chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient did not get full dose; the needle was faulty and some vaccine leaked out while; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 56-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5277j, expiry date 12th November 2023) for prophylaxis.   On 8th November 2021, the patient received the 1st dose of Boostrix. On 8th November 2021, unknown after receiving Boostrix, the patient experienced incomplete dose administered and needle leak. On an unknown date, the outcome of the incomplete dose administered and needle leak were unknown.  Additional details provided were as follows: The health care professional reported that, Boostrix was administered to the patient and the needle was faulty and some vaccine leaked out while administering and patient did not get full dose which lead to incomplete dose administered. No Product complaint was filed. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary.
Fever, arthralgia probably hallucinations presented to ER on 5/17/13 at 9:23am and discharged at 11:10 am. Patient was given 400 mg MOTRIN po and TYLENOL 640 mg po. Stable and improved on discharge.
This spontaneous report was received from an other reporter via a company representative refers to a female patient of unknown age (reported as in her 30's) with cervix carcinoma (several times). On an unknown date, when the patient was 30 years old, she was vaccinated with GARDASIL 9 (concentration, dose, frequency, lot #, expiration date and indication were not reported) directly into her cervix (incorrect route of drug administration). It was reported, that after the patient received GARDASIL 9 this way, she had not cervical cancer again (pre-existing condition improved). The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not provided.
Patient received PREVNAR 13 on 4-16-13. TC from patient this pm (5-2-13) reporting he has had vomiting since 4-17-13. He is able to keep water down. Also now reports laryngitis.
joint pain, hardness, redness & itching @ the inject site, red streaks on arm, arm pain, & feeling feverish are reported in a pt receiving fluogen 25OCT93; pt exp redness & itchiness @ the inject site on the day of vax;
Pt received vaccination around 2 pm. Later in the day, she began to experience dizziness. In addition, she is experiencing numbness on the left side of her mouth and upper left arm. Since yesterday, the dizziness has decreased, but is still present. Pt has been able to do normal activities of daily living, including laundry and other things around house.
Pt came in to urgent care with redness swelling and rash on the left thigh, where a tdap and hep a vaccine were given at a recent well child visit.
Redness, itching, hot to touch around injection site area- md diagnosis: localized cellulitis.
malaise, weakness, fatigue, anorexia, tingling in both legs; tingling subsided 11FEB;
p/ pt recv vax approx 1yr later pt devel chickenpox all over the body, treated w/benadryl for itching
Mother states child started having fever the evening of 8/2/2011. Pt. was "whining and not eating". Vomited x 1. Developed red rash (raised) all over body. Fever up to 101 degrees. Fever 99.3 today in clinic. Red, raised rash present over body. Pt. seen by Dr. Pt in no distress.
Lower back pain; could not walk; This non-serious case was reported by a consumer via call center representative and described the occurrence of low back pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included osteoporosis. Concomitant products included pitavastatin calcium (Livalo) and risedronate.   In JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced low back pain (Verbatim: Lower back pain) and unable to walk (Verbatim: could not walk).  The patient was treated with non-drug therapy (Physical Therapy). The outcome of the low back pain was not resolved and the outcome of the unable to walk was resolved.   It was unknown if the reporter considered the low back pain and unable to walk to be related to Shingrix.     It was unknown if the company considered the low back pain and unable to walk to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR138069   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter reported that the patient received Shingrix vaccine and within 3 weeks of receiving the vaccine she experienced lower back pain and could not walk and after going to physical therapy, it got better in April 2023. The reporter stated that although she can still feel it if she was not cautious. Patient had no further information available about this vaccine, no lot number, expiry date route of administration, or location of administration. This US2023AMR138069 case has been linked to the case reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR138069:same patient, 2nd dose US-GSK-US2023AMR138069:same patient, 1st dose
2 days post vaccination parents noted an increase in eczematous patches behind knees inner thigh abdomen across hip. 3 days post vaccine noted cheeks & eyelids affected which have never been affected with eczema in past. Mom describes eczema as "intense". Eczema has been manageable for the past 6 months. No other symptoms are present.
Pt recvd 3 doses of Engerix-B on 8DEC90 & 12JAN91 & 15JUN91 & exp no adverse reactions; 3-4 months later HBSAB was neg p/completing the series; recvd booster dose 6NOV91 still had neg antibodies; 7JAN92 titer to be rechecked;
Hives/rash (red raised dots that later became itchy) on ears, face, arms, and thighs Extremely red ears and face Low grade fever Fatigue Pain at injection site
tested positive for Covid-19 5days afterward; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19 5days afterward) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19 5days afterward) (seriousness criterion hospitalization). The patient was hospitalized on 29-Dec-2020 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19 5days afterward) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included Remdesivir; Sender's Comments: This case concerns a 48-year-old female hospitalized with a serious unexpected event of SARS-CoV-2 test positive. Event onset 6 days after first dose mRNA-1273. Treated with Remdesivir. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient states she developed chills with achiness all over within 48 hrs. of receiving vaccine. Patient also developed redness and swelling at the injection site on left deltoid. Patient seen on 4/14/14 and left arm still red from shoulder to elbow, slightly raised rash. Patient denied pain and not hot to touch.
Arm was just sore a little bit; 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 41-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Aug2021 (Lot number: FC3182) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Arm was just sore a little bit".  Additional information: Received first dose of Pfizer COVID vaccine on 25Aug2021. After the first dose he was fine, states his arm was just sore a little bit.   No follow-up attempts are possible. No further information is expected.
pt recv vax 3AUG98 & 1hr later exp repetitive contractions on lt side of hand & leg which developed into a full blown focal sz on lt side of child body;the sz lasted 5min;
The patent describes heavy sweating, body aches, fever, and sore throat, plus 1 day of chest pain earlier in the week.
She continued to have swelling in her knees due to this tear; In OCT2022, she tore her meniscus while exercising; This spontaneous case was reported by a consumer and describes the occurrence of MENISCUS INJURY (In OCT2022, she tore her meniscus while exercising) and JOINT SWELLING (She continued to have swelling in her knees due to this tear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 939905, 037A21B and 042L20A) for COVID-19 prophylaxis.     Patient did not have previous diagnosis of COVID-19.  Concurrent medical conditions included Allergic sinusitis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced MENISCUS INJURY (In OCT2022, she tore her meniscus while exercising). On an unknown date, the patient experienced JOINT SWELLING (She continued to have swelling in her knees due to this tear). On 06-May-2023, JOINT SWELLING (She continued to have swelling in her knees due to this tear) had resolved. At the time of the report, MENISCUS INJURY (In OCT2022, she tore her meniscus while exercising) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  In OCT2022, patient tore her meniscus while exercising. Patient did not have to get surgery for it but continued to swelling in her knees due to this tear.  However, patient noticed on Saturday morning (6MAY2023), that her knee was no longer feeling uncomfortable and there was no swelling anymore.   Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2023-723494 (Patient Link).
improperly stored vaccine administered; No adverse effect; This spontaneous report was received from a medical assistant regarding unspecified patients of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date (also reported as on multiple unspecified dates), the patients were vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (Strength, dose, frequency and anatomical location were not reported) intramuscularly of lot # R016791 with an expiry date of 16-APR-2020 for prophylaxis and hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (Strength, dose, frequency and anatomical location were not reported) intramuscularly of lot # R007212 with an expiry date of 04-NOV-2020 for prophylaxis (Product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 1.4 Celsius (C) for a time frame of 10 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  Follow-up information was received from a office manager on 01-NOV-2019. A call was placed to the medical assistant, but the pharmacist was no longer worked in the office. The phone was then transferred to the office manager who stated that there was no new information concerning the report and additionally there were no patient identifiers.  This is a non-valid case due to lack of patient identifiers.
Narrative: COVID infection after completion of COVID vaccine series: 01/18/2021 COVID vaccine dose #1 02/08/2021 COVID vaccine dose #2 07/11/2021 Pt reported onset of myalgia, congestion, rhinorrhea, productive cough (green sputum), and fever 07/15/2021 Pt presented to ED c/o above sx 07/15/2021 COVID positive per agency nasopharyngeal swab 07/16/2021 Pt reported onset of chills, fatigue, and HA. Continuation of other sx. 07/17/2021 Pt reported onset of loss of sense of taste/smell 07/18/2021 Pt reported improvement  of cough with use of OTC med 07/19/2021 Pt reported most symptoms mild in  nature and usually worst in the morning 07/21/2021 Pt dc'd from daily telephone contact since completed agency self-isolation criteria
After receiving the flu vaccine, felt tachycardic, SOB, and sense of not feeling well, no localized reaction to injection site; she went to emergency room within 5 hours of taking vaccine, no abnormal findings; took Benadryl over the weekend.
spotting; irregular period; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the arm left on 26Mar2021 at 17:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included beta thalassemia. Concomitant medication included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC D). The patient did not have any allergies to medications, food, or other products. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 05Mar2021 at 17:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021, the patient experienced spotting and irregular period. The patient did not have any prior history of irregularity. The patient did not receive any treatment for the event.  The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events spotting, irregular period was not recovered.   No follow-up attempts are needed. No further information is expected.
mom stated pt started to cry p/vax given then for 1 wk inconsolable crying, not self, alert, no lethargic, no eating, fussy, wouldn't smile;
Information has been received from a certified medical assistant concerning a 64 year old female with hypertension who on 31-MAY-2007 was vaccinated IM in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 655289/0958F).  Concomitant therapy included ATENOLOL MF, glucosamine, calcium (unspecified) and vitamins (unspecified).  On 10-JUN-2007 the patient developed redness, itching, warmth, soreness and a raised 1 1/2 by 1 1/4 inch around the injections site of the left deltoid muscle.  The physician prescribed cold compress, TYLENOL and BENADRYL.  On 01-JUN-2007 symptoms were improving.  Additional information has been requested.
sore arm (left arm)/At the injection site; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (himself and his wife). This report is for himself. A 75 (unit unknown) male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 14Jan2021 at single dose in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer on 14Jan2021. On 11Feb2021, he was scheduled for the next vaccine which was more than the 21 days. (place name) was only administering the Moderna vaccine, but he received the Pfizer vaccine, which was fine, but he had the appointment scheduled for the second dose according to the Moderna vaccine time frame. He wanted to know need to have that appointment changed. On 14Jan2021, the patient experienced a sore arm (L ARM) an hour after vaccination he felt the soreness, it lasted maybe less than a day. At the injection site, but it was no biggie. The patient asked what was the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine and if she can receive it earlier or later than 3 weeks. The outcome of event was resolved in Jan2021.  Information on the batch/lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021059580 same reporter/drug/event, different patients
Pt. stated he felt dizzy. Pt placed in recumbent position, observed, vitals taken.  Pt. returned home to with mom.
rash on arm and across chest, numbness and tingling on L side of face and numbness of L fingers on side of covid shot x 3-4 days , blurry vision x 2 weeks light sensitivity   2nd shot  rash on arm and pain/ hot to touch, numbness and tingling on L side of face and numbness of L fingers/hand ongoing to date
CHILLS, TEMP 99.6, SWOLLEN, TENDER LYMPH NODES UNDER ARM OF INJECTION SITE, NOT FEELING WELL ALL OVER; HIGHEST TEMP = 101.3
fatigue, slight shortness of breathe for couple hours, especially if i went for a walk,  sore arm that got worse a day after shot then started to subside 36 hours after shot.
Information has been received from a certified medical assistant concerning a 12 month old male with no pertinent medical history and no drug reactions/allergies, who on 30-JAN-2008 was vaccinatedin the right arm SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot number: 659342/1517U). Concomitant vaccinations subcutaneous dose in the left arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and PREVNAR vaccine (CRM197). On 25-FEB-2008 the patient experienced chickenpox. The lesions began on 25-FEB-2008 and became worse on 26-FEB-2008. The patient did not present with a fever and was given diphenhydramine hydrochloride (BENADRYL) for symptomatic relief. No further information was available. There were no lab diagnostic studies performed. Unspecified medical attention was sought,  the patient was seen by the physician. On unspecified date, the patient had recovered. There was no product quality complaint. Further information is not expected.
Approx 5 minutes after receiving Tdap and Flu shot. Pt walked out of exam room, then reported not feeling well. Sat down in waiting room, became minimally responsive, slowly answering question. Hypotensive, EMS Called taken to hospital and later discharged home. Pt described feeling of burning 5 minutes after injection throughout entire body.
Swollen left thigh with rash, not itchy. Consistent with varicella vaccine site.
My back started really bothering me to a point where it kept getting worse and now got a rx for PT. Lower back. I have had issues with  my back in the past...when I run or from a weight lift injury so I haven't run since 2019 and walk instead. I also do much lighter hand weights. I have been fine since 2019 but after covid booster my back started hurting more and more. I was fine with the first two shots . I did ask my dr if I was crazy connecting the two and she said no because she is seeing this more and more, My husband too has issue with his shoulder and was told that the shot does aggravate things that were issues in the past .. So my past issue from years ago is my back and not the covid booster aggravated my issue and I now have to pay $35 twice a week for PT to get better and to take away from my day. This is sucky and I thought you need to know.
flu symptoms followed by leg weakness, suspicious for guillain-barre syndrome.  11/09/09 ED records received service date 11/3/09. Assessment: Post vaccination leg weakness but not consistent with Guillain-Barrie at this time. Patient has had flu symptoms for one week. Developed myalgias and arthralgias which seemed to resolve, but has been having shaky tremulous legs since that time.
Resident received Pfizer BiValent Booster on 2.15.2023. On 2.16.2023 resident had fever of 103.8 F resulting in febrile seizure and transported to ER via EMS.
Redness and swelling at injection site - 14 x 5 cm induration. Rx: MEDROL 4 mg. Dose pak.
This spontaneous report was received from a registered nurse concerning a 25 year old female patient with chronic idiopathic purpura disorder, drug reaction/allergy to aspirin and sulfa. The patient's medical history included stroke. On 26-JAN-2015, the patient was vaccinated with the first dose of GARDASIL (dose number not reported), lot # K009482, expiration date 06-MAR-2017, 0.5 ml, intramuscular. Co-suspect and concomitant therapies were not reported. The registered nurse reported that on 28-JAN-2015, the patient called to report pain at the injection site. The nurse practitioner advised patient to take an unspecified dose of BENADRYL. The registered nurse reported that on 29-JAN-2015, she/he examined the patient and found a small swollen, red area at the site of injection and found a palpable, swollen, left subclavicular lymph node. The patient also reported pain at the site of injection and tenderness around the left clavicular area. The nurse practitioner advised patient to take an unspecified dose of TYLENOL. At the time of the report the outcome of the events were reported as unknown. The patient seeks medical attention with the registered nurse. No diagnostics lab tests were performed. Additional information has been requested.
Started with soreness and redness at injection site and progressed to neck pain (like a pulled muscle) that has persisted to this day
Itching/hives throughout body that started approx 24 hours after receiving vaccine. Also developed lip swelling, eyelid swelling, hand swelling. No shortness of breath. Pt did not seek care. Took Benadryl and symptoms gradually improved over the next 5 days. Has had similar reactions to medications in the past. Denied any other new exposures.
Few hrs p/having shot pt devel fever, tiredness, cough, & vomiting; Taken to ER & treated w/DPH & ASA; 12 hrs later rash developed around inject site;
Patient complains of easy bruising since receiving his Covid 19 vaccine.  Was into the clinic to establish care and reports this.  Labs taken and noted platelet count of 25.  He states that he has not had any prior issues with this that he is aware of.