chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient had a fever approximately 100.5 fatigue flu like symptoms headache muscle pain nausea.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a pharmacist via a physician, referring to a 27-year-old female patient, who had no children but "did had intercourse". The patient's pertinet medical history, drug reactions/allergies and concomitant medications were not reported. On 06-NOV-2009, the patient was vaccinated with the first dose of GARDASIL, then on 21-JAN-2010 and 26-MAY-2010, she received the second and the third dose of GARDASIL injection (dose, route of administration, lot # and expiration date were not provided for all). On an unknown date, the patient became positive for human papilloma virus (HPV) with 2 abnormal Papanicolaou (Pap) Smear. It was unknown if a treatment was given for the events. The outcome of the events was not recovered, as the patient's events persisted at the time of the report. The relatedness between the patient's being positive for HPV with 2 abnormal Pap Smear and quadrivalent human GARDASIL was unknown.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 38 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAR-2018, the patient was vaccinated with PROQUAD recombinant human albumin (rHA) (lot # M041508, Expiry date : 09-APR-2018), subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT). On 24-MAR-2018, the patient had dose administered outside indications and usage from prescribing information (product use issue). There was no adverse event reported. There was no product quality complaint involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. The patient's medical history, current medical conditions, historical drugs, drug reactions and allergies information was not provided. The reporter stated that, on 22-MAR-2018 and on 03-APR-2018, the patient was vaccinated with the first and second dose, respectively, of GARDASIL 9 (inappropriate schedule of drug administration), intramuscularly, for prophylaxis (anatomical site of vaccination, lot number and expiration date were not reported). The reporter also stated that there were no known adverse effects. All the reported information was reconfirmed with the reporter, and no further information was provided.
Sex: U
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a less than 1-year-old patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On an unknown date in 2018 (reported as "on or after 28-MAR-2018"), the patient was vaccinated with a dose of improperly stored due to long transit during shipment LIQUID PEDVAXHIB injection, lot # N034006, expiration date 01-FEB-2020 (exact doses and route of administration were unknown), for prophylaxis. On an unknown date in 2018 (reported as "later unspecified date after receiving the vaccine"), the patient experienced a red, hard, tender lump at the injection site that was 3 inches wide by 4 inches long. The patient did not receive any treatment for this adverse events. The outcome of the events was unknown. The causality assessment was not provided. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1804USA009888.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 10 year old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 subcutaneously, as prophylaxis (Strength, dose, frequency, lot # and expiration date were not reported). No adverse effects were noted.
Sex: F
Vaccine: HPV9
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report has been received from a physician via a company representative, and refers to a 16 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly for HPV prevention (strength, dose, dose number, anatomical location, lot number and expiration date were not reported). On an unknown date, after administration of GARDASIL 9, the patient had a stroke. It was unknown if the patient sought medical attention, if received treatment or if laboratory diagnostics or studies were performed. The outcome of the cerebrovascular accident was unknown. The reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the event. Upon internal review the event cerebrovascular accident was considered to be medically significant.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 13 year old female patient. The patient had no pertinent medical history, drug reactions/allergies and concomitant medication. On an unknown date in August 2017, the patient was vaccinated with first dose of GARDASIL 9 and on 10-APR-2018, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly for prevention of human papillomavirus (HPV) (dose, frequency, lot # and expiry date were not reported). On 15-APR-2018 (reported as approximately 5 days after receipt of second dose), the patient began to break out in red, itchy, welts all over the body from head to toe. The patient's mother also stated that that patient had not been exposed to any new environmental changes or potential skin irritants and the reaction began while the patient was sleeping in her bed. The patient was administered with BENEDRYL to counteract the reaction, which was initially successful, however, after the effects of the BENEDRYL wore off, the reaction began to spread again. The patient was also prescribed with ZANTAC (dose unspecified) and prednisone (manufacturer unknown) 60 mg in addition to BENEDRYL once every 6 hours by the pediatrician. The patient had responded well to BENEDRYL, prednisone (manufacturer unknown) and ZANTAC regimen and was able to attend the school. The patient's mother closely monitored the patient for rebound signs of breaking out again. The patient's mother explained that the patient was not expected to need any future dosing with the GARDASIL 9 as she had followed the 2 dose series for the vaccine. It was reported that, the patient sought medical attention for the events. The outcome of pruritus, erythema and urticaria was reported as recovering/resolving. The relationship between the events and GARDASIL 9 was not provided.
Sex: M
Vaccine: HPVX
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 28 year old male patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On an unspecified date in June 2016, the patient was vaccinated with the first dose of GARDASIL 9, for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided. Subsequently on 10-NOV-2016, the patient was vaccinated with a dose of (dose 2 in GARDASIL series) GARDASIL. Finally, it was reported that on 19-APR-2018 (reported as "today"), the patient had presented to the reporter office to have his third dose of GARDASIL 9. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. On 19-APR-2018 the patient was inadvertently vaccinated with expired dose of VAQTA (dose, units and frequency unknown) (lot# N005605 and expiration date 08-APR-2018) (expired product administered). No adverse effects were reported. No product quality complaint was reported.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Muscle spasms
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 77 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. The patient did not have any drugs allergies. On 20-APR-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R000579, expiration date 9-SEP-2019, for preventive of pneumococcal disease (strength, dose, route and frequency were not reported). On the same day (reported as "immediately after injection"), the patient experienced severe back spasms and after 10 minutes back spasms were resolved with no intervention. The medical assistant reported that physician was requesting a lot check for PNEUMOVAX 23 lot R000579 expiration date 09-SEP-2019. The causality assessment between back spasm and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter; Sender's Comments: US-009507513-1804USA009486.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Immediate post-injection reaction, Muscle spasms, Rash, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 68 year old, non pregnant female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. It was stated that the patient did not have drug reactions or allergies. On 20-APR-2018, the patient was vaccinated with PNEUMOVAX 23 lot number R000579 with expiration date on 09-SEP-2019, as a preventive of pneumococcal disease (strength, dose, route of administration and anatomical location were not reported). On 20-APR-2018, reported as "immediately after injection", the patient experienced rash on chest, severe back spasms (muscle spasms), flushing and vomiting. On the same day, 10 minutes after symptoms started and by the time the physician finished his assessment of patient all aforementioned events were resolved with no intervention. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the events. Additionally, it was stated that the physician was requesting a lot check for PNEUMOVAX 23. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA009456.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report from a nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 18-APR-2018 the patient was vaccinated with M-M-R II injection via the intramuscular route (dose, frequency, lot # and expiry date were not reported) for prophylaxis (incorrect route of drug administration). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.
Sex: M
Vaccine: PNC13
Symptoms: Eczema
Clinical narrative: This is a spontaneous report from a contactable nurse. A child male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient received concomitantly two other unspecified vaccines. The patient experienced eczema flare up on an unspecified date with outcome of unknown. The information on the batch number has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthritis, Burning sensation, C-reactive protein
Clinical narrative: Patient received 1st dose of SHINGRIX (shingles "non-live" attenuated vaccine) on 4/11/2018 approx. at 9:26AM, and per patient she started developing swelling and redness aprox 2 hrs. later (11:30AM). The swelling grew and spread from the injection site on Left upper arm(deltoid area) into the under arm pit area and even developed a red rash in the Left breast with skin peeling back. Area of swelling is bigger than a "baseball size" and very hard induration with very warm to found. Pt. advised to be seen at Clinic (appt made for 4/19 w/ PAC). Patient is icing/elevating and taking BENADRYL for which has been effective. 61 yo female presents to the clinic with complaint of red swelling on the left upper arm after receiving the SHINGRIX vaccination (shot #1) that was administered on 04/11/2018). She stated that the erythematous area on her left upper arm started in the anterior aspect, with the pain and swelling subsiding considerably after the use of diphenhydramine and cold pack applications. She subsequently developed a vesicular rash on the underside of her right breast that is responded very well to diphenhydramine. She states that she was having pain with a little bit of bleeding related to this rash, which peeled as well, stating that the pain now had dissipated considerably. She denies any shortness of breath (although she states that she did have pronounced fatigue and some sensation of having a hard time catching her breath). No angioedema expressed. She did describe an additional suspected adverse reaction after she received an injection into her right knee to help reduce swelling and inflammation (suspected to be a corticosteroid with or without and additional agent added). She states that the next day she developed a significant reddening of her face that was burning. She has also described symptoms of severe muscle pains, lightheadedness and dizziness, and near passing out when eating certain foods.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Depressed level of consciousness, Dizziness, Dyspnoea, Erythema, Fatigue
Clinical narrative: Patient received 1st dose of SHINGRIX (shingles "non-live" attenuated vaccine) on 4/11/2018 approx. at 9:26AM, and per patient she started developing swelling and redness aprox 2 hrs. later (11:30AM). The swelling grew and spread from the injection site on Left upper arm(deltoid area) into the under arm pit area and even developed a red rash in the Left breast with skin peeling back. Area of swelling is bigger than a "baseball size" and very hard induration with very warm to found. Pt. advised to be seen at Clinic (appt made for 4/19 w/ PAC). Patient is icing/elevating and taking BENADRYL for which has been effective. 61 yo female presents to the clinic with complaint of red swelling on the left upper arm after receiving the SHINGRIX vaccination (shot #1) that was administered on 04/11/2018). She stated that the erythematous area on her left upper arm started in the anterior aspect, with the pain and swelling subsiding considerably after the use of diphenhydramine and cold pack applications. She subsequently developed a vesicular rash on the underside of her right breast that is responded very well to diphenhydramine. She states that she was having pain with a little bit of bleeding related to this rash, which peeled as well, stating that the pain now had dissipated considerably. She denies any shortness of breath (although she states that she did have pronounced fatigue and some sensation of having a hard time catching her breath). No angioedema expressed. She did describe an additional suspected adverse reaction after she received an injection into her right knee to help reduce swelling and inflammation (suspected to be a corticosteroid with or without and additional agent added). She states that the next day she developed a significant reddening of her face that was burning. She has also described symptoms of severe muscle pains, lightheadedness and dizziness, and near passing out when eating certain foods.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count, Haemorrhage, Induration, Injection site swelling, Joint injection
Clinical narrative: Patient received 1st dose of SHINGRIX (shingles "non-live" attenuated vaccine) on 4/11/2018 approx. at 9:26AM, and per patient she started developing swelling and redness aprox 2 hrs. later (11:30AM). The swelling grew and spread from the injection site on Left upper arm(deltoid area) into the under arm pit area and even developed a red rash in the Left breast with skin peeling back. Area of swelling is bigger than a "baseball size" and very hard induration with very warm to found. Pt. advised to be seen at Clinic (appt made for 4/19 w/ PAC). Patient is icing/elevating and taking BENADRYL for which has been effective. 61 yo female presents to the clinic with complaint of red swelling on the left upper arm after receiving the SHINGRIX vaccination (shot #1) that was administered on 04/11/2018). She stated that the erythematous area on her left upper arm started in the anterior aspect, with the pain and swelling subsiding considerably after the use of diphenhydramine and cold pack applications. She subsequently developed a vesicular rash on the underside of her right breast that is responded very well to diphenhydramine. She states that she was having pain with a little bit of bleeding related to this rash, which peeled as well, stating that the pain now had dissipated considerably. She denies any shortness of breath (although she states that she did have pronounced fatigue and some sensation of having a hard time catching her breath). No angioedema expressed. She did describe an additional suspected adverse reaction after she received an injection into her right knee to help reduce swelling and inflammation (suspected to be a corticosteroid with or without and additional agent added). She states that the next day she developed a significant reddening of her face that was burning. She has also described symptoms of severe muscle pains, lightheadedness and dizziness, and near passing out when eating certain foods.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint swelling, Myalgia, Pain, Rash erythematous, Rash vesicular
Clinical narrative: Patient received 1st dose of SHINGRIX (shingles "non-live" attenuated vaccine) on 4/11/2018 approx. at 9:26AM, and per patient she started developing swelling and redness aprox 2 hrs. later (11:30AM). The swelling grew and spread from the injection site on Left upper arm(deltoid area) into the under arm pit area and even developed a red rash in the Left breast with skin peeling back. Area of swelling is bigger than a "baseball size" and very hard induration with very warm to found. Pt. advised to be seen at Clinic (appt made for 4/19 w/ PAC). Patient is icing/elevating and taking BENADRYL for which has been effective. 61 yo female presents to the clinic with complaint of red swelling on the left upper arm after receiving the SHINGRIX vaccination (shot #1) that was administered on 04/11/2018). She stated that the erythematous area on her left upper arm started in the anterior aspect, with the pain and swelling subsiding considerably after the use of diphenhydramine and cold pack applications. She subsequently developed a vesicular rash on the underside of her right breast that is responded very well to diphenhydramine. She states that she was having pain with a little bit of bleeding related to this rash, which peeled as well, stating that the pain now had dissipated considerably. She denies any shortness of breath (although she states that she did have pronounced fatigue and some sensation of having a hard time catching her breath). No angioedema expressed. She did describe an additional suspected adverse reaction after she received an injection into her right knee to help reduce swelling and inflammation (suspected to be a corticosteroid with or without and additional agent added). She states that the next day she developed a significant reddening of her face that was burning. She has also described symptoms of severe muscle pains, lightheadedness and dizziness, and near passing out when eating certain foods.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Skin exfoliation, Skin warm, Swelling
Clinical narrative: Patient received 1st dose of SHINGRIX (shingles "non-live" attenuated vaccine) on 4/11/2018 approx. at 9:26AM, and per patient she started developing swelling and redness aprox 2 hrs. later (11:30AM). The swelling grew and spread from the injection site on Left upper arm(deltoid area) into the under arm pit area and even developed a red rash in the Left breast with skin peeling back. Area of swelling is bigger than a "baseball size" and very hard induration with very warm to found. Pt. advised to be seen at Clinic (appt made for 4/19 w/ PAC). Patient is icing/elevating and taking BENADRYL for which has been effective. 61 yo female presents to the clinic with complaint of red swelling on the left upper arm after receiving the SHINGRIX vaccination (shot #1) that was administered on 04/11/2018). She stated that the erythematous area on her left upper arm started in the anterior aspect, with the pain and swelling subsiding considerably after the use of diphenhydramine and cold pack applications. She subsequently developed a vesicular rash on the underside of her right breast that is responded very well to diphenhydramine. She states that she was having pain with a little bit of bleeding related to this rash, which peeled as well, stating that the pain now had dissipated considerably. She denies any shortness of breath (although she states that she did have pronounced fatigue and some sensation of having a hard time catching her breath). No angioedema expressed. She did describe an additional suspected adverse reaction after she received an injection into her right knee to help reduce swelling and inflammation (suspected to be a corticosteroid with or without and additional agent added). She states that the next day she developed a significant reddening of her face that was burning. She has also described symptoms of severe muscle pains, lightheadedness and dizziness, and near passing out when eating certain foods.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site induration, Injection site warmth, Purpura
Clinical narrative: Patient received 1st dose of SHINGRIX (shingles "non-live" attenuated vaccine) on 4/11/2018 approx. at 9:26AM, and per patient she started developing swelling and redness aprox 2 hrs. later (11:30AM). The swelling grew and spread from the injection site on Left upper arm(deltoid area) into the under arm pit area and even developed a red rash in the Left breast with skin peeling back. Area of swelling is bigger than a "baseball size" and very hard induration with very warm to found. Pt. advised to be seen at Clinic (appt made for 4/19 w/ PAC). Patient is icing/elevating and taking BENADRYL for which has been effective. 61 yo female presents to the clinic with complaint of red swelling on the left upper arm after receiving the SHINGRIX vaccination (shot #1) that was administered on 04/11/2018). She stated that the erythematous area on her left upper arm started in the anterior aspect, with the pain and swelling subsiding considerably after the use of diphenhydramine and cold pack applications. She subsequently developed a vesicular rash on the underside of her right breast that is responded very well to diphenhydramine. She states that she was having pain with a little bit of bleeding related to this rash, which peeled as well, stating that the pain now had dissipated considerably. She denies any shortness of breath (although she states that she did have pronounced fatigue and some sensation of having a hard time catching her breath). No angioedema expressed. She did describe an additional suspected adverse reaction after she received an injection into her right knee to help reduce swelling and inflammation (suspected to be a corticosteroid with or without and additional agent added). She states that the next day she developed a significant reddening of her face that was burning. She has also described symptoms of severe muscle pains, lightheadedness and dizziness, and near passing out when eating certain foods.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Scab, Scar
Clinical narrative: Patient received 1st dose of SHINGRIX (shingles "non-live" attenuated vaccine) on 4/11/2018 approx. at 9:26AM, and per patient she started developing swelling and redness aprox 2 hrs. later (11:30AM). The swelling grew and spread from the injection site on Left upper arm(deltoid area) into the under arm pit area and even developed a red rash in the Left breast with skin peeling back. Area of swelling is bigger than a "baseball size" and very hard induration with very warm to found. Pt. advised to be seen at Clinic (appt made for 4/19 w/ PAC). Patient is icing/elevating and taking BENADRYL for which has been effective. 61 yo female presents to the clinic with complaint of red swelling on the left upper arm after receiving the SHINGRIX vaccination (shot #1) that was administered on 04/11/2018). She stated that the erythematous area on her left upper arm started in the anterior aspect, with the pain and swelling subsiding considerably after the use of diphenhydramine and cold pack applications. She subsequently developed a vesicular rash on the underside of her right breast that is responded very well to diphenhydramine. She states that she was having pain with a little bit of bleeding related to this rash, which peeled as well, stating that the pain now had dissipated considerably. She denies any shortness of breath (although she states that she did have pronounced fatigue and some sensation of having a hard time catching her breath). No angioedema expressed. She did describe an additional suspected adverse reaction after she received an injection into her right knee to help reduce swelling and inflammation (suspected to be a corticosteroid with or without and additional agent added). She states that the next day she developed a significant reddening of her face that was burning. She has also described symptoms of severe muscle pains, lightheadedness and dizziness, and near passing out when eating certain foods.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. In January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the patient experienced injection site discoloration, swelling arm, pain in arm and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site discoloration, swelling arm, pain in arm and injection site pain were recovered/resolved. The reporter considered the injection site erythema, injection site discoloration, swelling arm, pain in arm and injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to the doctor. The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient's injection site was initially red after the vaccination. But, the following day (1 day after receiving SHINGRIX), it turned black and blue. The patient described that, her arm was swollen, hurt really bad and was painful. All the symptoms were resolved after one week. After the second week post vaccination, the patient developed pain at the injection site that lasted a couple of days. On an unknown date, the patient recovered from injection site pain. The patient denied permission to contact their physician and would not provide her address or date of birth. Also, she did not have the lot number or expiry date of the vaccine. The patient stated that, she reported the symptoms to her pharmacist and they told her that, they would report it. The patient could not provide the name of the pharmacist that reported the information.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever, malaise.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient reported on 4/23/18 swelling in entire arm down into forearm. She was advised to seek medical attention from a physician as soon as possible.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Severe shivering, mild fever, moderate muscle pain. The shivering lasted 2 hours. The muscle pain is still on-going.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever, pain at injection point.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Welts started on 04/22/2018 in AM. Pt mother states welts were over upper body, chest and arms. Pt mother states large in size and multiple. Pt mother states pt did develop fever 101 for 2 days after injection given but treated with MOTRIN and pt had not other issues. Fever also noted after pt first injection in series of MMRV and PEDIARIX on 01/12/2018 but subsided 2 days later. Pt mother gave pt BENADRYL on 04/22/18 for welts and pt tolerated well. Pt mother denies pt having any other issues or complaints. Pt mother states then this AM (4/24/18) welts moved to lower body and only one small one on upper body. Pt mother states again pt denies any discomfort or other signs or symptoms other than some itching. Pt mother did apply hydrocortisone cream to areas and also gave pt BENADRYL and sent pt to school. Dr. aware of situation. Pt mother states will contact office if any changes noted or pt does not get better.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Hypersensitivity, Injection site discolouration, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: MOTHER STATES THAT PATIENT WAS COMPLAINING OF PAIN IN ARM EVENING OF VACCINATION. GAVE HIM MOTRIN AND ICE PACK. THE NEXT DAY SITE WAS RED/PURPLE IN COLOR AND WARM TO TOUCH. SHE CONSULTED FAMILY DOCTOR WHO RECOMMENDED THAT HE TAKE BENADRYL AND STATED TO MOTHER THAT CHILD HAD AN ALLERGIC REACTION. MOTHER STATED THAT BY SATURDAY CHILD WAS MUCH IMPROVED. NEVER HAD FEVER OR PROBLEMS BREATHING, JUST SITE REACTION ONLY.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On 01-JUL-2015, the patient was vaccinated inadvertently with VARIVAX, 0.5 ml once, via intramuscular route (strength, lot # and expiration date were not reported) for prophylaxis. No concomitant medications were reported. No adverse effect was reported. Follow up information has been received from the pharmacist on 02-SEP-2015, concerning the 5 years old male patient. It was reported that, on 01-JUL-2015, the patient received the second dose intramuscularly of VARIVAX lot # L004653 (expiration date was not reported) and received also the second dose subcutaneously of M-M-R II lot # K015374 (dose and expiration date were not reported), fifth dose of KINRIX. The reporter emphasized there was no adverse event, only VARIVAX was given by the incorrect route. Additional information is not expected because all correspondence was received. Reporter information, suspect and concomitant therapies and narrative were updated.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 22 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 12-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot number N019923, expiration date 28-APR-2018 (dose and route were not reported) for preventive of cervical cancer (prophylaxis). On 12-APR-2018, 4 hrs after onset of therapy, the patient experienced swelling of her eyes. Afterwards, she was seen in an unspecified emergency room for treatment of swelling with BENADRYL and an unspecified steroid. On the same date, the patient was recovered from the event. The causal relationship between the event and GARDASIL 9 was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-APR-2018, the patient received an expired dose of ZOSTAVAX (lot: M038864; expiry date: 25-DEC-2017) subcutaneously (dose not reported) (expired product administration). The vaccine was reconstituted with a sterile diluent (manufacturer unknown) (co-suspect drug). No adverse effects reported.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: Pt reported to Clinic next day complaining of an itchy burning scalp with no other symptoms. Pt stated that the reaction occurred while driving.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Shortly after receiving the shot (Saturday), I developed a large red welt at injection site that was warm & painful to the touch. About 24 hours later, it started itching at injection site. I'm filing this claim about 64 hours after receiving the shot, and these symptoms are diminishing, although not completely gone. Later in the evening (Saturday), I noticed that I was very tired and went to bed early. By the time I woke up the next morning (Sunday), I ached all over and had a low-level headache, in addition to the fatigue. I experienced these symptoms all day Sunday, but they had resolved by the time I woke up Monday morning.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pain, Urticaria
Clinical narrative: Shortly after receiving the shot (Saturday), I developed a large red welt at injection site that was warm & painful to the touch. About 24 hours later, it started itching at injection site. I'm filing this claim about 64 hours after receiving the shot, and these symptoms are diminishing, although not completely gone. Later in the evening (Saturday), I noticed that I was very tired and went to bed early. By the time I woke up the next morning (Sunday), I ached all over and had a low-level headache, in addition to the fatigue. I experienced these symptoms all day Sunday, but they had resolved by the time I woke up Monday morning.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Anaphylactic reaction, Throat tightness, Wheezing
Clinical narrative: Anaphylactic reaction - severe stomach pain; tightening of throat; wheezing.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives on core and inner arms x 3 weeks.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Pain and swelling at injection site, hard outgrowth, difficulty sleeping, possibly febrile.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Myalgia, Pain, Paraesthesia, Rash pustular
Clinical narrative: Redness around injection site started the day after injection. Patient developed severe myalgia that radiated from neck to shoulder and small pustules on 4/18/18. Describes pain as burning and tingling. Has office visit with PCP. PCP did not treat as the symptoms were receding.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Vaccination failure
Clinical narrative: Redness around injection site started the day after injection. Patient developed severe myalgia that radiated from neck to shoulder and small pustules on 4/18/18. Describes pain as burning and tingling. Has office visit with PCP. PCP did not treat as the symptoms were receding.
Age: 64.0
Sex: M
Vaccine: VARZOS, PPV
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills, aches, fatigue.
Age: 64.0
Sex: M
Vaccine: VARZOS, PPV
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Chills, aches, fatigue.
Sex: U
Vaccine: FLU4
Symptoms: Documented hypersensitivity to administered product, Pharyngeal oedema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of throat swelling in a elderly patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included egg allergy and latex allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced throat swelling (serious criteria life threatening) and documented hypersensitivity to administered product. On an unknown date, the outcome of the throat swelling and documented hypersensitivity to administered product were unknown. It was unknown if the reporter considered the throat swelling to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The healthcare professional reported that the patient experienced throat swelling after the flu vaccine (healthcare professional unsure which brand flu vaccine the patient received). This was due to the fact that the patient had an allergy to eggs and latex. The healthcare professional called to find out if the patient could receive SHINGRIX and mentioned that the patient had a reaction to the flu vaccine so he collected all the information he had but the patient received this vaccine elsewhere and he did not have any further information. Also, the healthcare professional assumed the patient went to the emergency room but he was not sure.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Rash around injection site and then scattered raised rash over body less than 50.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Pt reported that after receiving SHINGRIX vaccine his arm became sore, he developed slight chills, and redness at the site of injection. Pt reports he took acetaminophen and went to sleep. Woke up and chills were gone. Arm was still sore at site of injection. Pt. reported event 4/23/18 -via online portal.
Age: 75.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Pain in extremity
Clinical narrative: Redness, blisters around sites of injection with pain in the arm. Inform to see provider or go to ER. Patient is not concern to go to provider or ER. Told her if symptoms worsening go to ER.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Patient vomited 3/4 dose of ROTATEQ.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema on right deltoid 4 1/4" wide by 4 1/2" long. Area is warm and firm to touch. Slightly painful. Patient treated with BACTRIM DS 1 tablet twice a day x 7 days. Patient was afebrile when rechecked in clinic.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Rash with blisters neck, right side of chest and back all on the right side not crossing midline.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelling, itch.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Cough, Fatigue, Nasal congestion, Pyrexia
Clinical narrative: Cough, congestion, fatigue, fever  treated with TAMIFLU 12-29-17 - 12-31-17.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Chills, Insomnia, Pyrexia
Clinical narrative: Night of SHINGRIX chills, A-Fib (therefore secondary insomnia), low grade fever, Stronger legs following 2 days.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chills, Fatigue, Tremor
Clinical narrative: Chills, shaking, anxiety and fatigue night after administration. Symptoms resolved by next morning.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Skin reaction
Clinical narrative: Pt received shot 4/11 came in 4/17. Reports of severe itching and redness at site and at spot on L. lower back, had received a dose of  REMICADE on 4/12, went to MD and to urgent care to see if was shingles, they thought just a delayed response due to REMICADE, checked for cellulitis and told pt just to watch area.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Patient had no reaction immediately after vaccination. She came back the following morning (at 8:30a) and reported a diffuse, splotchy pink/red rash all over her body. She said it was itchy, and wanted to let me know. She was directed to take OTC diphenhydramine for the itching. Her doctor's office was alerted, and I suggested she tell her doctor as well.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Bone contusion, Bone disorder, Bursitis, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: Unable to raise left arm, severely limited ROM initially. Employee health sent me to MD (11/27/2017) who ordered x-ray. Second opinion MD (12/13/2017) ordered steroids PO and physical therapy 3x/week. F/U 1/5/2018 Minimal improvement. MRI ordered. F/U (1/21/2018) Orthopedic MD seen 3/2/2018, F/U 3/23/2018. Diagnosed with left shoulder bone contusion and bursitis S/P flu shot with penetration of bone and rotator cuff. Received steroid injection 3/2/2018. Physical therapy put on hold, light duty at work, limited 5 lbs. No significant improvement noted at this time. Continues to ache, throb, limited ROM, pain level from 4-8 on daily basis.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Nuclear magnetic resonance imaging, Pain, Rotator cuff syndrome, X-ray
Clinical narrative: Unable to raise left arm, severely limited ROM initially. Employee health sent me to MD (11/27/2017) who ordered x-ray. Second opinion MD (12/13/2017) ordered steroids PO and physical therapy 3x/week. F/U 1/5/2018 Minimal improvement. MRI ordered. F/U (1/21/2018) Orthopedic MD seen 3/2/2018, F/U 3/23/2018. Diagnosed with left shoulder bone contusion and bursitis S/P flu shot with penetration of bone and rotator cuff. Received steroid injection 3/2/2018. Physical therapy put on hold, light duty at work, limited 5 lbs. No significant improvement noted at this time. Continues to ache, throb, limited ROM, pain level from 4-8 on daily basis.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Patient experiencing low grade fever and flu like symptoms - tired, low, energy, aches and pains.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: None, accidently used expired vaccine that expired on 3/29/18.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 52-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included carvedilol, doxycycline, fluconazole, isosorbide mononitrate, lisinopril, omeprazole, COLESTID, PROTONIX and glimepiride. On 13th April 2018 20:08, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site lump (serious criteria disability), injection site pain (serious criteria disability), injection site itching (serious criteria disability), pustule (serious criteria disability), injection site erythema and injection site induration. On an unknown date, the outcome of the injection site lump, injection site pain, injection site itching, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the pustule was recovered/resolved. The reporter considered the injection site lump, injection site pain, injection site itching, pustule, injection site erythema and injection site induration to be almost certainly related to SHINGRIX. Additional information was reported as follows: The pharmacist reported that, the patient came to his pharmacy one night prior to the date of reporting that is on 16th April 2018, with a hard, red lump with 6 inches in diameter on her injection site arm. The area was painful to touch and itchy. The patient stated that, a few days ago she had clear circles in that area that looked like eggs, yellow on the inside and clear on the outside, but that area is was just red at the time of reporting. The symptoms were painful enough that she could not lay on that side and she could not use her arm at full capacity. The patient has had similar reactions to various insulins in the past.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash pustular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 52-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included carvedilol, doxycycline, fluconazole, isosorbide mononitrate, lisinopril, omeprazole, COLESTID, PROTONIX and glimepiride. On 13th April 2018 20:08, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site lump (serious criteria disability), injection site pain (serious criteria disability), injection site itching (serious criteria disability), pustule (serious criteria disability), injection site erythema and injection site induration. On an unknown date, the outcome of the injection site lump, injection site pain, injection site itching, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the pustule was recovered/resolved. The reporter considered the injection site lump, injection site pain, injection site itching, pustule, injection site erythema and injection site induration to be almost certainly related to SHINGRIX. Additional information was reported as follows: The pharmacist reported that, the patient came to his pharmacy one night prior to the date of reporting that is on 16th April 2018, with a hard, red lump with 6 inches in diameter on her injection site arm. The area was painful to touch and itchy. The patient stated that, a few days ago she had clear circles in that area that looked like eggs, yellow on the inside and clear on the outside, but that area is was just red at the time of reporting. The symptoms were painful enough that she could not lay on that side and she could not use her arm at full capacity. The patient has had similar reactions to various insulins in the past.