chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Influenza like illness, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer and refers to her nephew, an approximately 16 year old male patient. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unspecified date approximately in 2017 (reported as "last year"), the patient was vaccinated with the first dose of GARDASIL 9 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). After that, on an unknown date, the patient experienced flu-like symptoms. Then, also on an unknown date, the patient received the second dose of GARDASIL 9 Injection, for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). After that dose, he experienced fever of 103 F. The patient sought medical attention. According to the reporter, the patient and his parents decided to refuse the administration of the third dose of GARDASIL 9. The outcome of the events was reported as recovered on unknown dates. The reporter did not provide the causal relationship between the events and vaccination with GARDASIL 9. This is one of several reports coming from the same source. Sender's Comments: US-009507513-1807USA011111.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 31 year old female patient. The patient's concomitant medications included labetalol and her concurrent conditions included high blood pressure. The patient had not known drug allergies or drug reactions. On 17-MAY-2018, the patient was vaccinated with (Oka/Merck) VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine was reconstituted with MERCK STERILE DILUENT (lot number and expiration date were not reported). On approximately 24-MAY-2018, reported as "1 to 2 weeks post-vaccination", the patient found to have conceived a child. The patient sought medical attention but treatment was not given. The gestational age at the time of reporting was 6 weeks and two days; consequently the last menstrual period (LMP) was on 04-JUN-2018, the estimated date of conception was on 18-JUN-2018, the estimated date of delivery (EDD) was on 11-MAR-2019.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report was received from a registered nurse and refers to an unspecified patients of an unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. Since 17-JUL-2018, also reported as "beginning 17-JUL-2018", the patients were administered an unspecified number of doses of improperly stored Oka/Merck VARIVAX lot # M046005 with an expiration date 05-NOV-2018 (also reported as 18-NOV-2018) (dose, route of administration and anatomical location were not reported) for prophylaxis, STERILE DILUENT (doses, route of administration and anatomical location, lot# and expiration date were not reported) for prophylaxis or and Oka-Merck) PROQUAD N014759 with an expiration date 30-NOV-2018 (also reported as 08-NOV-2018) (albumin status was not reported) (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse effects were reported. Administered doses of medicines experienced the temperature excursion form 15 degrees Fahrenheit to 46 degrees Fahrenheit (25.2) for 14 hours. There was no previous temperature excursion. A digital data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. On 24-JUL-2018, the patient was vaccinated with an expired dose of M-M-R II (dose, route and anatomical location were not provided) (lot # N001490, expiration date: 12-JUL-2018) for prophylaxis. The physician reported that the sterile diluent used to reconstitute the M-M-R II was not expired. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On 29-JAN-2018, the patient was vaccinated with a first dose of VAQTA (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecidies date in February 2018, (reported as "one month after the initial dose"), the patient was vaccinated with a second dose of VAQTA injection, 25U/0.5ML PED PF SYR CARTON OF 6, 00006409509, lot number N005605 with expiration date on 08-APR-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a consumer, referring to her daughter, a 20 year old, non-pregnant female patient. Concurrent conditions, medical history, historical or concomitant drugs were not reported. On an unspecified date in 2009 (reported as "at age 12"), the patient was vaccinated with a dose of GARDASIL Injection, for prophylaxis (strength, dose number, dose, route, anatomical location, lot # and expiration date were not reported). The reporter informed that on an unspecified date in July 2017, the patient underwent a pap smear test and the result was abnormal. The patient sought medical attention. The outcome of this event and its relationship with GARDASIL were not provided by the reporter. This is one of several reports coming from the same source. Sender's Comments: US-009507513-1807USA007802.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Injection site erythema
Clinical narrative: I received my 2nd (booster) shot of Zoster Vaccine (RZV) on 7/24/2018 at approx. 6:00pm by the pharmacist. By the next day (Wednesday), my entire arm was sore with redness at the injection site. By evening of 7/25/2018, I had fever, chills, achiness, headache, joint pain, nausea, and could barely move without feeling dizzy. My fever spiked to 102.3. I drank mostly water throughout the night. By morning, my fever was gone and I am feeling much better. My arm is still a little sore with redness at the injection site. I did not have this reaction with the first dose, only the 2nd dose. I've never had such a reaction to vaccines before. It lasted about 24 hours and now is mostly subsided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: I received my 2nd (booster) shot of Zoster Vaccine (RZV) on 7/24/2018 at approx. 6:00pm by the pharmacist. By the next day (Wednesday), my entire arm was sore with redness at the injection site. By evening of 7/25/2018, I had fever, chills, achiness, headache, joint pain, nausea, and could barely move without feeling dizzy. My fever spiked to 102.3. I drank mostly water throughout the night. By morning, my fever was gone and I am feeling much better. My arm is still a little sore with redness at the injection site. I did not have this reaction with the first dose, only the 2nd dose. I've never had such a reaction to vaccines before. It lasted about 24 hours and now is mostly subsided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Injection site pruritus, Urticaria
Clinical narrative: Hives/welp left axilla with burning, itching at site, flu like symptoms.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: I had the chicken pox shot and it was okay that day the next day it was red and puffy. It was sore and warm well today the redness has gotten bigger.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: Left Arm Pain Fever sweating chills Dizzy Fainted in bathroom. Dehydrated Called 911. At 530am in morning Wanted me to go to hospital said I was feeling better they said to rest and follow up with your doctor which I did 930am that morning took ADVIL and TYLENOL.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope, Urine analysis normal
Clinical narrative: Left Arm Pain Fever sweating chills Dizzy Fainted in bathroom. Dehydrated Called 911. At 530am in morning Wanted me to go to hospital said I was feeling better they said to rest and follow up with your doctor which I did 930am that morning took ADVIL and TYLENOL.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle rigidity, Pallor, Syncope
Clinical narrative: 15-30 seconds after administration of GARDASIL the patient had a syncopal episode lasting approximately 15 seconds, during this time noted rigid extremities and pale in color. Patient monitored for one hour post reaction and normal procedures were followed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Presyncope
Clinical narrative: Vaccine administered per Doctor order. After administration of vaccine pt was laid down supine and shortly after dad called out for help. Pt seemed to be having a vasovagal episode and recovered mins after. Vitals obtained and within normal range. PCP and Nurse at bedside entire time. PCP referred pt to cardiology to have further testing done
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Discomfort, Injection site pain, Insomnia
Clinical narrative: During vaccine administration did not feel needle. At night, arm was really hurting and then pain in stomach started. The pain in the stomach was not in one area but covered a large area of abdomen. The discomfort was such that couldn't fall sleep. Pain at site of injection continued and lasted about 3 more days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: During vaccine administration did not feel needle. At night, arm was really hurting and then pain in stomach started. The pain in the stomach was not in one area but covered a large area of abdomen. The discomfort was such that couldn't fall sleep. Pain at site of injection continued and lasted about 3 more days.
Sex: U
Vaccine: HPV9, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N030987), expiration date on 15-MAY-2019 (dose, frequency, route of administration not reported) or with improperly stored GARDASIL 9 (lot N020353 with expiration date on 28-APR-2020) or (lot N021572 with expiration date on 01-MAY-2020) or (lot N022728 with expiration date on 31-MAY-2020) (dose, frequency, route of administration not reported) for prophylaxis. It was stated that the vaccine PNEUMOVAX 23 underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours 8 minutes; no previous temperature excursion was performed. It was stated that the vaccines GARDASIL 9 underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours 16 minutes with previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 56 hours 38 minutes. No adverse effects were reported. This is a non-valid case due to lack of patient identifier.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. Concomitant therapies included sterile diluent. On unknown dates between 23-MAY-2018 and 28-JUN-2018, the patients were vaccinated with improperly stored doses of PROQUAD lot # N028444, expiration date: 09-APR-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 2.5 hours. Data logger was involved. There was a previous excursion of 15 to 46 degrees Fahrenheit for 3 hours.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Occupational exposure to product
Clinical narrative: This spontaneous report was received from a nurse, who is also the patient: a female of unknown age. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 10-JUL-2018, during the process of withdrawing VARIVAX (lot # N034553, expiry date: 05-DEC-2019, for prophylaxis) from vial into syringe, it just sprayed like an aerosol can all over the nurse's hands, arms and the counter top, and very little liquid went into the syringe. There was no adverse event reported. Product quality complaint was involved.
Age: 1.08
Sex: F
Vaccine: HEP, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant refers to a 13 month old female patient. The patient's concurrent condition included dacryostenosis congenital, otitis media, viral upper respiratory tract infection. The patient had no medical history and no known drug allergies. The patient's concomitant medications included PEDVAXHIB and oral probiotics. On 05-MAR-2018, the patient was vaccinated with 3rd dose of RECOMBIVAX HB (dose, units and frequency not reported) (lot # M029233 and expiration date: 09-AUG-2018) which was improperly stored. On 13-OCT-2017, RECOMBIVAX HB had temperature excursion due to power outage. Alert has been sent and all vaccines transported to hospital for continued storage and returned after temperatures were verified to be in range. The administered dose of RECOMBIVAX HB was stored at a temperature from 9 degree Celsius (9 C) to 25 C (also reported as 10.7 C) for 1 hour 8 minutes as recorded by digital data logger. The administered RECOMBIVAX HB had previous temperature excursion from 9 C to 25 C for 2 hours and 17 minutes. No product quality complaint and no adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # R003534, expiration date 3108-2019 for prophylaxis. The vaccine underwent a temperature excursion of 0 to 1 degrees Celsius (or above) for 12 hours. There was no previous temperature excursion. The digital data logger was involved.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Myalgia, Nausea
Clinical narrative: Recombinant Zoster: Significant muscle pain, headache, shivering, stomach pain, nausea. This was my second dose. Symptoms were more severe than for first dose. In bed most of July 25, day after injection. Much better July 26.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: She experienced fever of 100 degrees Fahrenheit and chills the entire night after the SHINGRIX shot. She took TYLENOL and the symptoms resolved the next day. She felt much better after the symptoms stopped and she is doing fine now.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Shivering, achiness started during the night after my injection. Still achy the following morning.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Haemoglobin decreased, Hypotonia, Platelet count decreased, Presyncope
Clinical narrative: After shot we walked to cashier to checkout and schedule 2nd shot. After scheduling patient became limp. I grabbed her and yelled she was fainting. They placed her in a chair. She would not answer when I called her name and asked if she was ok. I asked if they could get her orange juice, there was none. I finally said are you going check her blood pressure. Her pressure on arrival was 120/80. At this time it was 90/50. Her heart rate was in the 50s. Finally she came around I had her drink some Sprite and eat a few Oreos the cashier gave her. They took her back to exam room. She threw up in the garbage can in exam room. They finally got the Dr who came in, laid her down and raised her legs. She proceeded to instruct staff to hold her legs up because she had a vagal response. She also said she remembered how she passed out while getting blood drawn in college. I said she didn't pass out from a blood draw she passed out from that shot. She left room and never returned. The staff checked her blood pressure a few times until her top number came up to 109. Staff member said she is not to get second shot, I agreed. We left the office. We were got given any instructions. I was very nervous watching her. I gave her BENADRYL. I was not satisfied that she was still drowsy. I decided to take her to the ER that evening to be evaluated. They drew blood work and she ended up being admitted to Hospital and received 3 bags of blood. Her hemoglobin and platelets were very low. She is now following up with a pediatric hematologist.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Somnolence, Syncope, Transfusion, Unresponsive to stimuli, Vomiting
Clinical narrative: After shot we walked to cashier to checkout and schedule 2nd shot. After scheduling patient became limp. I grabbed her and yelled she was fainting. They placed her in a chair. She would not answer when I called her name and asked if she was ok. I asked if they could get her orange juice, there was none. I finally said are you going check her blood pressure. Her pressure on arrival was 120/80. At this time it was 90/50. Her heart rate was in the 50s. Finally she came around I had her drink some Sprite and eat a few Oreos the cashier gave her. They took her back to exam room. She threw up in the garbage can in exam room. They finally got the Dr who came in, laid her down and raised her legs. She proceeded to instruct staff to hold her legs up because she had a vagal response. She also said she remembered how she passed out while getting blood drawn in college. I said she didn't pass out from a blood draw she passed out from that shot. She left room and never returned. The staff checked her blood pressure a few times until her top number came up to 109. Staff member said she is not to get second shot, I agreed. We left the office. We were got given any instructions. I was very nervous watching her. I gave her BENADRYL. I was not satisfied that she was still drowsy. I decided to take her to the ER that evening to be evaluated. They drew blood work and she ended up being admitted to Hospital and received 3 bags of blood. Her hemoglobin and platelets were very low. She is now following up with a pediatric hematologist.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: HIVES AND SWELLING OF THROAT.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema
Clinical narrative: Vaccine given on 7/24/18 - redness noticed that night. Increased redness during the day 7-25-18 and went to ER. Placed on KEFLEX.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Headache, Insomnia, Pruritus, Rash
Clinical narrative: Headaches and sleeplessness about 3 days after injection. Back began itching with bumps which turned to some dime size hives on nable, legs, back and private parts also buttocks. Never had this before. Left chest pain, for past 2 wks.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Headaches and sleeplessness about 3 days after injection. Back began itching with bumps which turned to some dime size hives on nable, legs, back and private parts also buttocks. Never had this before. Left chest pain, for past 2 wks.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Mom called day after vaccines given to report redness/pain-advised cold compresses, TYLENOL/MOTRIN, BENADRYL-walking fine but redness extends from hip and knee (left leg) pt came in 7/20/18 per mom area improving but still present. Parent feels like it's an adverse reaction to the HIB. Advised MOTRIN, cool pads if unable to walk or worse come back to the office. Parent ask that we report this.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Cough, Eye swelling, Injection site swelling, Irritability
Clinical narrative: 10 min. after administration patient developed anaphylaxis rash, swelling of eyes, lips and site of injection, cough, wheezing and irritability. Received Epinephrine, BENADRYL and Dexamethasone. Was taken by ambulance to ER.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Lip swelling, Rash, Wheezing
Clinical narrative: 10 min. after administration patient developed anaphylaxis rash, swelling of eyes, lips and site of injection, cough, wheezing and irritability. Received Epinephrine, BENADRYL and Dexamethasone. Was taken by ambulance to ER.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Immediate post-injection reaction, Insomnia, Pain
Clinical narrative: TRUMENBA vaccine given on 6/26/18. Felt sore right after administered which progressed to deep sharp pain. Patient states unable to sleep that night. Took ADVIL with no improvement with pain of arm. Notices slight swelling and no redness, seen in office 6/29/18 pain and soreness slightly better but not completely resolved.
Age: 86.0
Sex: M
Vaccine: TD
Symptoms: Dyspnoea, Oxygen saturation decreased, Wheezing
Clinical narrative: Within 6-7 mins. after T-D booster - pt. became very dyspneic, wheezing and desatted to low 90's - was given (1) injection of Adult EPI-PEN with prompt resolution. Transferred to ER - remained stable and was D/C'd to home.
Age: 2.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Urticaria
Clinical narrative: Follow up on 7/18/2018 for urticarial rash given Hydroxyzine Hydrochloride.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Confusional state, Loss of consciousness, Tremor
Clinical narrative: Patient passed out for several seconds, shaking and felt confused. He was examined by Dr. and started feeling better.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Erythema, Nausea, Pain, Pain in extremity
Clinical narrative: SWELLING, HOTNESS, REDNESS/PURPLE, NAUSEOUSNESS, PAIN, SORENESS ON ARM AND UNDER PITS.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: SWELLING, HOTNESS, REDNESS/PURPLE, NAUSEOUSNESS, PAIN, SORENESS ON ARM AND UNDER PITS.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Papule
Clinical narrative: More than 24 hour after receiving the Hepatitis B vaccine, he started experiencing papules on scalp. Non itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient is complaining of right thigh pain. He had swelling of his left thigh yesterday. Today he has a red area smaller than a dime, and some swelling. Patient's mother states patient feels hot, and has chills.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Decreased appetite, Dizziness, Ear pain, Headache, Oropharyngeal pain
Clinical narrative: The next day after HPV vaccination, the patient reported headache, dizziness, loss of appetite and throat pain. The symptoms persisted. 4 days later parents took to an express care. 6 days later seen by me for new symptoms of earache and facial swelling. The earache was felt to be attributable to allergies, but discussed the symptoms he reported after vaccination could be side effects of the vaccine.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Streptococcus test, Swelling face
Clinical narrative: The next day after HPV vaccination, the patient reported headache, dizziness, loss of appetite and throat pain. The symptoms persisted. 4 days later parents took to an express care. 6 days later seen by me for new symptoms of earache and facial swelling. The earache was felt to be attributable to allergies, but discussed the symptoms he reported after vaccination could be side effects of the vaccine.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Papule
Clinical narrative: Papules on head.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Acupuncture, Injected limb mobility decreased, Injection site pain, Insomnia, Nuclear magnetic resonance imaging
Clinical narrative: QUAD FLU VAC GIVEN AT PRIMARY DR OFC. Thought the next week soreness would be expected, then became unbearable stab like pain where injection was given, I was unable to lift my arm above chest level, unable to sleep with severe pain. I got an appointment with out of network ortho doc thru recommendation to avoid any type of cover up. It a few weeks to get in with him. On 11/22 had xrays, exam and steroid inj. into the same site was performed. He had suspected SIRVA at that time. I had about 10 14 day relief. The pain came back with a vengeance. Saw him again 12/14/17. PE another injection and Rx for PT. Did 6 months of PT hitting plateau, though got most of range of motion back, I still have pain. I did do 5 acupuncture visits to help with the pain from 3/23/18 to 5/11/18. It did give some relief. Pt told me to have follow up with Dr. MRI was performed, and follow up with him was done 7/11/18. He told me to report this to CDC as I still have pain. I have also spent a lot of $ with all co-pays.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder injury related to vaccine administration, X-ray
Clinical narrative: QUAD FLU VAC GIVEN AT PRIMARY DR OFC. Thought the next week soreness would be expected, then became unbearable stab like pain where injection was given, I was unable to lift my arm above chest level, unable to sleep with severe pain. I got an appointment with out of network ortho doc thru recommendation to avoid any type of cover up. It a few weeks to get in with him. On 11/22 had xrays, exam and steroid inj. into the same site was performed. He had suspected SIRVA at that time. I had about 10 14 day relief. The pain came back with a vengeance. Saw him again 12/14/17. PE another injection and Rx for PT. Did 6 months of PT hitting plateau, though got most of range of motion back, I still have pain. I did do 5 acupuncture visits to help with the pain from 3/23/18 to 5/11/18. It did give some relief. Pt told me to have follow up with Dr. MRI was performed, and follow up with him was done 7/11/18. He told me to report this to CDC as I still have pain. I have also spent a lot of $ with all co-pays.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Decreased appetite, Dysstasia
Clinical narrative: Arm at injection site starting hurting a bit then by nighttime hurt a a lot and whole body hurt a lot. Could barely stand up and walk. Chills-felt cold in 82 degree room. Stomach pain. Headache, achy joint pain. No appetite. This morning feel a like a severe hangover.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Gait disturbance, Hangover, Headache, Injection site pain
Clinical narrative: Arm at injection site starting hurting a bit then by nighttime hurt a a lot and whole body hurt a lot. Could barely stand up and walk. Chills-felt cold in 82 degree room. Stomach pain. Headache, achy joint pain. No appetite. This morning feel a like a severe hangover.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Arm at injection site starting hurting a bit then by nighttime hurt a a lot and whole body hurt a lot. Could barely stand up and walk. Chills-felt cold in 82 degree room. Stomach pain. Headache, achy joint pain. No appetite. This morning feel a like a severe hangover.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediately upon administration of the Varicella and PENTACEL (left thigh), there was swelling and redness at the injection sites and surrounding circumference. The same occurred on the right thigh with the administration of the MMR and PREVNAR.
Age: 24.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Gave Ped dose instead of adult dose.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Injection site swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Urticaria over face, chest, arms, legs back, extreme pruritus, facial swelling, right thigh swelling that developed rapidly over the morning of her reaction, on the day after her visit. Treatment included BENADRYL, DECADRON 4mg oral, greater than 1 hour observation in office until improving, followed by a 1mg/kg bid prednisolone course for 5 days. Subsequent allergist testing revealed the previously unknown allergies and she will receive subsequent MMR under observation at the allergist's office.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On 28-JUN-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, route of administration, vaccination site, lot# and expiration date were not reported) for prophylaxis. No adverse effects were reported. Product Quality Complaint (PQC) was not involved.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-JUL-2018, at wellness visit, the patient was inadvertently vaccinated with 2 doses of (wistar ra 27-3) M-M-R II injection, lot # N025891, expiration date 19-SEP-2019 (exact dose, route of administration and anatomical localization were not reported), which were reconstituted with sterile diluent, lot # M040413, expiration date 25-MAY-2019. No adverse effects were reported. Lot number N025891 has been verified to be a valid lot number for (wistar ra 27-3) M-M-R II.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 16-JUL-2018, the patient was vaccinated with properly stored but expired dose of Oka-Merck PROQUAD lot # N001489, expiration date 12-JUL-2018 (strength, site of administration and route of administration were not reported) for prophylaxis. No adverse events were reported.
Age: 0.42
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 5 month old male patient. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 20-JUL-2018, the patient was inadvertently administered at an unspecified medical practice a dose of GARDASIL 9 (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of eye swelling in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 3 days after receiving SHINGRIX, the patient experienced eye swelling and erythema. On an unknown date, the outcome of the eye swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the eye swelling and erythema to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The health care professional (HCP) stated that his patient received a dose of SHINGRIX 3 days ago from the date of reporting and experienced swelling under her eye and redness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 56-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. Concurrent medical conditions included latex allergy. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced facial swelling. SHINGRIX was discontinued. On an unknown date, the outcome of the facial swelling was recovered/resolved. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported an adverse event on behalf of the patient. At the time of reporting, the patient was approaching the date for the 2nd dose of SHINGRIX. The patient had dramatic swelling of face without rash or blotchiness. The swelling lasted for 3 to 4 days and then decreased to its normal state. The patient had decided not to get the 2nd dose of SHINGRIX. The reporter did not aware of any hospital visits in association to this event nor did he know how soon the swelling started after receiving the dose. The consent was provided for contacting the patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX. In February 2018, several days after receiving SHINGRIX, the patient experienced generalized pruritus, headache, pain in arm and fatigue. In February 2018, the outcome of the generalized pruritus, headache, pain in arm and fatigue were recovered/resolved. It was unknown if the reporter considered the generalized pruritus, headache, pain in arm and fatigue to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in unknown arm. The patient reported that she experienced itching all over her body that started several days after receiving SHINGRIX vaccine. It lasted for about two days. The 1st night itching was pretty bad, the next day it was better. The patient also experienced pain in the arm where she received SHINGRIX vaccine. It started that same night and it lasted about two days. The patient experienced fatigue and headache started on the day after receiving the SHINGRIX vaccine. The symptoms went away on the following day. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site erythema, Muscle tightness, Nausea
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of dizziness in a female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced dizziness, muscle tightness, chills, injection site erythema, nausea and fever. The patient was treated with ibuprofen and Epsom Salt. On an unknown date, the outcome of the dizziness, muscle tightness, chills, injection site erythema and nausea were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the dizziness, muscle tightness, chills, injection site erythema, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she has redness at the injection site. On the day of vaccination (Monday) at night, the patient started getting dizziness, nausea, fever, chills, and muscle tightness. The patient took a bath in Epsom salt and took some ibuprofen, and was finally able to sleep at 4 am. On the next of vaccination (Tuesday), the patient woke up feeling better, but than she started feeling worse again. The patient took her temperature and which was recorded as 100.2 degrees F. The patient took another bath of Epsom salt and ibuprofen, and her fever has finally broken. No further details were left on the after hours voice message.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of dizziness in a female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced dizziness, muscle tightness, chills, injection site erythema, nausea and fever. The patient was treated with ibuprofen and Epsom Salt. On an unknown date, the outcome of the dizziness, muscle tightness, chills, injection site erythema and nausea were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the dizziness, muscle tightness, chills, injection site erythema, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she has redness at the injection site. On the day of vaccination (Monday) at night, the patient started getting dizziness, nausea, fever, chills, and muscle tightness. The patient took a bath in Epsom salt and took some ibuprofen, and was finally able to sleep at 4 am. On the next of vaccination (Tuesday), the patient woke up feeling better, but than she started feeling worse again. The patient took her temperature and which was recorded as 100.2 degrees F. The patient took another bath of Epsom salt and ibuprofen, and her fever has finally broken. No further details were left on the after hours voice message.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Feeling hot, Peripheral swelling, Seizure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a 68-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 14 days after receiving SHINGRIX, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), confusion (serious criteria hospitalization), swelling arm and feeling hot. On an unknown date, the outcome of the seizure, confusion, swelling arm and feeling hot were recovered/resolved. It was unknown if the reporter considered the seizure, confusion, swelling arm and feeling hot to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The pharmacist reported that the patient experienced swelling in the left arm. The patient was hospitalized for confusion and seizure.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 52-year-old female patient who received SHINGRIX (batch number 75GJ5, expiry date 2nd February 2021) for prophylaxis. Concomitant products included Amoxicillin. On 17th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 17th July 2018, 3 hrs after receiving SHINGRIX, the patient experienced muscle pain (serious criteria disability). On 18th July 2018, the patient experienced fatigue (serious criteria disability) and general body pain (serious criteria disability). On an unknown date, the outcome of the muscle pain, fatigue and general body pain were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, fatigue and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to VAERS by the pharmacy. The patient received SHINGRIX vaccine on right arm. The pharmacist reported that the patient had to take the next day off of work because of the muscle pain, fatigue and full body pain.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Frustration tolerance decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 2nd dose of SHINGRIX. On 4th July 2018, 2 days after receiving SHINGRIX, the patient experienced injection site pain, shoulder pain, wrist pain and frustration. The patient was treated with codeine and TYLENOL. On an unknown date, the outcome of the injection site pain, shoulder pain and wrist pain were recovered/resolved and the outcome of the frustration was unknown. It was unknown if the reporter considered the injection site pain, shoulder pain, wrist pain and frustration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown arm on Monday and on Wednesday began to experience arm pain in the injection arm around the site and from her elbow up over her shoulder. At the time of reporting, it had been 10 days and the pain was also spread down to her wrist and had retained intensity for the full 10 days. The patient went to see her physician on Thursday 5th July 2018 and was prescribed TYLENOL 3 with Codeine which had had very little effectiveness in masking the pain, failing to even make the pain tolerable. The arm was not sensitive to touch but rather felt like it was being pulled from its socket. At several points, specifically the wrist, elbow and upper back or scapula, the patient had pain that felt like a knife stabbing deep into that particular area. Just letting gravity pulls her arm down caused pain and was best when she held her arm above her head. There was nothing the patient had done over the last two weeks that could have caused any muscle or tendon injuries to her left arm. This was very frustrating and it had been excruciatingly painful. The reporter was writing to GSK as manufacturer of SHINGRIX in hope that they might help her physician and figure out how to address and alleviate that pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Fatigue, Feeling abnormal, Hallucination, Mental disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist (father of the patient). A 17-year-old female patient received the first dose of TRUMENBA at single dose on 13Jul2018 for immunization. Concomitant products included doxycycline since 09Jul2018 and ongoing at 100mg once a day by mouth for acne and minocycline in Jun2018 at 100mg once a day by mouth for acne, for one month. On 14Jul2018 the patient experienced fever up to 103°F that resolved on 15Jul2018, on 15Jul2018 the patient experienced weakness, she can't stay awake for long, only wakes up to eat and goes back to bed, fatigue, she had mental issues "says she doesn't feel real", hallucination and she was very weird. The patient was treated for the fever with TYLENOL 500mg and Ibuprofen 600mg alternately. The outcome of the events weakness, somnolence and hallucination was reported as not recovered, the outcome of the other events was unknown. The events weakness, somnolence and hallucination were considered serious. Information on the batch 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: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Somnolence
Clinical narrative: This is a spontaneous report from a contactable pharmacist (father of the patient). A 17-year-old female patient received the first dose of TRUMENBA at single dose on 13Jul2018 for immunization. Concomitant products included doxycycline since 09Jul2018 and ongoing at 100mg once a day by mouth for acne and minocycline in Jun2018 at 100mg once a day by mouth for acne, for one month. On 14Jul2018 the patient experienced fever up to 103°F that resolved on 15Jul2018, on 15Jul2018 the patient experienced weakness, she can't stay awake for long, only wakes up to eat and goes back to bed, fatigue, she had mental issues "says she doesn't feel real", hallucination and she was very weird. The patient was treated for the fever with TYLENOL 500mg and Ibuprofen 600mg alternately. The outcome of the events weakness, somnolence and hallucination was reported as not recovered, the outcome of the other events was unknown. The events weakness, somnolence and hallucination were considered serious. Information on the batch 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.