she was like a burning. The patient later elaborated that she woke up with the high fever. The mother didn't check the temperature because she just wanted to bring the patient right over to the pediatrician but she felt warm like probably like 101, 102 so the mother bought her to the doctor's office. The doctor later stated that he mother probably just "chalking up to patient" kind of being like a perfect storm in her body. The patient later stated that like her body was going to start a period or hormones like all this stuff was going on and she said maybe if she wasn't going to start a period she would only have the two symptoms like her twin sister. So the mother kind of left with the feeling like a little more comfortable thinking alright perfect storm in patient body she maybe she would have just have had what her twin sister had if she haven't been starting her periods. The outcome of the adverse events was unknown.
Age: 4.0
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a four-years old patient (gender not reported) who received a IPOL from a IPOL shipment should be returned due to it being in transport a day longer than it should have, no adverse event. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose 0.5 ml of suspect IPOL lot N1K92 via unknown route in unknown administration site. Caller reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Caller stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Caller stated that she had already talked to someone about returning the shipment.  Lab data and corrective treatment: not applicable. 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. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 12-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked with: 2018SA203963 (same reporter, same suspect). This case involves a female patient (gender and age not reported) who experienced vaccine underdose and syringe broke while the vaccine was being given, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history and concomitant medication were not provided. On 06-Jul-2018, the patient received a partial dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5875AA, expiry date-14 Feb 2020. It was a case of actual medication error due to vaccine underdose (underdose). It was also a case of (syringe issue). It was unclear whether the flange was cracked before. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTP
Symptoms: Urticaria
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a patients mother. This case involves male patient (age not reported) who experienced hives all over his arm, while he received vaccine DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious hives all over his arm (urticaria) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. (Other relevant tests included no lab test.) Final diagnosis was hives all over his arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hives all over his arm.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Product preparation error
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who had "extra hib" that was administered and hib portion of the PENTACEL only mixed with a vial of distilled water, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ. The nurse called to report that Hib portion of the PENTACEL only mixed with a vial of distilled water that came with the MMR vaccination in the office. The pediatric doctor realized that the PENTACEL did not get reconstituted as recommended with the PENTACEL liquid component  correctly on 09Jun2018 to a male pediatric patient by another pediatric nurse at the office. This dose on 09Jun2018 was administer in the left thigh of the pediatric patient and this patient only received the HIB portion of the vaccine. The error was realized by the attending doctor and the mother was contacted to come in for a correct PENTACEL dose. Other vaccination administered that day to patient: ROTATEQ (by Merck.) The nurse calling today reported that a full single .5 ml dose PENTACEL vaccine was correctly administered on 17Jun2018 by herself since she is aware that the first vaccine is not valid. The attending doctor on 17Jun2018. She wanted us to know that the mother was concerned about the "extra HIB" that was administered due to this error with the PENTACEL and wanted to know if this "was harmful." Provided the nurse with our recommendations for this event and did discuss the Reconstitution Guide as a resource for the office staff. The Lot number to the PENTACEL HIB vial was C5439AA and the MMR diluent not available (another manufacturer and not available in computer.) The portion of the PENTACEL with the Polio, Diptheria and Pertussis that was NOT given on 09Jun2018 has a lot number of C5264AA. The nurse reported that she has the Lot number of C5438AA for the correctly administered PENTACEL from 17Jun2018 but did not have the liquid component of the vaccine Lot number because they only record the reconstituted lot number only in their records (Liquid portion LOT number with Polio, Diptheria and Pertussis NOT available for template.) This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a four-months old patient (gender not reported) who was administered PENTACEL without diluent. This was actual medication error case, as the patient received vaccine without diluent (product preparation error). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 18-Jul-2018, the patient received a dose of 0.5 ml of suspect PENTACEL lot number, exp date not reported via intramuscular route in the right thigh. It was not reported if the patient experienced any adverse event. Lab data and corrective treatment: not applicable. Outcome: not applicable.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a four-years old patient (gender not reported) who received a IPOL from a Ipol shipment should be returned due to it being in transport a day longer than it should have, no adverse event. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose 0.5 ml of suspect IPV (VERO) lot N1K92 via unknown route in unknown administration site. Caller reported that by the time they received notification that their Ipol shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Caller stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Caller stated that she had already talked to someone about returning the shipment.  Lab data and corrective treatment: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 14 months old patient who experienced patient received expired vaccine, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation. On 19-Jul-2018, the patient received a 0.5 ml once dose of suspect PENTACEL lot C5219AA, expiry date-17-Jul-2018 in the left thigh, DTAP/IPV portion- C5390AA Expiry date- 17-Jul-2018. It was a case of actual medication error due to expired vaccine used. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the. 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: 68.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old male patient who was vaccinated with DAPTACEL instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: None.
Age: 18.0
Sex: F
Vaccine: MENB, HPV9, MENB
Symptoms: Back pain, Chills, Headache, Mobility decreased, Pain
Clinical narrative: Painful, can not lift arm at shoulder, pain in back (worse when walking), fever started the night of up to 101F, chills, headache.
Age: 18.0
Sex: F
Vaccine: MENB, HPV9, MENB
Symptoms: Pyrexia
Clinical narrative: Painful, can not lift arm at shoulder, pain in back (worse when walking), fever started the night of up to 101F, chills, headache.
Age: 18.0
Sex: F
Vaccine: MENB, HPV9, MENB
Symptoms: Back pain, Musculoskeletal stiffness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Painful, can not lift arm at shoulder, pain in back (worse when walking), fever started the night of up to 101F, chills, headache.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Pain on left arm shoulder, tired, lack of energy, fain feeling, swollen left upper arm, warm to the touch low grade fever.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Pain on left arm shoulder, tired, lack of energy, fain feeling, swollen left upper arm, warm to the touch low grade fever.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Cough, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Around 9pm on 06/29/2018 patient started with a cough and runny nose. On Saturday 06/30/2018 the immunization area was very big, very red, warm to touch and hard. I drew a circle around it to make sure it didn't spread and kept a close eye on it while using ibuprofen and TYLENOL alternating doses for pain and swelling. I called the doctors office Monday and they got her in and checked her out, said to keep a close eye on it and if it spread or got worse bring her back. We are at a month later and she still has a hard pea sized bump in immunization spot and you can still see the area that was all swollen and red. Talked to Drs. office this morning 07/26/2018 around 11am and they said to keep an eye on it and they were going to talk to Dr. to see if he wants to see her.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Rhinorrhoea
Clinical narrative: Around 9pm on 06/29/2018 patient started with a cough and runny nose. On Saturday 06/30/2018 the immunization area was very big, very red, warm to touch and hard. I drew a circle around it to make sure it didn't spread and kept a close eye on it while using ibuprofen and TYLENOL alternating doses for pain and swelling. I called the doctors office Monday and they got her in and checked her out, said to keep a close eye on it and if it spread or got worse bring her back. We are at a month later and she still has a hard pea sized bump in immunization spot and you can still see the area that was all swollen and red. Talked to Drs. office this morning 07/26/2018 around 11am and they said to keep an eye on it and they were going to talk to Dr. to see if he wants to see her.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Soreness in arm at injection site at time of injection and for several days after; fever, flu-like aches, weakness about 12 hours after injection which lasted for 1 or 2 days. Also upset stomach but may not be associated with vaccine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Muscle and joint pain at 3hrs post injection (injection site also). 12hrs Post injection woke with headache, dizzy, severe muscle, skin, and joint pain, nausea, tiredness and brain fog from all the rush of symptoms.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Injection site pain, Myalgia, Nausea, Pain of skin
Clinical narrative: Muscle and joint pain at 3hrs post injection (injection site also). 12hrs Post injection woke with headache, dizzy, severe muscle, skin, and joint pain, nausea, tiredness and brain fog from all the rush of symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Significant edema, erythema (extending 13cm circumferentially), increased warmth, and pruritus to injection site.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 88-year-old male patient who received SHINGRIX for prophylaxis. On 11th May 2018 12:41, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was recovered/resolved. It was unknown if the reporter considered the localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm. The patient experienced a red patch of 2 by 2 inches in size about an inch down from the area of the shot. It lasted for about total of 2 to 3 days. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of stiff neck in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced stiff neck, pain in arm, headache and blister. On an unknown date, the outcome of the stiff neck, pain in arm and headache were unknown and the outcome of the blister was recovered/resolved. The reporter considered the stiff neck, pain in arm, headache and blister to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. Twenty four hours after receiving vaccination, the patient experienced sore arm, stiff neck and headache. Forty eight hours after receiving vaccination, the patient experienced fluid filled blisters on right leg clearing 5 days later.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient returned to the pharmacy on 7/26/18 at 10:30AM with a swollen arm and red arm that was warm to touch. The reaction was similar to that of a bee sting. I asked her how she was feeling, and she stated she felt a lot of soreness in the arm as well as weakness. I used a cold pack to help alleviate the soreness in her arm and instructed her to take diphenhydramine when she gets home, and to contact EMS if she her condition gets worse.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was scheduled for his second SHINGRIX vaccine, and was given Varicella in error. Pt suffered no ill effects from the Varicella vaccine. Our local HD was notified as was the patient of this error. His physician was also notified.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives on upper torso and arms, mild fever.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Blood count normal, Blood smear test abnormal, Contusion, Gingival bleeding, Immune thrombocytopenic purpura
Clinical narrative: Development of severe bruising, gum bleeding, and petechia rash, starting around 5/18/2018. Blood test from ER on 5/21/2018 showed a low platelet count of 4, but all other blood counts were normal. His symptoms, blood results, and blood smear reviewed by hematology doctors are consistent with the diagnosis of idiopathic thrombocytopenia purpura (ITP). His ITP was treated with IVIG. Still ongoing with monitoring of platelet count via blood labs bi-weekly.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Development of severe bruising, gum bleeding, and petechia rash, starting around 5/18/2018. Blood test from ER on 5/21/2018 showed a low platelet count of 4, but all other blood counts were normal. His symptoms, blood results, and blood smear reviewed by hematology doctors are consistent with the diagnosis of idiopathic thrombocytopenia purpura (ITP). His ITP was treated with IVIG. Still ongoing with monitoring of platelet count via blood labs bi-weekly.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: PROQUAD and KINRIX administered to patient on 7/25/18 at 9:30am after his routine well child exam. Mother then brought him to school. Mother received a call from the school nurse around 2pm letting her know patient had developed an itchy rash under each armpit. Mother picked patient up from school and brought him home. She reports the rash was on his trunk at this time. Through the evening mother administered BENADRYL every 6 hours. At 8am patient was in the office for an evaluation. Diffuse generalized hives noted throughout his body including his face. No facial swelling, cough or wheeze noted. Rash very itchy. CLARITIN administered in the office with moderate effect. Prednisone (15mg/5ml) 5ml PO BID x 5 days was prescribed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient states there is tenderness in a large area of the injection site.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Crying, Culture urine negative, Decreased appetite, Irritability
Clinical narrative: 3 blisters on chest developed on 7/18/18 and then scabbed/resolved after 2 days. Fever for 24-36 hours at that time. Fever resolved. On 7/21/18 she developed fever. Tmax 102. Fever persisted until 7/24/18. Concurrent lip smacking, fussiness, crying out at night. Erythematous macular rash over buttocks started 7/25/18. Mother reports she is complaining of mouth pain. Decreased appetite but drinking ok.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Oral pain, Pyrexia, Rash macular, Scab, Tardive dyskinesia
Clinical narrative: 3 blisters on chest developed on 7/18/18 and then scabbed/resolved after 2 days. Fever for 24-36 hours at that time. Fever resolved. On 7/21/18 she developed fever. Tmax 102. Fever persisted until 7/24/18. Concurrent lip smacking, fussiness, crying out at night. Erythematous macular rash over buttocks started 7/25/18. Mother reports she is complaining of mouth pain. Decreased appetite but drinking ok.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: 3 blisters on chest developed on 7/18/18 and then scabbed/resolved after 2 days. Fever for 24-36 hours at that time. Fever resolved. On 7/21/18 she developed fever. Tmax 102. Fever persisted until 7/24/18. Concurrent lip smacking, fussiness, crying out at night. Erythematous macular rash over buttocks started 7/25/18. Mother reports she is complaining of mouth pain. Decreased appetite but drinking ok.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Dyspnoea, Tachycardia
Clinical narrative: Cellulitis, dyspnea, tachycardia.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Induration, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: Cellulitis, dyspnea, tachycardia.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Eye swelling, Injection site pain, Lip swelling, Throat irritation, Vomiting
Clinical narrative: Pt woke at 0200 on 7/26/18 with vomiting x 7. Then again at 0730 x 5 had emesis. Top lip swollen. No tongue swelling, no SOB, No wheeze, No chest tightness, No rash. The injection site was without induration, redness, swelling, no rash. Pt stated it was tender to touch. No fever-but possible low grade fever per mom. Mom called with sx and also explained she gave Benedryl 25mg x 1 by mouth at 0800. Pt had a banana and water with Benedryl admin. Reviewed with mom signs and sx of what to watch for for indication to go to ER. Mom verbalized understanding and was comfortable with plan. Apply cool wash cloth to lips and monitor for any changes in swelling, breathing problems. Mom then called back at 1030 explaining that his eye was starting to swell, hand another episode of vomiting from water ingestion and was worried about dehydration. At this point the pt still without sx of tongue swelling or any breathing concerns. Employee spoke to mom --encouraged to go to ER if worried. Mom comfortable with waiting. Around 11am mom called stating she is taking to ER now because of throat feeling itchy. Employee went to ER to check on pt and he was given a dose of Decadron and Phenergan--released in stable condition. R.N.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Swelling face
Clinical narrative: Patient got swelling in the injection site about 2-3 inches in diameter 1 day after the injection and swelling in the left side mandibular jaw, shin and lip. Patient took ibuprofen otc and CLARITIN beginning the day the swelling occured. Patient reported to the primary physician and was prescribed Valacyclovir 500mg four times a day for 6 days. Patient has yet to pick up the medication. Patient said the swelling started to subside on the 4th day even though she has not taken the anti-viral drug.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Erythema, Injection site abscess, Injection site extravasation, Injection site induration, Injection site mass
Clinical narrative: Reports developing injection site reaction about 5-7 days following vaccination, followed by fevers beginning 6/22/18. Was seen by medical provider on 6/25/18 for fevers and arm redness, swelling, and warmth, given antibiotics. Fevers resolved and arm tenderness decreased, but a hard lump remained at injection site. On 7/22/18, lump began leaking fluid. Reported to medical provider on 7/23/18, where she was told she had an abscess and would require wound care.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Reports developing injection site reaction about 5-7 days following vaccination, followed by fevers beginning 6/22/18. Was seen by medical provider on 6/25/18 for fevers and arm redness, swelling, and warmth, given antibiotics. Fevers resolved and arm tenderness decreased, but a hard lump remained at injection site. On 7/22/18, lump began leaking fluid. Reported to medical provider on 7/23/18, where she was told she had an abscess and would require wound care.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site cellulitis, Injection site discharge, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Reports developing injection site reaction about 5-7 days following vaccination, followed by fevers beginning 6/22/18. Was seen by medical provider on 6/25/18 for fevers and arm redness, swelling, and warmth, given antibiotics. Fevers resolved and arm tenderness decreased, but a hard lump remained at injection site. On 7/22/18, lump began leaking fluid. Reported to medical provider on 7/23/18, where she was told she had an abscess and would require wound care.
Age: 56.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Injection site swelling, Local reaction, Measles antibody negative, Pyrexia, Wound abscess
Clinical narrative: Reports developing injection site reaction about 5-7 days following vaccination, followed by fevers beginning 6/22/18. Was seen by medical provider on 6/25/18 for fevers and arm redness, swelling, and warmth, given antibiotics. Fevers resolved and arm tenderness decreased, but a hard lump remained at injection site. On 7/22/18, lump began leaking fluid. Reported to medical provider on 7/23/18, where she was told she had an abscess and would require wound care.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has red, raised area under his right bicep. The affected area is not hot.
Sex: U
Vaccine: RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: 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 medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, during as reported "2 month well visit", the patient was vaccinated with ROTARIX. On an unknown date, during the patient's "4 month well visit", the patient was vaccinated with a dose of ROTATEQ lot # N030175, expiry date 16-JUN-2019 (also reported as 15-JUN-2019), orally (exact dose was not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HEPA
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Intensive care, Paraesthesia oral
Clinical narrative: This literature marketed report has been received from the authors of a published article, titled as stated above and refers to a 57-year old female patient. Her medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, she presented with dyspnea, wheezing, throat tightness and worsening angioedema of the face and was admitted to the critical care unit, where an extensive review of her history did not reveal any suspicious ingestion or skin exposure. The patient was treated with parenteral antihistamines and high dose methylprednisolone. However, her symptoms including angioedema persisted, with further development of hives and lip paresthesia. Intermittent epinephrine intramuscular (IM) injection provided temporary relief. Further exploration of her history revealed that the patient received the hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided) vaccination two days prior to onset of symptoms. Treatment with systemic glucocorticoids continued for 2 weeks with a combination of diphenhydramine, famotidine, cetirizine, montelukast, and hydroxyzine added. The outcome of anaphylactic reaction and angioedema was unknown, however it was also provided that she slowly improved on this regimen. The reporter considered protracted anaphylaxis and angioedema to be related to hepatitis a vaccine, inactivated (manufacturer unknown). Upon internal review, the events of anaphylactic reaction and angioedema were considered to be medically significant.
Sex: F
Vaccine: HEPA
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: This literature marketed report has been received from the authors of a published article, titled as stated above and refers to a 57-year old female patient. Her medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, she presented with dyspnea, wheezing, throat tightness and worsening angioedema of the face and was admitted to the critical care unit, where an extensive review of her history did not reveal any suspicious ingestion or skin exposure. The patient was treated with parenteral antihistamines and high dose methylprednisolone. However, her symptoms including angioedema persisted, with further development of hives and lip paresthesia. Intermittent epinephrine intramuscular (IM) injection provided temporary relief. Further exploration of her history revealed that the patient received the hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided) vaccination two days prior to onset of symptoms. Treatment with systemic glucocorticoids continued for 2 weeks with a combination of diphenhydramine, famotidine, cetirizine, montelukast, and hydroxyzine added. The outcome of anaphylactic reaction and angioedema was unknown, however it was also provided that she slowly improved on this regimen. The reporter considered protracted anaphylaxis and angioedema to be related to hepatitis a vaccine, inactivated (manufacturer unknown). Upon internal review, the events of anaphylactic reaction and angioedema were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The date of birth of the patient was unknown. The age at vaccination was not reported. The pain was so bad that the patient could not raise her arm for 4 days. It hurt more than any other vaccine which the patient had received. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 19-Jul-2018 regarding an unsolicited pregnancy valid non-serious case received from a nurse. This case involves a 33 years old female patient who experienced swelling and redness at the injection site, while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported occurred at unknown gestation period. The date of last menstrual period was reported as 8 Dec 2017. The estimated due date is 15-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient previously received ADACEL dose in 2014. On an unknown date, the patient received a booster dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number not reported via subcutaneous route instead of intramuscular route, used ¾ needle. The patient developed a non-serious swelling and redness at the injection site (vaccination site inflammation) (Unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. Patient did not have any fever or shortness of breath at this time. It is an actual medication error due to inappropriate route of vaccination. Other relevant tests included No lab data. Final diagnosis was swelling and redness at the injection site. Corrective treatment included ice pack treatment. The patient outcome is reported as Unknown for swelling and redness at the injection site. Additionally, at time of reporting, the pregnancy is still ongoing. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: After 2nd dose, patient experienced arm pain, fever, and flu-like symptoms for 24 hours after administration.
Age: 0.58
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Injection site warmth, Posture abnormal, Pyrexia, Tremor
Clinical narrative: Of course heat in injection area and small fever but I am worried about her having spasms or convulsions, mostly when eating, she will bite down extremely hard and start full body shakes and she has a strong neck and has been able to hold her head up fine for a couple of months but since her vaccinations she acts like her head is to heavy for her to hold up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Severe arm pain, stiff neck, fever that occurred within 24 hours of administration and lasted for 1 day.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Injection site red, swollen, tender, some what pruritic. Macular rash on abdomen. The reaction occurred within 24 hr of injection. Macular rash on abdomen occurred approximately 48 hr after injection. Patient instructed to take BENADRYL for rash.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Rash macular
Clinical narrative: Injection site red, swollen, tender, some what pruritic. Macular rash on abdomen. The reaction occurred within 24 hr of injection. Macular rash on abdomen occurred approximately 48 hr after injection. Patient instructed to take BENADRYL for rash.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient stated she experienced red, itchy skin at injection site area that persisted for several days.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site urticaria, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever, chills, hives around area vaccine given.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Administration site reaction, Administration site swelling, Erythema
Clinical narrative: Red swollen skin on site of administration occurred 24 hours after administration.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Red swollen skin on site of administration occurred 24 hours after administration.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Red swollen skin on site of administration occurred 24 hours after administration.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: Dizziness, nausea and near syncope. Gave him alcohol swab to sniff on, had him lay down and gave him water to drink. Monitored vital signs. Patient felt better after 10-15 minutes.
Age: 32.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose instead of an adult dose. Patient was given a new apt for 07/27/18 to administer correct adult dose, patient is aware of situation and agreed to come in clinic. Pt did not state to have any abnormal symptoms.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient reports redness and hard feeling at injection site 2 months from injection.
Age: 33.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Underdose
Clinical narrative: Patient was given a pediatric dose of HEP A instead of an adult dose. Patient was given an apt on 07/26/18 to administer correct adult dose, patient is aware of situation and agreed to come in clinic. Pt did not state to have any abnormal symptoms.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site plaque, Injection site warmth
Clinical narrative: 4.5 in diameter erythematous plaque to right upper arm, warm to touch and tender to touch.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Injection site haemorrhage, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: Bleeding at injection site. Nausea and dizziness. Pain radiating up the neck and through the shoulder blade.
Age: 36.0
Sex: F
Vaccine: HEPA
Symptoms: Pain
Clinical narrative: Bleeding at injection site. Nausea and dizziness. Pain radiating up the neck and through the shoulder blade.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Nausea, Syncope
Clinical narrative: Employee reported feeling lightheaded and fainted approximately 5 minutes after vaccination. Loss of consciousness approximately 5 seconds. When employee woke up, he reported feeling nauseous and warm. Employee recovered quickly (5 minutes).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient experienced swelling at the injection site that has now persisted for 6 days as well as redness and warmth. Also the day after the vaccine she had 3 raised blisters on her index finger that resolved after she popped them that day. She is following up by going to her physician tomorrow.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hyperaesthesia, Migraine, Nausea, Pain
Clinical narrative: Pain over entire body (sensitive to bed sheets touching the patient's skin), migraine with nausea, fatigue. All symptoms lasted 2 days before resolving completely.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Loss of consciousness, Pyrexia, Vomiting
Clinical narrative: MOTHER WAS CONCERNED WHEN CHILD DEVELOPED A FEVER, VOMITING AND PASSED OUT. MOTHER STATED SHE DID NOT TAKE CHILD TO THE HOSPITAL BECAUSE CHILD FELT BETTER.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Patient reports that her arm is itchy and had raised red bumps around the injection site. No systemic reactions were reported.