chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 61-year-old female patient who received SHINGRIX (batch number P539L, expiry date unknown) for prophylaxis. On 25th February 2018, 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 injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in left arm. The pharmacist stated that, the patient experienced a rash at the injection site. The rash was about 3 inches in height and no width information. In 2018, the patient had recovered from the rash.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 36 years old patient who experienced patient was administered vaccine that had been out of recommended temperature range for 8 days, while he/she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2018, the patient received a 0.5 ml single dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot NIK811M; expiry date: - 19-Oct-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was not reported whether the patient experienced any adverse events 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. Documents held by sender: none
Sex: U
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial unsolicited report received from a nurse on 09-Aug-2018. This case involves a six month old patient (gender not reported) who was vaccinated with a dose of PENTACEL (Batch number: C5545AA, expiration date: 06-Oct-2019, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate reconstitution technique. It was reported that, the ACTHIB was reconstituted with sterile water and administered to a six month old child and the DTap-IPV portion was not administered. It was not known whether the patient had any adverse event. 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: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Adult female patient who experienced pink/red patch (discoloration) and soreness, while she received vaccine IMOVAX RABIES. The patient's past vaccination(s) included IMOVAX rabies with Patient received her 1st injection in her left arm but did not give the date she received the injection. The patient's other past medical history, medical treatment(s) and family history were not provided. On 10-Aug-2018, the patient received a second dose of suspect IMOVAX RABIES lot N16401M, expiry date 29 July 2019 via intramuscular route in the right arm. On an unspecified date, post vaccination patient developed a non-serious pink/red patch at the site and vaccination site erythema and pink/red patch at the site and soreness. It was reported that, patient got injection at the emergency department. Lab data not reported. Final diagnosis was pink/red patch at the site and soreness. No corrective treatment was received (States it was not treated because she doesn't go back until tomorrow.). The patient outcome is reported as Unknown for pink/red patch at the site and soreness and as Unknown for pink/red patch at the site and soreness.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ, TDAP
Symptoms: Fatigue, Headache, Optic nerve disorder, Pain in extremity
Clinical narrative: Initial information received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 11 years old male patient who experienced arm pain from the injection, tiredness, headache and optic nerve was elevated, while he received vaccines HPV VACCINE, TDAP and MENACTRA. The patient's past medical history included Headache. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 02-Aug-2018, the patient received a first dose of suspect MENACTRA lot number not reported via unknown route. On 02-Aug-2018, the patient received a dose of suspect TDAP not produced by Sanofi Pasteur lot number not reported via unknown route. On 02-Aug-2018, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported. The patient developed a non-serious arm pain from the injection following the administration of MENACTRA, following the administration of TDAP and following the administration of HPV VACCINE. The patient developed a non-serious tiredness following the administration of MENACTRA, following the administration of TDAP and following the administration of HPV VACCINE. The patient developed a non-serious headache following the administration of MENACTRA, following the administration of TDAP and following the administration of HPV VACCINE. The patient developed a non-serious optic nerve was elevated (optic nerve disorder) following the administration of MENACTRA, following the administration of TDAP and following the administration of HPV VACCINE. (Other relevant tests included No lab test.) Final diagnosis was optic nerve was elevated, headache, tiredness and arm pain from the injection. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for arm pain from the injection, as Unknown for tiredness, as Unknown for headache and as Unknown for optic nerve was elevated.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case was linked with 2018SA226678, 2018SA226687 and 2018SA226689. This case involves a 17 years old female patient who administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA and TRUMENBA in the same visit. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Aug-2018, the patient received 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA, expiry date- 09 Oct 2019 in the right deltoid. It was a case of actual medication error due to Deteriorated drug administered. 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: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a unknown. This case was linked with 2018SA226678, 2018SA226687 and 2018SA226688. This case involves a 17 years old female patient who administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA and TRUMENBA in the same visit. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Aug-2018, the patient received a first dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (Lot U6016AA), in the right deltoid and HPV Vaccine VLP RL1 4V (Yeast) on same visit. It was a case of actual medication error due to poor quality drug administered. (Other relevant tests included No lab test.) Final diagnosis was MENACTRA shipment at 3 days instead of 2 days and administered. The patient outcome is reported as Not Applicable for MENACTRA shipment at 3 days instead of 2 days and administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who experienced 17 year old girl who received an extra dose of MENACTRA, while she received vaccine MENACTRA. 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 MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA in left deltoid. It was a case of actual actual medication error due to extra dose administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from other health professional on 14-Aug-2018. This case involves a male patient (age not reported) who was vaccinated with 0.5 ml dose of ADACEL (used around the time or after the time of the excursion) (Batch number: U5810AA, expiration date: 22 Nov 2019, dose and site of administration was not reported) via intramuscular route on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (excursion was actually for 9 days, starting in May, and ranged from 48-49 F). It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case is linked with 2018SA226820, 2018SA226818, 2018SA226819, 2018SA226816, 2018SA226817 (same reporter). This case involves an unknown age male patient. The vaccine was reported to have an excursion for 45 minutes, but caller states the excursion was actually for 9 days, starting in May, and ranged from 48-49 f, vaccines were used before they found out about the excursion. The patient received MENACTRA. This is actual medication error case as the patient received vaccine 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 of suspect MENACTRA lot U5833AA, exp date 25-February-2019 via intramuscular route in unknown administration site. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: 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: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves an unknown age female patient. The vaccine was reported to have an excursion for 45 minutes, but caller states the excursion was actually for 9 days, starting in May, and ranged from 48-49 f, vaccines were used before they found out about the excursion. The patient received MENACTRA. This is actual medication error case as the patient received vaccine 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 of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot U5833AA, exp date 25-February-2019 via intramuscular route in unknown administration site. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: 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: 3.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who was vaccinated with a dose of QUADRACEL (Batch number: C5248AA and expiry date: 21-AUG-2019) via intramuscular route in the right thigh on 24-Jul-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and PREVNAR for Immunisation on an unknown date. It was a case of actual medication error due to drug dose administration interval too long because patient was behind in vaccine series and had no vaccine records. It was reported that QUADRACEL given early, patient had 2.5 weeks until 4 birthday. It was unknown if any adverse event was occurred or not following the vaccination. No reported symptoms or need for treatment. 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. Documents held by the sender: None.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA227019 (same reporter). This case involves child male patient (age not reported) who was vaccinated with a 0.5 ml dose of QUADRACEL (Batch number: C5248AA and expiry date: 21-Aug-2019) via intramuscular route on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because stability on QUADRACEL, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. 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 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 the sender: None.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Extra dose administered, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who experienced body aches, swollen lymph nodes and fever, while he received vaccine MENACTRA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; and HPV VACCINE. On 08-Aug-2018, the patient received 0.5 ml first dose of suspect MENACTRA lot U6015AA via intramuscular route in the left arm. On 12-Aug-2018 he also received a second dose of the same vaccine lot M17037. On an unknown date, the patient developed a non-serious body aches (pain), swollen lymph nodes and fever, following the administration of MENACTRA. It was also a case of actual medication error due to extra dose administered. As the patient received two MENACTRA vaccinations within 4 days. Relevant tests were not reported. Final diagnosis was fever, swollen lymph nodes and body aches. The patient was treated with TYLENOL. The outcome of the events was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: None.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blood electrolytes normal, C-reactive protein increased, Chest X-ray, Febrile convulsion, Full blood count
Clinical narrative: Patient had a simple febrile seizure 9 days after receiving MMR vaccine. Patient without any other symptoms at time of seizure event. Family was away on vacation and child was brought to ER.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Respiratory viral panel
Clinical narrative: Patient had a simple febrile seizure 9 days after receiving MMR vaccine. Patient without any other symptoms at time of seizure event. Family was away on vacation and child was brought to ER.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Achy and fatigued "I feel like I have the flu" no fever-exam done 8/17/18 normal follow-up call 8/21/18-pt doing well.
Age: 17.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Fatigue, Wheezing
Clinical narrative: Mother called on 8/20/18 and stated "she did not approve of the Hepatitis A vaccine it made her son tired, wheezing, dizziness, and shortness of breath. 8/21/18 I talked to mother she stated that on 8/20/18 her son was feeling better he is tired and not short of breath".
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Eye pain, Fatigue, Headache, Injection site pain
Clinical narrative: Pt. complained of feeling tired with sore arm at injection site on the evening that the vaccine was given. By the next day she developed headache, low grade temperature, anterior cervical lymphadenopathy, pain behind her eyes and the vaccine area was erythematous and warm. Also noticed on either the second or third day that she developed another concentric area of erythema and tenderness in her mid-left arm, below the injection site. She felt much improved by the evening of the third day post vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Pt. complained of feeling tired with sore arm at injection site on the evening that the vaccine was given. By the next day she developed headache, low grade temperature, anterior cervical lymphadenopathy, pain behind her eyes and the vaccine area was erythematous and warm. Also noticed on either the second or third day that she developed another concentric area of erythema and tenderness in her mid-left arm, below the injection site. She felt much improved by the evening of the third day post vaccination.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count, Metabolic function test, Petechiae
Clinical narrative: Petechiae on L arm and legs.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever 4 degrees F above normal, dizziness, nausea, soreness in right arm.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Mom reported "she had hives starting about 18 hours after her shots" "more like welts" "The hives lasted 2 1/2 days" "She used oral BENADRYL and topical BENADRYL" Denies any previous reaction to vaccinations, denies medication or other known allergies.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Blood glucose normal, Fall, Postictal state, Seizure, Somnolence
Clinical narrative: The day after given vaccines-DTaP and IPV, Patient had his first afebrile seizure.-fell, convulsing for 5 minutes, with postictal sleepiness for 45 minutes and bladder incontinence. He was seen in the Emergency Room-still afebrile, normal glucose. He was later evaluated by Pediatric Neurology. Family history febrile seizure-paternal grandfather.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urinary incontinence
Clinical narrative: The day after given vaccines-DTaP and IPV, Patient had his first afebrile seizure.-fell, convulsing for 5 minutes, with postictal sleepiness for 45 minutes and bladder incontinence. He was seen in the Emergency Room-still afebrile, normal glucose. He was later evaluated by Pediatric Neurology. Family history febrile seizure-paternal grandfather.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Hyperaesthesia, Pruritus, Skin warm
Clinical narrative: Red, hot, itchy, sensitive to touch. Pt prescribed benadryl, clindamycin, ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Arm swelled significantly from shoulder to elbow, skin from shoulder to elbow very red and hot to the touch.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Nausea, Pyrexia, Retching
Clinical narrative: Dizziness, feeling faint, fever, aching joints throughout body, nausea (retching).
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On 30th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that the dose of SHINGRIX hurt like a bugger.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site mass in a 63-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received about 3 to 5 years before the reporting date). On 14th August 2018, the patient received the 1st dose of SHINGRIX 50 mcg/mg. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site mass, injection site pain, injection site itching, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site mass, injection site pain, injection site itching, injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site mass, injection site pain, injection site itching, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The patient received SHINGRIX on left arm. The patient experienced bumpy, pain, itching, burning, redness and swelling at the injection site with an area of 2 inches by 3 inches. The patient had reported this events to the pharmacy but not to her physician. The health care professional was not asked and not involved at that point of reporting.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Skin burning sensation
Clinical narrative: 6 days after administration pt had a burning sensation in skin on chest and next day broke out in a shingles rash.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: 6 days after administration pt had a burning sensation in skin on chest and next day broke out in a shingles rash.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pyrexia, Tenderness
Clinical narrative: Fever, Body aches, erythema at site, tenderness. Provided NSAIDs and H1 blocker orally.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Injection site cellulitis, Injection site warmth, Wheezing
Clinical narrative: Cellulitis to left upper arm, hot to touch. Patient presenting with wheezing and sob. Prescribed KEFLEX and PROAIR inhaler.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-AUG-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly, lot # M038216, expiration date reported as 09-MAY-2018 (exact dose and anatomical localization were not provided). No adverse effect was reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received SHINGRIX (batch number 957J3, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site rash (1st dose received on 25th February 2018, see the case US2018GSK151929). On 10th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced fever and enlargement of lymph nodes. On an unknown date, the outcome of the fever and enlargement of lymph nodes were unknown. It was unknown if the reporter considered the fever and enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX in left arm. The patient experienced fever and swollen lymph node along her collar bone area with the 2nd dose of the SHINGRIX vaccine. No further details were provided by the pharmacist.
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA227374 (same reporter). This case involves a two months old female patient who received DTaP-IPV component, while he received a 0.25 mL dose of vaccine PENTACEL lot C5545AA in the left thigh on 15-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PREVNAR 13 for Immunisation. It was also a case of actual medication error due to inappropriate reconstitution technique. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza, Malaise, Pyrexia, Tremor
Clinical narrative: HIGH FEVER, VOMITING, CHILLS, SHAKES, SICK IN BED, STARTED THE EVENING AFTER THE INJECTION CONTINUING TODAY, PATIENT MISSING WORK WITH SEVERE FLU SYMPTOMS. HE STATES HE HAD CHICKEN POX WHEN HE WAS ABOUT 20 YEARS OLD.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: HIGH FEVER, VOMITING, CHILLS, SHAKES, SICK IN BED, STARTED THE EVENING AFTER THE INJECTION CONTINUING TODAY, PATIENT MISSING WORK WITH SEVERE FLU SYMPTOMS. HE STATES HE HAD CHICKEN POX WHEN HE WAS ABOUT 20 YEARS OLD.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Nervousness, Tremor
Clinical narrative: Light headed, shaky, nervous, lost appetite.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: 10 days after the injection, I experienced an itchy rash at the injection site. It was a little over 1 inch in diameter. The injection site and surrounding area, over 2 inch in diameter, were sore to the touch. I developed a headache and stiff/painful neck. I felt very fatigued. About two days later I noticed a small itchy bump behind my knee. Over the next few days I developed 5 more bumps on my torso and thigh. The bumps ended up scabbing over in the middle. 18 days after the injection, my headache has resolved. The bumps are still scabbed over but I haven't developed anymore bumps. However, my neck is still very stiff and painful. I do not have very good range of motion from this. The rash has disappeared on my arm and turned into a bruise. My arm aches from shoulder to wrist and I have had a few muscle spasms.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Joint range of motion decreased, Muscle spasms, Musculoskeletal stiffness, Neck pain
Clinical narrative: 10 days after the injection, I experienced an itchy rash at the injection site. It was a little over 1 inch in diameter. The injection site and surrounding area, over 2 inch in diameter, were sore to the touch. I developed a headache and stiff/painful neck. I felt very fatigued. About two days later I noticed a small itchy bump behind my knee. Over the next few days I developed 5 more bumps on my torso and thigh. The bumps ended up scabbing over in the middle. 18 days after the injection, my headache has resolved. The bumps are still scabbed over but I haven't developed anymore bumps. However, my neck is still very stiff and painful. I do not have very good range of motion from this. The rash has disappeared on my arm and turned into a bruise. My arm aches from shoulder to wrist and I have had a few muscle spasms.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity, Rash pruritic, Scab, Varicella post vaccine
Clinical narrative: 10 days after the injection, I experienced an itchy rash at the injection site. It was a little over 1 inch in diameter. The injection site and surrounding area, over 2 inch in diameter, were sore to the touch. I developed a headache and stiff/painful neck. I felt very fatigued. About two days later I noticed a small itchy bump behind my knee. Over the next few days I developed 5 more bumps on my torso and thigh. The bumps ended up scabbing over in the middle. 18 days after the injection, my headache has resolved. The bumps are still scabbed over but I haven't developed anymore bumps. However, my neck is still very stiff and painful. I do not have very good range of motion from this. The rash has disappeared on my arm and turned into a bruise. My arm aches from shoulder to wrist and I have had a few muscle spasms.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Skin discomfort
Clinical narrative: Patient reported feeling like having a full body sunburn for 24 hours the morning after the vaccine. No lingering effects or other adverse events.
Age: 54.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Rash
Clinical narrative: Three days after patient received SHINGRIX, small patch erupted on skin above left breast. Spoke with RN on 8/20/2018 and after describing the site, RN considered it most likely minor contact dermatitis unrelated to vaccination. Patient seen by PCP on 8/22/18 after no improvement w/ skin and eruption continued with itching, redness. PCP stated that likely Shingles and put on Valacyclovir 1 gm 3 times per day. Patient is concerned that she contracted shingles from vaccine and VIS does not state this is a possible side-effect from vaccine. Picture of skin eruption is available.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Gait inability, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The day after receiving the vaccinations patient had her second seizure, the first seizure being 2 weeks after receiving the first dose of vaccinations. Her left thigh where the vaccines were injected was very hot to the touch, went from bright red to dark red and spread to half her thigh area, around 4-5 inches in diameter. She was unable to walk all of Saturday, 08/11/2018, this persisted for 5 days. Although the swelling has gone she still has a hard lump in the area and is sore to the touch.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site warmth, Seizure
Clinical narrative: The day after receiving the vaccinations patient had her second seizure, the first seizure being 2 weeks after receiving the first dose of vaccinations. Her left thigh where the vaccines were injected was very hot to the touch, went from bright red to dark red and spread to half her thigh area, around 4-5 inches in diameter. She was unable to walk all of Saturday, 08/11/2018, this persisted for 5 days. Although the swelling has gone she still has a hard lump in the area and is sore to the touch.
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain, Aphasia, Bladder catheterisation, Blood creatine phosphokinase increased, Computerised tomogram normal
Clinical narrative: This is a spontaneous report obtained from a contactable physician. A male patient of an unspecified age received, on 30Jul2018, PREVNAR 13 at single dose, for immunization. It was specified that  the patient received several vaccinations and one of them was PREVNAR 13. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2018, the patient experienced abdominal pain, hypotonic-hyporesponsive episode, urinary retention, elevated creatine kinase (CK), unresponsive and he was obtunded, very lethargic, unable to stand and to walk. It was also reported that he couldn't speak. His CK was 1200 and computerised tomogram (CT) was normal. A Foley catheter was put to get about a liter urine. He was not febrile. Clinical outcome of the adverse events was unknown at time of this report. The physician reported that the patient had some medical problems, but did not know if it was a chance; the reaction could be related to any other vaccinations that he received. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: PNC13
Symptoms: Depressed level of consciousness, Dysstasia, Gait inability, Hypotonic-hyporesponsive episode, Lethargy
Clinical narrative: This is a spontaneous report obtained from a contactable physician. A male patient of an unspecified age received, on 30Jul2018, PREVNAR 13 at single dose, for immunization. It was specified that  the patient received several vaccinations and one of them was PREVNAR 13. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2018, the patient experienced abdominal pain, hypotonic-hyporesponsive episode, urinary retention, elevated creatine kinase (CK), unresponsive and he was obtunded, very lethargic, unable to stand and to walk. It was also reported that he couldn't speak. His CK was 1200 and computerised tomogram (CT) was normal. A Foley catheter was put to get about a liter urine. He was not febrile. Clinical outcome of the adverse events was unknown at time of this report. The physician reported that the patient had some medical problems, but did not know if it was a chance; the reaction could be related to any other vaccinations that he received. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: PNC13
Symptoms: Unresponsive to stimuli, Urinary retention
Clinical narrative: This is a spontaneous report obtained from a contactable physician. A male patient of an unspecified age received, on 30Jul2018, PREVNAR 13 at single dose, for immunization. It was specified that  the patient received several vaccinations and one of them was PREVNAR 13. Relevant medical history and concomitant medications were unknown. On an unspecified date, in 2018, the patient experienced abdominal pain, hypotonic-hyporesponsive episode, urinary retention, elevated creatine kinase (CK), unresponsive and he was obtunded, very lethargic, unable to stand and to walk. It was also reported that he couldn't speak. His CK was 1200 and computerised tomogram (CT) was normal. A Foley catheter was put to get about a liter urine. He was not febrile. Clinical outcome of the adverse events was unknown at time of this report. The physician reported that the patient had some medical problems, but did not know if it was a chance; the reaction could be related to any other vaccinations that he received. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Diarrhoea, Erythema, Peripheral swelling
Clinical narrative: Cellulitis infection. Side effects: 102 fever, Shivering, Red Swelling Traveling Down Arm, Warm to Touch, and Diarrhea. Treatment: Levofloxacin 10 Day Caplets.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Cellulitis infection. Side effects: 102 fever, Shivering, Red Swelling Traveling Down Arm, Warm to Touch, and Diarrhea. Treatment: Levofloxacin 10 Day Caplets.
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscle strain, Paraesthesia
Clinical narrative: Had a pulling in his right shoulder and numbness and tingling down his right arm whenever he moved neck up/down to the left side.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Pain in extremity, Ultrasound joint, Ultrasound scan abnormal
Clinical narrative: Severe right upper arm pain at site of Men B vaccine developed later on the day of vaccine. Pain radiated to right shoulder. Pain persisted and only improved minimally with acetaminophen and ibuprofen. Patient has difficulty using his right arm d/t pain. Seen by physician on 07/31/18. Treated with ibuprofen 500mg BID with resolution.
Age: 0.5
Sex: M
Vaccine: HEP, PNC13
Symptoms: Erythema, Haematoma, Pyrexia
Clinical narrative: Following administration of Hep B and PCV-13 in (L) thigh pt. developed fever, hematoma and area of erythema (3.5 x 1.5 cm). Self resolved after 2 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Impaired work ability, Nodule
Clinical narrative: Extreme fatigue, chills and fever of 101.8. Big red knot on arm given injection. Could not work and had to stay home in bed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, chills and fever of 101.8. Big red knot on arm given injection. Could not work and had to stay home in bed.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient's mother called to report rash on lower left arm that started shortly after vaccination. Rash did not occur after first dose of GARDASIL. Rash is raised, itchy bumps about 1/8" in diameter. Do not look fluid filled. No other accompanying symptoms. Patient does not remember when the rash began.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling face
Clinical narrative: 8/16 Per mother, patient had face swelling which started in the morning and improved during the day, but then returned again the next morning (8/17) and worsened throughout the day. Attended school that day and mother reports that face was swollen when she got home.
Age: 76.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site pruritus, Injection site warmth
Clinical narrative: Itching, bruising, discoloration, and hot temperature around site of injection.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance, Muscular weakness, Pain, Pyrexia
Clinical narrative: PT STATES ABOUT 8 HOURS AFTER VACCINE PT EXPERIENCED FEVER, MUSCLE WEAKNESS/TROUBLE WALKING, JOINT PAIN OF THE WRIST, ANKLE, AND KNEES. SKIN CRAWLING, TREMBLING. SYMPTOMS LASTED UNTIL 3AM. PT TOOK MOTRIN 600MG ONCE AT ABOUT 2AM AND WOKE UP  FEELING FINE. TODAY 8/22 PT HAS SLIGHT SORENESS AND NO OTHER SYMPTOMS. NO REDNESS, NO SWELLING, NOT HOT TO THE TOUCH, NO BRUSING. PT STATES HE HAS A PRIOR HISTORY OF BEING DIAGNOSED WITH EPSTEIN-BARR VIRUS AS A CHILD.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Pallor, Vomiting
Clinical narrative: After 3 shot given, patient got pale and asked for a trash can and started vomiting right after. Patient has not eaten prior to visit. Provider asked that we contact VAERS and recommend patient to be advised to eat prior to receiving vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Vomiting
Clinical narrative: Less than 10 min following injections patient vomited x1. Patient was in facility less than 20 minutes following administration without any other symptoms.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Electrocardiogram normal, Myalgia, Tenderness
Clinical narrative: L SCM pain suddenly today (unsure if related to vaccine). L arm tenderness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: 6/8/18-right arm "extremely sore," felt tired and low fever; 6/9/18-nauseous, but did not throw up; 6/10/18-nausea resolved, arm still sore; 6/11/18-right arm red around injection site, some itching, spread towards elbow area also developed fever blister; 6/15/18-both left and right elbows itching with little red blisters, painful to touch 6/23/18--all symptoms resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Oral herpes, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: 6/8/18-right arm "extremely sore," felt tired and low fever; 6/9/18-nauseous, but did not throw up; 6/10/18-nausea resolved, arm still sore; 6/11/18-right arm red around injection site, some itching, spread towards elbow area also developed fever blister; 6/15/18-both left and right elbows itching with little red blisters, painful to touch 6/23/18--all symptoms resolved.