chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Negative titers; therapy non-responder; Drug dose administration interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis b antibody negative in a 42-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 22nd February 2005, the patient received the 1st dose of Engerix B. On 22nd March 2005, the patient received the 2nd dose of Engerix B. On 17th September 2005, the patient received the 3rd dose of Engerix B. On an unknown date, less than a year after receiving Engerix B, Engerix B and Engerix B, the patient experienced hepatitis b antibody negative, therapy non-responder and drug dose administration interval too long. On an unknown date, the outcome of the hepatitis b antibody negative, therapy non-responder and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the hepatitis b antibody negative and therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The batch number and expiry date was unknown. The reporter stated that, the patient received full series of Hepatitis B vaccine(unsure of manufacturer) and experienced hepatitis b antibody negative and therapy non-responder. The patient received 3rd dose late than the recommended schedule, which led to lengthening of vaccination schedule. The patient stated that, he was tested within a year following the series completion because of a change in insurance. The patient received another full series in 2009 with 1st dose on 14 January 2009, 2nd dose 14 February 2009 and 3rd dose 10 July 2009 and titer came back positive. The reporter consented to follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 19-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K006681, expiration date: 21-OCT-2015) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. Additional information has been requested.
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, sometimes ago, the patient was vaccinated with ZOSTAVAX (19400 PFU) (dose, route and frequency were not reported). On an unknown date, the patient experienced rash. It was reported that the patient did not develop rash immediately after vaccination with ZOSTAVAX (19400 PFU). The physician reported that on an unknown date, the rash was painful. The patient sought medical attention and visited the office. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
This spontaneous report as received from a physician refers to a 11 year old patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 21-AUG-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M040412 with expiration date on 30-JUN-2019 (dose and route of administration were not reported). Since 19-MAY-2017, the administered dose of GARDASIL 9 underwent multiple temperature excursions between 33 degrees Fahrenheit and 50 degrees Fahrenheit, which lasted for 16, 40, 46 or 70 hours. A digital data logger was not involved in recording the excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
Some viral type thing or bad cold; sore throat; congested; cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Some viral type thing or bad cold), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and COUGH (cough) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (had lung cancer and only has one lung).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Some viral type thing or bad cold), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and COUGH (cough). At the time of the report, NASOPHARYNGITIS (Some viral type thing or bad cold), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (congested) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        The patient was appointment for the second shot on Friday 26Mar2021.  No concomitant medication details were provided. The patient has been taking antihistamines.
Tested positive for COVID-19 on 08/06/2021 after receiving 2 doses of the Pfizer vaccine at Hospital on  Dec 30, 2020 and Jan 20, 2021
10/27/07 Got shingles vaccine to prevent getting them.  March 6, 2008 had to go to the doctor "medical center" for shingles again.  The doctor gave me a prescription for Valtrex 500 mg.  I had to pay $200 for the shingle vaccine - my insurance would not cover this.  Should I get a booster shot or is there any help for me with this problem (shingles)?
pt legs both had small amount of swelling on noc of 27JUL98 & had low temp;29JUL98 had fever of 103.6A @ 630AM & went to MD later in AM;no fever there but had 1-2cm raised area on leg;also rt ear pink;given ATB;30JUL98 broke out in rash;
Information has been received from a medical assistant concerning a 21 month old male, with unknown medical history and unknown drug reactions/allergies, who on an unspecified date was vaccinated (route unknown) with a dose of Varivax (Lot # unknown). Subsequently, "recently" on an unspecified date, the patient developed a "moderate" rash which may be chickenpox or hives. The patient's present status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pain in their hands; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in their hands) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in their hands). At the time of the report, PAIN IN EXTREMITY (Pain in their hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported
Presented with n/v, near syncope, cough; + Covid in ED; Admit 9/18 to  medical with Covid infection, hypoxia; tx with steroids, merrem, Vit C, Symbicort, Vit D3, heparin (sq), singulair, zinc (all started 9/18); O2 @ 2 LPM on admission; remains on O2 @ 2 LPM at d/c
Cellulitis of right upper extremity given Triamcinolone Acetonide 0.1% cream.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 10-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K021935, expiration date 10-NOV-2016, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
6 months pregnant, due December 2021. Experienced dizziness, nausea, vomiting, loss of balance, needed help walking.
Right arm joints swollen and painful from shoulder to hand, hot to touch and unable to raise right arm above head.
I received the DTaP a week before the MMR immunization. Before these immunizations I could say Mama, Dada, "dawbry dink", "I wuv u" whilst looking at my family and spending time snuggling and playing with them. Within a week after the MMR immunization, I became a blank slate. I looked only at the ground and never spoke to people other than to echo what they would say. We believe I developed encephalitis from these vaccines. I needed years of therapy to improve my speech.
On 06/26/2022 I took a test that was positive. My nose was running and I was sneezing. I called the doctor and he prescribed PAXLOVID and picked it up and started taking it on Monday, 06/27/2022. I never got sicker beyond being extremely tired and sneezing and runny nose. I coughed a little but didn't seem like much of anything.
I developed leg pain in my right leg 2 weeks after vaccination. A week later, I went to the hospital and they confirmed  "Acute deep vein thrombosis) DVT of calf muscle vein of right lower extremity" and at least one additional superficial clot. I was prescribed blood thinners apixaban (Eliquis) and was discharged.   I'd previously had a clot in the same leg in 2009.
Lack of Response - Information has been received from a pharmacist concerning a patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Subsequently the patient failed to sero convert.  The patient was them administered a blooster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation and still had no titers.  Additional information has been requested.
On April 10, 2021 out of 4? x 4? rash on my upper left arm where the shot was given was a very warm and tender.  First day I took some Tylenol and kept ice on it still there on the morning of the 11th put antibacterial cream on it still red and warm.  tomorrow morning I am going to the walk-in clinic to find out if I have an infection.
The Fluad HD NDC 70461-0123-03-  Patient is 60 years old and the patient recieved the flu vaccine for 65 year old plus.
I experienced tightness in my chest and my doctor (messaged her on 01/12/2021). She scheduled a video visit with her on the same day and I sent her a message. A telephone call was placed on 01/13/2021 to her and I was asked to come in so she could administered a COVID-19 and strep throat tests. She informed me that I experienced an adverse event from the vaccine. I received a prescription for antibiotics and I felt better.
Hives from scalp all over body to in between toes. Per allergist request, started with up to 4 cetirizine a day to prevent itching. After two days, hives were worse and itching more so started on prednisone 40mg for 5 days and famotidine 20mg twice daily. Over the course of a week after the hives started, they started to go away but then would show up randomly all over body again and continued to itch.
pt recvd Recombivax HB on 5NOV92 approx 2 wks later on 19NOV pt noticed raised red wheals over trunk & extremities w/itching; rash idsappeared that day 24 hrs but reappeared on 22NOV same pattern & character;
No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No relevant concomitant medications were reported.  Dose was administered on 01-Dec-2022 from lot number 021H22A, best use by date of 26-Nov-2022. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-685141 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685141:Samer Reporter
9-25-11 at 1920 I received the flu shot (R) upper arm. At 1945 while driving, became tachycardic & short of breath. All symptoms resolved within 90 seconds. No symptoms since.
states it feels like a "gas pocket"; nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout; she was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 02Oct2021, outcome "recovered" (Oct2021), described as "nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout"; PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (Oct2021), described as "she was sore"; FEELING ABNORMAL (non-serious), outcome "recovered" (Oct2021), described as "states it feels like a "gas pocket"". Therapeutic measures were taken as a result of feeling abnormal.  Additional Information: Caller states she received the Pfizer COVID-19 vaccine last Wednesday and on Thursday she was sore. On Saturday, she started having a nagging pain on the left side under her rib cage, feels like she pulled something, just like after a workout. She has had the pain since then , and states it feels like a "gas pocket". She has put a waist trainer belt.  She does not have fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, chills Narrative:  1/7 received the vaccine. 1/8 woke up with chills, body aches, and headache. Symptoms lasted until 1/9/21.
administered Kinrix Prevnar, & Varivax on right arm on 10/7/08; Pain, swelling, induration, edema at injection site beginning about 4 hours post-injection; patient also complained of mild itching; the swelling & erythema increased along the right arm, peaking at the time the patient returned for f/u on 10/10/08 at 12pm.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL/HCTZ, start date: 03Jun2019; AMLODIPINE BESYLATE, start date: 03Jun2019, stop date: 03Jun2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022 at 19:00, outcome "not recovered" and all described as "I tested negative on 27Apr2022 and began to feel symptoms again late on 02May2022. I tested positive for the second time on 03May2021 with a home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2021) positive, notes: I tested positive with a home test; (27Apr2022) Negative. Therapeutic measures were not taken as a result of vaccination failure, Covid-19.
PLAN Acute respiratory failure with hypoxia COVID-19 pneumonia: - symptom onset: 10/06 - (+) COVID: 10/21 - fully vaccinated - CTA chest: No PE.  Bilateral pneumonia, likely COVID.  Chronic changes of sarcoidosis - started on decadron.  Continue for 10 day course - Begin remdesivir. - if continues to have fever or worsening symptoms begin antibiotics for superimposed bacterial pneumonia - supportive measures, prone positioning - daily labs   Sarcoidosis OSA on CPAP: - continue symbicort - continue combivent - on chronic steroids--hold for now while on decadron. - CPAP at HS   Hyperlipidemia: - statin   DVT prophylaxis: lovenox sq Code Status:  Full code   History obtained from patient, ED physician/records, and personally reviewed past medical records.   History of Present Illness Patient is a 63 y.o. male who presents today with fatigue and shortness of breath.  Patient has a history of sarcoidosis, OSA on CPAP, Hyperlipidemia.  Per patient, about a week ago he began having fatigue, chills, shortness of breath and cough.  It became much worse about 3-4 days ago and he thought that it was improving, however, he started having severe fatigue and shortness of breath and cough over the last 24-48 hours.  He has had fever, chills, body aches.  He has had diarrhea which is now seeming to improve, however, he has not been eating very much and trying to stay hydrated.  He is fully vaccinated against COVID.  He does not have any known sick contacts, however, he does have children who work in retail and feels he may have gotten something from 1 of them.   In ED, patient was hypothermic in ED and placed on Bear Hugger.  Temperatures improved.  Found to be hypoxic to low 80s.  Placed on HFNC.  COVID positive.  CTA chest shows covid pneumonia.  Started on decadron
Lump in  (left side) of neck.  I felt fine. Felt lump in neck at 4:30pm Friday May 7,2021. It was about the size of an almond. Over the next 5+ hours it grew.  Went to the ER 10:30pm.   EKG , CT scan, blood work. Discharged 6:30am May8, 2021.
After my first injection from County Public Health, I started swelling and feeling very hot around my injection site. The next morning I woke up with a bright red raised rash on my upper chest, my injection site was still red and swollen, as well as my lymph nodes under my arm.  The rash lasted for about 4-5 days, along with my swelling around vaccine site.  The lymph node swelling lasted longer.  Also had a headache, which dissipated to some degree over a period of days.
Patient was given IMZ for Covid on 5/28/2021 and came into pharmacy today 6/7/21 to report adverse reaction starting 6 hours after injection with head falling to table while sitting at table in her home and right side of head hitting table.  Patient reports "burning inside" and running into items into her home since that moment and and continuing up until the current day.  Patient also stated "Look at my leg."  Patient states there were no related symptoms of such before IMZ and symptoms have not improved.   It was recommended that the patient seek immediate medical attention and the patient acknowledged,  agreed and left the pharmacy to seek treatment.
pt c/o redness & burning to face & chest, rash noted to chest, no c/o itching, red watery eyes, no c/o problems breathing;has had same type of rxn w/niacin in post;pt took DPH;
Information has been received from a physician concerning an 18 months old patient of unknown gender. Information about concomitant medications, medical history and drug reactions was not provided. On 05-NOV-2018 (reported as three days ago), the patient received one dose of GARDASIL 9 (lot #, expiration date and route were not provided) for prophylaxis instead of PREVNAR 13 (wrong product administered and product administered to patient of inappropriate age). No adverse effects were reported.
Pt. called our office on 5.23.18 stating her arm was hot and had a lump, also had a headache, joint pain and general aches. Pt. states she will not be getting the 2nd dose.
Loss of milestones and change in behavior x 1 day. Self resolved. Mother describing that child would not eat, drink, talk, walk or crawl. Would just stand there and do nothing. Did not describe any staring or anything to suggest seizure activity. Rash in genitalia and backs of legs x 1 day. Hive like, as described by mother. Also fever x 3 days. Tmax 104 but mostly low grade. At time of visit, mother stating that fever still present but behavior was starting to return to normal. Mainly tried to reassure mother, but she was very upset and wanting report of vaccine event documented
States she never "felt well" after receiving vaccine but at approx 1 week, on 7/11/07, she was complaining of severe joint pain that was debilitating enough that she could not work, mild rash, fever at night, fever blister on lip, fatigue.  She was seen in our ED on 7/12/07 and advised to remain home and rest for 1 week.
COVID-19 TEST POSITIVE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1805022 expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000188783.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Patient received the vaccine on 5/31/2023. She came to the pharmacy on 6/5/2023 with swollen arm. She said it was painful, itchy and tingling. She was prescribed hydroxyzine 10 mg at bedtime on 6/5/2023. She then developed a fever of 101 degrees  on 6/5/2023. She was prescribed doxycycline mono 100 mg capsules twice a day for 7 days.
41 yr/o female  covid vaccinee this AM First dose of pfizer Medication and food allergy, but no vaccinee Throat tight, hot, scratchy Tingling sensation No swelling sensation No rash, itching No dyspnea, wheezing Got benadryl 50mg IM Mild improvement
8-10APR excessive sleepiness, diarrhea, pale; 11-15APR pt recvd blood transfusions for profound anemia-hemoglobin 2.8, hematacrit 8.1; 15-19APR blood transfusions dx-autoimmun hemalytic anemia;
Varicella -like rash developed 7 days after vaccine. 8 papul-vesicular lesion, malaise, T99.8, cough, loose stool.