chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Blister rupture, Erythema, Pain, Scab
Clinical narrative: 6/23/2019 swelling, redness and blister near left eye with small blisters on forehead traveling toward hairline, thought to be spider bite, painful to touch 6/24/2019 swelling subsided, blister crusting over, pain mediated 6/27/2019 large outbreak on chest, bilateral,  pain like insect bite, growing during the day, blisters forming nd breaking, facial scabs completely formed and hardened 6/28/2019 chest outbreak worsening by the hour, blisters forming and breaking, small new breakout on throat, 2 on face, 2 farther up on chest, bilateral 6/29/2019 chest oubreak continuing to worsen, very large and fragile blisters, but pain subsided, other sites unchanged 6/30/2019 chest outbreak large blisters, now some bleeding, pain nearly gone, other sites unchanged
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Skin haemorrhage, Swelling face, Tenderness
Clinical narrative: 6/23/2019 swelling, redness and blister near left eye with small blisters on forehead traveling toward hairline, thought to be spider bite, painful to touch 6/24/2019 swelling subsided, blister crusting over, pain mediated 6/27/2019 large outbreak on chest, bilateral,  pain like insect bite, growing during the day, blisters forming nd breaking, facial scabs completely formed and hardened 6/28/2019 chest outbreak worsening by the hour, blisters forming and breaking, small new breakout on throat, 2 on face, 2 farther up on chest, bilateral 6/29/2019 chest oubreak continuing to worsen, very large and fragile blisters, but pain subsided, other sites unchanged 6/30/2019 chest outbreak large blisters, now some bleeding, pain nearly gone, other sites unchanged
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Fatigue, Injection site pain, Injection site rash
Clinical narrative: 4" rash and soreness at injection site.  Blurred vision, Low Grande fever, Chills, Muscle & Bone Aches. Tiredness.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Vision blurred
Clinical narrative: 4" rash and soreness at injection site.  Blurred vision, Low Grande fever, Chills, Muscle & Bone Aches. Tiredness.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Borrelia test, Chills, Chromaturia, Electrocardiogram normal
Clinical narrative: At approximately 4:30 pm on June 24, 2019, when I stood up, head to toe every single muscle and joint was stiff. I was trying to finish some work on my computer and everything came on all of a sudden. I had an uneasy pain feeling in my head and I struggled through the pain just to get my work finished. I took some Advil for my headache and went to bed right after taking the Advil. As soon as I laid in bed, I started shaking uncontrollably because I felt so cold and my teeth were chattering. I was unable to stop either of these things. And then came the fever which started at 101 degrees F and peaked overnight at 103 degrees F. The next day, June 25, 2019, I woke up and my head was off--it felt very cloudy, I had a super bad headache and the fever continued to go up and down throughout the day. My wife and I went to the walk-in, at the clinic (in the same building as my primary care doctor), and I was seen around 8:30 am. They did bloodwork and mentioned testing my white blood count and checking for Lyme disease. They also did an EKG which came back normal. The doctor called me later to tell me my white blood cell count was fine, and liver and kidney function was also fine. I still have not heard anything back in regards to the Lyme disease testing. The walk-in doctor thought I may have a sinus infection and I was prescribed an antibiotic for that. I didn't think it was a sinus infection, because normally when I get those I have dark nasal discharge and this time I didn't have any. After leaving the walk-in, I went home to rest and I started the antibiotic the walk-in had prescribed. Later that night, I  went to use the bathroom, and my pee was very dark yellow and had a brown plume disperse in it. I also started feeling very itchy all over. I went to bed and battled with a fever again that night. It went to a high of 102 degrees F that night. The next day, June 26, 2019, I stopped the antibiotic because I was still itchy and thought I might be having a reaction to the antibiotic. I took a total of 3 doses of the antibiotic before stopping it. My fever had stopped by this day but I was very sweaty all over my body. The sweatiness lasted all day. My head was still off and felt cloudy. The next day, June 27, 2019, I was feeling much better, but not 100%. I still had a cloudy head but it seemed to be improving. I felt like I was getting my strength back. The following day, June 28, 2019, I was basically back to normal, with only a slight headache. Throughout this whole process, I tried to contact my primary care provider. My wife originally spoke with the on-call doctor, who said they would forward a message to my PCP. To date, we still have not heard anything back from her.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Feeling abnormal, Feeling cold, Headache, Hyperhidrosis, Joint stiffness
Clinical narrative: At approximately 4:30 pm on June 24, 2019, when I stood up, head to toe every single muscle and joint was stiff. I was trying to finish some work on my computer and everything came on all of a sudden. I had an uneasy pain feeling in my head and I struggled through the pain just to get my work finished. I took some Advil for my headache and went to bed right after taking the Advil. As soon as I laid in bed, I started shaking uncontrollably because I felt so cold and my teeth were chattering. I was unable to stop either of these things. And then came the fever which started at 101 degrees F and peaked overnight at 103 degrees F. The next day, June 25, 2019, I woke up and my head was off--it felt very cloudy, I had a super bad headache and the fever continued to go up and down throughout the day. My wife and I went to the walk-in, at the clinic (in the same building as my primary care doctor), and I was seen around 8:30 am. They did bloodwork and mentioned testing my white blood count and checking for Lyme disease. They also did an EKG which came back normal. The doctor called me later to tell me my white blood cell count was fine, and liver and kidney function was also fine. I still have not heard anything back in regards to the Lyme disease testing. The walk-in doctor thought I may have a sinus infection and I was prescribed an antibiotic for that. I didn't think it was a sinus infection, because normally when I get those I have dark nasal discharge and this time I didn't have any. After leaving the walk-in, I went home to rest and I started the antibiotic the walk-in had prescribed. Later that night, I  went to use the bathroom, and my pee was very dark yellow and had a brown plume disperse in it. I also started feeling very itchy all over. I went to bed and battled with a fever again that night. It went to a high of 102 degrees F that night. The next day, June 26, 2019, I stopped the antibiotic because I was still itchy and thought I might be having a reaction to the antibiotic. I took a total of 3 doses of the antibiotic before stopping it. My fever had stopped by this day but I was very sweaty all over my body. The sweatiness lasted all day. My head was still off and felt cloudy. The next day, June 27, 2019, I was feeling much better, but not 100%. I still had a cloudy head but it seemed to be improving. I felt like I was getting my strength back. The following day, June 28, 2019, I was basically back to normal, with only a slight headache. Throughout this whole process, I tried to contact my primary care provider. My wife originally spoke with the on-call doctor, who said they would forward a message to my PCP. To date, we still have not heard anything back from her.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Pruritus generalised, Pyrexia, Renal function test normal, Tremor
Clinical narrative: At approximately 4:30 pm on June 24, 2019, when I stood up, head to toe every single muscle and joint was stiff. I was trying to finish some work on my computer and everything came on all of a sudden. I had an uneasy pain feeling in my head and I struggled through the pain just to get my work finished. I took some Advil for my headache and went to bed right after taking the Advil. As soon as I laid in bed, I started shaking uncontrollably because I felt so cold and my teeth were chattering. I was unable to stop either of these things. And then came the fever which started at 101 degrees F and peaked overnight at 103 degrees F. The next day, June 25, 2019, I woke up and my head was off--it felt very cloudy, I had a super bad headache and the fever continued to go up and down throughout the day. My wife and I went to the walk-in, at the clinic (in the same building as my primary care doctor), and I was seen around 8:30 am. They did bloodwork and mentioned testing my white blood count and checking for Lyme disease. They also did an EKG which came back normal. The doctor called me later to tell me my white blood cell count was fine, and liver and kidney function was also fine. I still have not heard anything back in regards to the Lyme disease testing. The walk-in doctor thought I may have a sinus infection and I was prescribed an antibiotic for that. I didn't think it was a sinus infection, because normally when I get those I have dark nasal discharge and this time I didn't have any. After leaving the walk-in, I went home to rest and I started the antibiotic the walk-in had prescribed. Later that night, I  went to use the bathroom, and my pee was very dark yellow and had a brown plume disperse in it. I also started feeling very itchy all over. I went to bed and battled with a fever again that night. It went to a high of 102 degrees F that night. The next day, June 26, 2019, I stopped the antibiotic because I was still itchy and thought I might be having a reaction to the antibiotic. I took a total of 3 doses of the antibiotic before stopping it. My fever had stopped by this day but I was very sweaty all over my body. The sweatiness lasted all day. My head was still off and felt cloudy. The next day, June 27, 2019, I was feeling much better, but not 100%. I still had a cloudy head but it seemed to be improving. I felt like I was getting my strength back. The following day, June 28, 2019, I was basically back to normal, with only a slight headache. Throughout this whole process, I tried to contact my primary care provider. My wife originally spoke with the on-call doctor, who said they would forward a message to my PCP. To date, we still have not heard anything back from her.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: White blood cell count normal
Clinical narrative: At approximately 4:30 pm on June 24, 2019, when I stood up, head to toe every single muscle and joint was stiff. I was trying to finish some work on my computer and everything came on all of a sudden. I had an uneasy pain feeling in my head and I struggled through the pain just to get my work finished. I took some Advil for my headache and went to bed right after taking the Advil. As soon as I laid in bed, I started shaking uncontrollably because I felt so cold and my teeth were chattering. I was unable to stop either of these things. And then came the fever which started at 101 degrees F and peaked overnight at 103 degrees F. The next day, June 25, 2019, I woke up and my head was off--it felt very cloudy, I had a super bad headache and the fever continued to go up and down throughout the day. My wife and I went to the walk-in, at the clinic (in the same building as my primary care doctor), and I was seen around 8:30 am. They did bloodwork and mentioned testing my white blood count and checking for Lyme disease. They also did an EKG which came back normal. The doctor called me later to tell me my white blood cell count was fine, and liver and kidney function was also fine. I still have not heard anything back in regards to the Lyme disease testing. The walk-in doctor thought I may have a sinus infection and I was prescribed an antibiotic for that. I didn't think it was a sinus infection, because normally when I get those I have dark nasal discharge and this time I didn't have any. After leaving the walk-in, I went home to rest and I started the antibiotic the walk-in had prescribed. Later that night, I  went to use the bathroom, and my pee was very dark yellow and had a brown plume disperse in it. I also started feeling very itchy all over. I went to bed and battled with a fever again that night. It went to a high of 102 degrees F that night. The next day, June 26, 2019, I stopped the antibiotic because I was still itchy and thought I might be having a reaction to the antibiotic. I took a total of 3 doses of the antibiotic before stopping it. My fever had stopped by this day but I was very sweaty all over my body. The sweatiness lasted all day. My head was still off and felt cloudy. The next day, June 27, 2019, I was feeling much better, but not 100%. I still had a cloudy head but it seemed to be improving. I felt like I was getting my strength back. The following day, June 28, 2019, I was basically back to normal, with only a slight headache. Throughout this whole process, I tried to contact my primary care provider. My wife originally spoke with the on-call doctor, who said they would forward a message to my PCP. To date, we still have not heard anything back from her.
Age: 71.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Reported large rash 48 hours after initial immunization on upper right arm ( site of shingrix injection). Site was warm, blotchy red, larger than 5 inches
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arrhythmia, Influenza like illness
Clinical narrative: per patient: experienced arrhythmia s and flu-like symptoms. Pt went to cardiologist but unaware if patient received any treatment there. Patient came in today 6/30/19 to let pharmacy know about the symptoms but he is ok now.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Bronchitis, Butterfly rash, Diarrhoea, Inflammation
Clinical narrative: About 2 hrs after the injection my right deltoid became very hot swollen.painful..itchy.....then the redness and swelling,which was like massive hives ,eventually went all around my upper arm from my shoulder to my elbow,that nightI vomited,had diarrhea,a fever,extreme weakness..I started taking 100 mgm.of benedryl every 6 hours..the next day which was sat.,I was weak,had a fever,my atlrm a mess nauseated, then on Sunday my sinusez started bleeding and I knew that I now,has a sinus infection and bronchitis..I saw my family Doctor on mon...my arm was a bit less inflamed,I showed him pictures of  how it was ,,oooh and my face brokevout in a butterfly rash that took 2 weeks to heal.. I prayed that the Lupus wasn't rearing its ugly head..Dr.  put me on antibiotics for the resp .infections..Thankfully I was recovered in about a week..
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: About 2 hrs after the injection my right deltoid became very hot swollen.painful..itchy.....then the redness and swelling,which was like massive hives ,eventually went all around my upper arm from my shoulder to my elbow,that nightI vomited,had diarrhea,a fever,extreme weakness..I started taking 100 mgm.of benedryl every 6 hours..the next day which was sat.,I was weak,had a fever,my atlrm a mess nauseated, then on Sunday my sinusez started bleeding and I knew that I now,has a sinus infection and bronchitis..I saw my family Doctor on mon...my arm was a bit less inflamed,I showed him pictures of  how it was ,,oooh and my face brokevout in a butterfly rash that took 2 weeks to heal.. I prayed that the Lupus wasn't rearing its ugly head..Dr.  put me on antibiotics for the resp .infections..Thankfully I was recovered in about a week..
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Paranasal sinus haemorrhage, Pyrexia, Respiratory tract infection, Sinusitis
Clinical narrative: About 2 hrs after the injection my right deltoid became very hot swollen.painful..itchy.....then the redness and swelling,which was like massive hives ,eventually went all around my upper arm from my shoulder to my elbow,that nightI vomited,had diarrhea,a fever,extreme weakness..I started taking 100 mgm.of benedryl every 6 hours..the next day which was sat.,I was weak,had a fever,my atlrm a mess nauseated, then on Sunday my sinusez started bleeding and I knew that I now,has a sinus infection and bronchitis..I saw my family Doctor on mon...my arm was a bit less inflamed,I showed him pictures of  how it was ,,oooh and my face brokevout in a butterfly rash that took 2 weeks to heal.. I prayed that the Lupus wasn't rearing its ugly head..Dr.  put me on antibiotics for the resp .infections..Thankfully I was recovered in about a week..
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: About 2 hrs after the injection my right deltoid became very hot swollen.painful..itchy.....then the redness and swelling,which was like massive hives ,eventually went all around my upper arm from my shoulder to my elbow,that nightI vomited,had diarrhea,a fever,extreme weakness..I started taking 100 mgm.of benedryl every 6 hours..the next day which was sat.,I was weak,had a fever,my atlrm a mess nauseated, then on Sunday my sinusez started bleeding and I knew that I now,has a sinus infection and bronchitis..I saw my family Doctor on mon...my arm was a bit less inflamed,I showed him pictures of  how it was ,,oooh and my face brokevout in a butterfly rash that took 2 weeks to heal.. I prayed that the Lupus wasn't rearing its ugly head..Dr.  put me on antibiotics for the resp .infections..Thankfully I was recovered in about a week..
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Hypoaesthesia, Joint range of motion decreased, Paraesthesia
Clinical narrative: alergy to bee venom; melon allergy; back pain; HYPOAESTHESIA; MOBILITY DECREASED; PARAESTHESIA; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act, referring to a 12 year old female patient with chronic mild intermittent asthma. Concomitant therapies included cetirizine hydrochloride(ZYRTEC).     On 18-DEC-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N020353, intramuscular in the right arm for prophylaxis and meningococcal acyw conj vaccine (crm197)(MENVEO) in the right art for prophylaxis. On 22-DEC-2017, the patient experienced numbness and tingling in all four extremities, back pain, reduced range of motion of back. Referred to physical therapy.Currently she was seeing physical therapy weekly. Patient did not report improvements of symptoms(not recovered).  The causality between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Follow up information has been received from a registered nurse on 23-MAY-2019. This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. The patient's concurrent condition included drug allergy to penicillin.  Follow up information has been received from the registered nurse on 06-JUN-2019. On an unknown date, the patiet experienced allergy to melon and allergy to bee venom. On an unknown date in 2019, the patient recovered from of hypoaesthesia and paraesthesia. The outcome of back pain and decreased mobility was reported as improved intermitent(not recovered). At the reporting time, the outcome of allergy to melon and allergy to bee venom was not recovered and no treatment was administered for the aformentioned events. The patient was referred to orthopedic specialist, neurologist and physical therapy. Ordered over-the-counter (OTC) diphenhydramine(BENADRYL) and ibuprofen(MOTRIN).; Sender's Comments:  US-009507513-1906USA011568:
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: My son woke up with swelling and large hives around his injection site. The hives/rash spread and persisted although the swelling was reduced with Benadryl. By day 2 the hives smoothed down, but a red rash covered his thigh and remained there for 3 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Headache, Neck pain, Pain in extremity
Clinical narrative: First three days after shot severe left arm pain and Mild headache, 6/28 severe headache , 6/29 severe headache and mild neck and ear pain on left side, evening - 6/30  phn pain, face, neck (level 10), 7/1 phn pain continues (level 7.)
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: First three days after shot severe left arm pain and Mild headache, 6/28 severe headache , 6/29 severe headache and mild neck and ear pain on left side, evening - 6/30  phn pain, face, neck (level 10), 7/1 phn pain continues (level 7.)
Age: 53.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; a patient, 53 years old, inadvertently received a dose of PROQUAD.; This spontaneous report was received from a nurse referring to a 53 years old male patient. Information about pertinent medical history, concurrent conditions and drug reactions/allergies was not provided. The patient's vaccination history was unknown. The patient's concomitant therapy included sterile diluent.   On 30-MAY-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 milliliter(ml) (lot #S002495 with expiration date 23-JUL-2020; strength was not reported) subcutaneously for prophylaxis (adult use of a child product). No adverse effects was reported. The outcome of the event was unknown. The causality of the event was not provided.
Age: 53.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; the 53 year old patient, was inadvertently administered PROQUAD.; This spontaneous report was received from a nurse referring to a 53 years old patient of unknown gender. Information about pertinent medical history, concurrent conditions and drug reaction/allergy was not provided. The patient's concomitant therapy included sterile diluent.  On 14-JUN-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type rHA (recombinant Human albumin); lot # S003171 with expiration date 30-JUL-2020; strength, dose and route were not reported) for prophylaxis (inappropriate age at vaccine administration). No adverse effects was reported. The outcome of the event was unknown. The causality of the event was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; 1 patient was administered a dose of improperly stored PROQUAD; 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, concomitant medications and drug reactions or allergies was provided.  On 18-JUN-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live(PROQUAD) (lot # S005879 has been verified to be a valid lot number, expiration date was reported as 25-AUG-2020, but upon internal validation established as 18-JUN-2020) (therapy type rHA; dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (lot # N035974 and expiry date 25-AUG-2020). Administered dose of vaccine experienced the temperature excursion 78 degrees Fahrenheit or warmer (79 degrees Fahrenheit) for 60 hours. There were no previous excursions reported. The data logger was not involved. There were no adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions reported; patient received one dose of expired vaccine; This spontaneous report was received from a nurse and refers to a 6-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-JUN-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit not provided), one dose, intramuscularly, lot # R009953, expiration date 12-JUN-2019 (site of administration was not reported) for prophylaxis. Administered hepatitis a vaccine, inactivated (VAQTA) was expired. The administered vaccine had not any temperature excursions. No adverse reactions were reported.
Sex: F
Vaccine: VARCEL
Symptoms: Audiogram, Tinnitus
Clinical narrative: left ear tinnitus; This spontaneous report was received from a Registered Nurse concerning a 43-year-old female patient. The patient's concurrent condition included asthma and hypothyroidism. Her concomitant medication included cholera vaccine (unspecified), and the patient's drug allergies include penicillin and sulfa.  On 12-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported; lot # R034390 and expiration date 27-NOV-2020) as prophylaxis (the patient was planning international traveling).      On 13-JUN-2019, the patient experienced left ear tinnitus (tinnitus). The patient went back to the office and she was examined by the unspecified doctor on the same date. The nurse reported that the patient saw an unspecified Otolaryngologist on an unspecified date and received a dose of prednisone. On an unknown date, the patient had an audiogram (result was not provided).   The outcome and causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX)  and tinnitus was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; administered an improperly stored VARIVAX; This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported.  On 20-JUN-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R018142 and expiration date 25-JUN-2020) (product storage error). The temperature excursion of vaccines was at 15 F to 46F (39) (F degree Fahrenheit) for 19 hours 15 minutes. The Previous temperature excursion was not reported. Data logger was not involved. There was no product quality compliant reported. The patient experienced no adverse event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PROQUAD was inadvertently administered instead of MMR II.; No reported adverse affects.; Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On an unknown date, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(lot # R011803, expiration date: 21-OCT-2019, therapy type: recombinant Human albumin (rHA); strength, dose and frequency were unknown) subcutaneously instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis (wrong vaccine administered). No reported adverse affects. The nurse confirmed that this was "human error".
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: The employee received 2 doses for he M-M-R II vaccine; The patient was tested for serology, which was negative for the measles disease, test was under 25; The employee received 2 doses for he M-M-R II vaccine; This spontaneous report was received from a nurse referring to a non-pregnant 40-year-old female patient. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  The patient received at her place of employment, two doses of the with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N032750 (expiration date: 20-NOV-2019) (additional dosage regimen information was not reported) for prophylaxis on 03-APR-2019 and 01-MAY-2019 respectively.  On 20-JUN-2019, the patient was tested for serology, which resulted negative for measles disease, but positive for the mumps and rubella disease. The serology test was under 25 (units were not specified) for measles immunity.  At the time of the report, the outcome of measles antibody negative was reported as not recovered. No causality assessment was provided.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1906USA011008:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: On 27-JUN-2019 patient is in office to receive second dose of GARDASIL 9.; This spontaneous report was received from a nurse concerning to a 15 year old patient of unknown gender. The patient's historical conditions, concurrent condition and drug reactions/ allergies were not reported.  On 27-JUN-2019, the nurse reported that the patient at the age of 14 year old was vaccinated with 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, lot number and expiration date were not reported) as prohylaxis. On 27-JUN-2019, the patient was vaccinated with the 2 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration was not reported; lot number R005341 and expiration date 06-DEC-2020) (experienced inappropriate schedule of product administration) as prophylaxis. No adverse effects reported.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes  may differs from the expiration date reported by the source.
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Hypoaesthesia, Paraesthesia
Clinical narrative: back pain; HYPOAESTHESIA; PARAESTHESIA; Information has been received from a registerd nurse and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N020353, for prophylaxis(strength, dose, frequancy, lot # and expiration date wete not provided)  On an unknown date, the patient experienced numbness and tingling in all four extremities and back pain. At the reporting time, the outome of the event was unknown.  The causality between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-1808USA004811:
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Spondylitis
Clinical narrative: back spinal arthritis; This case was reported by a consumer via call center representative and described the occurrence of spondylarthritis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced spondylarthritis. On an unknown date, the outcome of the spondylarthritis was unknown.   The reporter considered the spondylarthritis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was not on any medication when had the vaccination. The patient experienced the back spinal facet arthritis, which had not been a problem for three years. The patient assumed that it was because of the vaccination. The patient was hoping it was only temporary.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, 2 hrs after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced flu like symptoms and was wondering how long they would last. The representative answered to the patient that symptoms typically last 2-3 days but might vary from person to person. The representative advised the patient to follow up with their physician
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Malaise, Nausea
Clinical narrative: really sick; nausea; diarrhea; chills; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, nausea, diarrhea and chills. On an unknown date, the outcome of the sickness, nausea, diarrhea and chills were unknown.   It was unknown if the reporter considered the sickness, nausea, diarrhea and chills to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 80 or 81 years old. The patient was really sick with nausea and diarrhea and chills. The patient asked what would happen if do not  take the 2nd shot of vaccine.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Rash
Clinical narrative: striped rash on opposite arm; joint pain; soreness at injection site; tredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2019, the patient received the 2nd dose of Shingrix 50 mcg/mg. In June 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, tiredness and joint pain. On 20th June 2019, the patient experienced rash. On an unknown date, the outcome of the injection site pain, tiredness, joint pain and rash were unknown.   It was unknown if the reporter considered the injection site pain, tiredness, joint pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient stated that after receiving Shingrix experienced soreness at injection site, tredness for 2 and half days, and joint pain. Thursday evening or Friday morning, the patient striped rash on opposite arm. The patient stated that, the daughter at the time of reporting was trying to get pregnant and could possibly be pregnant but she never had chickenpox but she had the immunization for it in 1998. The patient asked was it safe for her to be near her daughter and if not, how long should she stay away.
Age: 74.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Malaise, Nightmare
Clinical narrative: Nightmare; Did not feel right; This case was reported by a pharmacist via call center representative and described the occurrence of nightmare in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date unknown) for prophylaxis.   Co-suspect products included diphtheria toxoid + pertussis toxoid + tetanus toxoid (Adacel) for prophylaxis.   Previously administered products included Antipsychotic.   On 13th June 2019, the patient received Shingrix and Adacel at an unknown dose and frequency. In June 2019, less than a month after receiving Shingrix, the patient experienced nightmare and feeling unwell. On an unknown date, the outcome of the nightmare and feeling unwell were unknown.   It was unknown if the reporter considered the nightmare and feeling unwell to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and Adacel and experienced nightmares, and did not felt right.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Neck pain
Clinical narrative: Neck pain; Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 2Y9R4, expiry date 28th June 2021) for prophylaxis.   On 23rd March 2019, the patient received the 1st dose of Shingrix. On 23rd March 2019, immediately after receiving Shingrix, the patient experienced neck pain and influenza-like symptoms. On 24th March 2019, the outcome of the neck pain was recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the neck pain and influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced neck pain which lasted for 24 hours. The patient also had flu like symptoms which lasted for 4-5 days.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: achy; feverish; arm was killing her; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 17th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a day after receiving Shingrix, the patient experienced pain, fever and pain in arm. On an unknown date, the outcome of the pain, fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the pain, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that a patient was achy, feverish and her arm was killing her after her dose of Shingrix. The patient experienced symptoms within a day after vaccination with Shingrix. The pain, fever and pain in arm was lasted for 3 days after vaccination. The patient reportedly spoke with other women who received Shingrix, dose closer to the two month mark rather than six months experienced a higher rate of symptoms. The reporter did not have information for the other patients mentioned. The reporter consented to follow up. This case has been linked with case US2019AMR113878, reported by same reporter.
Sex: F
Vaccine: HEPA
Symptoms: Therapy non-responder
Clinical narrative: therapy non responder; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 62-year-old female patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Havrix.  Additional details were provided as folows: The patient received the 1st dose of Havrix and her physician told her she had no immunity, thus leading to patient to be therapy non-responder. The patient had not received the booster dose and had no time to get it because she has to travel. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: patient reported swelling and redness at injection site which started almost immediately..she also reported headache and fatigue for the first 3 days. She no longer has the headache or fatigue (today the day she reported) but continues to have the redness and swelling which she called to confirm was normal to still be experiencing.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: patient reported swelling and redness at injection site which started almost immediately..she also reported headache and fatigue for the first 3 days. She no longer has the headache or fatigue (today the day she reported) but continues to have the redness and swelling which she called to confirm was normal to still be experiencing.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Echocardiogram normal, Electrocardiogram normal, Insomnia, Nuclear magnetic resonance imaging normal
Clinical narrative: 09-11-18 pharmacy, first Shingrix injection. Within a couple of days I began having pain at level 3 on scale of 1-10 with 10 being worst. I did not connect the pain to the injection at that time. 02-08-19 pharmacy, 2nd Shingrix injection. The next day my pain was up to level 6. 05-02-19 Dr OV for pain. 05-02-19 Medical Center for Echocardiogram, was normal. Electrocardiogram was normal. 05-09-19 Imaging for CT, was normal. 05-17-19 Dr for pain now level 8. 05-30-19 Imaging for MRI, pain now level 10. I was not able to lay down for MRI. 06-01-19 Stand Up MRI, I had to drive 90 miles to have MRI, was normal. 06-04-19 Neurological, Dr. He referred me to Rehabilitation Services for physical therapy. 06-12-19, 06-17-19, 06-19-19 Rehab. For physical therapy. 06-17-19 Dr for pain, continuing at level 10. He advised that condition could continue for a few weeks or for a very long time. Prescribed Gabapentin 300 mg, 1 three times daily. This medicine has brought my pain level down to a 6 and I am still unable to lay on my back. I have to sleep sitting in a recliner.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 09-11-18 pharmacy, first Shingrix injection. Within a couple of days I began having pain at level 3 on scale of 1-10 with 10 being worst. I did not connect the pain to the injection at that time. 02-08-19 pharmacy, 2nd Shingrix injection. The next day my pain was up to level 6. 05-02-19 Dr OV for pain. 05-02-19 Medical Center for Echocardiogram, was normal. Electrocardiogram was normal. 05-09-19 Imaging for CT, was normal. 05-17-19 Dr for pain now level 8. 05-30-19 Imaging for MRI, pain now level 10. I was not able to lay down for MRI. 06-01-19 Stand Up MRI, I had to drive 90 miles to have MRI, was normal. 06-04-19 Neurological, Dr. He referred me to Rehabilitation Services for physical therapy. 06-12-19, 06-17-19, 06-19-19 Rehab. For physical therapy. 06-17-19 Dr for pain, continuing at level 10. He advised that condition could continue for a few weeks or for a very long time. Prescribed Gabapentin 300 mg, 1 three times daily. This medicine has brought my pain level down to a 6 and I am still unable to lay on my back. I have to sleep sitting in a recliner.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Decreased appetite, Erythema
Clinical narrative: The morning after (6/28) my 6/27 injection, I felt fine until about 10 a.m., when I started feeling extremely fatigued. My left upper arm was also sore, but I expected that. By noon I was having trouble sitting up because of fatigue. By 1 p.m., I ended my work day early because I was no longer able to sit up from fatigue. I was having stomach pains (not quite the same pains as from Gastroparesis or IBS) and nausea. I went to bed with cold chills. I slept a few hours. By 6 p.m. I was still freezing (it was 78 in the house) so I stayed in bed, but I was feeling better. I did not eat anything but a piece of toast, and went back to bed. I remained cold until about 1 a.m. (1 a.m. on 6/29) when I woke drenched in sweat, horribly nauseated, with a horrible headache. My body was bright red. My temperature was 101. I showered to cool off, took Ibuprofen, dressed in dry clothes, and returned to bed with an ice pack for my head. I fell back asleep. When I woke again at 7 a.m., the fever had broke and though I still felt tired, I felt "over it" and I was hungry. My left upper arm is still (mildly) sore today - 7/1 - and I expected that.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Hyperhidrosis, Impaired work ability
Clinical narrative: The morning after (6/28) my 6/27 injection, I felt fine until about 10 a.m., when I started feeling extremely fatigued. My left upper arm was also sore, but I expected that. By noon I was having trouble sitting up because of fatigue. By 1 p.m., I ended my work day early because I was no longer able to sit up from fatigue. I was having stomach pains (not quite the same pains as from Gastroparesis or IBS) and nausea. I went to bed with cold chills. I slept a few hours. By 6 p.m. I was still freezing (it was 78 in the house) so I stayed in bed, but I was feeling better. I did not eat anything but a piece of toast, and went back to bed. I remained cold until about 1 a.m. (1 a.m. on 6/29) when I woke drenched in sweat, horribly nauseated, with a horrible headache. My body was bright red. My temperature was 101. I showered to cool off, took Ibuprofen, dressed in dry clothes, and returned to bed with an ice pack for my head. I fell back asleep. When I woke again at 7 a.m., the fever had broke and though I still felt tired, I felt "over it" and I was hungry. My left upper arm is still (mildly) sore today - 7/1 - and I expected that.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: The morning after (6/28) my 6/27 injection, I felt fine until about 10 a.m., when I started feeling extremely fatigued. My left upper arm was also sore, but I expected that. By noon I was having trouble sitting up because of fatigue. By 1 p.m., I ended my work day early because I was no longer able to sit up from fatigue. I was having stomach pains (not quite the same pains as from Gastroparesis or IBS) and nausea. I went to bed with cold chills. I slept a few hours. By 6 p.m. I was still freezing (it was 78 in the house) so I stayed in bed, but I was feeling better. I did not eat anything but a piece of toast, and went back to bed. I remained cold until about 1 a.m. (1 a.m. on 6/29) when I woke drenched in sweat, horribly nauseated, with a horrible headache. My body was bright red. My temperature was 101. I showered to cool off, took Ibuprofen, dressed in dry clothes, and returned to bed with an ice pack for my head. I fell back asleep. When I woke again at 7 a.m., the fever had broke and though I still felt tired, I felt "over it" and I was hungry. My left upper arm is still (mildly) sore today - 7/1 - and I expected that.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Infection, Malaise, Peripheral swelling
Clinical narrative: Patient stated she had a headache, fever, chills, swollen arm the day of the vaccine.  The next day she felt very sick went to the Dr and the Dr stated she had an infection and prescribed an antibiotic.